A Guide for

Employee Training and Performance Management

Generic Corporation

November 9, 2012

Adapted by Mitchell W. Manning Sr. for use by Business and Industry from the work of the Training and Performance Management Project Team at Catalytica Pharmaceuticals

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A Guide for Employee Training and Performance Management

Employee Training and Performance Management documents are required for all employees (first phase to be completed by July 1, 2012/see Attachment A). These documents are the official records of training requirements and documentation for each Job Description and employee. The minimum requirement for each manual is compliance with CORPORATE TRAINING POLICY (see Attachment B - Key Roles and Responsibilities). The goal is for the workforce to become more productive, flexible, and responsive (see Attachment C, Charter).

Guidelines for the process are:Step One Assemble all job descriptions, relevant training requirements, Performance Plans, and

documentation (see Attachment D for guidelines).

Step Two Complete a skills matrix for each Job Description in your area (see Attachment E, instructions and blank skills matrix, 2 pages).The objective is to identify the critical skills for each Job Description.

Step Three Assess all employees (full-time regular, temporaries, contractors, and others).A completed example is provided as a guide (see Attachment F). The objectives are to: 1) determine the skills levels of all employees within a Job Description.2) identify the skills and skill needs of the organization.2) identify potential for training others and need for training for each skill.3) provide focus for employee training.4) define the potential for sharing employee resources throughout the company.

Step Four Segment the matrix into quarters to provide a 15 month training and assessment progression.

Step Five Assemble simple training and assessment requirements for each job task/skill. For example: 1) Read SOPs... 2) Read Equipment Operating Manuals... 3) Perform the job task/skill with skilled assistance three times. 4) Perform the job task/skill twice unassisted to complete assessment by a skilled employee. 5) Complete the training and skills assessment documentation with the trainer/skill assessor.

Step Six Maintain and update (as needed) the Employee Training and Performance Management Document.

Identify training initiatives to facilitate sharing resources.

The accuracy and currency of the compiled information is key to building the success of your work team and GENERIC CORPORATION CP. The collected data can be used as a management tool to determine:

Skills required for the Job Description Skills employees in the job possess Skills employees in the job lack Training needs for employees in each job Identification of employees capable of training others Identification of skills that could potentially utilize shared resources

For Assistance See Attachment G

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ATTACHMENT A

Employee Training and Performance Management DocumentsPhased Implementation Plan (2012-2013)

Phase Things To Do Deliverables

Phase One Documents On-LineFeb. 19 Identify all jobs -take the most simplistic approach

Involve/assign all supervisors -assemble current materialPut manuals on-line/protect -use existing training documentsControl on-line manuals -compiled/assembled at supervisory level

Mar. 31 First 3 groups (CMO, PPO, SPO) on-lineJuly 1 All manuals on-line

Phase Two Refine On-line DocumentsBegin July 1 -content review/updateStatus Report Dec 1 -software standardized

-referenced documents reviewed/updated-Supervisors trained to use system

Phase Three Validate Systems Support for Begin January 2, 2012 -training and performance management

documentationMonthly status report (navigation is not an issue)

Phase Four Maintain On-line Begin July 1, 2012 Training and performance managementAudit twice yearly documents

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ATTACHMENT BKey Roles and Responsibilities

Refer to CORPORATE TRAINING POLICY (The Regulatory Training Process)

Area Management - the supervisory team that determines, supports, and ensures documentation and change control of required training and skills proficiency for direct reports.

Create and manage area Job Curriculums and Training Plan(s)Identify required regulatory training for each Job DescriptionDecide Training Frequency.Complete a Curriculum Maintenance FormDevelop and manage area Training Plan(s)Identify, direct, and support Qualified Instructor(s).Identify, direct and support area TRIAD (training information and documentation) Administrator(s).Manage and document regulatory training and skills proficiency to ensure regulatory training compliance.Manage the regulatory training documents according to the Records Retention Schedule.Document and explain all exceptions to requirements for training and skill proficiency.Ensure documentation change control.

Qualified Instructor - The person with the education, training, and experience, or any combination thereof, necessary to perform the specific training assignment.

Conduct and document Regulatory Training.Use the current Regulatory Training.Complete the Training Attendance Document.Submit the completed document(s) to area management or designee(s).

Employee - The person responsible for completing and documenting (sign and date) required training and skills assessments and performing job duties and responsibilities as trained.

Complete training according to assigned Job Curriculum and Training Plan.Participate in training.Complete Training Attendance Document.Confirm that related performance assessment (skill proficiency) is documented.Confirm documentation of all exceptions to requirements for training and skill proficiency.

TRIAD Administrator - The person responsible for maintaining employee training information and documentation.

Administer TRIAD for the assigned area.Enter Job Curriculum data.File Job Curriculum.Enter Employee Profile data.File Employee Profile.Enter Training Attendance Document data.File Training Attendance DocumentUse TRIAD for prompting area training.

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ATTACHMENT C

Lean Training Charter (updated February 13, 2012)

Lean Training MissionDetermine and define current skills throughout GENERIC CORPORATION - Global, identify and implement needed training, and implement activities that ensure the best utilization of resources in order to maximize throughput and optimize resource utilization throughout the company.

ObjectiveTo identify the skills, and skill needs, and provide training in order to facilitate sharing resources.

Team MembersGeneric Corporation Terry Solo SPO Mitch Must HR

Don Case SPO Greg Alder PPOBeth Booth CMO Pat Goslin QODon Bald TS Open ENGWayne Potts EHS

Highland Group Bob Miller

BackgroundOpportunities to better utilize resources and to share resources exist throughout GENERIC CORPORATION - Global. Sharing of resources can be enhanced by confirming critical skills and by determining training needed to optimize those skills. GENERIC CORPORATION - Global will be enabled to operate more efficiently by better utilization of resources. Overtime can be reduced. Resources gaps can be filled. Resources can be more effectively utilized.

Duration Four-phased implementation/on-going

Deliverables Shared services benefits Consolidation of resources Job analysis for all jobs Updated Job Descriptions Confirmed training needs Documented training plans Enhanced knowledge, skills and abilities Documentation of skills proficiencies. Documented levels of proficiency by position

Benefits Reduced headcount requirements Increased skills among employees Enhanced moral Enhanced efficiency/quality of operations Enhanced regulatory compliance Enhanced flexibility/adaptability Reduced bottom line expenses Documented of training and skill proficiencies Consolidation of job duties and new Job Descriptions Consolidation/reduction of Job Descriptions

Key Performance Indicator - the ratio for shared resources to number of employees by work area

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ATTACHMENT DTraining Requirements Guidelines/Area Training Program Assessment

Position: Job Code: Division: Cost Center:

Key Components

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Employee Profile

Job Description

Job Training Curriculum

Performance Plan

Training Plan

Skills Proficiency Assessment

Safety Orientation Checklist

Departmental Orientation Checklist

Training Attendance Documentation

Other Jobs Held In C

File Location

Supervisor

TRIAD Administrator

Training Program Assessment Completed By

Date Training Program Assessment Completed

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ATTACHMENT E, 1 of 2 pages

Instructions for Completing Skills Matrix and Assessments

The attached template is to be used by the Area Management Team to complete skill matrices for each Job Description and employee in the area. The matrices are to be completed by the immediate supervisor(s). The completed matrices must be available on the computer in the provided template

List thirty, or less, critical skills (job tasks) for the Job Description. List the employees in the job alphabetically on the matrix. Assess the current skills level of each employee, not what you think they can attain. Use the following scale:

A – Competent and capable of training othersB – Competent and works independentlyC – Requires assistance to complete the task

NS – Employee does not have the skill (if the employee is not currently performing the task you should still assess the skill as A, B, or C)

Assessment accuracy can help to ensure success in future job assignments. Employees with a skill rating of “A” for a given job task are expected to train others in that job task. Use the assessments to address training needs within the job and the company.

Assess each job task for “transferability”. “Transferable” means the job task is one that can be performed easily by employees from other jobs and areas. Transferable skills are important when extra resources are urgently needed, and during normal operations which utilize shared resources. As a rule, transferable skills require minimal training, are not complex, and are the less critical of the critical job tasks. Mark the appropriate column with “T” if the job task skill is “Transferable”.

List the previous job title(s) on the matrix for other positions held by the employee within the company.

For assistance see Attachment G. Use the person from or nearest your area.

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ATTACHMENT E, 2 of 2 pagesSkills Matrix

Position: Job Code: Division: Cost Center:

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1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.16.17.18.19.20.21.22.23.24.25.

Other Positions Held Within Company:1.2.3.4.5.Completed by: ext. Date:

Supervisor’s Name

T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee. Under the column, for each employee mark “A”, “B” or “C” for the competency level of each skill.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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ATTACHMENT F, 1 of 6 pages

Skills Matrices (SIX EXAMPLES), 1 of 6 pages

Position: Validation Specialist Job Code: XXXXDivision: Quality Operations Cost Center: XXXX

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1. GMP/test result analysis of computer info. systems A B B B2. GMP/test result analysis of computer auto. systems A B B B3. GMP/test result analysis of products & cleaning B B A B4. GMP/test result analysis of lab instrument systems B B B A5. GMP/test result analysis of equipment systems B A B B6. GMP/test result analysis of utilities B A B B7. Write rationale for objectives and AC B B B B8. Write test procedures B B C B9. Test computer information systems B B C C10. Test computer automation systems B B C C11. Test products & cleaning B B B B12. Test laboratory instrument systems B B B B13. Test equipment systems B B B B14. Test utilities B A B B15. Resolve issues & failures of computer info. systems B B NS C16. Resolve issues & failures of computer auto. Systems A B NS C17. Resolve issues & failures of products & cleaning C B A B18. Resolve issues & failures of lab instrument systems B B C A19. Resolve issues & failures of equipment systems B B B A20. Resolve issues & failures of utilities B A B B21. Writing packages without deviations B B C C22. Writing packages with deviations B B B B23. Maintain company document databases T B B B B24. Defend validation program and documentation B B B B25. Label/prepare documents for records storage T B B B B26. Train lower level staff B B NS NSOther Positions Held Within Company:1.2.3.4.

Completed by: ext. Date:

Supervisor’s Name

T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Skills Matrix (EXAMPLE), 2 of 6 pagesPosition: Control Scientist II Job Code: XXXXDivision: Quality Operations Cost Center: XXXX

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1. Calculations to convert lab data into reportable form B B B B2. Maintain laboratory notebooks and records B C B B3. Compare laboratory results with specifications for

acceptability and determine if repetition is requiredB B C B

4. Report results on company databases B B B C5. Prioritize work assignments B NS B B6. Write summary reports/memos NS A B B7. Write and review SOPs and laboratory procedures B B B B8. Revise analytical procedures B B C B9. Implement laboratory instrumentation B B NS C10. Troubleshoot instrumentation, technical/non-technical

problemsB B C C

11. Approve data of other scientists B B B B12. High Performance Liquid Chromatography Systems B B B B13. pH Meters B B B B14. Gas Chromatography Systems B A B B15. Ultra-violent/Visible Spectrophotometer (UV/VIS) B B A C16. Fourier Transform Infrared Spectrophotometer 17. (FT-IR)

A B A C

18. Atomic Absorption Spectrophotometer (AA) A B A B19. Dissolution B B A A20. Total Organic Carbon (TOC) analysis B B B A21. GC Mass Spectrophotometer B A B B22. Physical Examination T B B B B23. Mobile Phase Preparation T B B B B24. Content Uniformity B B B B25. Out of Specifications (OOS) Investigations T B B B B26. Laboratory Safety T B B B BOther Positions Held Within Company:1.2.3.4.5.

Completed by: ext. Date:

Supervisor’s Name T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Skills Matrix (EXAMPLE), 3 of 6 pagesPosition: Flex Technician Job Code: XXXXDivision: PPO Cost Center: XXXX

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1. Performs item number check on components used

T B B B B

2. Line Clearance Checks T B B B B3. Log Book entries B B A B4. Load/fill packaging equipment with packaging components

T B B B B

5. Operate/Clean/Change-over Siebler Strip Packer B A B B6. Operate/Clean/Change-over Bosch Thermoformer

(lines 21,22,23)B NS B B

7. Operate/Clean/Change-over Bosch Cartoner (lines 21,22,23)

B B B B

8. Operate/Clean/Cahnge-over Uhlmann Thermoformer(line 26)

B B NS B

9. Operate/Clean/Change-over Klockner LA 500 B B C C10. Operate/Clean/Change-over Uhlmann Cartoner

B B NS C

11. Operate Color Verification System B B B B12. Operate Pac 100 Pack Detection System B B B B13. Operate Security Labelers B B B B14. Operate/Program Bar Code Inspection System

B NS B B

15. Operate/Clean/Change-over Kiener Bundler B B B C16. Operate/Program Hi-Speed Checkweigher A B B C17. Operate ARO Leak Tester C B A B18. Operate 3M taper T B B C A19. Operate/Program Okura Palletizer B B B A20. Operate Lakso Tablet Hoist B A B B21. Operate/Clean/change-over Gemel Deblister B B C C22. Perform in-process checks ( leak test, seal test,

preforation test,etc)B B B B

23. Purge lines of components before and after packaging operations

T B B B B

24. Change or replace exhausted packaging components on packaging equipment( lables, outserts, foils, etc)

B B B B

25. Perform Batch Reconciliation to ensure packaging was completed within acceptable limits

B B B B

Other Positions Held Within Company:1.2.Completed by: ext. Date:

Supervisor’s Name T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Skills Matrix (EXAMPLE), 4 of 6 pagesPosition: General Operator Job Code: XXXXDivision: PPO Cost Center: XXXX

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1. Performs item number check on components used

T A B B B

2. Line Clearance Checks T A B B B3. Log Book entries B B A B4. Load/fill packaging equipment with packaging components

T B B B A

5. Operate Stalberger Unscrambler/ U.S. Bottle Blower/Omega Unscrambler

B A B B

6. Operate Omega Desiccant Inserter B A B B7. Operate Lakso Reformer 990 Filler B B B B8. Operate wift Check Tablet Counter B B C B9. Operate Lakso Tablet Hoist B B C C10. Operate Lakso 150 Cottoner B B C C11. Operate Filma-seal machine B B B B12. Operate Resina Screwcapper B B B B13. Operate Cap elevator B B B B14. Operate New Jersey Labeling Machine B A B B15. Operate Cart 204 Cartoner B B B C16. Operate Fasson Carton Taper A B B C17. Operate Pester Bundler C B A B18. Operate/Setup Hi-Speed Check Weigher B B C A19. Operate 3M taper T B B B A20. Perform in-process checks ( Cap torques, fill weights,

tablet counts, etc)B A B B

21. Supply and services packaging lines as required. T B B B B22. Purge lines of components before and after packaging

operationsT B B B B

23. Perform equipment cleanings as required. B B B B24. Change or replace exhausted packaging components

on packaging equipment( labels, outserts, foils, etc)B B B B

25. Perform Batch Reconciliation to ensure packaging was completed within acceptable limits

B B B B

Other Positions Held Within Company:1.2.Completed by: ext. Date:

Supervisor’s Name

T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Skills Matrix (EXAMPLE), 5 of 6 pagesPosition: Checker Operator Job Code: XXXXDivision: SPO Cost Center: XXXX

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1. Line clearance checks T A B B B2. Logbook entries A B B B3. Load components on line/equipment T B B A B4. Load/Unload accumulator tables T B B B A5. Pack shippers/outers T B NS B B6. Particulate inspection (liquid products) B A B B7. Particulate inspection (lyophilized products) B B B B8. Aseptic filling weight checks B B C B9. Packaging quality checks B B C C10. Filling quality checks B B B B11. Inspection quality checks B B B B12. Operate Bosch vial washer B B B B13. Operate Gilowy vial washer B B B B14. Operate Bosch ampul washer B A B B15. Work in aseptic areas B B NS C16. Work in clean rooms B B B B17. Operate Avery labeler with laser and ITRAN vision

systemB B A B

18. Change labels on Avery labelers B B C A19. Operate Jones Cartoner B B B A20. Operate Minnesota Traypacker B A B B21. Set-up Oliver Shrink Wrap tunnel B B C C22. Operate Bosch Ampul Cartoner B B B B23. Operate AK-2 Ampul Inspection Equipment B B B B24. Operate Densok Pinhole Inspection Equipment B B B B25. Operate Brevetti Vial Inspection Equipment B NS NS B

Other Positions Held Within Company:1.2.3.4.5.Completed by: ext. Date:

Supervisor’s Name T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Skills Matrix (EXAMPLE), 6 of 6 pagesPosition: Processor Job Code: XXXXDivision: SPO Cost Center: XXXX

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1. Line clearance checks T A B B B2. Logbook entries A B B B3. Load components on line/equipment T B B A B4. Load/Unload accumulator tables T B B B A5. Aseptic filling weight checks B A B B6. Operate Bosch vial washer T B A B B7. Operate Gilowy vial washer T B B B B8. Operate Bosch ampul washer T B B C B9. Work in aseptic areas B B C C10. Work in clean rooms B B C C11. Set-up TL Filler B B B B12. Operate TL Filler B B B B13. PM for TL Filler B B B B14. Set-up Bosch Ampul Filler B A B B15. Operate Bosch Ampul Filler B B B C16. PM for Bosch Ampul Filler B B B B17. Set-up Chase Logeman Drop Dose Filler C B A B18. Operate Chase Logeman Drop Dose Filler B B NS A19. PM for Chase Logeman Drop Dose Filler B B B A20. Set-up Chase Logeman Vial Filler B A B B21. Operate Chase Logeman Vial Filler B NS C C22. PM for Chase Logeman Vial Filler NS B B B23. Integrity Test Filters T B B B B24. Clean/Preps Filling Parts T B B B B25. Operate West Capper T B B B B26. Operate Alcoa Capper T B B B BOther Positions Held Within Company:1.2.Completed by: ext. Date:

Supervisor’s Name T is the “Transferable” column and means the skill could be performed by another area when resources are needed or to utilize shared resources (i.e. minimal training required, not highly skilled, less critical task). Mark “A”, “B”, “C”, or "NS" for the competency level of each skill in the column for each employee.

A Competent and capable of training others B Competent and capable of working independently C Requires assistance to complete task NS Employee does not have skill (if the employee is not currently performing the task, you should still assess the

skill as A, B or C)

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Attachment G

For Assistance

Team MembersGeneric Corporation Terry Solo ext. 7131 SPO Mitch Must ext. 7210 TODon Kaster ext. 7080 SPO Greg Alright ext. 7241 PPOBeth Booth ext. 7522 CMO Pat Goslin ext. 7257 QODon Fountain ext. 7602 TS Open ENGWayne Potts ext. 7210 EHS

Highpaid Consulting Group Bob Profit ext. 72667

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