Train the Trainer for FDA Regulated Industries

Train the Trainer Guide Book:

For FDA Regulated Companies

compiled and edited by

MITCHELL W. MANNING Sr.

Updated August 3, 1994And again on June 2, 2015

Why: To share the training legacy of a gifted, talented, and motivated team from all disciplines and levels in the best company in the best of times for the pharmaceutical industry dedicated to the mission to qualify each employee to contribute to the work of ensuring the identity, strength, purity, and quality of all their pharmaceutical products.

How To Use: As Needed

Table of Contents

On The Job Train the Trainer Course

Example: Training Action Plans

Example: Training Customer Survey

Example: The Huge Curve Ball

Example: Training Tasks and Projects after the Curve Ball

Example: Training Statistics

Example: Training Action Plans

Example: Technical Training and Qualification Procedure

Example: Training, Testing, and Follow-up Procedure

Example: CGMP Training Procedure

Example: Qualification and Requalification of Employees Procedure

Example: Administration of Operating and Administration Procedures

Example: Writing Operating and Administration Procedures

Example: Training Records and Information Administration Procedures

Example: Training Attendance Documentation Form

Example: Job Description for Training

Example: Training Duties and Responsibilities by Job Title

Example: Status Update Report for Training

Procedures Analysis Handbook

ON-THE-JOB-TRAINING AND ASSESSING TECHNIQUES

DAY ONE

8:00 a.m. Course Introduction, Agenda/Logistics, Participant Introductions, Course Objectives

Defining On-The-Job-Training and Assessing Techniques

What we know about Adult Learning Theory

Why and How Adults Learn

10:00 a.m. Break

10:20 a.m. Characteristics of On-The-Job-Training

11:00 a.m. Developing Training Plan and Materials

12:00 a.m. Lunch

1:00 p.m. Developing Training Materials (continued)

Conducting On-The-Job Training

2:00 p.m. OJT Practice Training

4:00 p.m. Adjourn

DAY TWO

8:00 a.m. OJT Practice Training

12:00 p.m. Lunch

1:00 p.m. OJT Practice Training

2:00 p.m. Next Steps

3:00 p.m Adjourn

OJT COURSE OBJECTIVES

ON-THE-JOB TRAINING AND ASSESSING TECHNIQUES

A workshop for subject matter experts (SMEs) to enhance their ability to transfer their understanding of job responsibilities to other people.

PURPOSE

To improve the training effectiveness of subject matter experts in one-to-one or small group training settings by providing logical and systematic training techniques and skills .

LEARNING OUTCOMES

Understand and apply adult learning principles

Distinguish between knowledge and skill (education vs. training)

Develop systematic teaching methods for OJT

Develop training plans

Develop a working model for OJT

Apply procedures to actual hands-on skills

ADVANTAGES of OJT

Provides consistent methods of procedure training and retraining of skills

Aids the employee in "Getting it right the first time"

Aids in time management, and productivity of work force ultimately leading to customer satisfaction

Aids in the continuous improvement and feedback process

Aids in setting of performance standards and criteria for job tasks

Develops training expertise among those closest to the work to be performed

OJT DESIGN PROCESS

Identify Job

Analyze job

Identify critical job responsibilities

Identify required knowledge, skills and abilities.

Identify education, training and experience needs

Select potential job performer

Determine training and practice needs

Identify Subject Matter Expert(s)

Design instruction

Develop training plan

Prepare Subject Matter Expert(s) to teach and assess

Document SME qualifications

Deliver training

Evaluate results

Document and file results

OJT LEARNING PROCESS

Motivate by showing relevancy to job success

Transfer Understanding

Evaluate for understanding

Involve in a Practical application

Provide feedback

Involve on the job

Show results on the job

INFLUENCING LEARNING

Comfort

Confidence

Competence

Credibility

Commitment

PRACTICE

Describe things that you can do to influence learning for each of the "5 c's."

TRANSFER UNDERSTANDING

Awareness

Belief

Comprehend

Do

SYSTEMATIC TEACH FOR OJT

What Provide the overview of the job responsibility

A short statement of the job responsibility to be coveredList the equipment and procedures in sequenceIdentify the education, training and experience requiredIdentify the knowledge, skills and abilities required

Why Provide the motivation

A short statement of the value of the job responsibility

How Provide the content knowledge

Prepare the traineePresent the trainingReinforce the training

Example Provide a demonstration

Short and specificEasily understood

Test For Understanding

Complementary CritiqueLevels of CompetenceTest and teach to competence-Relate this to another job responsibility-Identify the importance of this responsibility-Analyze the impact of good and bad performance

Application Involve trainee on-the-job

Short review of what, why and howDo it normal, Do it slow, Do it together, Then let'em goFirst time assessment on-the-job

Transition

Quick review what and whyExplain assessment and agree on follow-upSet target date for qualification and documentation

ON-THE-JOB TRAINING

a Skill, e.g., operating a piece of equipment

an Art e.g., playing the piano or guitar

the knowledge and ability to apply a procedure or process, e.g., filling out a check requisition form

PRACTICE

Give examples from work (eg. Voice Mail, Computer Log-on)

EDUCATION VS. OJT

Education focuses on the instructor; OJT focuses on the trainee.

Educational testing measures the student; OJT tests measure program effectiveness, the trainer and the trainee.

Education accepts distribution of learning; OJT requires all trainees to do well.

Education is intended to serve the student; OJT is intended to serve the organization.

The student is responsible for learning in Education; the trainer/subject matter expert is responsible with OJT.

With education learning is the solution to a myriad of problems; OJT is sometimes only a partial solution.

With education there is a belief that learning is always good; sometimes OJT can be harmful

HOW ADULTS LEARN

Involvement

Success at Learning

Big Picture

Task Structure

WHY ADULTS LEARN

Desire for Reward

Fear of Punishment

Curiosity

ADVANTAGES OF OJT

Time

Less Interference With Operations

Actual Working Conditions

Economics

Subject Matter Experts

PRACTICE

Describe how each of the advantages can also be a disadvantage and how to turn them into advantages.

OJT vs CLASSROOM TRAINING

DIFFERENCES

Communication

Environment

Distractions

Instructor - StudentTrainer - Trainee

SIMILARITIES

Good Communication

Transfer of Knowledge

POTENTIAL PROBLEMS WITH OJT

No clear cut process or structure

Procedure not broken down into steps

No effective way to evaluate results

Forget to inform all necessary facts

Trainer doesn't know how to train

INSTRUCTIONAL DESIGN PROCESS

1. ANALYSIS

2. DESIGN

3. DEVELOPMENT

4. DELIVERY

5. EVALUATION

TYPES OF ANALYSES

Needs analysis

Job Analysis

Learner analysis

OTJ EFFECTIVENESS

THE KEY IS NOT

What you want to present

How you want to present it

What techniques you will use

THE KEY IS

Knowing behavioral objectives

Knowing required learning outcomes

WRITING OJT OBJECTIVES

1. Task Statement

2. Conditions

3. Performance Standard

PRACTICE: Decide which are good OJT objectives

1. Using a controlled sample of 50 vials, the trainee will be able to correctly identify and record 7 defects within 1 minute.

2. The trainee will know how to operate the bundler efficiently.

3. Given a set of circumstances, the trainee will be able to make a log book entry in compliance with company standards.

4. From a tablet analysis report with 20 readings, the trainee will be able to correctly calculate the tablet weight mean and standard deviation.

5. Given a copy of the secretaries manual, and a handwritten letter, the trainee will type a business letter according to company standards.

6. Participants will learn to identify product defects.

SEQUENCING OJT CONTENT

1. Follow the normal sequence

2. Teach pre-requisite tasks first

3. Start with the most difficult task

4. Start with an enjoyable task

DETERMINING OJT SEQUENCING

1. What is the trainee ready for?

2. Which steps are easiest: and which are more complex?

3. Is there any step that is the center of interest?

4. Which steps provide skills or knowledge essential to other steps?

For example,

Select Prepare Sketch Paint Preparetheme paints construction subject frame

lines

Select Prepare Paint Seal Mountcanvas canvas background surface painting

PRACTICE

Pretend you are about to instruct someone to serve as a temporary back-up to you in your current job. List your critical job responsibilities.

Review the four factors above. Which factor most applies to each job responsibility?

OJT Practice Exercises and Materials

Anytime a step requires acquisition of a skill or application, in-depth instruction should be followed by practice before going on to the next step.

Example:

Step 1 Step 2 Step 3 PRACTICE Step 4

Daily-life Obvious, Use of Obvious,skill simple resource not simple

application familiar to applicationof daily-life participants of resourceskill

PRACTICE

If your participants have no experience with woodwork tools or carpentry, where would you insert practice?

Drill holes Screw 4 Nail bottom Solder pins nailwhere marked sides together in place into holes top

PRACTICE

If participants have experience with woodwork, carpentry and the tools required, except for soldering - where would you insert a practice exercise?

Drill holes Screw 4 Nail bottom Solder pins nailwhere marked sides together in place into holes top

PRACTICE

Select a simple job responsibility. Break it into steps. Determine where you would insert practice. Describe a practice activity and how you would assess the trainees understanding and ability to perform the job responsibility.

OJT JOB AIDS

Job aids are devices used frequently to complement OJT. A job aid may take the form of such things as a printed checklist, a step-by-step manual, or a plastic measuring wheel. Whatever its form, the job aid provides on-the-job information and instruction.

GUIDELINES FOR USING JOB AIDS

WHEN TO USE

Use job aids for instructions in:

Infrequently performed tasks, whether simple or complex. For example, performing a simple calculation or assembling complicated testing equipment.

Infrequently performed tasks involving high risk to either the employee or expensive equipment. For example, operating a fire extinguisher near highly flammable materials.

Tasks that are complicated or that have many steps. For example, filing a federal income tax return

Tasks that require close attention to detail because of risk to either the employee or expensive equipment. For example, preparing an airplane for flight.

Tasks with frequent changes in performance. For example, tasks relying on rapidly changing technology.

WHEN NOT TO USE

Job aids are not always appropriate. Use some other method of instruction, not a job aid, for:

Tasks requiring quick response or quick completion. For example, assembly line tasks.

Situations where using a job aid could have a negative effect on customers. For example, performing service tasks that a customer would expect the company technician to know by heart.

CONSTRUCTING OJT JOB AIDS

Analyze the job responsibility in question to determine whether a job aid is appropriate. Base your analysis on the "When to Use" and "When Not to Use" lists.

If a job aid is appropriate, follow these construction steps:

Determine whether the task should be supported by a job aid alone or by a job aid and some other instructional method. Base your decision on the amount of information recall needed to perform the task, the complexity of the task, and the skills required in using the job aid.

- If recall is needed, instruction and practice in recalling information are needed in addition to the job aid.

- If the task is complex, demonstration and practice in performing the task with the job aid are necessary.

- If using the job aid is skill in itself (such as using a able of numbers or a resource manual), training in that skill is needed.

Determine the main performance requirement for the task. Choose from these requirements:

- Making decisions that are complex but that involve no sequence. For example, "Take order if request is for first version of product, no matter what quantity is requested. Take order for second version of product if quantity requested is less than five: otherwise refer caller to marketing division. . ."

- Making decisions within a sequence. For example, "Press #1 on system, requesting go-ahead. If receive, press SEND button. If do not receive go-ahead, press RETRY.

- Making decisions leading to alternate sequences. For example, "If contents of test tube turn green, follow these steps . . ."

- Following a sequence that involves no decisions. For example, "Lift receiver. Press RECALL. Dial 115. Listen for three short tones. . ."

Decide format for the job aid. It can be anything from a wallet-size card to a desktop printed stand to a stick-on label for equipment. Ask questions such as these:

- How will the job aid be used? For example, will the employee be sitting at a desk or walking around while using the job aid?

- How often will the job aid be used: Must it be built to last through frequent use?

- Will the job aid go with particular piece of equipment? For example, will the job aid consist of operating instructions that should be affixed to the equipment?

Write text for the job aid. Include these elements:

- Name of the job responsibility.

- Who should use the job aid.

- When to use the job aid.

- How to use the job aid.

- Any assumed conditions or prior events necessary for using the job aid.

- Any equipment or supplies necessary for using the job aid.

Follow these writing guidelines:

- Write clearly and specifically. Use short, concise, concrete terms.Keep sentences short.

- Use as few words as possible. Only include directions for performing the job. Do not include information on such things as the logic behind the job responsibility.

- Highlight critical words by italicizing, underlining, or typing in all capital letters. Always highlight the word "not."

Design and produce the job aid.

Test the effectiveness and accuracy of the job aid.

Maintain current and highly effective job aids.

PREPARE THE TRAINEE

Check level of interest.

Grab interest, focused on the subject.

Establish why learn this.

Let trainee(s) know what to look for.

Use the WHOLE - PARTS - WHOLE approach to provide an overview of what is expected. This helps focus on what is to be learned before getting into details.

PRESENT THE TRAINING

Show, tell and instruct the trainee concerning the job responsibility.

Use terms that are specific.

Use training aids when appropriate.

Provide repeated practice at each step requiring proficiency and skill.

Achieve competence through questions:

- Ask trainee to explain what has just been done.

- Ask trainee to identify deviations from presented techniques.

- Ask how presented techniques could have avoided a problem.

- Ask what, when and why things are going correctly.

Use side-by-side technique for demonstrations.

Introduce exceptions only after normal procedure is "locked in."

REINFORCE TRAINING

Make sure that trainee knows where and when to ask for help.

Require performance of whole process on-the-job.

Ask for explanations during performance.

- what are you doing?

- how are you doing it?

- why are you doing it that way?

- how would you handle key exceptions on-the-job?

Provide constructive and productive feedback.

Encourage peer feedback during performance.

Encourage self-development and self-management.

PRACTICE: PREPARE, PRESENT & REINFORCE

Instructions: Record observations during example for each step you observe. Be prepared to share with group during discussion.

PREPARE THE TRAINEE_____ Put trainee at ease by encouraging talk about present skill level.

_____ Reduce fear by expressing confidence in trainees ability.

_____ Orient trainee to the work area and job duties.

_____ Explain the importance of the job or task.

_____ Show trainee the personal benefits of good job performance.

PRESENT_____ Show and explain each step in a logical and systematic way.

_____ Use side-by-side technique to avoid teaching in reverse.

_____ Emphasize key points by explaining the reasons and importance.

_____ Use terms that are familiar and be consistent.

_____ Ask questions to determine understanding.

_____ Have trainee demonstrate the task.

_____ Have trainee explain the task.

_____ Correct any errors immediately.

_____ Use training aids.

REINFORCE AND FOLLOW-UP_____ Make sure trainee knows where and when to ask for help.

_____ Observe trainee on-the-job.

_____ Give positive feedback throughout instruction for things done well.

THE COMPLEMENTARY CRITIQUE

What - Providing feedback on the work of another

Why - To achieve exemplary performanceTo build on strengthsTo identify weaknesses for improvement

How - Select feedback typeDirect - between feedback coach/observer and performerImmediate - to protect relevanceCertain - performer is informed of the process

Assign responsibilitiesPerformerFeedback coachObservers/Peers

Critique performanceMaintain self-esteem and self-respectDocument specific observations - Time/Observations/CommentObjective commentsBalanced feedback- strengths- weaknesses

Conduct the CritiqueOrder of Critique-Performer/Feedback coach/ObserverAsk performer-how do you feel?-What would you change?Provide feedback- Feedback Coach/Observer-Specific and sincere-Tell if a basic idea is not used or is misused-Focus on process not content-Make important points relative to effectiveness and efficiency-Limit to points where corrective action can be taken-Provide useful and practical way to improve skill on the jobSummarize strengths and weaknesses-Agree on Actions and follow-up

GIVING BEHAVIORAL FEEDBACK

PURPOSE: To clearly, correctly and concisely communicate the observed behavior in a manner that the information will be accepted and used.

HOW: Document Factual Information.

Be Specific -Describe what the trainer actually said or did, the circumstances, and the trainees verbal and nonverbal responses and the time of the observation.

Provide Behavioral Descriptions of training actions and reactions to those actions.

- "When you asked the trainee..., I felt he might have had a hard time understanding what you wanted."

- "I know the trainee must have been pleased about your comment regarding... I know I would have been.

STEPS TO DELIVER ON-THE-JOB TRAINING

Prepare the learner

Present the information

Reinforce and follow-up

ASSESS THE TRAINEE'S STAGE OF LEARNING

FOUR STAGES OF LEARNING

STAGE 1 - Unconsciously Incompetent

STAGE 2 - Consciously Incompetent

STAGE 3 - Consciously Competent

STAGE 4 - Unconsciously Competent

MANAGE THE TRAINEE'S STAGE OF LEARNING

TRAINEE

Unconsciously Incompetent

Consciously Incompetent

Consciously Competent

Unconsciously Competent

TRAINER

APPLICATION: OJT PRACTICE TRAINING

Purpose: Practice for OJT Trainers, Trainees and Observers.

Practice using Systematic Teaching.

Apply Adult Learning Principles.

Obtain feedback and suggestions for improvement.

Practice using the Complementary Critique.

Build training and assessing ability.

Build confidence in training and assessing ability.

Increase insight into On-the Job training process.

Practice and observe various behavior and styles of OJT

PRACTICE

Prepare to teach someone to serve as your temporary back-up in the event of your absence from work.

GUIDELINES FOR RESPONDING TO FEEDBACK

LISTEN AND TAKE BRIEF NOTES

ASK FOR MORE INFORMATION WHEN NEEDED

ASK FOR SPECIFIC BEHAVIORAL DESCRIPTIONS

RESTATE FEEDBACK TO ENSURE UNDERSTANDING

ALWAYS THANK THE FEEDBACK COACH

KEY FEEDBACK AREAS TO OJT TRAINERS

TRAINING ATMOSPHERE

TRAINER'S BODY LANGUAGUE

- MANNER (STIFF, FORMAL, RELAXED)- POSTURE- BODY MOVEMENTS- TIME- INTEREST- EYE CONTACT

TRAINER'S COMMUNICATION STYLE

- CLEAR, CONCISE, CORRECT- DIRECTED TO THE TRAINEE'S LEARNING STAGE- CONCERN FOR UNDERSTANDING BY TRAINEE

TRAINER'S STYLE AND USE OF OJT TECHNIQUES

- PREPARED AND WELL-ORGANIZED TRAINING PLAN- LOGICAL AND SYSTEMATIC SEQUENCING- APPRORIATE USE OF TRAINING AIDS- APPROPRIATE USE OF MEDIA- PREPARED THE TRAINEE/CHECKED LEARNING LEVEL- EFFECTIVE REINFORCEMENT OF TRAINING- EFFECTIVE WHOLE - PARTS - WHOLE PRESENTATION- MAINTAINED SELF ESTEEM OF TRAINEE- AMPLE OPPORTUNITIES TO PRACTICE- EFFECTIVE SIDE-BY-SIDE TRAINING TECHNIQUE

NEXT STEPS

ISSUES

ACTIONS

RESPONSIBILITIES

RESOURCES

DATES

Technical Trainer SPECIFIC OBJECTIVESMITCH1. CUSTOMER SURVEY 12/31 50 POINTS2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 10 POINTS4. DEPT INDICATORS 12/31 100 POINTSERNEST1. CUSTOMER SURVEY 12/31 40 POINTS

BPCS 40 POINTS2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 60 POINTSTONY1. CUSTOMER SURVEY 12/31 40 POINTS2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 80 POINTS JAMES1. CUSTOMER SURVEY 12/31 60 POINTS

PMD TRAINING TASK FORCE 20 POINTS

2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 60 POINTSMICHAEL1. CUSTOMER SURVEY 12/31 80 POINTS2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 60 POINTSJERRY1. CUSTOMER SURVEY 12/31 60 POINTS2. TRIAD 12/31 15 POINTS3. CURRICULA 12/31 15 POINTS4. SITE CGMP TRAINING 12/31 10 POINTS5. RECYCLING TRAINING/12/31 10 POINTS6. TO BE ASSIGNED 12/31/95 10 POINTS7. DEPT INDICATORS 12/31/95 60 POINTSJEAN1. CUSTOMER SURVEY 12/31 40 POINTS

SPF UTILITIES INSPECTION 20 POINTSSPF PRE-APPROVAL INSPECTION 20 POINTS

2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 60 POINTSFRANK1. CUSTOMER SURVEY 12/31 80 POINTS2. TRIAD 12/31 20 POINTS3. CURRICULA 12/31 20 POINTS4. DEPT INDICATORS 12/31 60 POINTS

TTSNWT TRAINING ACTION Fiscal YearMANNING, MITCH\ EIN O36241. TRIAD II 11/xx2. 2-6010-0036 11/xx3. 2-6010-0046 11/xx4. TTS CURRIC REQMNTS 12/xx

ERNEST1. TRIAD II 11/xx2. 2-6010-0036 11/xx3. 2-6010-0046 11/xx4. TTS CURRIC REQMNTS 12/xx5. LEADERSHIP ASSMNT 12/xx

TONI1 - 4 PLUS5. TARGETED SELECTION 12/xx

JIM1 - 5 PLUS6. NEW PMD EQUIPMENT TRAINING 12/xx7. BULK PHARMACEUTICAL CHEMICAL PROCESS VALIDATON 12/xx

MIKE1 - 5

JERRY1 - 5 PLUS6. NEW EQUIPMENT\PROCESS TRAINING 12/xx7. TARGETED SELECTION12/xx8. FDA INTERACTIONS 12/xx 9. KEPNER TREGOE PS/DM 12/xx

JEAN1 - 5 PLUS6. TARGETED SELECTION12/95

FRANK1. TRIAD II 11/xx2. 2-6010-0036 11/xx3. 2-6010-0046 11/xx4. TTS CURRIC REQMNTS 12/xx5. LEADERSHIP ASSMNT12/95

From: Mitchell W. Manning To: P&E Executive CommitteeDate: November 1, xxSubject: Technical Training Customer Survey for Fiscal Year Tasks and Projects

The following information will be presented and discussed at the P&E Staff meeting on November 7. This is to inform you of the Customer Survey, the Technical Trainer assignments by area, the survey approach, the survey results, the recommendations and the proposed action plan to address the identified tasks and projects. Call Mitch Manning at extention 72810 if you have questions, or recommendations, that you want to discuss before the meeting.

CUSTOMER SURVEY OVERVIEW

Survey Objectives:

Identify specific customer training tasks and projects by area.Document the diversity of requests across P&E Unit.Group training requests into major categories.Estimate resource requirements to complete identified tasks and projects.Contrast resource requirements with available resources.Initiate action planning by area to prioritize tasks and projects.

Survey Background and Approach:The Technical Training Specialists - Natural Work Team conducted area customer surveys between July 13, xx and September 7, xx. They collected information from one-on-one meetings and correspondence in assigned areas. They asked "how do you want my time spent in Fiscal Year?" The responses were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion dates were identified when provided by management. (Note: The TTSs have continued to review and refine the compiled information with their assigned line management and Division Managers.)

TTS Assignments by Area:Area TTSEngineering Division MikeLogistics Administration FrankPharmaceutical Production Services, Small Scale Formulations Jerry

and Ointments, Creams & Liquids Formulations DivisionsPrimary Manufacturing Division JimSolid Dose Formulation Division (Packaging and Manufacturing) ErnestSPF & Manufacturing Documentation Control & Validation Division JeanSterile Products Division FrankGreenville Site Mitch

RESULTS OF THE CUSTOMER SURVEY:

A high number of diverse training tasks, projects and responsibilities were identified.

The following major categories were identified:1. Compliance Training2. TRIAD3. Curricula for Active Job Codes4. Training Plans5. Training Programs6. Training Support7. Performance Audit8. Work Place Learning Center and General Education Improvement Program (WPLC/GEIP)Note: See attached chart (DIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS AND PROJECTS BY CUSTOMER AREA)

The POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours required annually) were calculated. Requirements exceed TTS capacity.Note: See attached charts for POTENTIAL CAPACITY REQUIREMENTS and KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING.

Other Results of the Customer Survey:Key issues around roles, responsibilities and customer expectations were identified.1. Some line managers believe the TTS is responsible for job related employee qualifications.2. Some line managers believe that the TTS is responsible and accountable for all SOP

training and documentation.

The understanding of technical and regulatory training compliance needs was enhanced.1. CFR 211.25 - Personnel Qualifications was reviewed and discussed.2. SOPs 2-6010-0036 - Technical Training and Qualification and 2-6010-0046 - TRIAD were reviewed and discussed.

Note: These SOPS have been rewritten and approved for site-wide application by Ranthi Dev, Joyce Aydlett, Dr. John Bettis and Dr. Craig Williams. Mandatory training for line management will be completed by December 12, 1994.

The customers indicated an enhanced appreciation for the TTS direction and support for regulatory training compliance.

Customers and TTSs have indicated that they think the survey was value-added.

RECOMMENDATIONS:

Establish a Training Task Force in each area to do the following:1. Review the Customer Survey to identify opportunities for merging and piggybacking tasks, projects and responsibilities (eg. Production Technician Training, Packaging Area Technician Training, Chemical Process Operator Training, Multiskill and SPF Core Curriculum).2. Review the survey for opportunities to distribute the training workload (eg. SOP pending

training reports to area clerical/secretarial designees)3. Determine priority, or necessity, and resource requirements of each task, project and

responsibility with regulatory compliance as priority one.4. Establish agreement on priorities based on resource requirements and contribution to

function.5. Identify source and allocation of people (time), money, and other required resources.6. Establish goals, measurement and schedule for each task, project and responsibility.7. Develop, approve, implement and track Area Specific Training Action Plans.

Submit Requests for Service to Site Training and Development for each required task, project and responsibility.

Establish minimum compliance training as the highest priority (mandatory without exception).

Develop and maintain curricula for each active job code and use to provide operational control of minimum compliance training for each employee.

Monitor and manage minimum compliance training utilizing printed reports from Training Database Administration:1. First-line supervisor Monthly2. Middle manager Quarterly3. Senior manager Interim and Annual4. Executive manager Annual

Appoint SOP Designees at clerical/secretarial level to provide administrative support (monitor New and Revised SOPs, prompt required SOP training, prepare and distribute training materials, collect completed Training Attendance Documents, review with instructor for accuracy and completeness and ensure timely delivery to Training Database Administration, eg. SDFD pilot program).

Concentrate Technical Training Specialist assignments on approved Requests For Service for new, or changed, equipment, procedures and regulations within assigned area with expressed approval of the area Division Manager.

PROPOSED ACTION PLAN:

TTS to review survey with Division Manager or designee(s) November 30, xx

Division Manager or designee establishes Training Task Force November 30, xx

Training Task Force establishes Training Action Plan December 31, xx

Division Managers monitor progress against the plans On-going

pemgtprs.doc

TECHNICAL TRAINING HOURS REQUIRED FOR Fiscal YearTASKS/PROJECTS BPCS ENG LOG PPS/

SSF/OCL

PMD SDFMD SPD SPF SITE

Regulatory Compliance 0 1380 375 1044 175 200 575 2020 0416/ 1872/ 0700/0000Technical Training 1200 1420 0 1040 800 180 1312 400 0416/ 0150/ 0400/0000Other 1200 735 120 200 595 60 0 256 0832/ 0390/ 0400/1000REQUIRED HOURS 2400 3535 495 2284 1570 440 1887 2676 1664/ 2412/ 1500/1000TTS-NWT HOURS 1664 1704 495 1704 1664 440 1169 1744 1664/ 1784/ 1500/1000

HOURS NEEDED 736 1831 0 580 +94 0 718 932 0000/ 0628/ 0000/0000TTS-NWT Member Clemons Langley Taylor McRoy Hodges Allen Taylor Mitchell Manning/ Harrell/ Wall/ LaMotte

CALCULATIONS:REQUIRED HOURS: Regulatory Compliance + Technical Training + OtherTTS NWT HOURS: 52wks x 40hrs - (vacation + holidays(88) + training(24) + meetings(40) + sick time(24) + performance management(40))HOURS NEEDED: Required Hours - TTS NWT Hours

PROJECTS/TASKS PRIMARY CONTACT: BPCS - Ernest Engineering - Mike Logistics - Frank Pharmaceutical Production Support, Small Scale Formulations, and Ointments, Creams and

Liquids Formulations - Jerry Primary Manufacturing Division - Jim Solid Dosage Formulations Division - Lou (assigned from ST&D staff) Sterile Products Division - Frank Sterile Products Facility - Jean Site - Mitch

Training Database Administration - ToniSite-Wide Technical Training Projects - Michelle (assigned from ST&D staff)Work Place Learning Center - Joyce (Pitt Community College)

.

KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING

FACTORS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPFNumber of Employees 408 154 165 176 193 093 163

Operative/Craft 217 066 140 121 168 074 015Prof/Tech/Admin 125 088 007 023 006 024 122Supervisors 042 016 012 015 014 009 015Department Heads 015 003 004 005 003 002 007Managers 006 005 000 001 000 000 002Directors 002 000 002 001 001 001 000Vice Presidents 001 001 000 000 001 000 001

Active Job Codes 231 087 048 042 25 041 047Procedures 206 152 201 240 210 147 065 aprvdTTS-NWT Member Langley Taylor McRoy Hodges Allen Taylor Mitchell

Note: Employee numbers include temporary employees.

Calculations Based On Past Performance:Compliance Training: 2 hours for each procedureCurricula: 4 hours for each active Job CodeTraining Plans: 1 hour for each employeeTRIAD: 1 hour for each employee**Training Programs: 400 hours to design, develop and implement/ 100 hours to customize and implement (for each program)**Training Support: 400 hours to design, develop and implement/ 100 hours to customize and implement (for each type support)Performance Audit: 1 hour for each employeeWPLC/GEIP: 2 hours for each enrolled employee (2% of employee pool)

Estimates are based on experience, past performance and guidelines

From: Mitchell W. Manning To: Craig & Jim EDate: February 13, XXXXSubject: Technical Training Action Plans for YEAR

The technical training action plans (by area) are attached. Each plan has been reviewed by the area division manager and/or designee(s). Significant progress has been made in all areas since I presented the results of the Technical Training Customer Survey to the P&E Executive Committee on December 2, XXXX. The progress is recorded in bold on the attached copies of the original presentation documents. Please review the action plans and the progress reports. I would like to meet with you on Tuesday or Wednesday (2/14 or 2/15) to review the plans and to discuss our next steps.

attachments:

Area Action PlansMike - EngineeringFrank - Logistics and Sterile Products DivisionJim - Primary Manufacturing DivisionJerry - Ointments, Creams and Liquids Formulations, and Pharmaceutical Production Support & Small Scale FormulationsLou - Solid Dosage Formulations & Manufacturing DivisionJean - Sterile Products Facility

Status Report on the Original Presentation

mm/stored on C:aplnmemo.doc

STATUS REPORT: 2/13/XXXX (see Recommendations and Proposed Action Plan for progress)

TTS-NWT TASKS AND PROJECTS FOR YEAR BY CUSTOMER

Presented to the P&E Executive Committee on November 7, XXXX (actual 12/02/XXXX)By Mitch Manning, Section Head Technical Training SITE TRAINING & DEVELOPMENT


Survey Objectives:Identify specific customer training tasks and projects by area.Document the diversity of requests across P&E Unit.Group training requests into major categories.Estimate resource requirements to complete identified tasks and projects.Contrast resource requirements with available resources.Initiate action planning by area to prioritize tasks and projects.

Survey Background and Approach:The Technical Training Specialists - Natural Work Team conducted area customer surveys between July 13, XXXX and September 7, XXXX. They collected information from one-on-one meetings and correspondence in assigned areas. They asked "how do you want my time spent in XXXX?" The responses were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion dates were identified when provided by management. (Note: The TTSs have continued to review and refine the compiled information with their assigned line management and Division Managers.)


and Ointments, Creams & Liquids Formulations DivisionsPrimary Manufacturing Division JimSolid Dose Formulation Division (Packaging and Manufacturing) ErnestSPF & Manufacturing Documentation Control & Validation Division JeanSterile Products Division FrankSite Mitch Manning

Note: updated on 2/13/95, mm/ stored on c:\aplnmemo.doc

From: Mitchell W. Manning To: P&E Executive CommitteeDate: November 1, XXXXSubject: Technical Training Customer Survey for XXXX Tasks and Projects

The following information will be presented and discussed at the P&E Staff meeting on November 7. This is to inform you of the Customer Survey, the Technical Trainer assignments by area, the survey approach, the survey results, the recommendations and the proposed action plan to address the identified tasks and projects. Call Mitch Manning at extention 72810 if you have questions, or recommendations, that you want to discuss before the meeting.


Survey Objectives:Identify specific customer training tasks and projects by area.Document the diversity of requests across P&E Unit.Group training requests into major categories.Estimate resource requirements to complete identified tasks and projects.Contrast resource requirements with available resources.Initiate action planning by area to prioritize tasks and projects.

Survey Background and Approach:The Technical Training Specialists - Natural Work Team conducted area customer surveys between July 13, and September 7, XXXX. They collected information from one-on-one meetings and correspondence in assigned areas. They asked "how do you want my time spent in xxxx?" The responses were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion dates were identified when provided by management. (Note: The TTSs have continued to review and refine the compiled information with their assigned line management and Division Managers.)


and Ointments, Creams & Liquids Formulations DivisionsPrimary Manufacturing Division JimSolid Dose Formulation Division (Packaging and Manufacturing) ErnestSPF & Manufacturing Documentation Control & Validation Division JeanSterile Products Division FrankGreenville Site Mitch

RESULTS OF THE CUSTOMER SURVEY:

A high number of diverse training tasks, projects and responsibilities were identified.

The following major categories were identified:1. Compliance Training2. TRIAD3. Curricula for Active Job Codes4. Training Plans5. Training Programs6. Training Support7. Performance Audit8. Work Place Learning Center and General Education Improvement Program (WPLC/GEIP)Note: See attached chart (DIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS AND PROJECTS BY CUSTOMER AREA)

The POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours required annually) were calculated. Requirements exceed TTS capacity.Note: See attached charts for POTENTIAL CAPACITY REQUIREMENTS and KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING.

Other Results of the Customer Survey:Key issues around roles, responsibilities and customer expectations were identified.1. Some line managers believe the TTS is responsible for job related employee qualifications.2. Some line managers believe that the TTS is responsible and accountable for all SOP

training and documentation.

The understanding of technical and regulatory training compliance needs was enhanced.1. CFR 211.25 - Personnel Qualifications was reviewed and discussed.2. SOPs 2-6010-0036 - Technical Training and Qualification and 2-6010-0046 - TRIAD were reviewed and discussed.

Note: These SOPS have been rewritten and approved for site-wide application by Senior Management. Mandatory training for line management will be completed by December 12, xxxx.

The customers indicated an enhanced appreciation for the TTS direction and support for regulatory training compliance.

Customers and TTSs have indicated that they think the survey was value-added.

RECOMMENDATIONS:

Establish a Training Task Force in each area to do the following:

1. Review the Customer Survey to identify opportunities for merging and piggybacking tasks, projects and responsibilities (eg. Production Technician Training, Packaging Area Technician Training, Chemical Process Operator Training, Multiskill and SPF Core Curriculum).2. Review the survey for opportunities to distribute the training workload (eg. SOP pending

training reports to area clerical/secretarial designees)3. Determine priority, or necessity, and resource requirements of each task, project and

responsibility with regulatory compliance as priority one.4. Establish agreement on priorities based on resource requirements and contribution to

function.5. Identify source and allocation of people (time), money, and other required resources.6. Establish goals, measurement and schedule for each task, project and responsibility.7. Develop, approve, implement and track Area Specific Training Action Plans.

Progress: It was not deemed necessary to form Task Forces. The review and planning was handled by ST&D and line management in each area. 1. The survey was reviewed to merge and piggyback projects.2. The workload was distributed within ST&D and in the area. All areas are using SOP designees.3. Priorities have been established per the attached Action Plans. 4. Same as #3. 5. Resource management will be on-going. 6. Target dates were set. Other goals and measurements need additional work. 7. Action Plans are attached.

Submit Requests for Service to Site Training and Development for each required task, project and responsibility.

Progress: All areas are submitting RFSs for training needs not identified in the Action Plans.

Establish minimum compliance training as the highest priority (mandatory without exception).Progress: Compliance training is the highest priority in each area.

Develop and maintain curricula for each active job code and use to provide operational control of minimum compliance training for each employee.

Progress: More than 250 curricula have been compiled and entered into TRIAD for the operative and craft positions. More than 200 professional/technical/management curricula have been completed.

Monitor and manage minimum compliance training utilizing printed reports from Training Database Administration:1. First-line supervisor Monthly2. Middle manager Quarterly3. Senior manager Interim and Annual4. Executive manager Annual

Progress: TRIAD training in all areas has enabled management/supervision to track training on an on-going basis.

Appoint SOP Designees at clerical/secretarial level to provide administrative support (monitor New and Revised SOPs, prompt required SOP training, prepare and distribute training materials, collect

completed Training Attendance Documents, review with instructor for accuracy and completeness and ensure timely delivery to Training Database Administration, eg. SDFD pilot program).

Progress: SOP designees have been appointed and trained in all areas. There have been no complaints with the work that they have performed.

Concentrate Technical Training Specialist assignments on approved Requests For Service for new, or changed, equipment, procedures and regulations within assigned area with expressed approval of the area Division Manager.

Progress: The Technical Training Specialist and ST&D staff assignments have become more focused on technical training assignments through RFSs.

PROPOSED ACTION PLAN:

TTS to review survey with Division Manager or designee(s) November 30, xxxx

Progress: Completed. See attached Action Plans. Changed to 12/23/xx

Division Manager or designee establishes Training Task Force November 30, xx

Progress: Completed without establishing Task Force(s). Changed to 12/23/xx

Training Task Force establishes Training Action Plan December 31, xx

Progress: Completed without establishing Task Force(s) Changed to 1/31/xx

Division Managers monitor progress against the plans On-going

Progress: OngoingTECHNICAL TRAINING SPECIALIST P&E UNIT - MASTER TRAINING PLAN

REQUIRED TRAINING FORM FOR CFR 211.25 PERSONNEL QUALIFICATIONS

Job Description(title): Error! Reference source not found.Employee/EIN: Error! Reference source not found. Department/cc: Error! Reference source not found.

Supervisor/EIN: Error! Reference source not found. Training Period: Error! Reference source not found.

INSTRUCTIONS: This form is designed to assist the Supervisor in developing a technical training and qualification plan to support employee qualification for the essential duties identified in the applicable Job Description. Required training is defined as training which targets job specific orientation, regulatory compliance(eg CGMPs, OSHA, EPA, DOL, DOT, AF&T, etc.), procedures (SOPs, GAPs, SPBs, etc) equipment, process, and technology. Record internal and external courses and programs on this form. ST&D staff are available to assist upon request.

TRAINING AND QUALIFICATION ACTION PLAN) Target Date Frequency

Identification Number/Title or Description Start/Complete Update1. ORIENTATION

2. REGULATORY COMPLIANCE (list all MANDATORY procedural training)

3. PROCEDURES (list any non regulatory compliance procedural training)

4. EQUIPMENT

5. PROCESS

6. TECHNOLOGY

7. OTHER

SIGNATURES: Employee _______________________________ Date: _______________________

Supervisor_______________________________ Date: _______________________

Send a signed and dated copy of the completed form and a copy of the working Job Description (may be pending approval by line management, Human Resources and Compensation) to the Section Head - Technical Training. Give the employee a signed and dated copy of the completed form to encourage self-development and self-management of the Training and Qualification Plan.

The Huge Curve BallFebruary 2, xxxx

Mr. Robert xxxxxxMajor Vendor CorporationAddress Hidden

Dear Bob:

Thanks for providing the references on mergers and acquisitions. I had no idea when we talked that Wellcome Plc was about to be acquired. It looks as if we will soon be Glaxo Wellcome Plc. The books will be useful in understanding the process. Hopefully, I will be able to enhance my

effectiveness during the transition as a result of the information you have provided. Thanks very much.

Sincerely,

Mitch ManningSection Head, Technical and Regulatory Compliance Training

ps Are you familiar with the work and writing of Dr. Kathryn Harrigan of Columbia University? I heard her speak on M&A implementation strategies a couple of years ago.

Training Tasks and Projects after the Curve Ball

From: Mitchell W. Manning To: VP Production and Eng. and StaffDate: October 5, xxxxSubject: TTS-NWT Tasks and Projects for xxxx

(Note: This information is provided in advance for the P&E Staff meeting scheduled on October 11.)

The Technical Training Specialists - Natural Work Team conducted a customer survey between July 13, xxxx and September 7, xxxx. The objective was to identify what the area line management wants the assigned Technical Training Specialist to do in 1995. The full report was submitted to Mr. VP for review on September 9. This is to inform you of the Customer Survey, the Technical Trainer assignments by area, the findings, the recommendations and the action plan to address the identified tasks and projects.

TTS AssignmentsArea TTSEngineering Division (GVL & RTP) MikeLogistics Administration FrankPharmaceutical Production Services, Small Scale Formulations Jerryand Ointments, Creams & Liquids DivisionPrimary Manufacturing Division JimSolid Dose Formulation Division (Packaging and Manufacturing) ErnestSPF & Manufacturing Documentation Control & Validation Division JeanSterile Products Division FrankGreenville Site Mitch

Approach:The TTS-NWT collected information from one-on-one meetings and correspondence in assigned areas. They asked "how do you want my time spent in xxxx?" The responses were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion dates were identified when provided by management. (Note: The TTSs will review the compiled information with their assigned Division Manager.)

Results:A high number of training tasks, projects and responsibilities were identified.

The identified tasks, projects and responsibilities fall into the following major categories:Auditing Regulatory Compliance TrainingDesign and Delivery of New or Modified Procedure TrainingDesign and Delivery of New or Modified Equipment TrainingAdministrative Support for Training Curricula and Training Plans

More in-depth thinking on technical and regulatory training compliance needs was initiated.

Issues around roles, responsibilities and customer expectations were identified.

The customer response to the survey was positive.

The customer expectations of the TTS were adjusted.

Recommendations:Empower a Training Task Force in each area to do the following:

Review the lists to identify opportunities for merging and piggybacking (eg. Production Technician Training, Packaging Area Technician Training, Chemical Process Operator Training and Multiskill).Review the list for opportunities to distribute the training workload (eg. SOP pending training reports to area clerical/secretarial designees)Determine priority, or necessity, and resource requirements of each task, project and responsibility with regulatory compliance as priority one.Establish agreement on priorities based on resource requirements and contribution to function.Identify source and allocation of each resource.Establish goals, measurement and schedule for each task, project and responsibility.Develop, approve, implement and track Area Specific Training Action Plans.

Proposed Action Plan:TTS to review list with Division Manager or designee(s) October 31, xxxx

Division Manager or designee(s) establishes Training Task Force October 31, xxxx

Training Task Force establishes Training Action Plan December 31, xxxx

Division Manager monitors progress against the plan On-going

tkspjts95

pemgtprs.docDIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS AND PROJECTS BY CUSTOMER AREA

TASKS/PROJECTS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF

Compliance Training yes yes yes yes yes yes yesSOPs, SOMS, etc. yes yes yes yes yes yes yesFDA/CGMP yes yes yes yes yes yes yesOSHA yes yes yes yes yes yes yesEPA yes yes yes yes yes yes yesOther yes yes yes

TRIAD yes yes yes yes yes yesCurricula yes yes yes yes yes yesTraining Plans yes yes yes yes yes yesTraining Programs

Equipment O&M yes yes yes yes yes yesBasic Computer yes yes yesAdvanced Computer yes yes yes yesOne-of-a-Kind 8 4 9 19 10 5New Employee yes yes yes yesNWT yes yes yesSkill Upgrades yes yes yes yesPre-employment yes yes yesSupervisor yes

Training SupportComputer Based yes yes yes yes yesClassroom yes yes yesMultimedia yes yesLaser Disc yesOutside/Vendor yes yes yesManuals yes 6

Performance Audit yes yes yesWPLC/GEIP yes yes

TTS-NWT Member Langley Taylor* McRoy Hodges Clemons* Taylor* Mitchell

POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours required annually)

TASKS/PROJECTS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF

Compliance Training 412 304 402 480 420 394 130TRIAD 408 154 165 176 193 93 163Curricula 924 348 192 168 100 164 188Training Plans 408 154 165 176 193 93 163Training Programs** 4400/1100 3200/800 6400/1600 10400/2600 5200/1300 400/100 3200/800Training Support** 1600/400 0 1600/400 1600/400 2800/700 000 1200/300Performance Audit 000 154 000 176 000 000 163WPLC/GEIP 018 006 006 008 008 004 006

TTS-NWT Member Langley Taylor* McRoy Hodges Clemons* Taylor* Mitchell

*Frank is assigned to Logistics, Sterile Products Division and is TRIAD Project Leader.*Ernest has been assigned full-time to BPCS.

*Joyce is the Pitt Community College instructor for the Work Place Learning Center/General Education Improvement Program

Calculations Based On Past Performance:Compliance Training: 2 hours for each procedureTRIAD: 1 hour for each employeeCurricula: 4 hours for each active Job CodeTraining Plans: 1 hour for each employee**Training Programs: 400 hours to design, develop and implement/ 100 hours to customize and implement (for each program)**Training Support: 400 hours to design, develop and implement/ 100 hours to customize and implement (for each type support)Performance Audit: 1 hour for each employeeWPLC/GEIP: 2 hours for each enrolled employee (2% of employee pool)

**High/Low estimates are provided to establish a range for hours required. Estimates are based on experience and guidelines.

KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING

FACTORS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF

Number of Employees 408 154 165 176 193 093 163Operative/Craft 217 066 140 121 168 074 015Prof/Tech/Admin 125 088 007 023 006 024 122Supervisors 042 016 012 015 014 009 015Department Heads 015 003 004 005 003 002 007Managers 006 005 000 001 000 000 002Directors 002 000 002 001 001 001 000Vice Presidents 001 001 000 000 001 000 001

Active Job Codes 231 087 048 042 25 041 047Procedures 206 152 201 240 210 147 065 aprvdTTS-NWT CAPACITY 1704 1664 1704 1664 000 000 1744PT. CAPACITY REQ** 8170/3670 4320/1920 8930/2930 13184/4184 8914/2914 1148/848 5213/1750CAPACITY DEFICIT** 6466/1966 2656/256 7226/1226 11520/2520 8914/2914 1148/848 3469/006

TTS-NWT Member Michael Frank Jerry Jim Ernest Frank Jeanl

*Frank is assigned to Logistics, Sterile Products Division and is TRIAD Project Leader.*Ernest has been assigned full-time to BPCS (1664 hours).*Joyce is the Pitt Community College instructor for the Work Place Learning Center/General Education Improvement ProgramNote: Employee numbers include temporary employees.

Calculations:TTS-NWT Capacity: 52wks times 40hrs minus (vacation + holidays + training + meetings + sick time + performance management)(vacation + holidays(88) + training(24) + meetings(40) + sick time(24) + performance management(40))Potential Capacity Requirements: Total from Potential Capacity Requirements chartCapacity Deficit: Potential Capacity Requirements minus TTS-NWT Capacity

**High/Low estimates are provided to establish a range for hours required. Estimates are based on experience and guidelines.

MEMORANDUMBurroughsWellcome

Co.

SITE TRAINING AND DEVELOPMENT

FROM: Mitch Manning TO: Craig and SheilaCC: Michelle

DATE: 02/15/xxxx

SUBJECT: Technical Training Assignments for Michelle

Please consider assigning the technical training responsibilities listed below to Michelle. The responsibilities are listed in priority order. Michelle and I have discussed the responsibilities and believe that she can do an excellent job with them. I accept full responsibility for performance

management and evaluation relative to the final assignments. A prompt response is requested due to the immediacy of the responsibilities.

1. Curricula development and implementation for all P&E job codes not assigned to Technical Training Specialists.

- Identify cost centers/job codes not covered- Conduct curriculum development interviews with appropriate line management- Enter curricula into TRIAD- Prompt and track related training plans

Estimated Time Required: 600 hours Targeted Completion: 12/31/xxxx

2. Staff liason/coordinator for the Work Place Learning Center.- Interface with Pitt Community College instructor/counselor- Research and develop "best practices" job-related WPLC services- Interface with testing function in Human Resources- Design, develop and implement value-added WPLC services- Provide direction and support for customers (all areas and levels) of WPLC


3. TRIAD audits and management reports (if requested.)- Randomly audit TRIAD and support records for accuracy and timeliness- Develop customer reliance and expertise on TRIAD management tools- Prepare and present executive summary reports quarterly


4. Multi-Media projects on Test Construction Set.- Identify, design, develop and deliver core curriculum courses on TCS

1) BW Co. Products and Processes 2) EPA and SiteEstimated Time Required: 400 hours Targeted Completion: 12/31/xxxx

5. Re-approval of existing SPF curricula for Pre-approval Inspection.- Establish plan with Jean and Mike- Implement the plan

Estimated Time Required: 100 Hours Targeted Completion: 4/03/xxxx

6. Liason with Human Resources for updating Change in Employee Status (P&E Unit only).- Interface for technical training specialists and HR on CES- Resolve CES issues- Inform technical training specialists

Estimated Time Required: 100 Hours Targeted Completion: 12/31/xxxxPROJECTS/PRIORITIES FOR xxxx

TRAINING DATABASE ADMINISTRATION - Toni

Priority: TRIAD II SYSTEM ADMINISTRATION

ACTION RESPONSIBLEEnsure the testing and training system environments are maintained and administered to meet the needs of the system users. Toni lSupport TRIAD II system data and functionality so as to coordinate training relevant information and provide system control and troubleshooting of system oriented problems. Toni lControl, limit, and manage access to the TRIAD II data entry system. Act as liaison between training database operators.

Toni /Mitch Manning/PEIS

Provide PeopleSoft/TRIAD II system training and system training and access to the Reports and Queries TRIAD II database via CICS logon.

Toni /TTS/PEIS

Estimated Time: 780 hours

Priority: TRIAD II DATABASE OPERATOR

ACTION RESPONSIBLEProvide timely entry of training records into the TRIAD II system and ensure accuracy of such records for the P&E unit employees and employees from other units not covered by a database operator.

Toni

Return incorrect training documentation to originators and track returns of documentation back to the Training Database office.

Toni

Maintain course information relevant to courses specific to the assigned area. ToniReceive and enter curricula from each support area into TRIAD II system. TTS/Toni Maintain curricula for each support area job code as changes are needed Toni /TTSProvide up-to-date training reports as requested by area management, supervision, etc. Toni l

Estimated Time: 1,040 hours

Priority: MIGRATION STRATEGY TEAM

ACTION RESPONSIBLEFacilitate TRIAD II Migration Strategy Team to develop system enhancements, troubleshoot, and maintain data control over system.

Toni

Set up and maintain meeting schedule for Migration Strategy Team and prompt members of meetingschedule.

Toni

Keep MST updated on system enhancements and problems. ToniWork with system programmers regarding system enhancements. Toni /Migration

Team/Programmers


Priority: HARD COPY STORAGE & RETRIEVAL OF REGULATORY TRAINING DOCUMENTATION

ACTION RESPONSIBLEProvide storage of hard copy training documentation for regulatory compliance training in the event of an inspection.

Toni

Maintain current files on SOPs/SOMs/GAPs/Validation Procedures/Equipment Training and external training assigned to Cost Centers within the P/E Unit and other units not covered by an administrator. ToniBe prepared to produce hardcopy regulatory compliance documentation for inspection upon request by supervisors, QAT Teams, Management, and FDA within one hour of request. ToniArchive out dated documentation according to Record Retention Schedules. Toni


Project: MAINTAIN CODE OF FEDERAL REGULATIONS BOOKLET

ACTION RESPONSIBLEMaintain Code of Federal Regulations Booklet Parts 210 and 211. Keep up-to-date changes incorporated into booklet for in-house publication.

Toni

Stock and distribute CFR Booklet for BWCo employees (site, RTP, UK, etc.). ToniEstimated Time: 50 hours

Project: MAINTENANCE OF TEST CONSTRUCTION - BWCO ELECTRONIC TESTING SYSTEM

ACTION RESPONSIBLEMaintain registration to Test Construction Set. Toni Enter employee data on to RosterMaker for test sign on. Toni Run manual report daily to pass test data results to the TRIAD II system. Toni


Project: MULTIMEDIA CGMP TUTORIAL

ACTION RESPONSIBLEAssist project team develop in-house MultiMedia CGMP ( Test Construction Software) using Parts 210 and 211 of the Code of Federal Regulations.

Toni /Project Team

Maintain information regarding CGMP MultiMedia tutorial via Test Construction Set. Toni Register personnel to RosterMaker for the CGMP MultiMedia tutorial.


TECHNICAL TRAINING ACTION PLANSFOR xxxx PROJECTS IN SDFMD

Project Request: Curricula development for all job positions in SDFMD Estimated Hours Required: 200

ACTION RESPONSIBLE COMPLETE BY

Deliver sample curricula and SOP catalog to area supervisors Allen 1/15/xxxx

Receive approved curricula Allen 2/28/xx

Forward approved curricula for entry into TRIAD AllenHarrell

3/15/xx

Project Request: Assist with developing and implementing Pharmaceutical Production Technician CourseEstimated Hours Required: 180


Develop training curriculum for new technicians Allen Anderson

Angel

2/28/xx

Deliver initial technician training ST&D StaffSMEs

Ongoing

Develop task lists/assessments as required by area management Allen McRoy

8/31/xx

Assess training to determine the need for additional training. AllenSupervision

9/29/xx

Project Request: Complete Korsch Training ManualEstimated Hours Required: 20


Complete Korsch Training Manual for SDFMD Compressing

3/15/xx

Project Request: Complete Training Manuals for Coating Rooms C&DEstimated Required: 20


Complete training manuals for coating rooms C&D - SDFMD Coating 3/15/xx

Project Request: Complete Training Manual for D/3 System in Room M2-83Estimated Hours Required: 20


Complete training manual for D/3 System in Room M2-83 - SDFMD Granulating 3/15/xx

CONTENTS Table of Contents

Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Designated Individual . . . . . . . . . . . . . . . . . . . . . . 2.1 Training Frequency: C . . . . . . . . . . . . . . . . . . . . .3.0 List of SOP Cross References . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0

FIGURES Figures

ID: 2-6010-0036 EFFECTIVE: 10/15/xx

PICTURE 1 SUPERSEDES NO. DATED: 09/19/xx

2-6010-0036

DEPARTMENT(S) IMPACTED: SITE

REVIEW CYCLE: 1 year REVISION CODE: 00

TITLE: Technical Training and Qualification Procedure for all P&E Employees

Authored by: Approved by:

09/21/xxST&D Sec. Hd.

10/08/xxSr. V.P.10/08/xxSect. Hd., QA

Issued by: Supv. SOP Oper. 10/08/xx

1.0 Purpose

The purpose of this procedure is to define the minimum training requirements and to outline the duties, responsibilities and accountability for providing training and administering the activities necessary to maintain a skilled work force.

2.0 Procedure The procedure is as follows: I. SCOPE

This SOP will address only those activities associated with orienting and training new employees in their job duties, qualifying employee proficiency, meeting regulatory requirements and providing ongoing training as may be necessary to maintain employee knowledge and skill levels. Career development and advancement training, such as that provided through apprenticeship programs, will not be covered by this SOP.

II. GENERAL REQUIREMENTS AND RESPONSIBILITIES

2.1 Designated Individual

A. DIVISION MANAGER

As stated throughout this SOP, it is primarily the responsibility of the Division Manager to ensure that the requirements of this SOP are met. However, the specific action required to meet this objective will be accomplished through the delegation of this responsibility to Department Heads, Supervision, Technical Training Specialists, and the Supervisor - Operative Technical Training. B. TECHNICAL TRAINING SPECIALIST

The role of the Technical Training Specialist is to coordinate the development, implementation, and documentation of training programs for the non-exempt production and engineering staff in their respective division(s).

C. DEPARTMENTAL TRAINING PROCEDURES

Each division shall establish a divisional and/or departmental technical training procedure that provides for proper administration and documentation of training within their groups. These procedures will be in compliance with the guidelines provided in this document.

D. BUDGETS

ST&D will budget, based on division input, for operative technical training and CGMP training. It shall be the responsibility of each Division Manager to budget funds necessary to obtain training

programs, materials, audio visual aids, etc. as may be required to provide the necessary job training for non-operative employees within the division. In addition, where specialized training can only be acquired by bringing in outside specialists or sending employees out to vendor and supplier schools, it is the cost center manager's responsibility to ensure that course registration, travel and outside services funds are budgeted.

Programs for unit wide topics will be budgeted for and developed by ST&D based on direction from the Training Steering Committee.

Programs for the Technical Lecture Series and Technical Training Series will be funded by P&E Administration. The Training Steering Committee and the High Technology Committee will approve the topics for these programs.

E. BASIC JOB TRAINING CURRICULUM

Each Division Manager shall be responsible for insuring that a training curriculum is established for each job classification assigned to cost centers in his/her division. This curriculum shall include division/department orientation, job training, related technical instruction, safety instruction and CGMP Regulations training requirements. All new employees shall be required to complete all courses listed on their training curriculum. In addition, all applicable SOP's for each job shall be identified and included as part of the training curriculum requirements for each job. F. EMPLOYEE QUALIFICATION

It shall be the responsibility of the Division Manager to insure that training requirements are established and maintained for each position in his/her cost centers. The basic training requirements for a new employee shall include:

1. Successful completion of appropriate curriculum courses.

2. Training on all SOP's related to the employee's job.

3. Successful demonstration of critical job skills.

G. ONGOING/REINFORCEMENT TRAINING

Division Managers shall be responsible for insuring that appropriate reinforcement training is provided to their staff such

that required job knowledge and skills are properly maintained. In addition, each Division Manager shall also be responsible for insuring that training is provided on an ongoing basis as may be necessary to comply with regulatory requirements and to meet the changing job demands created by the introduction of new technology and equipment. To meet this requirement, each division shall establish an annual training plan for all employees in their area. This plan shall provide for formal training for each employee in addition to regular SOP training. The amount and type of training required for each employee or position will be evaluated and discussed during their performance review. From this, a training plan for the next year will be developed. H. TEMPORARY EMPLOYEE TRAINING PROCEDURES

It shall be the responsibility of each Division Manager that utilizes outside temporary employees or employees temporarily assigned from another division to insure that a temporary employee training procedure is established and followed within their department. This procedure shall include an outline or list of training requirements and copies of training log sheets, forms, etc. to be utilized in administering and documenting this training.

I. COURSE ABSTRACTS

It shall be the responsibility of the Division Manager to insure that course abstracts are prepared for each course or program included in a job training curriculum. Site Training and Development Department will provide assistance in developing course abstracts.

J. RESPONSIBILITY FOR TRAINING ACTIVITIES

The supervisor of new employees shall be responsible for insuring that a schedule of training is established and that each employee completes the training prescribed in their training curriculum. Supervisors, group leaders, OJT trainers, and/or the area Technical Training Specialist shall be responsible for conducting or providing the job training for employees, as may be required.

K. ANNUAL AUDIT OF TRAINING CURRICULUM

Once each year, all departments shall review and update the training curriculum and job knowledge and skills tests for all jobs in their area. This update should reflect changes that have occurred in the job and also improvements made in courses or programs used for training. The SOP training list for each job should also be critically reviewed to insure that it reflects the current requirements for each job.

L. COURSE CATALOG

It shall be the responsibility of the Site Training and Development Department to publish and maintain a course catalog of all technical training programs developed and used within the P/E Unit.

III. DOCUMENTATION

A. RESPONSIBILITY FOR DOCUMENTATION

It shall be the responsibility of the employee's supervisor to insure that all training required by this procedure is properly documented and recorded within one calendar week of each training event.

B. TRAINING CURRICULUM TRANSCRIPT

A training curriculum transcript, outlining job training requirements for new employees, shall be prepared and a record of the employee's training progress maintained in that document.

C. ATTENDANCE LOGS

An attendance log, sign-up sheet, or training curriculum record shall be used to record attendance at all training sessions conducted at BW Co. Each employee shall verify their attendance and participation in the training activity by signing or initialling the appropriate document.

D. VERIFICATION OF COMPLETION OF TRAINING

Each departmental training procedure shall provide for a periodic review of training records to insure that all employees have completed required training and that make-up sessions are scheduled and conducted for those who may have missed a regularly

scheduled session. E. OUTSIDE COURSES

Attendance at "outside" job related courses by an employee at the request of BW Co. should be documented on the employee's training record. In addition, certificates of completion, attendance, etc. should be filed in the employee's personnel folder.

IV. REQUIRED TRAINING

Regulatory agencies such as the FDA, EPA, OSHA, etc. have mandated through legislation and various guidelines that specific training be required for employees involved in certain types of work. It shall be the responsibility of the Division Manager to review the requirements for each job category in their area and to establish the required courses to be included on the training curricula for any of their jobs. The Supervisor - Operative Technical Training will maintain a list of required regulatory training.

V. STANDARD OPERATING PROCEDURE TRAINING

DOCUMENTATION OF SOP TRAINING

It shall be the responsibility of the first line supervisor to insure that each employee is trained on all SOP's relevant to their job and that the training has been properly documented. For more information refer to SOP #2-6010-0041. VI. CGMP TRAINING

TRAINING IN CURRENT GOOD MANUFACTURING PRACTICES

Training in CGMP's as they relate to the employee's job function shall be included in the training curriculum for each job classification. For more information refer to SOP #2-6010-0042.

VII. NEW TECHNOLOGY (EQUIPMENT AND SYSTEMS)

In addition to scheduled ongoing training activities, each Division Manager shall also be responsible for insuring that appropriate training is provided whenever new equipment or systems are installed in their area.

A. P&E UNIT PROJECTS

It shall be the responsibility of the P&E Unit Project Leader to arrange for and insure that necessary training is provided for personnel who will be responsible for operation and maintenance of any equipment or systems installed through project activities. The development of a training program and plan shall be considered an integral part of all projects and the project will not be allowed to be closed out until the training plan and materials have been approved by the Customer Department, the appropriate Division Manager, and/or the area Technical Training Specialist. It is therefore recommended that the area Technical Training Specialist be involved as a team member or an ad hoc project team member to help evaluate the need for training and to insure that proper training materials are prepared. For more information refer to SOP #4-6490-0007. B. PACKAGING EQUIPMENT SELECTION

The assigned Packaging Engineer shall be responsible for arranging and insuring that operation and maintenance training is developed and made available prior to production start up for all equipment purchases. For more information refer to SOP #4-6420-0080.

C. REQUESTS FOR ENGINEERING SERVICES (RES)

The Project Engineer in cooperation with the Customer Department Division Manager, the area Technical Training Specialist, the Department Head of the Production Equipment Support and the Department Head of Plant Facilities and Services shall be responsible for insuring that initial start-up training for operators, line mechanics and maintenance personnel is provided. It shall be the responsibility of the Department Head to insure that on going training and job skill tests are developed to verify operator proficiency. D. DIRECT PURCHASE EQUIPMENT AND SYSTEMS

The Division Manager requesting the materials shall be responsible for insuring that initial start-up training is available for all direct purchases that are not covered by a P&E Unit Project, a Packaging Engineering Equipment Selection or a Request for Engineering Service.

E. RESTRICTED JOB ROTATION DURING START-UP

For major new automated systems and equipment installations, operators and mechanical staff may be dedicated to the operation

for up to one year to insure clear understanding and thorough evaluation of the system prior to across the board training of other personnel. This "restricted period" should provide time to learn unique features of the equipment, to debug operating problems and to revise training manuals and materials to reflect actual operating requirements. It shall be the responsibility of the affected department heads (Production, PES, PF&S) and the engineer or project team leader to agree to the need for a "Restricted Operations Period" and to the time when restrictions can be lifted and cross training of other personnel can begin. VIII. COURSE DEVELOPMENT AND EXECUTION

The Site Training and Development Department will provide the necessary support for technical training as required by P&E supervision. To this end, courses will be executed in-house and identification of courses presented by external services will be given to area managers for use in their respective departments.

3.0 Training Frequency: C

Training applicability and intervals for this SOP will be determined by area supervision.

4.0 List of SOP Cross References

SOP #2-6010-0041, "SOP Training, Testing and Follow-Up" SOP #2-6010-0042, "CGMP Training Program for Greenville Site Employees" SOP #2-6490-0007, "Process Equipment Selection and Installation Procedure" SOP #2-6420-0080, "Issue of the New Packaging Equipment Technical Training Manual"

5.0 List of Reviewers

AndersonConoverForemanGaynorHodgesLaviaPerry

Renn WilliamsWynne 6.0 Initial Distribution List

Senior Vice President, P&E Unit Vice President, Production Vice President, Engineering Vice President, Logistics Director, MMD General Manager, Greenville Site Manager, OH&S Manager, Human Resources All P&E Managers All P&E Department Heads All Technical Training Specialists SOP Administrator, Engineering (9) Supervisor, Operative Technical Training, ST&D SOP Admin., Pkg. Training Copy CONTENTS Table of Contents

Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Training Frequency: C . . . . . . . . . . . . . . . . . . . . . . 3.0 List of SOP Cross References . . . . . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0 Appendix A. Sample SOP Training Plan . . . . . . . . . . . . . . . A.0 Appendix B. SOP Training, Testing and Follow-Up Flowchart . . . . . B.0

FIGURES Figures

ID: 2-6010-0041 EFFECTIVE: 02/27/91

PICTURE 1 SUPERSEDES NO.4-6010-0041

DATED: 03/01/90

DEPARTMENT(S) IMPACTED: ST&D


TITLE: SOP Training, Testing and Follow-Up


02/19/xxST&D Supv.

02/19/xxSr. V.P.2/26/xxComp. Adm. Spec.

Issued by: Supv. SOP Oper. 02/26/xx

1.0 Purpose

The purpose of this procedure is to specify the manner in which SOP training for P&E operative employees will be developed, conducted and coordinated.

2.0 Procedure

The procedure is as follows:

I. SCOPE

This procedure pertains to operational SOPs which are defined as SOPs that impact upon the identity, strength, quality and purity of a drug product, component, or packing material. Operational SOPs are identified by an SOP number with a first digit of 1 or 2.

II. RESPONSIBILITY

Training and retraining of operative employees on SOPs is a primary responsibility of the first line supervisor. ST&D and the Technical Training Specialists will provide support to supervision in fulfillment of this responsibility. To comply with CGMP and ensure qualified employees, the following procedure should be followed.

III. FREQUENCY OF SOP TRAINING

Employees who transfer into jobs for which they are not already qualified must be trained on all SOPs relevant to that job during their initial training period. As new SOPs are developed or revised, training will be necessary before an employee can perform the procedure.

In addition, refresher training will be provided on an on-going basis. All SOPs relevant to the job require refresher training at least once every two calendar years (some more frequently). The specific training frequency for an SOP should be specified in the SOP under the heading "Training Frequency."

IV. TRAINING PLAN DEVELOPMENT

A. Plan Development

SOP Training plans will be developed for operational SOPs which directly impact operative level employees. Training plans should include instructions and materials to adequately deliver and evaluate training. (See sample in Appendix A, "Sample SOP Training Plan" in topic A.0.)

B. Test Validation

1. All training plans will include a concluding exercise or test designed to assess the trainee's knowledge and/or skill concerning items that are important to job performance. Tests may take several forms: pen and paper, competency (task demonstration), or a combination of both.

2. SOP tests will be assessed for content validity and reliability by the Technical Training Specialists using a minimum of three subject matter experts (SME). SMEs will be identified by department management and/or the SOP writer. All SMEs will be asked to evaluate a pool of test items related to an SOP. Each SME will rate each test item according to one of two categories: 1) Important to job performance, 2) Not important to job performance. Based on the SMEs ratings, a content validity ratio (CVR) will be calculated on each test item. Only items that have been rated as important to job performance, based on the CVR rating system established, will be used in SOP tests.

3. The test validation process is an on-going effort. Test results will be periodically analyzed to provide additional validity and reliability data. Test items will be analyzed on an on-going basis. Poor test results on a test item or section by a substantial number of employees will trigger a review of that item(s) by the Technical Training Specialist. After review, that item/section may be invalidated and training material revised as necessary.

C. Grouping SOPs

Related SOPs may be grouped together into one training plan and test. This might be appropriate for a cluster of cleaning SOPs on several rooms/lines or for a chain of SOPs that cover a sequence

of events regarding a process. The Technical Training Specialist should look at all SOPs in their areas and determine where grouping SOPs may be feasible. As with other training plans, content validation and approval by department management is required.

D. Segmented SOPs

Some SOPs may contain sections that apply to different work groups e.g. lineworkers or group leaders. In these instances, the test should contain sections that are designated for each particular group. In order to encourage everyone to understand the full scope of the SOP, employees will be asked to take the complete test but will be held accountable only for the section(s) that pertain to their job.

V. CONDUCT OF TRAINING

A. Preparation

SOP trainers should review all training materials (training plan, SOP, test questions and answers) prior to conducting a training session. The trainer must also ensure that adequate time has been scheduled to conduct the training. The estimated training time can be found on each SOP training plan. The trainer is also responsible for ensuring all materials, equipment and a suitable location have been arranged.

Several courses designed to enhance a trainer's skills in delivering training are available through the Site Training and Development (ST&D) Department.

B. Conduct

Training on operational SOPs should be conducted using the SOP training plans that have been developed and/or revised by the area Technical Training Specialist and approved by department management.

C. Test Administration

At the conclusion of a SOP training or retraining session, a validated test should be administered by the trainer to assess each employee's knowledge, understanding and/or skill concerning the SOP. After the tests have been completed and collected by the trainer, the test items and correct answers must be reviewed and discussed with all participants before concluding the session or beginning training on another SOP. All tests must be forwarded to the Technical Training Specialist upon completion of the training session.

D. Grading

Pen/paper tests must not be graded by the training participants themselves. These tests should be graded by either the trainer, supervisor or Technical Training Specialist. The individual responsible for grading the tests must be determined before the training session. If the supervisor does not grade the test, the grader should provide to the supervisor the names and grades of those who performed below the cutoff score so that follow up training can be scheduled. Tests must be graded by the end of the next work day. Test results will remain confidential at all times and will become part of the training documentation.

Competency (task demonstration) tests should be graded immediately upon test completion and feedback provided to the test participant. Follow-up training, if necessary, should be conducted according to VI.B of this SOP.

E. Cutoff Scores

Cutoff scores for SOP tests will be specified in the training plan. A cutoff score of 70% should be established for pen and paper tests. All competency (task demonstration) tests must require a cutoff score of 100%. Employees who don't meet or exceed the cutoff score on a test will not be considered "qualified" on that SOP(s). Test performance below the cutoff score will require follow-up training and another test. Employees who have not been qualified on an SOP will not be allowed to work independently until qualification is completed. This means that the supervisor must ensure that another qualified employee is responsible for coaching and/or monitoring the employee's performance on this procedure during the interim period.

VI. DOCUMENTATION AND FOLLOW-UP

A. Documentation

All SOP training activity must be documented by an attendance log which is initialed by training participants. SOP training records, including test results, should be entered into TRIAD.

Test results will be entered into EDMS or TRIAD. Training attendance will be recorded but qualification will be determined by test scores. Maintenance of these records is the responsibility of the area SOP Administrator. The Technical Training Specialist will serve as back-up for entering and retrieving records. This documentation must be maintained for seven years. The Technical Training Specialist must keep all graded tests in a locked file.

B. Follow-up Training

The supervisor must provide follow-up training and another validated test to employees who require it as soon as possible and by the end of the first available work week following the original test date. Employees who do not successfully complete the second test should be counseled concerning their progress during training and an action plan established to correct the deficiency. When applicable, Employee Relations should be consulted to determine appropriate action.


This SOP does not require training for operatives.


None


AndersonBabcockConover

Golden HodgesLaviaMosleyPerryRennWilliams

6.0 Initial Distribution List

Senior Vice President, P&E Unit Vice President, Production Vice President, Engineering Vice President, Logistics Director, MMD Director, CMD Director, MAIS General Manager, Greenville Site All P&E Managers All P&E Department Heads All P&E Supervisors All Technical Training Specialists All SOP Administrators


Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Cost Center Manager . . . . . . . . . . . . . . . . . . . . . . . 2.1 Training Frequency: C . . . . . . . . . . . . . . . . . . . . . . 3.0 List of SOP Cross References . . . . . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0

FIGURES Figures

ID: 2-6010-0042 EFFECTIVE: 07/09/92


DATED: 05/21/xx



TITLE: CGMP Training Program for Greenville Site Employees


06/05/xxST&D Supv.

06/07/xxGen. Site Mgr06/27/xxComp. Adm. Spec.

Issued by: Carney, J. Supv. SOP Oper. 07/08/91

1.0 Purpose

The purpose of this SOP is to outline the minimum CGMP training requirements for all Greenville Site employees and to provide consistency in CGMP training activities within and across divisions.

2.0 Procedure


I. RESPONSIBILITY

2.1 Cost Center Manager

CGMP training is the responsibility of the cost center manager. In performing this responsibility, assistance will be available from Human Resources, Quality Assurance, and Site Training and Development.

II. TRAINING PROGRAM

The CGMP Training Program will consist of three parts: CGMP orientation, initial CGMP training and ongoing CGMP refresher training.

A. CGMP Orientation

The purpose of CGMP orientation is to ensure that all new hires are aware of CGMPs before they report to their assigned work areas. All new employees, including temporaries, must attend CGMP orientation. CGMP orientation will be conducted by the Human Resources Department during the new employee orientation program. Upon completion of CGMP orientation, employees should know:

1. The nature of the relationship between the FDA and the pharmaceutical industry.

2. The philosophy of BW Co. concerning the responsibility of every employee to ensure quality and FDA compliance.

3. The importance of CGMPs to the production of quality pharmaceuticals.

4. The importance of SOPs to every job on the Greenville Site.

5. The importance of compliance with CGMPs and the consequences of non-compliance.

6. The necessity for documentation.

7. The range of CGMP regulations, as outlined in the various subparts of the Federal Register.

B. Initial CGMP Training

Initial CGMP training is specific training on the subparts of 21 CFR Parts 210 and 211 that relate to a person's job. This training should begin soon after employment and be complete within 90 days. It is the cost center manager's responsibility to decide which subparts (if any) are relevant to their employees and to provide sufficient training in those subparts.

NoteSite Training and Development maintains instructional materials that may be used to support initial CGMP Training.

C. CGMP Refresher Training

The cost center manager will decide which employees require CGMP refresher training and will ensure that this training is provided. All applicable employees must attend a minimum of one CGMP refresher training session per year. Quality Assurance and Site Training and Development will develop and deliver CGMP refresher training sessions. CGMP refresher training sessions should conclude with a test concerning session content.

Additional CGMP refresher training may be administered by a cost center provided that the training event is documented per this procedure.

III. DOCUMENTATION OF TRAINING

A. Responsibility for Documentation

It shall be the responsibility of Human Resources to ensure that CGMP orientation is documented immediately upon completion.

It shall be the responsibility of the cost center manager to ensure that initial CGMP training is documented immediately upon

completion.

It shall be the responsibility of ST&D to ensure that CGMP refresher training is documented immediately upon completion. In cases where CGMP refresher training is performed by the cost center, the cost center manager will be responsible for ensuring that the training event is documented.

B. Attendance Logs

An attendance log, sign-up sheet or equivalent shall be used to document all CGMP training activities.

At a minimum, this record will contain the subject and/or type of training, the date and the instructor's name.

Each employee shall verify their attendance and participation in the training activity by signing or initialing and dating the appropriate document.

C. Records Retention

Records will be retained for a minimum of seven years from the date of the training event.

Orientation training records will be maintained by Human Resources.

Initial CGMP training records will be retained by the cost center managers.

Refresher CGMP training records will be retained by ST&D.

NoteAll training records, including CGMP training, should be documented on the TRIAD (Training Records, Information and Documentation) system.




None


BalachandranBettisCochranDevGoldenHolmesLoccoMoldinPowellSeiglerWilliamsYeowell


All Greenville Cost Center Managers All Technical Training Specialists SOP Administrator, Engineering (9) Supervisor - Operative Technical Training, ST&D


Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Department Head/Supervisor . . . . . . . . . . . . . . . . . . . . 2.1 Supervisor/Trainer . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 TTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 Training Frequency: C . . . . . . . . . . . . . . . . . . . . . . 3.0 List of SOP Cross References . . . . . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0

Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0

FIGURES Figures

ID: 2-6010-0044 EFFECTIVE: 05/26/92

PICTURE 1 SUPERSEDES NO. DATED:

DEPARTMENT(S) IMPACTED: P&E


TITLE: Qualification/Requalification of Production and Engineering Unit Operative Staff


05/19/xxST&DSupv.

05/06/xx Sr. V.P.05/12/xx QADept. Hd.


1.0 Purpose

To describe the procedure for qualification/requalification of Production and Engineering operative staff. This procedure serves as the foundation for the OPTEC program.

2.0 Procedure


I. INITIAL TRAINING

Includes courses such as HR orientation, work area initial orientation/training, administrative paperwork, basic batch record documentation, basic emergency procedures, and basic safety precautions in the work environment. Testing will be conducted to verify understanding.

II. STRUCTURED ON-THE-JOB TRAINING

A. After completion of initial training, a new or temporary employee begins job training under the direct guidance of either a supervisor, lead person, or experienced operator. During this period the employee must not perform any critical job function without direct guidance/supervision until he/she is qualified on that function. Non-critical job functions are permitted (e.g. loading/unloading turn tables or conveyors).

B. Courses and SOPs include specific equipment/process cleaning operations, inspection operations, process monitoring, detailed batch record documentation, and quality issues. Testing should be completed on each of the above to ensure knowledge of operation or level of understanding of the process. After completion of training, the operator can be scheduled to operate the equipment/process.

III. QUALIFIED OPERATOR

A. An operator becomes qualified after completion of all required training (i.e. completed the training curriculum), including all SOPs required for the job and demonstrates knowledge and skill in all aspects of the job.

B. Additional courses that may be required for some operative jobs include: Statistical Process Control, Computer Literacy, HAZCOM, and Machine/Equipment Safety.

IV. REQUALIFICATION

Due to changes in equipment, processes, and the workforce, it is necessary to periodically update or renew employee qualifications. In order to renew qualifications, an operator must:

o demonstrate knowledge and/or skill concerning all SOPs relevant to

the job during the existing or previous calendar year.

o complete training on all major equipment installed since the last qualification.

o demonstrate competency in a minimum of twelve selected job skills/tasks for the job.

A. The following represent the steps to be taken for demonstrating task competency:

2.1 Department Head/Supervisor 2.2 Supervisor/Trainer 2.3 Supervisor 2.4 TTS

2.1 Department Head/Supervisor

1. Select 12 targeted tasks for the new fiscal year.

2. Announce the 12 tasks to operatives in September.

Note

During initial implementation of OPTEC, tasks will be announced as OPTEC is initially implemented. Dates for subsequent steps of requalification will be adjusted accordingly.

2.2 Supervisor/Trainer

3. Begin voluntary assessment of each task for operators requesting assessment.

2.3 Supervisor

4. If operator does not schedule assessment by December (three

months after initial announcement of targeted tasks), the supervisor will schedule the assessment.

5. All initial testing should be completed by May with the exception of those situations where equipment or processes are not available.

6. Retesting cannot occur the same day as test failure since the intention of testing is to verify ability to perform the job repeatedly. Retraining must be provided before retesting. Retesting should be within one month. The only exception should be production related situations (e.g. unavailability of equipment/process).

7. After retraining, a second failure to pass the targeted task will be treated as a performance problem. Any further disciplinary action should follow the discipline policy in the Supervisors Manual.

2.4 TTS

8. The Technical Training Specialist will maintain up-to-date records for each employee.

9. It is the intention that all 12 targeted tasks be completed within the fiscal year. Failure to complete this program will be considered a performance problem and will be reflected in the summary performance review.




None


LoccoIrwin Horn CappsClemmonsEbronEsareyPerryMooreCharlton


All Department Heads and Above, P&E Unit Supervisor, OTT, ST&D All Technical Training Specialist SOP Administrator, Site

CONTENTS Table of Contents Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . . 2.1 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.4 Reviewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.6 Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.8 Technical Training Specialist (TTS) . . . . . . . . . . . . . . . 2.9 Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . 2.10 Approver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.11 Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . 2.12 Supervisor, SOP Operations/Administrative Secretary, SOP Adminis 2.13 Holders of Official SOPs . . . . . . . . . . . . . . . . . . . . 2.14 Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.16 Supervisor, SOP Operations/Administrative Secretary, SOP Adminis 2.17 SOP Author . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.18 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.19 SOP Author . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.20 Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . 2.21 SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.22 Training Frequency: C . . . . . . . . . . . . . . . . . . . . . . 3.0 List of SOP Cross References . . . . . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0

ID: 2-6466-0001 EFFECTIVE: 11/6/92


DATED: 05/15/92



TITLE: P&E Administration of Standard Operating Procedures (SOPs), and General Administrative Procedures (GAPs)


10/27/xxDept. Hd.

10/29/xxSr. V.P.10/30/xx Sect. Hd., QA


1.0 Purpose

This Standard Operating Procedure (SOP) outlines the process and responsibilities associated with the creation, review, approval, control and distribution of SOPs and General Administrative Procedures (GAPs).

SOP Definition: An SOP is a company procedure that has regulatory impact (e.g., FDA, OSHA, EPA, DEA, ATF, DOT) on operations.

GAP Definition: A GAP is a company administrative procedure that does not have regulatory impact on company operations. Examples of appropriate GAP topics are listed below:

o Budgeting

o Requests for Engineering Services (RES)

o Communications Procedures

o Time Card/Overtime Procedures

o Handling Text Control Center Documents

o Targeted Selection Procedures

o Requesting Media Center Services

2.0 Procedure


I. SOP CONTROL

Standard Operating Procedures are controlled documents. Control is achieved through the use of standard procedures for SOP identification, review/approval, distribution and recall.

The SOP Administrator is responsible for ensuring that only procedures essential for regulatory compliance and business need are given SOP status.

An electronic document handling system is used to create, process, maintain, and control SOPs. Individuals responsible for building SOP's for review/approval and processing them through the electronic system should refer to the DCME User's Guide and the Critical Documentation Formats document for information on these functions. The DCME User's Guide may be viewed or printed through DCME on GVLCMS. The Critical Documentation Formats document may be viewed or printed through BKMPE on GVLCMS.

Individuals responsible for writing, reviewing, and approving SOP's should refer to the BookManager User's Guide for information on

performing these functions and the software/hardware requirements.This Guide may be viewed on-line or printed through BKMSOP on GVLCMS. Training for BookManager may be scheduled through the Site Training and Development Department.

Another resource document entitled "BookMaster Symbol and Tag Requirements for BookManager," is available through BKMSOP on GVLCMS and should be referred to as necessary by all individuals involved in the creation, processing, maintenance, and control of SOPs.

II. SOP IDENTIFICATION

Before an SOP is created on-line, it is assigned a unique identification number by the SOP Administration Department. Once assigned, the identification number shall not be reused. An SOP is numbered with nine characters:

First position: 1 (intra-departmental impact) or

2 (inter-departmental impact)

Next 4 positions: The Originator's cost center

Last 4 positions: Unique sequential number for the cost center or generating division.

III. SOP REVIEW/APPROVAL

An SOP shall be reviewed at least once annually. The annual review/approval process is initiated by the SOP Administration Department and is scheduled around the SOP anniversary month. The area SOP Administrator notifies the Author when an SOP is scheduled for an annual review and requests an initial update to the SOP and an electronic author response prior to routing the SOP to the Reviewers for comment.

When a new SOP is created or an existing SOP is revised in preparation for a change in operations, the review/approval process is initiated by the SOP Author. The Author notifies the area SOP Administrator with a draft of the new or revised SOP. Once initiated, the review/approval process is the same as it is for an annual SOP review. Any exceptions to this is noted in Section III.A of this procedure. A description of the annual SOP review/approval process and corresponding roles and responsibilities follows:

Note

SOP Reviewers and Approvers should take no more than five working days to complete the review/approval of an SOP. If a Reviewer or Approver is planning to be away from work for a period exceeding five working days, he/she should delegate SOP responsibilities to an appropriate individual and notify the area SOP Administrator or the Supervisor, SOP Operations.

A. SOP Review Cycle

2.1 Supervisor, SOP Operations 2.2 SOP Administrator 2.3 Author 2.4 SOP Administrator 2.5 Reviewer 2.6 SOP Administrator 2.7 Author 2.8 SOP Administrator 2.9 Technical Training Specialist (TTS) 2.10 Supervisor, SOP Operations 2.11 Approver 2.12 Supervisor, SOP Operations 2.13 Supervisor, SOP Operations/Administrative Secretary, SOP Administration2.14 Holders of Official SOPs 2.15 Author 2.16 SOP Administrator 2.17 Supervisor, SOP Operations/Administrative Secretary, SOP Administration2.18 SOP Author 2.19 SOP Administrator 2.20 SOP Author 2.21 Supervisor, SOP Operations 2.22 SOP Administrator

2.1 Supervisor, SOP Operations

1. Identify SOPs requiring annual review using the INQUIRE database and notify the SOP Administrators.

2.2 SOP Administrator

2. Initiate the SOP annual review by notifying the SOP Author and

requesting an initial update and electronic author response prior to routing the SOP to the Reviewers.

2.3 Author

3. Review the SOP on-line or from a printed hard copy and make modifications as appropriate to the following:

Note

All SOPs require the information outlined in this section (III.A.3). It is the responsibility of the SOP Author to provide the information when creating a new SOP or revising an SOP due to anticipated changes in operations, i.e., an Author initiated review.

a. SOP content and title. (Reference G-6010-010)

b. Photos or drawings

c. Departments Impacted

d. SOP Approvers

e. List of Cross References

f. List of Reviewers

g. Initial Distribution List

h. SOP Training Frequency

i. The Training Frequency options and definitions are as follows:

a) Training Frequency A - This SOP requires refresher training for operatives once every calendar year or when a significant change in content occurs.

b) Training Frequency B - This SOP requires refresher training for operatives once every two calendar years or when a significant change in content occurs.

c) Training Frequency C - Training applicability and intervals for this SOP will be determined by area supervision.

Note

Training Frequency A and B should only be used when an SOP directly impacts the job(s) of operative or craft personnel.

4. Using the BKMSOP Author Response, notify the SOP Administrator when the review is complete.

Note

When the SOP review process is initiated by the SOP Administrator, the on-line system requires an electronic author response to continue the review process.

5. Submit any SOP revisions to the SOP Administrator on a red lined hard copy of the procedure or send revision notes electronically. All review materials and electronic review responses are maintained by the SOP Administrator until the next update of the SOP.

Note

Electronic revision notes can only be sent if the SOP Administrator initiates the review process. When the Author revises an SOP in anticipation of a change in operations, a red lined hard copy should be provided to the SOP Administrator. New SOPs may be submitted to the SOP Administrator in handwritten or typed form. If the Author uses his/her personal computer to write a new SOP or to rewrite an existing SOP, a copy of the procedure and the computer diskette should be provided to the SOP Administrator.


6. Process SOP and route for review.

a. Advise the Author on the revision of the SOP Reviewer, Approver, and Initial Distribution Lists.

b. Type the SOP or any revisions or arrange work to be performed by the Text Control Center (TCC). Coordinate scanning and graphics work through TCC.

c. Ensure that the reading levels of operational SOPs meet the established guidelines for the areas impacted by the SOP. Request definitions for complex technical terms from the author.

i. Set the reading level below the 11th grade for SOPs impacting CMD, Instrumentation, and Production Mechanics.

ii. Set the reading level below the 10th grade for all other areas.

NOTE The established reading levels apply only to those SOP's requiring operative/craft training.

d. Send an electronic review request and route the SOP to the Reviewers for their review and comments.

Note

SOPs may be routed for review either manually (hard copy), electronically or through a combination of these methods.

2.5 Reviewer

7. Serve as the SOP subject matter expert.

a. Review the SOP content for accuracy and completeness.

b. Forward review notes indicating suggested revisions to the SOP Administrator as necessary.

Note

Review notes may be forwarded electronically or on hard copy.

c. Using BKMSOP, perform the review response for the SOP. This electronic response is automatically sent to the SOP Administrator.

Note

The on-line system requires an electronic response from each reviewer before the SOP can be sent to the approval process.


8. Expedite the review process.

a. Receive review notes indicating suggested revisions from the SOP Reviewers (hard copy or electronically).

b. Follow up with Reviewers who have not responded within five working days.

c. Organize review notes and forward to the SOP Author.

2.7 Author

9. Incorporate suggested modifications.

a. Read Reviewer comments and modify SOP as appropriate.

b. Resolve any disagreements with the Reviewers prior to forwarding final modifications to the SOP Administrator.

c. Forward modifications and all Reviewer comments to the SOP Administrator.

Note

The author is responsible for deciding whether an SOP

requires re-routing for followup review prior to being sent to the approval cycle. Depending on the circumstances, an SOP may need to be re-routed to gain agreement on significant or controversial changes to an SOP following the initial review.


10. Type SOP revisions as specified by the SOP Author.

11. Re-route the revised SOP for review upon the request of the SOP Author.

12. When the review cycle has been completed, move the SOP to the on-line library appropriate for approval routing and notify the SOP Center to initiate the approval cycle.

Note

Operational SOPs in the P&E Unit are forwarded to the area Technical Training Specialist for training impact review prior to being sent to the approval cycle. The SOP Administrator provides the author's definitions of terms to the Technical Training Specialist for training plan development/revision.

2.9 Technical Training Specialist (TTS)

13. Within the P&E Unit, serve as a Reviewer for operational SOPs focusing on training issues for operative/craft personnel. (Reference SOP 26010041).

a. Review operational SOP for training applicability.

b. Establish and maintain the SOP Revision Code.

c. Create SOP training plan and test or revise existing materials as necessitated by SOP revisions.

d. Move the SOP to the on-line library appropriate for

approval routing and notify the SOP Center to initiate the approval cycle.

B. SOP Approval Cycle


1. Initiate the approval cycle.

a. Verify the accuracy of preassigned SOP number, the final format, approval list and distribution list.

b. Verify that all sections of the SOP Header have been prepared, e.g., Departments Impacted.

c. Electronically route the SOP for approval.

Note

The list of Approvers for an SOP should include the Author, the manager responsible for all areas impacted by the SOP, and the manager responsible for ensuring regulatory compliance or advising on compliance issues.

Agency Approver

FDA QA management and as appropriate managers representing Validation and/or PRDL

OSHA Manager, OH&S

EPA Manager, Environmental Services

DEA Department Head, Traffic

ATF Department Head, PDD

DOT Department Head, Traffic

2.11 Approver

2. Give authority for implementing the SOP.

Note

The SOP should not be modified during the Final Approval unless the changes are of substance to the subject matter.

a. Using BKMSOP, perform an electronic approval response for the SOP. If modifications are requested, include a comment in the approval response.


3. Expedite the Approval Process

a. Receive electronic approval responses from the SOP Approvers.

Note

Any changes to the SOP during the approval cycle voids all approvals received, requiring the SOP to be re-routed for approval. Major modifications require that the SOP be sent back through the Review Cycle with all previous approvals removed.

b. Consult with the SOP Author on requested modifications.

Note

The SOP Author modifies the SOP according to the Approver requests as appropriate and notifies the TTS of the SOP modifications.

c. Correct minor text changes or spelling errors through TCC.

d. Move the SOP requiring major changes to the appropriate on-line library and notify the SOP Administrator to initiate the review cycle.

e. Maintain the Approver notes until the SOP is reviewed and updated on next update cycle.

f. Establish an effective date upon receipt of the final SOP approval and issue the SOP for distribution.

g. On the SOP effective date, move the SOP to the appropriate library for on-line storage and viewing of the official document.

IV. SOP DISTRIBUTION AND RECALL

A. SOP Center Responsibilities


Note

Anyone with the appropriate hardware/software having access to GVLCMS may view the official SOP on-line through BKMSOP. An "Informational" copy of the SOP may be printed from the on-line system by anyone having access to GVLCMS. An "Informational" copy is defined as an "Unofficial" copy of an "Official" SOP. Informational copies are not controlled and therefore will not be referenced or used to perform company operations. If the effective date on an "Informational" copy is the same as that on the "Official" SOP, the "Informational" copy may be used to start changes to the "Official" SOP.

2.13 Supervisor, SOP Operations/Administrative Secretary, SOP Administration

1. Print approved SOP original, make copies, and stamp each in red with the following information:

OFFICIAL COPY Do No Duplicate Do Not Destroy

Retain Until Recalled

2. Forward a hard copy of the approved SOP to the Quality Assurance Division for handwritten signature.

3. Prepare distribution memorandum and distribute hard copies of the official SOP as specified by the SOP Initial Distribution List.

4. Electronically notify Department Heads and above of the approved SOP if required by the SOP Initial Distribution List.

5. File official SOP in the central filing system.

6. Forward outdated official SOP to the Records Management Department for retention.

7. Refer to the Initial Distribution of the outdated SOP(s) and recall all outdated SOPs.

8. Verify that each Holder of an outdated SOP has responded to the Recall notice.

9. Dispose of outdated official SOPs according to company policy.

B. Responsibilities of the Holders of Official SOPs

Note

Holders of an Official SOP are responsible for its safekeeping until its return is requested by the SOP Center. "Official" SOPs are not to be written on or duplicated.

2.14 Holders of Official SOPs

1. Verify receipt of the approved SOP by completing the appropriate section of the distribution memorandum and forwarding it to the SOP Center.

2. Implement the SOP on its effective date.

3. Respond to requests for outdated SOP(s) by completing the "Outdated SOP Return Status" section of the distribution

memorandum and return it with all requested outdated SOPs to the SOP Center on the SOP effective date.

V. SOP CANCELLATION

An SOP may be cancelled when it is no longer applicable to the operations. The procedure for cancellation and recall is described below:

2.15 Author

A. Notify the SOP Administrator or the Supervisor, SOP Operations when an SOP is cancelled.

1. The author must provide a reason for the cancellation.

2. Notification should be put in writing using PROFS or using the on-line author response form for the author initial review.


B. Notify the SOP Center when an SOP has been cancelled and destroy SOP file.

2.17 Supervisor, SOP Operations/Administrative Secretary, SOP Administration

C. Notify the individuals on the Initial Distribution List and recall all official hard copies.

D. Move the SOP to the on-line library appropriate for historical documents.

E. Forward an official hard copy of the cancelled SOP to the Records Management Department for retention.

VI. SOP HOLDS

A. The SOP Author may place an SOP on hold during the annual review

process for the following reasons:

1. Writing a new SOP that will impact SOPs in process.

2. Waiting for a decision to cancel the SOP.

3. Waiting for replacement equipment/parts to be received so that an assessment can be made regarding the impact to the SOP.

4. Collecting product or operations data that will impact the procedure.

5. Waiting for validation completion.

6. Auditing SOP and comparing it with a pending process.

7. When several SOPs need to be approved as a group.

8. Waiting for decisions regarding changes to the procedure.

An SOP is effective and shall be followed until it is revised or cancelled. The procedure for placing an SOP on hold is described below:

B. SOP Review Cycle

2.18 SOP Author

1. Respond to the annual review request by indicating that the SOP should be placed on hold. Provide justification in the comment section of the response note.


2. Receive notification from the author stating to place the SOP "On Hold" and reason.

3. Review justification and remove the SOP from the review process as appropriate.

4. Note the hold status in the SOP Tracking Log and file.

5. Follow up every two weeks with the author.

6. When the SOP is removed from "On Hold" status, start the review process again.

C. SOP Approval Cycle

2.20 SOP Author

1. Forward a PROFS note to the SOP Center to request that an SOP be placed on hold. Indicate the reason for the "On Hold" status.


2. Review the request for "On Hold" status and remove the SOP from the approval process as appropriate.

3. Return the SOP to the on-line library appropriate for the review cycle.

4. Notify the SOP Administrator to place the SOP on hold.

5. Note the hold status in the SOP Tracking Log and file.

6. Follow up every two weeks with the SOP author.

7. When the SOP is removed from "On Hold" status, start the review process again.

VII. GAP CONTROL

General Administrative Procedures are processed using the same electronic document handling system as that used for the SOPs. GAPS, however, are not controlled in the same manner as SOP documents. A GAP is not distributed as a hard copy with a controlled distribution and hard copies printed from the system are not tracked for recall.

VIII. GAP IDENTIFICATION

A unique identification number is assigned to a GAP by SOP Administration before the procedure is created on-line. Once assigned, the identification number is not reused. A GAP is numbered

with eight characters:

First position: G

Next 4 positions: The Originator's cost center number

Next 3 position: Unique sequential number for the cost center or generating division.

IX. GAP REVIEW/APPROVAL

The review/approval process and the associated responsibilities are the same for GAPs as they are for SOPs. Exceptions to this are outlined below:

A. Frequency of Review

The GAP Author defines how frequently a GAP needs to be reviewed. Each GAP is reviewed at least once every three years. The author may choose a 1, 2, or 3 year cycle.

B. GAP Training

There is only one training frequency for GAPs. The statement is inserted automatically into the document. The GAP Training Frequency is presented below:


"Training applicability and intervals for this GAP will be determined by area supervision."

Technical Training Specialists in the P&E Unit do not develop training plans or tests for GAPs. If a training plan/test is necessary, it is the Author's responsibility to provide.

C. GAP Approval

The GAP Author and the manager responsible for all areas impacted by the GAP serve as the approvers. No other approvals are necessary.

D. GAP Distribution

The SOP Center electronically notifies the Initial Distribution

List of an approved GAP. No hard copies are distributed or recalled. Individuals may view or print the GAP through BKMSOP on GVLCMS.

X. SOP/GAP CATALOG

A catalog of all SOPs and GAPs is updated and maintained by the electronic document handling system. Anyone with access to GVLCMS can view or print the catalog through BKMSOP.

XI. SOP/GAP CROSS REFERENCING

Upon request, the SOP Administration Department conducts cross reference searches of SOPs and GAPs through the INQUIRE database. This service is particularly useful when an Author needs to decide whether to create a new SOP/GAP or to combine a new procedure with an existing SOP/GAP.




GAP #G-6010-010, "Writing Standard Operating Procedures and General Administrative Procedures" SOP #2-6010-0041, "SOP Training, Testing, and Follow-up"


Carney Ferrante, Haddock McCoy McLawhorn Winter

§211.25 Personnel qualifications.

(a) Each person engaged in the manufacture, processing packing,or holding of a drug product shall have education training,

and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) they relate to the employee's functions. Training in current goodmanufacturing practice shall be conducted by qualified individualson a continuing basis and with sufficient frequency to assure thatemployees remain familiar with CGMP requirements applicable tothem.(b) Each person responsible for supervising the manufacture,processing, packing, or holding of a drug product shall have theeducation, training, and experience, or any combination thereof, toperform assigned functions in such a manner as to provide assurancethat the drug product has the safety, identity, strength, qualityand purity that it purports or is represented to possess.(c) There shall be an adequate number of qualified personnel toperform and supervise the manufacture, processing, packing orholding of each drug product.

CONTENTS Table of Contents Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 Training Frequency . . . . . . . . . . . . . . . . . . . . . . . . . 3.0 List of Cross References . . . . . . . . . . . . . . . . . . . . . . 4.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0

FIGURES Figures

ID: G-6010-0010 EFFECTIVE: 16/17/xx

PICTURE 1 SUPERSEDES NO.G-6010-0010

DATED: 09/19/xx



TITLE: Writing Standard Operating Procedures and General Administrative Procedures


06/10/xxDept. Hd.

06/10/xxSr. V.P.

Issued by: SOP Oper. 06/10/xx

1.0 Purpose

The purpose of this GAP is to provide content and format guidelines for SOPs and GAPs.

NOTEA course on SOP Writing, reflecting these guidelines, is offered through the Site Training and Development Department.

2.0 Procedure


I. GUIDELINES FOR WRITING A PROCEDURE

First, decide if a formal procedure is necessary. A procedure created for a short-term project or company event may best be communicated through some form of general notification to the target audience. It may not need formal status because it has a definite beginning and end with no long range impact on company operations. If a formal procedure is required, the next step is to determine if it should be a Standard Operating Procedure (SOP) or a General Administrative Procedure (GAP). An SOP is defined as any procedure having regulatory impact. A GAP is defined as any administrative procedure with no regulatory impact. (See SOP 2-6010-0038 for further explanation.) SOPs and GAPs are created and maintained on ProcessMaster - VM Edition.

II. CONTENT

Following is a list of content guidelines to be followed in writing SOPs and GAPs.

A. Provide a short and concise title, limited to one line. B. Provide a brief statement of purpose to explain what the procedure is designed to accomplish.

C. Identify Departments impacted by the procedure.

D. Use headings that tell the reader how the document is organized and what is discussed in the text that immediately follows.

E. Utilize graphics and photographs to illustrate a point.

F. Identify switches and controls precisely as they appear on equipment.

G. Prepare the following lists.

1. Cross References for SOPs and GAPs.

2. Reviewers.

3. Initial Distribution.

H. Use the same tense and structure for all steps, headings, and instructions.

I. Begin procedural steps with action verbs, e.g., start, push, prepare. Use the active voice and the present tense consistently.

J. Use specific and concrete language. Avoid vagueness and ambiguity.

K. Use simple words and short sentences.

L. Do not omit articles, prepositions, and relative pronouns just to save space.

M. Write positive sentences. Avoid multiple negatives.

N. Use lists for items in sequence.

O. Make the writing sound conversational.

P. Standardize terms.

Q. Ensure SOP is written at the appropriate reading level established for operational SOPs (refer to SOP #2-6010-0038).

III. FORMAT

Following is a list of format guidelines to be followed in writing SOPs and GAPs.

A. Write procedure in step by step format. Generally, each step should contain one action only.

B. Procedure number and revision date will automatically be located in the lower left hand corner of each page.

C. In the lower right hand corner will be the page number (e.g., page 1 of 6).

D. The title will be listed at the top of each page following page 1.

E. A purpose will be stated after the signature box.

F. Primary headings will be placed on the left margin, in all capital

letters and bold.

G. Do not right justify margins.

H. Complex steps in the procedure may be followed by substeps.

I. Steps will be numbered consecutively under each primary heading with Roman numerals.

J. Substeps will be indented under step and labeled with upper case letters. In many cases SOP/GAP, substeps continue into Arabic numbers and lower case letters, and even into lower case Roman numerals.

K. Operational SOPs (identified through the numbering system by a prefix of 1 or 2) will use "Responsibility" and "Action" sections. These will not be listed as column headings.

L. There will be uniform amount of blank space on the left hand side of each page to allow for listing who is responsible.

M. If the SOP or an individual action does not apply to a particular job title, the term "Designated Individual" should be written in the left hand column.

N. Approval signature boxes will be located at the top of the page.

O. Title and signature box will remain a uniform size for each SOP and GAP.

P. Any graphic, figure or photograph corresponding to a particular procedure should be placed within the text, as close as possible to the procedure identifying the item.

Q. Label illustrations consecutively throughout the document, beginning with Figure 1.

R. Center small illustrations in the right-hand column of the text.

S. Enclose illustrations in boxes that align with boxes used for notes. If the referenced item is too long (i.e., one page or over) or needs to be an appendix (e.g., if it relates to the entire procedure), it may be listed as an appendix and placed at the end of the procedure.

T. Warnings and exceptions should be noted outside the steps or text.

Use only three titles: Note, Exception, and Warning.

U. If a note or warning relates to the entire procedure, the item should be listed in a box immediately beneath the "Purpose" section.

V. Generally, put notes and warnings above the steps they refer to, and put exceptions below them.

3.0 Training Frequency

Training applicability and intervals for this GAP will be determined by area supervision.

4.0 List of Cross References

SOP #2-6010-0038, "Administration of Standard Operating Procedures and General Administrative Procedures"


Carney McLawhornMcLawhornCONTENTS Table of Contents

Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE

Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS

Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 List of Cross References . . . . . . . . . . . . . . . . . . . . . . 3.0 List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 4.0 Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 5.0

Appendix A. Training Authorization Form . . . . . . . . . . . . . . A.0

Appendix B. TRIAD Employee Profile Worksheet . . . . . . . . . . . B.0

Appendix C. Pending Training Sign Off Report . . . . . . . . . . . C.0

Appendix D. Training Attendance Sheet . . . . . . . . . . . . . . . D.0

Appendix E. Training Attendance Sheet Instructions . . . . . . . . E.0

FIGURES Figures

To see the picture, enter PICTURE GAP2

ID: G-6901-001 EFFECTIVE: 01/21/xx REVIEW CYCLE: 1 year

SUPERSEDES NO. DATED:

DEPARTMENT(S) IMPACTED: P&E

TITLE: Maintenance and Administration of the TRIAD System (P&E Unit)


Getsinger,. Cipau,

Supv., ST&D Sr. V.P., P&E

Issued by: Ward. GAP Adm. 01/18/xx

1.0 Purpose

To provide for consistent entry, storage and retrieval of training records and other information from the TRIAD (Training Records Information and Documentation) System and to identify responsibilities concerning the operation and maintenance of the system.

INTRODUCTION: The TRIAD System is a mainframe relational database system that is used to record work-related training and experience of B.W. Co. employees. This information is collected to assist in the determination of individuals' qualifications to perform work assignments.

TRIAD allows for the following functions:

I. Document the training each employee has received.

II. Record training information by training type: Orientation, SOP, CGMP, Technical, Safety and External.

III. Link training requirements to specific jobs or job codes.

IV. Establish frequencies for refresher training.

V. Track the pending training each employee needs to comply with job training requirements.

VI. Identify employees who have had specific training.

In addition, the TRIAD System stores certain basic employee information such as cost center, supervisor's name, and date started present job. Other information such as project team experience, degrees, and membership in professional organizations is also stored in TRIAD.

Note

Training records prior to January 1, 1990 are not stored in TRIAD. Hardcopies of training records prior to 1990 are maintained in Records Retention. Computerized records may also be found on previous computerized training record systems such as the Employee Data Management System (EDMS). In the P&E Unit, these records may be located by contacting the area SOP Administrator.

2.0 Procedure


I. RESPONSIBILITY

Responsibilities concerning the TRIAD System are as follows:

Who Responsible Action

Supervision/Management View records/reports for accuracy and completeness in order to determine employee qualifications. Notify the area TechnicalTraining Specialist or SOP Administrator as soon as possible of job transfers and new hires to prompt updates to TRIAD.

SOP Administrator * Serve as the TRIAD Operator. Enter and update system information, employee trainingrecords and profile information.

Technical Training Maintain an up-to-date list of training Specialist requirements by job code. Monitor TRIAD

information to ensure regulatory compliance

MAIS Provide system support. Update the user manual as needed.

Site Training and Provide on-going end-user training. EnteDevelopment (ST&D) training attendance records for ST&D-spon

courses. Distribute TRIAD user manuals.

* The TRIAD Operators in Logistics and P&E Administration are the Technical Training Specialist and the Site Administrative Specialist.

II. SYSTEM ACCESS

In order to use TRIAD you must:

A. Have access to the CICS production system and

B. Have access to the CICS production transaction "TRAD". TRAD is a transaction code that allows you into the TRIAD database.

Note

Use USA Form 1090 CICS/VS TRANSACTION SECURITY REQUEST FORM to request access to these transactions.

III. TRIAD SYSTEM TRAINING

A. On-going training on the TRIAD System is offered through the Site Training and Development Department. You may register through normal course registration procedures or by calling the ST&D Training Coordinator at extension 2476.

IV. NOTIFICATION OF NEW HIRES AND JOB TRANSFERS

It is the Supervisor's responsibility to notify the area Technical Training Specialist with a Training Authorization Form (Attachment 1) of any new hires and job transfers under their supervision. This notification is needed as soon as possible so that TRIAD records can be updated and training plans can be prepared, if necessary.

The Technical Training Specialist is responsible for notifying the TRIAD System Operator so that TRIAD information can be updated.

V. UPDATING EMPLOYEE PROFILE OR TRAINING INFORMATION

It is each Supervisor's responsibility to ensure that their employee's training records and other information remain accurate and up-to-date. Whenever employees receive training (required or otherwise), new degrees, or join new project teams or professional organizations, the Supervisor should notify the TRIAD Operator immediately by completing a TRIAD Employee Profile Worksheet (Appendix B, "TRIAD Employee Profile Worksheet" in topic B.0). SOP refresher training should be submitted by completing a TRIAD Pending Training Signoff Report (Appendix C, "Pending Training Sign Off Report" in topic C.0). Other

training should be submitted by completing a Training Attendance Sheet (Appendix D, "Training Attendance Sheet" in topic D.0). ST&D-sponsored classes will be entered into TRIAD by ST&D.

Although updates are made to TRIAD records on an on-going basis, a review will be done at the beginning of each calendar year. A TRIAD report will be distributed to all employees who have records in the TRIAD system. It is the employee's responsibility to review this information and notify the TRIAD operator of any inaccuracies in the report.

VI. REPORTS

There are many different reports that can be viewed on screen or sent to a mainframe printer. These reports are described in the TRIAD User's Manual.

In order to print reports, you must contact the MAIS Systems Support Department and provide the VTAM ID of the terminal and printer you wish to use.

There are two batch reports that can be run for entire cost centers. These reports are the Pending Training Sign Off Report and the Employee Profile Report. To receive one of these reports, contact the area TRIAD Operator or ST&D.

3.0 List of Cross References

None


Williams Hardee. Taylor,


All P&E Department Heads and Above All Technical Training Specialists All SOP Administrators ST&D Office Manager

TRAINING ATTENDANCE SIGN-OFF FORM

DATE: ____________________

PROCEDURE NUMBER/TITLE:

REVISION CODE: EFFECTIVE DATE:

INSTRUCTOR:

(Instructor's BW Co. Employee No.)

COURSE DESCRIPTION:

(Complete this section for external, new or non-standard training)

Employee

NumberEmployee Name

CostCente

r

Completed

(i or c)

Employee

Initials

1. Complete the heading information. This information must be correct and complete in order to document the training on the TRIAD system. THE TRAINING START DATE MUST BE ENTERED.

2. Enter their employee number, name and cost center. Have each employee initial the attendance sheet at the completion of training.

3. At the completion of the training the instructor should complete the grading portion of the sheet. If the training concludes with a test a numerical grade must be included, otherwise only the completed (c) or incomplete (i) status is needed.

4. Submit the completed form to Toni, ST&D, Bldg. xx, for entry into the TRIAD (Training Records and Information Administration) system.

INCORRECT AND INCOMPLETE DOCUMENTATION WILL BE RETURNED TO THE TRAINER

TRAINING ATTENDANCE SHEET INSTRUCTIONS

USE BLOCK LETTERING ONLY AND ENSURE THAT ENTRIES ARE LEGIBLE

DATE: The date that the training actually took place. If the training involves multiple dates, please enter the beginning date.

PROCEDURE NUMBER/ TITLE: For SOP training enter the SOP number only, otherwise enter the formal course title.

REVISION CODE: Enter the revision code from the header of the procedure. GAP's will always be 00.

EFFECTIVE DATE: Enter the effective date from the header of the procedure. There must be an appropriate effective date in order to document training.

INSTRUCTOR: Enter the instructor's BW Co. employee number

COURSE DESCRIPTION: Complete this entry for new programs, one-time-only training not already on TRIAD, and external training.

Employee Number: Enter the employee's BW Co. employee number. For vendors or contract employees make an appropriate entry.

Employee Name: Enter the Last Name, First Name of the person(s) being trained.

Cost Center: Enter the cost center of the person(s) being trained.

Completed: Enter an "i" if the training is incomplete or a "c" if the training is complete.

Employee Initials: Each employee should initial the attendance sheet when he/she has completed the training, verifying the "i" or "c" entry.

Wellcome

JOB DESCRIPTIONU 1300 5/92

INSTRUCTIONS ON HOW TO COMPLETE THIS FORM CAN BE FOUND IN THE SUPERVISORS MANUAL

Job Title Unit Dept. Cost Center RTP

Technical Training Specialist/Regulatory Training Compliance - P&E Unit P/E ST&D 6901 X GVL

Other

This job description supersedes all previous job descriptions for Compensation Dept. Use Only: Exempt X

this position. Management retains the discretion to add to or Grade Code ________________ Nonexempt

change the duties at any time.

JOB SUMMARY

Briefly state the main purpose of and basic responsibilities of the job.

To provide technical and administrative facilitation for the design, development, coordination, and delivery of technical training within Production and Engineering Unit to ensure regulatory compliance relative to personnel training and qualification.

JOB DUTIES AND RESPONSIBILITIES

List in order of importance and/or frequency of occurrence each predominant and significant duty, task, or responsibility. Indicate if the job duty is essential (yes), which means that removing the function would fundamentally alter the job, or not essential (no). For each major job duty list the most important knowledge, skill, or ability (K, S, A) required to accomplish the duty.

JOB DUTIES

ESSENTIAL DUTIES

(YES/NO) REQUIRED K, S, A'S

Assess training needs at the job/individual/team/and organizational levels. Provide direction and support for line management, task forces, committees, natural work teams, project start-up teams and project engineering to design, develop and deliver training plans and materials for existing operations, new processes, automation, and equipment installations.

Yes Knowledge of pharmaceutical manufacturing, engineering and distribution disciplines and the basic principles of each. This includes ability to understand engineering drawings, operating manuals, process chemistry and automation/computer logic.Oral & written communication skills.Knowledge of all regulatory training requirements.Problem Analysis and Decision Analysis skills.Interaction skills.Leadership skills.Adult Learning principles and practice.Instructional Design Process and current technology.

Develop and validate procedural training plans/courses/training tools/training evaluation tools for regulatory controlled processes, automation and equipment specific training for operative, supervisory, technical, professional and management staff in P&E Unit.

Yes Same as above.

Observe & analyze key P&E Unit operations to recognize potential problems and opportunities. Advise

Yes Knowledge of key P&E disciplines and basic principles. Includes ability to understand engineering

management of recommendations for procedural changes and provide training solutions.

drawings, operating manuals, process chemistry & automation/computer logic.Knowledge of key operations.

Ability to recognize potential problems and opportunities, develop and implement effective action plans.

JOB DUTIES

ESSENTIAL DUTIES

(YES/NO) REQUIRED K, S, A'S

Develop recommendations for value-added improvements on regulatory controlled procedures, processes, equipment and training to ensure product quality and employee safety and gain the approval of line management and ST&D Technical Training Section Head.

Yes Knowledge of CGMPs and other regulations.Attention to detail.Knowledge of safety procedures.Knowledge of SOPs.

Problem analysis skills.

Serve as "subject matter expert" for appropriate training duties and responsibilities when necessary.

Yes Knowledge and skill of operations.Technical instruction skills.

Interact with all levels, skills, crafts and disciplines in P&E Unit on a regular basis to ensure effective communication of training needs & concerns.

Yes Leadership and interactions skills.Instructional assessment and design skills.

.Develop and submit technical training regulatory compliance reports to line management as well as ST&D summarizing all technical training activities.

Conduct annual review of all technical training for regulatory compliancewith line management.

Interact with line management to prepare annual training plan and budget based on scheduled projects identifying actions, resources, target dates and priority.

Develop and enhance training contacts within the pharmaceutical industry, educational institutions, training consulting firms and regulatory agencies to help identify and provide regulatory training in the most value-added and timely way.

Meet attendance requirements for job.

Yes

Yes

Yes

Yes

Yes

Knowledge of TRIAD system.Planning & organizing skills.Oral & written communication skills.Attention to detail.

Planning & organizing skills.Oral & written communication skills.Attention to detail.

Knowledge of budget system.Initiative.

Leadership and interaction skills.Regulatory compliance knowledge.Consulting and research skills.Public relations skills.Organizational and personal sensitivity.

Ability to attend work regularly.

PROBLEM SOLVING AND DECISION MAKING

In the first column describe three or four of the most important problems that the job incumbent must solve or decisions that must be made to achieve the primary objectives of the job. For each problem, indicate in the second column the checks or controls that exist to help improve the quality or accuracy of the problem-solving/decision-making process. Then, in the third column, estimate the potential impact these problems/decisions can have on the department/unit or Company if handled correctly or incorrectly.

Problem/Decision Checks/Controls Potential Impact

Determine if training is being provided and properly documented to meet regulatory requirements.

Internal audits, tests and assessments. Management, ST&D & QA Compliance Reviews. Regulatory agency review.

FDA non-compliance; EPA non-compliance; Quality/Safety problems on the job. Financial loss.

Determine if controlled procedures are clear, concise and correct. and that sufficient instruction for personnel qualification is achieved.

Determine the level and approach to training for changing technology, equipment and regulations.

Same as above.

Management, QA Compliance and ST&D management review and approval. Regulations.

FDA non-compliance; EPA non-compliance; Quality/Safety problems on the job. Financial loss.

FDA non-compliance, EPA non-compliance; Quality/Safety problems on the job. Financial loss.

CONTACTS WITH OTHERS

List the most significant interactions that the job has within the Company (other than the immediate supervisor and the subordinates) and outside the Company. Under "Purpose of Contacts" indicate the reason why the contacts are made and why they are important to B.W. Co.

Title of Contact Purpose

Vice Presidents, Directors, Department Heads, supervision, operatives, and professional , technical and administrative staff.

To provide technical and administrative facilitation for the design, development, coordination and delivery of technical training to ensure regulatory compliance relative to personnel training and qualification..

ST&D personnel To seek assistance/advice in completion of projects; work jointly on technical training projects.

P&E Project System

Project Engineering

QA Compliance and Technical Development

Regulatory Agency Investigators

Educational Institutions

Pharmaceutical industry and professional associations

To keep training current with the development and implementation of new technology and equipment.

To gather information for program/course/procedure development.

To partner for cost-effective and timely training for regulatory training compliance. To gain approval of training curricula for regulatory controlled job descriptions.

To develop, present and defend regulatory training for personnel qualification.

Partnerships for cost effective and timely training.

To help identify and provide regulatory training in the most value-added and timely way.

Media Center

SOP Center

For inclusion of audio-visual aids e.g. graphics, slides, videos, etc. in training materials. For assistance with computer-based training systems.

To discuss issues concerning SOPs.

Outside vendors To find off-the-shelf materials for use in training programs or consultants for special program development and/or delivery. To investigate operations of new equipment/automation installations for training development.

CREATIVE THOUGHT

What aspects of the position require the highest levels of creative thought (i.e., the conception and formulation of new ideas, techniques, procedures, programs, etc.)?

Developing technical training materials and delivering the material in a manner which generates the interest and enthusiasm of trainers and participants, and ensures effective and timely transfer of knowledge/skills to the job to meet regulatory requirements. Assessing of training and procedures to determine if employees are qualified to perform assigned job duties and responsibilities independently: and if not, developing and quickly implementing corrective action plans that effectively and correctly resolve the situation with the most positive outcome.

WORKING CONDITIONS AND SPECIAL REQUIREMENTS

List any adverse working conditions, exposure to hazardous materials or conditions, travel requirements, requirements for working long hours, at night, weekends, rotating shifts, etc. ALSO ATTACH A COMPLETED PHYSICAL AND ENVIRONMENTAL JOB DEMANDS FORM, U 294, IF A NORMAL SEDENTARY OFFICE ENVIRONMENT DOES NOT APPLY.

__ none __ see attached __ list followsform U 294

JOB SPECIFICATIONS

Basic Background

Check the minimum education level and list the base level of experience required to successfully perform the job include the time length of experience required, if appropriate, as well as the nature of the experience required. If different combinations of education and/or experience could be considered equivalent, check and complete all that apply. Indicate they are alternatives by typing "OR" after each option.

Education and ExperienceNo college required_____ year(s) experience in _____

Some college or technical school course work in _____PLUS _____ year(s) experience in _____

X Four-year college curriculum with a major concentration preferably in management, science, technology or adult education. PLUS three year(s) experience in pharmaceutical manufacturing or chemical development or technical training including one (1) year in a leadership position resulting in sound functional understanding of specific production processes and the ability to train and direct the work of others.ORFive (5) years experience in pharmaceutical manufacturing area, including leadership responsibility and accountibility resulting in sound functional understanding of specific production processes and the ability to train and direct the work of others along with the demonstrated ability to comprehend and apply basic pharmaceutical manufacturing principles.

Other factors to be Considered in Selection Include:List required KSAs not mentioned under Basic Background, Targeted Selection© Dimensions, and any preferred job related factors.

Must have excellent leadership skills.Must be free of drug allergies relating to the work area.Must be physically able to work in processing area.Must be willing to comply with departmental work schedules, including shift operations.Must have a satisfactory attendance record.Solving problems and making sound decisions.Planning and organizing work activities.Performing effectively in stressful situations.Seeing assignments and activities through to completion in an efficient and timely manner.Originating actions and actively influencing events rather than responding to events.Oral and written communication skills.Oral presentation skills.Effective working relationship with personnel within and outside working area.Skill in maintaining accurate records/attention to detail.

APPROVALS & DATE Signature Date

Immediate Supervisor

Supervisor's Supervisor

Compensation

HR Manager

PERFORMANCE PLANNING WORKSHEET

Technical Training Specialist/Regulatory Training Compliance - P&E Unit

PURPOSE AND BASIC RESPONSIBILITIES OF THE JOBTo provide technical and administrative facilitation for the design, development, coordination, and delivery of technical training within Production and Engineering Unit to ensure regulatory compliance relative to personnel training and qualification.

JOB DUTIES AND RESPONSIBILITIES

Assess training needs at the job/individual/team/and organizational levels. Provide direction and support for line management, task forces, committees, natural work teams, project start-up teams and project engineering to design, develop and deliver training plans and materials for existing operations, new processes, automation, and equipment installations.

Develop and validate procedural training plans/courses/training tools/training evaluation tools for regulatory controlled processes, automation and equipment specific training for operative, supervisory, technical, professional and management staff in P&E Unit.

Observe & analyze key P&E Unit operations to recognize potential problems and opportunities. Advise management of recommendations for procedural changes and provide training solutions.

Develop recommendations for value-added improvements on regulatory controlled procedures, processes, equipment and training to ensure product quality and employee safety and gain the approval of line management and ST&D Technical Training Section Head.

Serve as "subject matter expert" for appropriate training duties and responsibilities when necessary.

Interact with all levels, skills, crafts and disciplines in P&E Unit on a regular basis to ensure effective communication of training needs & concerns.

Develop and submit technical training regulatory compliance reports to line management as well as ST&D summarizing all technical training activities.

Conduct annual review of all technical training for regulatory compliancewith line management.

Interact with line management to prepare annual training plan and budget based on scheduled projects identifying actions, resources, target dates and priority.

Develop and enhance training contacts within the pharmaceutical industry, educational institutions, training consulting firms and regulatory agencies to help identify and provide regulatory training in the most value-added and timely way.

Problems/Decisions

Determine if training is being provided and properly documented to meet regulatory requirements.

Determine if controlled procedures are clear, concise and correct. and that sufficient instruction for personnel qualification is achieved.

Determine the level and approach to training for changing technology, equipment and regulations.

Communications

Title of Contact Purpose

Vice Presidents, Directors, Department Heads, supervision, operatives, and professional , technical and administrative staff.

To provide technical and administrative facilitation for the design, development, coordination and delivery of technical training to ensure regulatory compliance relative to personnel training and qualification..

ST&D personnel To seek assistance/advice in completion of projects; work jointly on technical training projects.

P&E Project System

Project Engineering

QA Compliance and Technical Development

Regulatory Agency Investigators

Educational Institutions

Pharmaceutical industry and professional associations

Media Center

To keep training current with the development and implementation of new technology and equipment.

To gather information for program/course/procedure development.

To partner for cost-effective and timely training for regulatory training compliance. To gain approval of training curricula for regulatory controlled job descriptions.

To develop, present and defend regulatory training for personnel qualifications.

Partnerships for cost effective and timely training.

To help identify and provide regulatory training in the most value-added and timely way.

For inclusion of audio-visual aids e.g. graphics, slides, videos, etc. in training materials. For assistance with computer-based training systems.

Production Documentation Department

Outside vendors

To discuss issues concerning SOPs.

To find off-the-shelf materials for use in training programs or consultants for special program development and/or delivery. To investigate operations of new equipment/automation installations for training development.

Creativity

Developing technical training materials and delivering the material in a manner which generates the interest and enthusiasm of trainers and participants, and ensures effective and timely transfer of knowledge/skills to the job to meet regulatory requirements.

Assessing of training and procedures to determine if employees are qualified to perform assigned job duties and responsibilities independently: and if not, developing and quickly implementing corrective action plans that effectively and correctly resolve the situation with the most positive outcome.

CURRENT STATUS ON ENGINEERING OPTEC PROGRAM

December 15,xxxx

Below is a progress report on the analysis of tasks for positions in Engineering, with each position requiring 12 tasks.

Instrumentation:

Mfg. Instrument Mechanic II............Complete

Mfg. Instrument Mechanic I.............2 tasks left

Prod. Instrument Mechanic II...........1 task left

Prod. Instrument Mechanic I............3 tasks left

Pipeshop:

Mfg. Plumber/Pipefitter Mechanic II. 2 tasks left

Mfg. Plumber/Pipefitter Mechanic I. .5 tasks left

Prod. Plumber/Pipefitter Mechanic II2 tasks left

Prod. Plumber/Pipefitter Mechanic I.5 tasks left

Mfg. Pipefitter/Welder Mechanic II...No one in position!

Mfg. Pipefitter/Welder Mechanic I....5 tasks left

Prod. Pipefitter/Welder Mechanic II..No one in position!

Prod. Pipefitter/Welder Mechanic I...5 tasks left

HVAC&R:

HVAC&R Mechanic II........................Task list collected; no tasks

analyzed yet.

HVAC&R Mechanic I.........................Task list collected; no tasks

analyzed yet.

PES:

CPD, OCL, SDF, SSPD.......................Met with supervisors to explain

program

and to give them all necessary

materials. They have begun collecting task

lists, but none are complete yet. Will collect

task lists at beginning of January, and

start analyzing tasks soon afterwards.Process for Completing a Procedure Analysis

The following is a synopsis of the responsibilities of the analysts in performing a procedure analysis. It has been broken down into four major components (situation, task, action, and results) to help clearly define the expectations of the program.

I. SituationThe environment in which the OPTEC and Multi-Skill procedure analyses are to be performed covers all of Engineering. For each job level (Mechanic I, Mechanic II, etc.), within each craft (Instrumentation, Pipefitting, etc.), in each work area(Production, Manufacturing, etc.), in the department of Engineering, approximately 12 tasks are to be extracted as being most representative of that job level. These 12 tasks are to be used in the development of a competency-based training program. The objective of the program is to find the few tasks that are considered to be most critical or relevant in the successful performance of a given

job, then to train all job incumbents and all subsequent employees in that position to meet certain standards of performance.

The necessary tasks to be completed by the analyst are listed below

II. TaskIn conducting a procedure analysis, there are three basic tasks to be completed:

a. Development of a task list for each job -- the process of extracting about 12 tasks for each job; there are usually many more than 12 tasks associated with a given job, so it is important to extract the key tasks for the job.

b. Consolidation of task lists -- once the task lists are collected for each job, it is usually helpful to compare these task lists and check for duplications; if

duplications exist, they may be eliminated in the analysis (this will prevent the analysis of the same task more than once); "elimination of repetition" does not mean that tasks are eliminated from a job, they are simply analyzed only one time and the information obtained from the analysis is shared among all jobs requiring that task.

c. Individual task procedure analysis -- this is the process of learning exactly how the task is done; accurate notes must be taken and all relevant supportive material (as necessary) must be obtained in order to create a successful training program;

remember, this information will be used to train all future employees in these positions.

III. ActionDetails of the actions or processes necessary for completion of the three mentioned tasks are given below:

a. Lengthy task lists have already been collected for several jobs in the plant. If these are available, they must be broken down into something that is more manageable and useful. If an earlier task list is not available, a working list must be generated through consultation with the supervisors, natural work teams, and subject matter experts (SMEs). The goal at this point is to get the employees in the area, as well as the supervisors, involved in the analysis and to get their support and input. THEY are actually the ones developing the training program, the analyst simply acts as a facilitator or administrator of the process. Once a working list of tasks is in hand, the SMEs and the supervisors must decide on the 12 most critical tasks associated with a given job. Worksheets can be easily created to help in the process of narrowing down the list to 12.

The analyst must be readily available to answer questions as they come up. Also, the analyst should at minimum maintain verbal contact with the supervisors to provide help and to keep the supervisors and the SMEs busy on the lists until they are complete. A record should be kept of all contacts made

with the supervisors or SMEs to ensure prompt completion of the project and to help the analyst track progress.

Once the SMEs and supervisors have come up with a list of tasks, they should send the list with the supervisor's approval on it to the analyst (this approval should be either written on the list or on an attached sheet).

b. The consolidation of the task lists may seem to be a simple process, but the analyst should be cautious in assuming that tasks are the same. Many times, a given task may be performed exactly the same way in Instrumentation as it is in the Pipe Shop (or in other areas as well). There may also be cases where the exact same task is performed in two different areas, but in one of those areas the piece of machinery that the task is performed on may be so complex that the task becomes much more difficult and time consuming. In this situation, the two tasks should be analyzed separately. If there is ever any doubt about whether or not two tasks are indeed the same, the analyst must notify Mike Langley or the supervisors of the areas.

In the end, 12 tasks will be obtained for all positions covered under the OPTEC and Multi-Skill programs. Consolidation of the task lists into a "macro task list" will quicken the analyses. Obvious similarities will be found between tasks for a Mechanic I and a Mechanic II in a given craft. However, similarities may also be found across crafts and across work areas.

c. Once the task lists for each job have been consolidated, the real analysis may be started. 1.) Scheduling -- The supervisor should be contacted in advance to schedule a

time to meet with a selected SME (the supervisor should have already selected the SMEs during the development of the task lists).

2.) Preparation -- In scheduling meetings with the SMEs, they should be asked to prepare for the meetings by gathering any relevant materials. These materials may be things to help clarify to the analyst how to perform the job, or they may be things that the employee will have at his/her disposal while actually performing the job in the work area. The analyst should also try to prepare for the meeting by learning a little about the tasks to be discussed. This will help the analyst to follow the steps in performing the task and in asking appropriate questions.

3.) Interviewing -- In order to maximize the SME's time, this should be a well planned meeting. The analyst should be very familiar with the "Procedure Analysis Worksheet." A copy of this worksheet may be used to take notes during the interview, but it may be easier to take notes on a blank sheet of paper in case diagramming or flow charting is used.

Probably the most important aspect of the meeting is to establish a good rapport; without it, the information obtained may only be a very watered-down version of what is actually done. The SME may try to explain only

the simple aspects of a task if he/she feels that they will be given performance appraisals by this in the future, which may affect their pay raises. It is imperative that the SME understand the importance of the analysis, and realize that complete details are necessary in the explanation of the tasks. The analyst should read the section of the procedure analysis handbook on "Conducting the Interview."

If any documentation is brought to the interview by the SME that is used out on the floor in the performance of the task (that is, not committed to memory), or is helpful in explaining how to perform the task the analyst should get a copy of it.

4.) Notation of KSAs -- Collection of KSAs is not a formal part of performing a procedure analysis, but they are helpful bits of information that should be gathered whenever possible throughout the process. The reason KSAs are not included in procedure analyses is that they are not steps in performing a task, they are the knowledge, skills, and abilities that someone must bring to the workplace in order to perform a given task or group of tasks. For example, if you were paying a mechanic to fix your brakes, you wouldn't want the first few hours of the labor cost to be devoted to the mechanic learning how to fix your brakes.

IV. Results

PROCEDURE ANALYSIS HANDBOOK

The following is provided as an introduction to performing a procedure analysis for the Multi-Skill and OPTEC (Operative/Technical) programs at Burroughs Wellcome.

TABLE OFCONTENTS:

General...............................................................................................................2

Process for Completing a Procedure Analysis (detailed)............... .......2

Situation ................................................................................. ....2

Task......................................................................................................2

Action...................................................................................................3

Results..................................................................................................5

Tasks and Writing Task Statements..............................................................5

Conducting the Interview................................................................................6

Establishing Good Rapport...............................................................7

Direct the Conversation.....................................................................8

Follow an Information Management Plan.......................................9

Complete the Procedure Analysis Worksheet.............................10

Close the Interview...........................................................................10

Observe Performance of the Task................................................................11

Glossary........................................................................................................12

Appendix A: Process Flow Diagram for Completing aProcedure Analysis............................................................15

P ROCEDURE A NALYSIS HANDBOOK

General

A procedure analysis (or task analysis) can be achieved through the following methods:

1. Analysis by observation (demonstration)

2. Analysis by interview (question and answer with subject matter expert, SME)

3. Combine these two methods.

An effective interview coupled with a task performance demonstration has proved to be the most efficient method for collecting accurate and complete task performance data.

This handbook is an explanation of how a procedure analysis should be performed, with a global view of the process, as well as an in depth discussion on conducting the interviews with subject matter experts and making preparations with the supervisor and the natural work teams.

Process for Completing a Procedure Analysis

The following is a synopsis of the responsibilities of the analysts in performing a procedure analysis. It has been broken down into four major components (situation, task, action, and results) to help clearly define the expectations of the program.

A. SituationThe environment in which the OPTEC and Multi-Skill procedure analyses are to be preformed.

For each job level(Mechanic I, Mechanic II, etc.), within each craft (Instrumentation, Pipefitting, etc.), in each work area(Production, Manufacturing, etc.), in the department of Engineering, approximately 12 tasks are to be extracted as being most representative of that job level. These 12 tasks are to be used in the development of a competency-based training program. The objective of the program is to find the few tasks that are considered to be most critical or relevant in the successful performance of a given job, then to train all job incumbents and all subsequent employees in that position to meet certain standards of performance.

The necessary tasks to be completed by the analyst are listed below

B. TaskIn conducting a procedure analysis, there are three basic tasks to be completed:1.Development of a task list for each job--the process of extracting about 12 tasks for each job;

there are usually many more than 12 tasks associated with a given job, so itis important to extract the key tasks for the job.

2. Consolidation of task lists--once the task lists are collected for each job, it is usually helpful to compare these task lists and check for duplications; if duplications exist, they may be eliminated in the analysis(this will prevent the analysis of the same task more than once); "elimination of repetition" does not mean that tasks are eliminated from a job, they are simply analyzed only one time and the information obtained from the analysis is shared among all jobs requiring that task.

3. Individual task procedure analysis--this is the process of learning exactly how the task is done; accurate notes must be taken and all relevant supportive material (as necessary) must be obtained in order to create a successful training program; remember, this information will be used to train all future employees in these positions.

C. ActionDetails of the actions or processes necessary for completion of the three mentioned tasks are

given below:

1. Lengthy task lists have already been collected for several jobs in the plant. If these are available, they must be broken down into something that is more manageable and useful. If an earlier task list is not available, a working list must be generated through consultation with the supervisors, natural work teams, and subject matter experts (SMEs).The goal at this point is to get the employees in the area, as well as the supervisors, involved in the analysis and to get their support and input. THEY are actually the ones developing the training program, the analyst simply acts as a facilitator or administrator of the process. Once a working list of tasks is in hand, the SMEs and the supervisors must decide on the 12 most critical tasks associated with a given job. Worksheets can be easily created to help in the process of narrowing down the list to 12.

The analyst must be readily available to answer questions as they come up. Also, the analyst should periodically contact the supervisors to provide help and to emphasize the importance of completing the task lists. A record should be kept of all contacts made with the supervisors or SMEs to ensure prompt completion of the project and to help the analyst track progress.

Once the SMEs and supervisors have come up with a list of tasks, they should send the list with the supervisor's approval on it to the analyst (this approval should be either written on the list or on an attached sheet).

2. The consolidation of the task lists may seem to be a simple process, but the analyst should be cautious in assuming that tasks are the same. Many times, a given task may be performed exactly the same way in Instrumentation as it is in the Pipe Shop (or in other areas as well). There may also be cases where the exact same task is performed in two different areas, but in one of those areas the piece of machinery that the task is performed on may be so complex that the task becomes much more difficult and time consuming. In this situation, the two tasks should be analyzed separately. If there is ever any doubt about whether or not two tasks are indeed the same, the analyst must notify the Area Training Specialist or the supervisors of the areas.

In the end,12 tasks will be obtained for all positions covered under the OPTEC andMulti-Skill programs. Consolidation of the task lists into a "macro task list" will quicken the analyses. Obvious similarities will be found between tasks for a Mechanic I

and a Mechanic II in a given craft. However, similarities may also be found across crafts and across work areas.

3. Once the task lists for each job have been consolidated, the real analysis may be started.a) Scheduling--The supervisor should be contacted in advance to schedule a time to meet with a

selected SME (the supervisor should have already selected the SMEs during the development of the task lists).

b) Preparation--In scheduling meetings with the SMEs, they should be asked to prepare for the meetings by gathering any relevant materials. These materials may be things to help clarify to the analyst how to perform the job, or they may be things that the employee will have at his/her disposal while actually performing the job in the work area. The analyst should also try to prepare for the meeting by learning a little about the tasks to be discussed. This will help the analyst to follow the steps for performing the task and in asking appropriate questions. Information about the tasks may be gathered from available SOPs for the related areas.

c) Interviewing--In order to maximize the SME's time, this should be a well planned meeting. The analyst should be very familiar with the "Procedure Analysis Worksheet." A copy of this worksheet may be used to take notes during the interview, but it may be easier to take notes on a blank sheet of paper in case diagramming or flowcharting is used.

Probably the most important aspect of the meeting is to establish a good rapport; without it, the information obtained may only be a very watered-down version of what is actually done. The SME may try to explain only the simple aspects of a task if he/she feels that they will be given performance appraisals by this in the future, which may affect their pay raises. It is imperative that the SME understand the importance of the analysis, and realize that complete details are necessary in the explanation of the tasks. The analyst should read the section of the procedure analysis handbook on "Conducting the Interview."

If any documentation is brought to the interview by the SME that is used out on the floor in the performance of the task (that is, not committed to memory), or is helpful in explaining how to perform the task the analyst should get a copy of it.

d) Notation of KSAs--Collection of KSAs is not a formal part of performing a procedure analysis, but they are helpful bits of information that should be gathered whenever possible throughout the process. The reason KSAs are not included in procedure analyses is that they are not steps in performing a task, they are the knowledge, skills, and abilities that someone must bring to the workplace in order to perform a given task or group of tasks. For example, if you were paying a mechanic to fix your brakes, you wouldn't want the first few hours of the labor cost to be devoted to the mechanic learning how to fix your brakes.

A collection of KSAs should be established for each task, and paired withthe final Procedure Analysis Worksheet for each task.

e) Observing--The observation of the SME performing the task may be done either before or after the interview, although it may be a little easier and more informative to observe after the interview (when some knowledge of the task has been established). It is very important to be unobtrusive while observing the SME perform the task (that is, do not make comments about how you may think the task is done or assumptions about what is being done; also, do not be in the way or place yourself in a dangerous position while observing),otherwise, the SME may not perform the task as he/she normally would. The performance should be as realistic as possible, and preferably when the SME is normally performing the task. As a last resort, a walk-through of the task performance is acceptable when it is very impractical for the SME to perform the task.

While observing the SME perform the task, the analyst should be fine tuning the notes already collected from the interview (if the interview is conducted first). Ask the SME for clarification of any inconsistencies noticed.

f) Completing the Worksheet--Upon completion of the observation, the Procedure Analysis Worksheet should be filled out. Then, the information in the Procedure Analysis Worksheet is compared with the related SOPs. If there is any conflict between the notes collected and the SOPs, consult with the Area Training Specialist or the supervisor in the related area.

The final copy of the Procedure Analysis Worksheet must be sent out to the supervisor of the area and the SME for final approval. At this point the supervisor or the SME may request other revisions or clarifications before they make their approval.

D. ResultsThe procedure analysis will have been completed when all of step #3 above has been performed

for a given task. Paired with the procedure analysis should be a list of KSAs for the task. The third step should be repeated for each task for a given job, until at least 12 tasks have been analyzed for the job. This collection of task procedure analyses will be used to develop a representative training program for the job.

Tasks and Writing Task Statements

A TASK is a measurable, observable, and manageable unit of work performed by an employee. A task consists of two or more steps and has a distinct beginning and end, resulting in a product or service for which someone is willing to pay. A task is performed under certain conditions, and correct performance must meet specific criteria. Analyzing at the task level allows the job to be described in detail and serves as a basis for designing an instructional system that can be developed and administered easily.

In developing a competency-based training program, how the tasks are stated is as important as the identification and selection of the tasks. Task statements written in vague, ambiguous terms are useless in designing and developing a CBT training program. Carefully worded task statements convey to all concerned what the desired performance will be.

A precisely worded TASK STATEMENT begins with an action verb in the present tense (what is done), followed by the object of the verb (what is being acted upon).For example:

ACTION VERB OBJECT(what is done)(what is acted upon)

Repair electric motor

Replace motor brushes

Adjust engine timing

Complete leave forms

Troubleshoot pump

Include one action verb and one object in each statement."Clean and inspect filters" should be separated into two statements:"Clean filters" and "Inspect filters."Occasionally, a task is only successful when performed within certain specified parameters; these parameters need to be included where applicable.

The task statement should be expressed in words familiar to the worker in the plant. The task statement, "Don PCs" is familiar to chemical plant workers who must dress out in boots, protective masks, gloves, and coveralls, but probably wouldn't mean much to a worker who dresses out in only coveralls.Do not write task statements that are too specific or too broad. Examine the task statements that follow. Identify the one task statement that could be developed as a training unit.

1. Service brakes

2. Resurface brake linings

3. Gauge lining thickness

Note that the first statement is broad and is really a duty encompassing several brake-related tasks (add brake fluid, adjust emergency brake, replace disc pads, etc.).

The second statement is a well-written task statement describing a complete unit of work for which someone would pay. It has definite beginning and ending points and may be broken down into two or more procedural steps for learning. It also states exactly what the trainee will be able to do upon mastering the task.

The third statement is too narrow in scope and is actually a step in performing the task:"Resurfacing brake linings."

Avoid starting task statements with "the trainee will be able to" or "the trainee should have," because they are meaningless phrases and do not accurately reflect competent performance of a job.

Precisely worded task statements ensure that learning activities are developed that focus on bringing about the precise performance stated in the task. The trainee knows what is expected, and the task evaluator knows what performance to assess.

Conducting the Interview (Table-Top Analysis)

In your role as an analyst, you must prepare for the interview by performing the following steps:

1. Obtain a task list for a given job byextracting tasks from a completed job analysis (ifavailable) orby consulting with the area supervisor(s) and Natural Work Team(s).Consultation with people in the area will ensure support by theemployees.

2. The SME will be selected by the supervisor of the area. Selection should be based on educational background, work experience, knowledge of subject matter, ability to communicate, attitude toward the job, and attitude toward training.

3. Schedule the initial interview and the task demonstration with the SME's supervisor in advance. Inform the SME's supervisor about the tasks you will be analyzing so arrangements

can be made, time set aside, and the best SME selected for the analysis. The chosen SME will then have time to select supporting data such as procedures, drawings, forms, and manuals that will be included in the analysis.

4. Before the interview, briefly discuss with the SME's supervisor the purpose of conducting the analysis, how much time will be required, and what will result from the analysis. A simple telephone call may be appropriate.

A complete and accurate procedure analysis depends upon the task analyst's interviewing skills. Like all skills, interviewing skills are developed through practice. Good interviewing requires the analyst to perform the following:

A. Establish a good rapport with the SME.

B. Direct the conversation.

C. Follow an information management plan.

D. Complete the Procedure Analysis Worksheet.

E. Close the interview.

A. Establish A Good Rapport With the SME

The quality and quantity of the data collected during the interview depends on the relationship established early in the interview process. For this reason the analyst must put the SME at ease at the very beginning of the analysis. The following steps will help create a comfortable, relaxed atmosphere for the analysis process:

1.Conduct analysis interview in a quiet areathat's private and relatively free of interruptions. If possible, conduct this session away from the SME's office or work area, (i.e., GEIP Center or Technical Training Center Conference Room, both in Building14).

2.Insure that there is space for spreading out the supporting materials brought to the analysis interview.

3.Begin the analysis session by exchanging greetings and introductions and determine how the SME prefers to be addressed.

4.Allow the SME to get comfortable by engaging in a few moments of small talk.

The SME should be informed in advance by the supervisor of the reason for the analysis interview; its location, time, and expected length. Any supporting task/job-related materials such as manufacturers manuals, company procedures, forms, and drawings that should be brought by the SME should be requested at this time.

Even though the SME should be prepared for the analysis, it is important to verify that he has been sufficiently advised by his supervisor. An unprepared or poorly prepared SME might

wonder what the purpose is for the interview, if he can be harmed by his answers, who will be told what he says in the interview, if he will be identified by certain comments and answers, and if he will be quoted. Remove these barriers by informing the SME that only those considered to be experts are selected for the analysis interview and that the training materials produced will be modeled after the SME's performance behaviors, and most of all that the interview is confidential. IMPORTANT: Make sure the SME understands that other SMEs will be interviewed and that the material will not identify any one subject-matter-expert.

As a task analyst, sometimes you will have a SME express that he doesn't believe you can function in your role without having some technical expertise in the job you are analyzing. The best way to handle this situation is to explain that you do not claim technical expertise in performing all the jobs you analyze, but you do have expertise in instructional design and, as a partnership, the two of you will produce a quality training product that's technically accurate and instructionally sound.

B.Direct the Conversation

There are times when the questions and responses flow well, producing pertinent information. Other times the process is much more difficult. The analyst is responsible for obtaining information through questioning, probing, and keeping the interview on track. Generally, the analyst might be faced with one of three SME types:

1. UNRESPONSIVE SMEs- Some people have trouble verbalizing what actually is done in practice. When this happens, the analyst must provide a way for the SME to explain or demonstrate tasks and task steps (i.e., blueprints, drawing, procedures, or just paper and pencil for sketches).

Providing physical objects or familiar tools, materials, references, and other aids will often provoke conversation.

2. TOO RESPONSIVE SMEs- When interviewing an SME who likes to talk, keep the interview relevant to the subject. This can usually be accomplished by initiating a new question or conducting a recap (reviewing aloud the data to that point).This tends to bring the SME back to the subject.

3. THERESPONSIVE BUT UNINFORMATIVE SME-This situation occurs when an analyst's questions are answered with phrases like, "it depends," "you know by experience," or "there are too many to list." At that point you might ask, "Upon what does it depend?"; "What kinds of experiences are helpful and in what way are they related to the knowledge?"; and "Give me the most common ones."

After getting the most common, ask for a few others until the list is exhausted. Even the otherwise informative SME will at times feel that the particulars are too many in number to even attempt to address. However, by breaking questions into smaller bites, the SME is not so overwhelmed.

Don't feel so compelled to direct the interview that the SME is not given time to think before answering. The SME might become frustrated or get the impression that a very general overview of the job is all that is needed. This could result in vague summarizations of his job activities.

To clarify unclear areas, ask "probing questions."Probing questions are "open-ended" questions that cannot be answered with a simple "yes" or "no."Ask short questions that begin with how, what, who, when, where, which, how long, and in some instances why? Short classification questions such as "What kind of assistance do you provide?," "How do you provide it?," and " When do you provide it?, "might follow the comment, "I provide assistance to the line workers."

When probing, avoid close-ended questions. Close-ended or "Do you" questions can be answered with a simple "yes" or "no."Of course, sometimes that is all that is needed. However, "why" questions tend to sound judgmental, and a SME may become defensive, feeling that he/she is being asked to justify his/her activities. The answer to WHY a task or step is done in some situations and not in others is a very important piece of information, but you may have to derive this information by asking WHAT are the cues that indicate a given task or step should be done.

Avoid leading questions which create the impression that the activity is expected to be performed. Even though the implied action may not be part of the task, the SME may respond accordingly.

C. Follow an Information Management Plan

Now that you know how to prepare for the interview, how to initiate an interview, and how to overcome some of the communication barriers, you must develop a plan for managing the information you obtain. An organized interview process focuses on the following:

1. SEQUENCING THE TASKS FOR ANALYSIS.

The best way for the analyst to gain knowledge of the tasks is to analyze the least complicated tasks first. The analyst's knowledge grows while progressing through the procedure analyses, just as the trainee's will while going through future training programs developed from the material.

2. ASKING "WHY" AND "WHEN" A TASK ISPERFORMED.

The answer to "why" will help you understand how this task fits into the job and will also bring a realization of the importance of the task. You must find out how the SME knows "when" to perform the task so you can identify the initiating cues.

3. OBTAIN A LIST OF THE STEPS REQUIRED TO PERFORM THE TASK.

The performance steps are the backbone of the procedure analysis. Obtain the task steps by asking the SME to describe the task from start to finish in chronological sequence. Then ask

what problems are likely to arise in carrying out the task and what actions must be taken in the event they do occur?

4. IDENTIFY THE SKILLS AND TECHNICAL KNOWLEDGETO PERFORM THE TASK.

Highly skilled employees often are aware of only a portion of the knowledge they use in carrying out their work. There is usually a great deal that they take for granted, don't ever think about, or assume that everyone knows.

Consequently, analystsmust draw from the SME as many of these out-of-awarenessprocesses aspossible.This can be done by asking forevery activity they mention, "Howspecifically do you do that?"Whenever they use a term whose reference is general orunclear (e.g., "check that it is done correctly" or "insert itcarefully"), ask the SME todescribe exactly what activities go into doing it that way or how do youknow that theprocedureis being done as it should be done.Thiswill make sure that the quick mentalprocesses that the experts perform without thinking can be put into thetraining materials.

Skill and knowledge analysis must also yield a list of skills and knowledge to perform each step. These skills must be identified by the analyst. They are not obtained by asking the SME what skills are required. The analyst must derive the task skills by interviewing the SME and observing the task demonstration.

5. IDENTIFYING THE TOOLS, EQUIPMENT,&REFERENCES.

This includes all materials required for a person to perform the task: hand tools, safetyequipment or clothing, manuals, procedures, blueprints, drawings, and specifications.

6. IDENTIFYING THE CRITERIA FOR COMPETENTPERFORMANCE.

Required standards for competent job performance may be provided by the SME's supervisor, plant or engineering standards and specifications. However, the SME can provide additional insights. The analyst should ask, "How do you know when someone does this job well?" or "What would you look for to determine when someone is sufficiently trained to do this job well?" If it can be determined what the expert perceives as worthy, instructional material developers will know what to emphasize in the training. The standards for evaluating someone's work usually has three components:

a. The time needed to complete a task.

b. The quality of the performance or work output.

c. The quantity or number of units completed.

D. Complete the Procedure Analysis Worksheet

The procedure analysis worksheet is a form on which the information you have collected is recorded in an organized manner. The worksheet should provide a space for all components of the procedure analysis, including the performance objective, task performance steps, the knowledge for performance steps, skills, tools, references, equipment, and special conditions which relate to those steps. A worksheet that has these sections allows the analyst to fill in the appropriate spaces without having to make headings along the way. A final draft of the procedure analysis worksheet should be submitted for SME verification and approval. This is important to insure that everything has been interpreted as the SME intended it to be. The SME's supervisor should also verify and approve the final draft of the procedure analysis worksheet.

This procedure analysis worksheet is ultimately used to develop the instructional materials.

E. Close the Interview

The analysis should not be a punishing experience for either the SME or the analyst. Keep the interview on track and end the session when it is time. Generally, it is time to close when the following has occurred:

1. All materials brought by the SME have been discussed.

2. All functions of the analysis have been covered.

3. The agreed-upon time has elapsed. If more time is needed to complete the analysis, obtain approval from the supervisor.

4. The interview and demonstration has been going on for more than three hours. This is about the maximum time before exhaustion and boredom sets in. Check with the SME and see if they want to continue.

Before concluding, allow the SME time to ask questions and to obtain additional information. Reconfirm the purpose of the procedure analysis, and thank the SME for his/her help and cooperation.

Effectively Observe the SME Perform the Task or a Walk-Through

In order to get a clear and accurate depiction of what is done in performing the task, the analyst must observe the SME perform the task or go through a detailed "walk-through."Watching a competent performer at work reveals considerable information for the skilled observer. Analysts must develop this skill in order to obtain all the information about performing the task.

While observing the task demonstration, look for the following:

1. Verification of the performance steps and other technical information obtained during the table-top analysis.

2. Environmental conditions.

3. Subconscious activities.

4. Physical constraints.

5. Fudge factors.

When observing the demonstration, look over the information collected in the interview. Verify the order of the performance steps, adding steps that you do not have.

Be awareof the environment. Is it hot, cold, dirty, dark, or well lighted and comfortable? Is the work performed off the ground (i.e., from a scaffold, a ladder, or a safety pallet suspended by a forklift)? Is the work heavy? Any environmental conditions that affect the task must be included in the analysis.

Look for subconscious activities performed by the SME. Watch the performer's eyes, hands, and feet for subtle movements. Ask the performer what they are doing when you detect such motions. Beware of physical demands such as weight lifted, pushed, or pulled. Observe and record distances required of the workers. How accessible are the areas or materials to the worker?

Record the fudge factors. Fudge factors are short cuts performed by the worker that are contrary to established guidelines but do not affect the final process output.Ask for clarification of unclear areas in the same way you did during the interview. When possible, repeat the demonstration as this will reveal a host of new information not noticed the first time. The interview coupled with the task demonstration provides thorough analysis of a task from which many instructional design decisions can be made.

Note: The observation or walk-through may be conducted as a final step of the interview process, or may be done at a different time.

Glossary

KeyTerms

JobAnalysis-first step in developing competency-basedtraining material, in which a job is broken down into tasks performed by jobincumbents; the objective is to make sure that the tasks required for competentjob performance are identified and included in the training program.

K.S.A.'s-knowledge, skills, and abilities; those things an employee must alreadypossess in order to perform certain tasks.

knowledge-specificinformationneeded tomake decisions or perform tasks.skills-thelevel ofproficiencyon a specifictask or group of tasksabilities-potentialto perform a behavior; ageneral trait which is inferred from certainresponse

tendencies;

Note:The developmentof proficiency (skill) on any given task is predicated in part on thepossession of relevant basic abilities

ProcedureAnalysis-(also known astaskanalysis)-the process of noting all of the steps,KSA's, and material necessary in order to perform a specific task at 100% of theacceptable performance criterion; also includes the notation ofwhereallinformation is obtained (i.e. SME, supervisor, specific manuals, specificcharts/drawings, SOPs, etc.) as it is gathered, to act as an index in thevalidation process and to help others follow the stages of the procedureanalysis; ultimately used in the development of instructional material and/orperformance appraisal.

S.M.E.-asubject matter expert; a job incumbent (worker), supervisor, or department headwho serves as a technical resource during the development of thecompetency-based training materials; selection of the SME should be made by thesupervisor with consideration given to educational background, work experience,knowledge of subject matter, ability to communicate, attitude toward the job,and attitude toward training.

S.T.A.R.-anacronym for remembering the key components in the analysis of a job:situation,task,action,results; each must be taken intoconsideration in order to fully understand the who, what, why, when, where, andhow of a job.

situation-what circumstances occur to indicate that a particular task needs to bedone?; whois responsible for thecompletion of the task?; where should the task be performed?; howwill the employee recognize these needs?;what type of environmental conditions must thetask be performed under?

task-what exactly is the task that is needed to remedy the situation?action-what are the behaviors (steps) that must be performed in order for thetask to

besuccessfullycompleted, and are there anyKSA's that the employee must possess in order toperform the task?

results-howdoes the employee recognize that the task is complete?; how does the employeerecognize (or make sure) that thecompleted task actually does or does not remedy thesituation?

Table-TopAnalysis-theinterviewwith the SME in whichthe task steps, KSA's, and important materials are gathered; both the analystand the SME must be prepared for this discussion; SME should bring anysupporting data such as procedures, drawings, forms, special equipment, andmanuals which are used in performing the task.

Task-adiscrete unit of work performed by an individual; a measurable, observable, andmanageable unit of work performed by an employee; consists of two or more stepsand has a distinct beginning and ending, resulting in a product or service forwhich someone is willing to pay (i.e. calibrate vacuum sensors, replace diskbrake pads, type term paper, etc.).

TaskStatement-a precisely worded statement that begins withan action verb in the present tense (what is done), followed by the object ofthe verb (what is being acted upon); (i.e. repair electric motor, replace motorbrushes, troubleshoot pump); where applicable, include parameters within whichthe task must be performed.

"Walk-Through"-having the SME show you the equipment that is used in the completion of atask and a step-by-step explanation of what is done with what materials; thisshould be done in place of the performance observation when it is not feasibleor practical to actual perform the task, (such as the set up and start up of theVECO Vacuum Pump/Helium Leak Detector, which is a very lengthy process, and isonly performed twice a year.

Appendix A

ProcessFlow Diagram for Completing a Procedure Analysis

PROCEDURE ANALYSIS WORKSHEET

Position:

Job Code: Dept.:

Task:

Analyst: Date:

SME(s):

PrimarySOP:

RelatedSOPs:

Indicate the primary source of information for each itemby writing a code letter in the blank to the left of thenumber.

P= primary SOPR= related SOPsS= Subject Matter ExpertO= Other

1.Why is this task performed?(Include prompts/cues)

2.What positions are responsible for performing thistask?

Primary Performer Co-Performer(s) Assistant(s)

3.Where is the task performed?Job-siteShopOther

4.What is done to complete this task?(narrative overview)

5.Time to perform this task?(under standard operating conditions)

6.What is the standard(s) of performance for this task?(STAR)

7.What is the consequence(s) of performing the task incorrectly orincompletely?(STAR)

8.Equipment, Tools, Supplies:

9.References, Drawings, and Procedures:

10.Safety Concerns (procedures, permits, clothing, equipment,etc.):

11.Prerequisite knowledge, skills, and abilities, and/or training (basicmath,metrics welding, SOPs, GMPs,Clothing, etc.):

12.Suggested Training Format:

Walk ThroughSelf StudyPerform on JobClassroom InstructionShop Training

13.Practice Activities:(include tool and equipment list)

14.TASK PERFORMANCE STEPS:(including knowledge/skill components under each step)

PROCEDURE ANALYSISAPPROVAL FORM

Position:

Dept.:

Task:

I have reviewed the procedure analysis for the tasknoted above and offer approval under the following condition(s):

Approve as is; no modifications necessary.

Approve with modifications as indicated.

Subject Matter ExpertApproval Date

PROCEDURE ANALYSIS WORKSHEET

Position(s): Manufacturing Instrument Mechanic I&II

Job Code: Dept.: ITSD

Task: Set-Up of the AMETEK ModCalSystem

Analyst: Chris Date: 11-16-92

SME(s): Bobby

PrimarySOP:

2-6280-0055 RelatedSOPs:

N/A

Indicate the primary source of information for each itemby writing a code letter in the blank to the left of thenumber.

P = primary SOP R = related SOPs S = Subject Matter Expert O = Other

S 1.Why is this task performed?(Include prompts/cues) To prepare the ModCal for use as a pressurestandard in calibrations and troubleshooting.

O 2.What positions are responsible for performingthis task?

Primary Performer Co-Performer(s) Assistant(s)

Instr. Mechanic I

Instr. Mechanic II

S 3.Where is the task performed? Job-siteShop Other

P,S 4.What is done to complete this task?(narrative overview) Turn power on, wait 15-minutes.Select appropriate engineering units onpressure indicator.Connect tubingbetween pressure indicator and pressure source module.Connect tubing between pressure source moduleand the device

to be tested or calibrated.May also have to make electrical connections for testing transmission ofconverted pressure signals from various pressure loopdevices.

O 5.Time to perform this task?(under standard operatingconditions) This task should take approximately5-minutes, once the ModCal has warmed-up.

S 6.What is the standard(s) of performance for thistask?(STAR) To properly prepare the ModCal system foruse as a pressure standard.

S,O 7.What is the consequence(s) of performing thetask incorrectly orincompletely?(STAR) Faulty set-up could damage or miscalibrateprocess devices (i.e., transmitters, recorder/controllers, I/P converters,etc.).Incorrect calibration of processdevices could lead to major problems in manufacturing andproduction.

S 8.Equipment, Tools,Supplies: a.Power supply for the ModCal unitb.Appropriate ModCal modules for the specificapplicationsc.Tubing and connecting wires (should be included in theModCal)d.External air line (when using the regulator module)

S,O 9.References, Drawings, andProcedures: AMETEK ModCal Manufacturer'sManual

O 10.Safety Concerns (procedures, permits,clothing, equipment, etc.): As with any spark-producing portable toolsor instruments, a Safety Work Permit is required before taking the ModCal intoany area where flammable vapors could be present.

O 11.Prerequisite knowledge, skills, and abilities,and/or training (basic math,metrics, welding, SOPs, GMPs,Clothing, etc.):

a.Knowledge of company safety policiesb.SOP Trainingc.CGMP Trainingd.Basic knowledge of electronics and pneumaticse.Using a multimeter

O 12.Suggested TrainingFormat:

Walk Through X Self StudyPerform on Job X Classroom Instruction

Shop Training X

O 13.Practice Activities:(include tool and equipmentlist)

The ModCal may be set-up for variousapplications in the shop under an SME's observation.This would require a ModCal unit, and any ofthe following devices: pressure transmitter, I/P converter, pressure recorder orcontroller, current alarm, or pneumatic transmitter.

P,S,O 14.TASK PERFORMANCE STEPS: (including knowledge/skill components under eachstep)

A.General1.Maintenance request to troubleshoot orcalibrate a pressure transmitter or

related instruments, indicating that aModCal should be used.2.If using external power source with theModCal, connect power line to the

power supply module and press the "on"button.If using battery power source, pressthe "on" button, and ensure that the

battery supply isadequate.3.Let the ModCal warm up for15-minutes.4.Ensure that the appropriate modules are inthe ModCal unit for the

application(s) to be performed.Note1 :Correct engineering units must be selected on the pressure

indicatorbefore pressure is applied to any device to preventdamage.Note2 :ASafety Work Permit is required before taking this device into an area

whereflammable vapors may be present.

B.Set-Up for Transmitter Calibration(for a 0-100 psi pressuretransmitter with a 4-20 mA output)

1.Requires the followingmodules:a.power supplyb.pressure indicatorc.pressure source (pump or regulator)d.transmitter/multimeter2.Select the appropriate engineering unitson the pressure indicator.3.If using a regulator module, connect theexternal air line to the supply port

on the regulator.4.Use tubing to connect the pressureindicator to one of the out ports on the

pressure source module (pump orregulator).5.Use tubing to connect the transmitter tothe other out port on the pressure

source module.6.Make a connection between the positiveterminals on the transmitter and

the transmitter/multimeter module under"Transmitter Excitation;"do the samefor the negative terminals.

7.Select transmitter excitation 24 or 48VDC.8.Depress mA switch under "TransmitterExcitation" section.9.The ModCal is ready for calibration of thetransmitter according

tomanufacturer'sinstructions.

C.Set-Up for Current to Pressure Converter (I/P)Calibration(for an I/P with 4-20 mA input and3-15 psi output)

1.Requires the followingmodules:a.power supplyb.voltage/current simulatorc.two pressure indicators

d.pressure source (pump or regulator)e.transmitter/multimeter2.Select the appropriate engineering unitson each of the pressure indicators.3.If using a regulator module, connect theexternal air line to the supply port

on the regulator.4.Use tubing to connect one of the pressureindicators to one of the out ports

on the pressure source module (pump orregulator).5.Use tubing to connect the supply port onthe I/P converter to the other out

port on the pressure sourcemodule.6.Use tubing to connect the out port on theI/P converter to the other pressure

indicator.7.Make a connection between the positiveterminals on the I/P converter and

the voltage/current simulator; do the samefor the negative terminals.8.Set the output pressure of the pressuresource module to 20 psi using the

pressure indicatormodule.9.Select "Simulator" and depress mA buttonon the simulator module.10.Output current of the simulator should beread on the multimeter LED

display; adjustments of the current (4-20mA) are madewith the coarse and fine adjustment knobs on thesimulator.

11.The ModCal is ready for calibration of theI/P converter according to manufacturer's instructions.

D.Set-Up for Recorder/Controller Calibration(simulation of a 4-20 mA input for a0-100% recorder or controller)

1.Requires the followingmodules:a.power supplyb.voltage/current simulatorc.transmitter/multimeter2.Make a connection between the positiveterminals on the voltage/current

simulator and the recorder/controller; do thesame for the negative terminals.

3.Select "Simulator" and depress mA buttonon the simulator module.4.Output current of the simulator should beread on the multimeter LED

display; adjustments of the current (4-20mA) are madewith the coarse and fine adjustment knobs on thesimulator.

5.The ModCal is ready for calibration of therecorder/controller according to manufacturer'sinstructions.

E.Set-Up for Current Alarm Calibration(setting high and low trip points ona current alarm with 4-20 mA input)

1.Requires the followingmodules:a.power supplyb.voltage/current simulatorc.transmitter/multimeter2.Make a connection between the positiveterminals on the voltage/current

simulator and the current alarm; do the samefor the negative terminals.

3.Make a connection between the positiveterminals on the multimeter input and the current alarm for the low trip point;do the same for the negative terminals.

4.Select "Simulator" and depress mA buttonon the simulator module.5.Set output of the simulator for the lowtrip point, output current will be

indicated on the multimeter LEDdisplay.6.The ModCal is ready for calibration of thelow trip point on the current

alarm according to manufacturer'sinstructions.Repeat the above steps incalibration of the high trip point.

F.Set-Up for Pneumatic Transmitter Calibration(for a 0-25 psi pneumatictransmitter)

1.Requires the followingmodules:a.two pressure indicatorsb.pressure regulator2.Select the appropriate engineering unitson each of the pressure indicators.3.Connect the external air line to thesupply port on the regulator.4.Use tubing to connect one of the pressureindicators to one of the 100 psi

out ports on theregulator.5.Use tubing to connect the pneumatictransmitter to one of the 100 psi out

ports on theregulator.6.Set the transmitter supply pressure to20-25 psi , readingthe pressure on the

pressure indicator module.Disconnect the pressure indicator moduleafter setting this supply pressure.

7.Use tubing to connect the output of thetransmitter to one of the pressure indicator modules.

8.Use tubing to connect one of the 30 psiout ports on the regulator to the process input on the transmitter; connect theother 30 psi out port on the regulator to a pressureindicator.

9.The ModCal is ready for calibration of thepneumatic transmitter, which has a pressure supply of 20-25 psi, a process inputof 0-25 psi, and an output of 3-15 psi.Follow manufacturer's instructions.

PROCEDURE ANALYSISAPPROVAL FORM

Position(s): Manufacturing Instrument Mechanic I&II

Dept.: ITSD

Task: Set-Up ofthe AMETEK ModCal System

I have reviewed the procedure analysis for the task noted above and offer approval under the followingcondition(s):

Approve as is; no modificationsnecessary.

Approve with modifications asindicated.

Subject Matter ExpertApproval Date

Train the Trainer for FDA Regulated Industries

Leadership & Management

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