TO

ISO/TS 16949 TRAINING ISO/TS 16949 TRAINING PROGRAMPROGRAM

TRAINING PROGRAMME TRAINING PROGRAMME ON ON

ISO/TS 16949ISO/TS 16949

CONTENTSCONTENTS

•PHILOSOPHY OF A SYSTEM•CORRECT UNDERSTANDING OF A GOOD SYSTEM•FIVE PILLARS OF TQM•NEED FOR ISO 9001:2000•KEY QUALITY MANAGEMENT PRINCIPLES•PROCESS APPROACH•ISO/TS 16949 STANDARD REQUIREMENTS

PHILOSOPHY OF THE SYSTEMPHILOSOPHY OF THE SYSTEM

•No one wants to make a mistake. Everyone wants to do a good job.•All problems are traceable to system issues.•System is an outcome of a policy. A Good Policy leads to a Good System. A Bad System implies outdated Policy.•A Policy creates a Good Environment.•Corrective Measures and Improvement should be System related.•Customer Satisfaction only through meeting expectations.•Everyone in the Company should be involved•The best way is through a System.

COMMON SYSTEM PROBLEMSCOMMON SYSTEM PROBLEMS

•NO SYSTEM

•NO COMMUNICATION

•NOT SUITABLE

•NOT EFFECTIVE

CORRECT UNDERSTANDING OF A CORRECT UNDERSTANDING OF A GOOD SYSTEMGOOD SYSTEM

•ORGANISATION HAS CERTAIN OBJECTIVES TO BE ACHIEVED

•THIS SHOULD BE ACHIEVED NOT BY INDIVIDUAL EXCELLENCE, BUT THROUGH AN EFFECTIVE INTEGRATED SYSTEM

•ACHIEVING THE ORGANISATIONAL OBJECTIVES WILL BE THE SAME AS GETTING THE DESIRED BENEFITS FROM THE SYSTEM

•ANY SYSTEM SHOULD BE DEFINED THROUGH AN INPUT, PROCESS AND OUTPUT MODEL.

CORRECT UNDERSTANDING OF A CORRECT UNDERSTANDING OF A GOOD SYSTEMGOOD SYSTEM

•SYSTEM IS AN ENVIRONMENT WHICH DEPLOYS THE POLICY.

•THE EFFECTIVENESS OF THE SYSTEM IS THE OUTCOME OF THE EFFECTIVE DEPLOYMENT OF THE POLICY.

•THE EFFECTIVE IMPLEMENTATION OF THE SYSTEM IS BASED ON THE EFFECTIVE DEPLOYMENT OF THE SYSTEM REPRESENTED BY POLICIES AND PROCEDURES INTO THE ORGANISATION IN THE FORM OF RESPONSIBILITIES AND AUTHORITIES.

EXAMPLES OF SYSTEMSEXAMPLES OF SYSTEMS

•Inspection System•Corrective Action System•Management Review System•Training System•Document Control System•Quality Records System•Recruitment System•Measurement Analysis System •Auditing System Etc.

POINTS TO CONSIDERPOINTS TO CONSIDER• ISO Systems – DOES NOT SAY “HOW TO DO”, IT ONLY SAYS “WHAT TO DO”

• ACTIVITIES TO BE VIEWED FROM THE “ASSURANCE” POINT OF VIEW.

•“ASSURANCE” SHOULD BE FELT BY THE INTERNAL/ EXTERNAL CUSTOMER.

•LOOK AT THE SYSTEM ADOPTED BY YOU AND VERIFY WHETHER ASSURANCE IS PROVIDED.

•ANY SYSTEM WILL BE ONLY EQUAL TO THE ORGANISATIONAL AVERAGE.

•ANY SYSTEM SHOULD PROVIDE CONSISTENCY, LEVEL OF PERFORMANCE AND INTEGRATION.

FIVE PILLARS OF TQMFIVE PILLARS OF TQM

PRODUCT

EFFECTIVENESS WASTE ELIMINATIONPROCESS

SYSTEM RE-ENGINEERING

PEOPLE

SUITABILITY CULTURE & MATURITY

LEADERSHIP

NEED FOR ISO 9001:2000NEED FOR ISO 9001:2000•EVOLVING USER AND CUSTOMER NEEDS

•ORIENTATION TOWARDS A PROCESS APPROACH

•PERCEPTION OF THE 20 CLAUSES AS A COMPLEX STANDARD, FROM THE POINT OF VIEW OF SMALL INDUSTRY

•ADVENT OF THE NEED FOR ENHANCED COMPATIBILITY WITH OTHER MANAGEMENT SYSTEM STANDARDS LIKE ISO 14001, QS 9000

•INCORPORATION OF THE ISO 9000 STANDARDS INTO INDUSTRY SPECIFIC REQUIREMENTS LIKE ISO/TS 16949 (QS 9000 and VDA 6.1 COMBINED)

•PROLIFERATION OF GUIDELINES, STANDARDS IN THE CURRENT ISO 9000 FAMILY

•IMPROVEMENT BASED ON FEEDBACK FROM VARIOUS USERS

•BASIC NEED FOR AN UPDATION OF A STANDARD ONCE IN A DEFINED PERIOD

KEY QUALITY MANAGEMENT KEY QUALITY MANAGEMENT PRINCIPLESPRINCIPLES

The eight Key Principles of ISO 9001:2000 which The eight Key Principles of ISO 9001:2000 which are embedded in ISO/TS 16949are embedded in ISO/TS 16949

1. Customer Focus2. Leadership3. Involvement of People4. Process Approach5. System Approach to Management6. Continual Improvement7. Factual Approach to Decision - Making.8. Mutually Beneficial Supplier Relationship

QMP 1 - CUSTOMER FOCUSQMP 1 - CUSTOMER FOCUS

Applying the principle of Customer Focus Typically leads to :

• Researching and understanding customer needs and expectations.• Communicating these needs and expectations throughout the organization.• Measuring customer satisfaction and acting on results• Managing customer relationships• Ensuring a balanced approach between satisfying customers and other interested parties.

QMP 1 - CUSTOMER FOCUSQMP 1 - CUSTOMER FOCUSKey Benefits :• Increased revenue and market share obtained through flexible and fast responses to market opportunities.• Increased effectiveness in the use of the organization’s resources to enhance customer satisfaction• Improved customer loyalty leading to repeat business.

Applicable Clauses of ISO/TS 16949 5.1 Management Commitment5.2 Customer Focus5.5.2 Management Representative6.1 Provision of Resources8.2.1 Customer Satisfaction8.4 Analysis of Data8.5.2 Corrective Action

QMP 2 - LEADERSHIPQMP 2 - LEADERSHIP

Applying the principle of Leadership Typically leads to :

• Establishing a clear vision of the organization’s future.• Setting challenging goals and targets.• Creating and sustaining shared values, fairness and ethical role models at all levels of the organization.• Educating, training, and coaching people• Promoting open and honest communication• Providing people with the required resources and freedom to act with responsibility and accountability.• Implementing strategy to achieve these goals and targets.

QMP 2 - LEADERSHIPQMP 2 - LEADERSHIP

Key Benefits :• People will understand and be motivated towards the organizational goals and objectives. • Activities are evaluated, aligned and implemented in a unified way.• Miscommunication between levels of an organization will be minimized. Applicable Clauses of ISO/TS 16949 5.1 Management Commitment5.3 Quality Policy5.4.1 Quality Objectives5.6 Management Review

QMP 3 - INVOLVEMENT OF PEOPLEQMP 3 - INVOLVEMENT OF PEOPLE

Applying the principle of Involvement of People Typically leads to :• People accepting ownership of problems and their responsibility for solving them.• People understanding the importance of their contribution and role in the organization.• People actively seeking opportunities to enhance their competence, knowledge and experience.• People freely sharing knowledge and experience.• People openly discussing problems, issues and identifying constraints to their performance.

QMP 3 - INVOLVEMENT OF PEOPLEQMP 3 - INVOLVEMENT OF PEOPLE

Key Benefits :• Motivated, committed and involved people within the organization. • Innovation and creativity in furthering the organization’s objectives• People being accountable for their own performance.• People eager to participate and contribute to continual improvement. Applicable Clauses of ISO/TS 16949 5.3 Quality Policy5.5.1 Responsibility and Authority5.5.3 Internal Communication6.2 Human Resources.6.4 Work Environment

QMP 4- PROCESS APPROACHQMP 4- PROCESS APPROACH

Applying the principle of Process Approach typically leads to:• Define the processes needed to achieve desired results.• Identify the interfaces of key activities within and between the functions of the organization.• Identify and measure inputs and outputs.• Evaluate the risks, consequences and impact on customers.• Establish responsibility and accountability for managing processes.• Focus on factors such as resources, methods, training, etc to achieve desired results.

QMP 4- PROCESS APPROACHQMP 4- PROCESS APPROACH

Key Benefits :• Lower Cost and Shorter Cycle time through effective use of Resources.• Improved,Consistent and Predictable Results• Focused and Prioritized Improvement Opportunities Applicable Clauses of ISO/TS 16949 4.1 QMS - General Requirements5.4.2 QMS - Planning5.5.2 Management Representative7.1 Planning of Product Realization7.2 Customer Related Processes7.3 Design and Development7.5 Production and Service Provision

QMP 5- SYSTEM APPROACH TO MANAGEMENTQMP 5- SYSTEM APPROACH TO MANAGEMENT

Applying the principle of System Approach typically leads to:• Structure the system to achieve the organization’s objectives in the most effective and efficient way.• Understanding the interdependencies between the processes in the system.• Continually improve through measurement and evaluation• Targeting and defining how specific activities within a system should operate.•Define and Develop processes.

QMP 5- SYSTEM APPROACH TO MANAGEMENTQMP 5- SYSTEM APPROACH TO MANAGEMENT

Key Benefits :• Integration and alignment of the processes that will achieve desired results.• Ability to focus effort on the key processes.• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization. Applicable Clauses of ISO/TS 169494.2 Documentation Requirements6.1 Provision of Resources6.3 Infrastructure

QMP 6- CONTINUAL IMPROVEMENTQMP 6- CONTINUAL IMPROVEMENT

Applying the principle of Continual Improvement Typically leads to:

• Employing a consistent organization-wide approach to continual improvement of the organization’s performance.• Providing training on continual improvement tools• Establishing measures and goals to guide and track improvements.• Recognizing and acknowledging improvements.

QMP 6- CONTINUAL IMPROVEMENTQMP 6- CONTINUAL IMPROVEMENTKey Benefits :• Performance advantage through improved organizational capabilities. • Alignment of improvement activities at all levels to an organization’s strategic intent.• Flexibility to react quickly to opportunities Applicable Clauses of ISO/TS 16949:4.1 QMS - General Requirements5.1 Management Commitment5.3 Quality Policy5.4.1 Quality Objectives5.5.2 Management Representative5.6 Management Review6.1 Provision of Resources8 Measurement, Analysis and Improvement

QMP 7- FACTUAL APPROACH TO QMP 7- FACTUAL APPROACH TO DECISION MAKINGDECISION MAKING

Applying the principle of Factual Approach Typically leads to:

• Ensuring that data and information are accurate, reliable and accessible.• Analyzing data and information using valid methods.• Making decisions and taking action on result of analysis.• Measuring and collecting data and information.

QMP 7- FACTUAL APPROACH TO QMP 7- FACTUAL APPROACH TO DECISION MAKINGDECISION MAKING

Key Benefits :• An increased ability to demonstrate the effectiveness of past decisions through reference to factual records• Increased ability to review, challenge and change, opinions and decisions.

Applicable Clauses of ISO/TS 16949 7.1 Planning of Product Realization 7.5.1 Control of production and service provision7.6 Control of Monitoring and measuring devices8.1 Measurement, Analysis and Improvement - General8.2.2 Internal Audits8.2.3 Monitoring and Measurement of Processes8.2.4 Monitoring and Measurement of Products8.3 Control of nonconforming product8.4 Analysis of Data

QMP 8- MUTUALLY BENEFICIAL SUPPLIER QMP 8- MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPSRELATIONSHIPS

Applying the principle of Mutual Beneficial Supplier Relationships Typically leads to:

• Identifying and selecting key suppliers. • Clear and open communication• Sharing information and future plans• Establish joint development and improvement activities.• Establish relationship that balance short term gains with long term considerations.

QMP 8- MUTUALLY BENEFICIAL SUPPLIER QMP 8- MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPSRELATIONSHIPS

Key Benefits :• Increased ability to create value for both parties • Flexibility and speed of joint responses to changing market or customer needs and expectations.•Organization of cost and resources.

Applicable Clauses of ISO/TS 16949

7.4 Purchasing

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Product

The Result of a Process

Categories of product

•Hardware

•Processed Materials

•Software

•Services

Most products are combinations of the above

Standard’s Requirement towards Process Approach

•Identify the process•Determine the Sequence of the Processes

•Determine the Interaction between the Processes

•Determine the criteria and methods needed to control the Processes

•Ensure the availability of resources and information necessary to carryout these processes

•Monitor, measure and analyze these processes•Implement actions necessary to achieve results and improve the processes

What is a Process?

Set of interrelated or interacting activities

Input

Process

Output

Procedure(“Specified way to

carryout an activity or a process”-may be

documented or not)

Monitoring and Measuring opportunities (Before, During & After the Process)

Effectiveness of process(Ability to achieve

desired results)

Efficiency of process(Results achieved

v/s. Resources used)

Customer Requirements

Man

agem

ent

Res

pons

ibili

ty

Measurement, Analysis and Improvement

Customer

Resource Management

Satisfaction

Product

Con

tinua

l Im

prov

emen

t of

Qua

lity

Man

agem

ent

Sys

tem

Pro

duct

R

ealiz

atio

n

Process ModelISO 9001:2000

Structure of ISO 9001:2000 based on Process Approach

Management Responsibility• Commitment, Customer focus, Policy, Planning,

• Responsibility, Authority & Communication, Review

Resource Management• Human Resources, Infrastructure, Work Environment

Product Realization• Customer Requirements, Design, Purchasing, Operations, Calibration

Measurement, analysis and improvement• Customer Satisfaction, Audit, Process/Product control,

Non-conforming product, Data Analysis, Improvement

Process Approach based on P-D-C-A cycleProcess Approach based on P-D-C-A cycle

Plan

DoCheck

Act

The cycle goes on

Process Approach based on P-D-C-A cycleProcess Approach based on P-D-C-A cycle

Plan

Top Management

Planning Done by the Management

• Establish Policy• Define Objectives• Identify and provide resources• Define Organization Structure• Focus on Customer Requirements

Process Approach based on P-D-C-A cycleProcess Approach based on P-D-C-A cycle

P

Top Management

Do:

• Show commitment• Communicate the importance of

customer requirements• Deploy policy throughout Organization• Define measurable objectives

• Delegate

D

Process Approach based on P-D-C-A cycleProcess Approach based on P-D-C-A cycle

• Is the system working for the Organization?

• Are the set objectives are being met?

• Do the people are following the framed policy?

• Are the customers happy?

• What is performance of the business?

• Is there any plan that could affect the system?

(new product line; re-organization etc.)

P

CD

Check:

Top Management

Process Approach based on P-D-C-A cycleProcess Approach based on P-D-C-A cycle

Act:

• Incorporate into next Business / Quality Planning

• Identify areas for continual improvement

• Identify and provide any resources, if required

• Re-organize

• “Convert”, “Sideline” or “Fire” non-believers / non-performers

P

C D

A

Top Management

ISO/TS 16949 STANDARD SPECIFIES ISO/TS 16949 STANDARD SPECIFIES REQUIREMENTS FOR A QMS WHERE AN REQUIREMENTS FOR A QMS WHERE AN

ORGANIZATIONORGANIZATION

• NEEDS TO DEMONSTRATE ITS ABILITY TO CONSISTENTLY PROVIDE A PRODUCT THAT MEETS CUSTOMER AND APPLICABLE REGULATORY REQUIREMENTS.

• AIMS TO ENHANCE CUSTOMER SATISFACTION THROUGH EFFECTIVE APPLICATION OF SYSTEM THROUGH PROCESS APPROACH.

• EXCLUSIONS TO THIS STANDARD ARE LIMITED TO REQUIREMENTS WITHIN CLAUSE 7

4. QUALITY MANAGEMENT SYSTEM (QMS)

4.1 GENERAL REQUIREMENTS

QUALITY MANAGEMENT SYSTEM IS TO BE ESTABLISHED,DOCUMENTED, IMPLEMENTED,  MAINTAINED AND CONTINUALLYIMPROVED FOR IT’S EFFECTIVENESS.

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL QMS DOCUMENTATION SHALL INCLUDE - • STATEMENT OF QUALITY POLICY & OBJECTIVES , QUALITY

MANUAL• PROCEDURES REQUIRED BY THE STANDARD• DOCUMENTS TO ENSURE EFFECTIVE PLANNING, OPERATION

AND CONTROL OF ITS PROCESSES• RECORDS REQUIRED BY THE STANDARD.

4.2.2 QUALITY MANUAL

• THE SCOPE OF QMS, INCLUDING JUSTIFICATION FOR EXCLUSIONS

• DOCUMENTED PROCEDURES ESTABLISHED , OR REFERENCE TO THEM

• DESCRIPTION OF INTERACTION BETWEEN THE PROCESSES OF QMS LIKE MANAGEMENT RESPONSIBILITY, RESOURCES, PRODUCT REALIZATION, MEASUREMENTS.

4.2.3 CONTROL OF DOCUMENTS• PROCEDURE TO DEFINE THE CONTROLS NEEDED TO APPROVE

DOCUMENTS FOR ADEQUACY PRIOR TO ISSUE • REVIEW & UPDATE AS NECESSARY AND RE-APPROVE• TO IDENTIFY CURRENT REVISION STATUS OF DOCUMENTS

4.2.3 CONTROL OF DOCUMENTS - CONTD.• AVAILABILITY OF RELEVENT VERSIONS OF APPLICABLE DOCUMENTS AT POINTS OF USE• LEGIBILITY AND IDENTIFICATION• IDENTIFICATION AND DISTRIBUTION CONTROL OF EXTERNAL ORIGIN DOCUMENTS• IDENTIFICATION OF OBSOLETE DOCUMENTS

4.2.3.1 ENGINEERING SPECIFICATIONS•HAVE A PROCESS FOR TIMELY REVIEW, DISTRIBUTION AND IMPLEMENTATION•MAINTAIN RECORD OF DATE ON WHICH CHANGE IS IMPLEMENTED

•

4.2.4 CONTROL OF RECORDS

RECORDS SHALL REMAIN LEGIBLE, READILY IDENTIFIABLE AND RETRIEVABLE AS PER A PROCEDURE DEFINING CONTROLS FOR • IDENTIFICATION • STORAGE• PROTECTION • RETRIEVAL• PROTECTION• RETENTION TIME ( SATISFY GOVT.& CUSTOMER REQMTS)

4.2.4.1 RECORDS RETENTIONMINIMUM SATISFY REGULATORY AND CUSTOMER REQUIREMENTSNOTE :

•DISPOSITION INCLUDES DISPOSAL•INCLUDES CUSTOMER SPECIFIED RECORDS

5. MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENTTOP MANAGEMENT’S COMMITMENT FOR THE DEVELOPMENT OF THE QMS AND FOR THE CONTINUAL IMPROVEMENT OF IT’S EFFECTIVENESS BY:

• COMMUNICATING THE IMPORTANCE OF MEETING CUSTOMER AS WELL AS STATUTORY & REGULATORY REQUIREMENTS• ESTABLISHING QUALITY POLICY & OBJECTIVES• CONDUCTING MANAGEMENT REVIEWS• ENSURING THE AVAILABILITY OF RESOURCES

5.1.1 PROCESS EFFICIENCY

TOP MANAGEMENT TO MONITOR THE PRODUCT REALISATION AND SUPPORT PROCESS TO ASSURE THEIR EFFECTIVENESS AND EFFICIENCY.

5.2 CUSTOMER FOCUS

TOP MANAGEMENT SHALL ENSURE THAT CUSTOMER REQUIREMENTS ARE DETERMINED AND FULFILLED WITH THE AIM OF ENCHANCING CUSTOMER SATISFACTION

5.3QUALITY POLICY • TO BE APPROPRIATE TO THE PURPOSE OF THE ORGANIZATION.

• SHOULD INCLUDE COMMITMENT TO COMPLY WITH REQUIREMENTS AND CONTINUALLY IMPROVE THE EFFECTIVENESS OF QMS.

• IS A FRAME WORK FOR ESTABLISHING & REVIEWING QUALITY OBJECTIVES.

• TO BE COMMUNICATED AND UNDERSTOOD WITHIN THE ORGANIZATION

• TO BE REVIEWED FOR CONTINUED SUITABILIY

5.4 PLANNING

5.4..1 QUALITY OBJECTIVES

• ESTABLISHED AT RELEVANT FUNCTIONS & LEVELS

• SHOULD BE MEASURABLE

• CONSISTENT WITH THE QUALITY POLICY

5.4.1.1 QUALITY OBJECTIVES – SUPPLEMENTAL

TO DEFINE QUALITY OBJECTIVES AND MEASUREMENTS IN THE BUSINESS PLAN TO DEPLOY THE QUALITY POLICY

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

• QMS PROCESS PLANNING • QUALITY OBJECTIVES • INTEGRITY TO BE MAINTAINED DURING QMS CHANGES

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY RESPONSIBILITY AND AUTHORITY IS TO BE DEFINED AND COMMUNICATED.

5.5.1.1 RESPONSIBILITY FOR QUALITY

•MANAGEMENT WITH RESPONSIBILITY AND AUTHORITY FOR CORRECTIVE ACTION SHALL BE PROMPTLY INFORMED OF • PRODUCTS OR PROCESSES WHICH DO NOT COMPLY WITH REQUIREMENTS•AUTHORITY TO STOP PRODUCTION TO CORRECT QUALITY PROBLEMS•ALL SHIFTS TO HAVE STAFF TO ASSURE PRODUCT QUALITY5.5.2 MANAGEMENT REPRESENTATIVE

• ESTABLISH, IMPLEMENT AND MAINTAIN THE PROCESSES NEEDED FOR QMS.

• REPORT TO TOP MANAGEMENT ON THE PERFORMANCE OF THE QMS, INCLUDING NEEDS FOR IMPROVEMENT.

• PROMOTE AWARENESS OF CUSTOMER REQUIREMENTS THROUGHOUT THE ORGANIZATION.

•

5.5.2.1 CUSTOMER REPRESENTATIVE

•TO DESIGNATE INDIVIDUALS WHO WILL REPRESENT THE NEEDS OF THE CUSTOMER LIKE

•SELECTION OF SPECIAL CHARACTERISTICS•SETTING QUALITY OBJECTIVES AND RELATED TRAINING•CORRECTIVE AND PREVENTIVE ACTION•PRODUCT DESIGN AND DEVELOPMENT

5.5.3 INTERNAL COMMUNICATION ESTABLISH COMMUNICATION CHANNELS WITHIN THE ORGANIZATION FOR EFFECTIVE COMMUNICATION OF QMS

5.6 MANAGEMENT REVIEW 5.6.1 GENERAL

• QMS REVIEW AT PLANNED INTERVALS.• REVIEW TO ASSESS OPPORTUNITIES FOR IMPROVEMENT.• NEED FOR CHANGES TO QMS, QUALITY POLICY & OBJECTIVES.

5.6.1.1 QUALITY MANAGEMENT SYSTEM PERFORMANCE

INCLUDES ALL ELEMENTS OF QUALITY SYSTEM AND ITS PERFORMANCE AS AN ESSENTIAL PART OF THE CONTINUAL IMPROVEMENT PROCESS

• MONITORING OF QUALITY OBJECTIVES• REPORTING AND EVALUATION OF THE COST OF POOR QUALITY •MINIMUM EVIDENCE FOR THE ACHIEVEMENT OF OBJECTIVES SPECIFIED IN THE QUALITY POLICY•OBJECTIVES SPECIFIED IN THE BUSINESS PLAN•CUSTOMER SATISFACTION WITH PRODUCT SUPPLIED

5.6.2 REVIEW INPUT

•RESULTS OF AUDITS •CUSTOMER FEEDBACK•PROCESS PERFORMANCE AND PRODUCT CONFORMANCE•STATUS OF PREVENTIVE AND CORRECTIVE ACTIONS.•FOLLOW-UP ACTIONS FROM PREVIOUS MANAGEMENT REVIEWS.• CHANGES THAT COULD AFFECT THE QMS.

• RECOMMENDATIONS FOR IMPROVEMENT

5.6.2.1 REVIEW INPUT – SUPPLEMENTAL

INCLUDES•SUMMARY RESULTS OF NEW PRODUCT DEVELOPMENT MEASUREMENTS•ANALYSIS OF FIELD FAILURES •THEIR IMPACT ON QUALITY, SAFETY OR THE ENVIRONMENT

5.6.3 REVIEW OUTPUT

• IMPROVEMENT OF THE EFFECTIVENESS OF QMS AND ITS PROCESSES.

• IMPROVEMENT OF PRODUCT RELATED TO CUSTOMER REQUIREMENTS. • RESOURCE NEEDS• RESULT OF MANAGEMENT REVIEW TO BE RECORDED.

6 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES

• TO IMPLEMENT AND MAINTAIN THE QMS AND CONTINUALLY IMPROVE ITS EFFECTIVENESS.• TO ENHANCE CUSTOMER SATISFACTION.

6.2 HUMAN RESOURCES

6.2.1 GENERAL

• QUALIFICATION ON THE BASIS OF APPROPRIATE EDUCATION, TRAINING, SKILLS AND EXPERIENCE.

6.2.2.1 PRODUCT DESIGN SKILLS

PRODUCT DESIGN PERSONNEL TO BE QUALIFIED TO ACHIEVEDESIGN REQUIREMENTS AND SKILLED

APPLICABLE TOOLS AND TECHNIQUES TO BE IDENTIFIED

6.2.2 COMPETENCE, AWARENESS AND TRAINING• ASSIGNMENT OF COMPETENT PERSONNEL PROVISION OF TRAINING• EVALUATE THE EFFECTIVENESS OF THE TRAINING• AWARENESS ABOUT CONTRIBUTION TOWARDS QUALITY OBJECTIVES.• MAINTAIN RECORDS OF EDUCATION, TRAINING, SKILLS AND EXPERIENCE.

6.2.2.2 TRAINING DOCUMENTED PROCEDURES FOR IDENTIFYING TRAINING NEEDS AND ACHIEVING COMPETENCE

SPECIFIC ASSIGNED TASKS QUALIFICATIONS TRAINING RECORDS TO BE MAINTAINED SPECIAL ATTENTION TO SATISFY CUSTOMER SPECIFIC REQUIREMENTS

6.2.2.3 TRAINING ON THE JOB FOR PERSONNEL IN ANY NEW OR MODIFIED JOB INCLUDE CONTRACT OR AGENCY PERSONNEL INFORM ABOUT THE CONSEQUENCE TO CUSTOMER

DUE TO NON-CONFORMANCE

6.2.2.4 EMPLOYEE MOTIVATION AND EMPOWERMENT PROCESS FOR EMPLOYEE MOTIVATION TO ACHIEVE

QUALITY OBJ ECTIVES AND MAKE IMPROVEMENTS PROMOTION OF QUALITY AND TECHNOLOGICAL

AWARENESS AT ALL LEVELS PROCESS FOR MEASUREMENT TO THE EXTENT TO

WHICH THE PERSONNEL ARE AWARE OF THE RELEVANCE AND IMPORTANCE OF THEIR ACTIVITIES AND CONTRIBUTION TOWARDS THE ACHIEVEMENT OF QUALITY OBJ ECTIVES

6.3 INFRASTRUCTURE

IDENTIFY, PROVIDE AND MAINTAIN THE INFRASTRUCTURE(WORKSPACE AND ASSOCIATED FACILITIES, EQUIPMNET, HARDWARE AND SOFTWARE, SUPPORTING SERVICES) TO ACHIEVE PRODUCT CONFORMITY.

6.3.1 PLANT, FACILITY AND EQUIPMENT PLANNING

•USE MULTIDISCIPLINARY APPROACH•OPTIMISE MATERIAL TRAVEL, HANDLING, SYNCHRONOUS FLOW•METHODS TO EVALUATE AND MONITOR EFFECTIVENESS OF EXISTING OPERATIONS

6.4 WORK ENVIRONMENT

DETERMINE AND MANAGE THE WORK ENVIRONMENT NEEDEDTO ACHIEVE CONFORMITY OF PRODUCT

6.4.1 PERSONNEL SAFETYADDRESS DUE CARE REGARDING PRODUCT SAFETY AND MEANS TO MINIMIZE POTENTIAL RISKS TO EMPLOYEES

6.4.2 CLEANLINESS OF PREMISES

MAINTAIN THE PREMISES IN A STATE OF ORDER, CLEANLINESS AND REPAIR

6.3.2 CONTINGENCY PLANS

PREPARE CONTINGENCY PLANS TO SATISFY THECUSTOMER SPECIFIED REQUIREMENTS

7. PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION

Product realization planning to determine the following:

• QUALITY OBJECTIVES• REQUIRED PROCESS DOCUMENTS AND RESOURCES• VERIFICATION, VALIDATION, MONITORING AND CRITERIA FOR PRODUCT ACCEPTANCE.• RECORDS TO PROVIDE EVIDENCE• THE OUTPUT OF PLANNING IS TO BE DOCUMENTED.

7.1.1 PLANNING OF PRODUCT REALISATION – SUPPLEMENTAL DEVELOP QUALITY PLAN WHICH INCLUDES CUSTOMER REQUIREMENTS AND REFERENCES TO TECHNICAL SPECIFICATIONS 7.1.2 ACCEPTANCE CRITERIA TO BE DEFINED BY THE ORGANISATION, WHEN REQUIRED APPROVED BY THE CUSTOMER. FOR ATTRIBUTE DATA SAMPLING, THE CRITERIA SHALL BE ZERO. 7.1.3 CONFIDENTIALITY ENSURE CONFIDENTIALITY OF CUSTOMER-CONTRACTED PRODUCTS AND PROJECTS UNDER DEVELOPMENT AND RELATED PRODUCT INFORMATION.

7.1.4 CHANGE CONTROL HAVE A PROCESS TO CONTROL AND REACT TO CHANGES THAT

IMPACT PRODUCT REALISATION ASSESS THE EFFECT OF CHANGES AND DEFINE VERIFICATION

AND VALIDATION ACTIVITIES VALIDATE THE CHANGES BEFORE IMPLEMENTATION FOR PROPRIETORY DESIGNS, IMPACT ON FORM, FIT AND

FUNCTION TO BE REVIEWED WITH THE CUSTOMER IF REQUIRED BY THE CUSTOMER, ADDITIONAL VERIFICATION/

IDENTIFICATION REQUIREMENTS TO BE MET.

7.2 CUSTOMER RELATED PROCESSES

7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT FOR :•REQUIREMENTS DETERMINED BY THE ORGANIZATION AVAILABILITY, DELIVERY AND SUPPORT•REQUIREMENTS FOR SPECIFIED AND INTENDED USE• REGULATORY AND STATUTORY REQUIREMENTS. •ANY ADDITIONAL.7.2.1.1 CUSTOMER DESIGNATED SPECIAL CHARACTERISTICS

•DEMONSTRATE CONFORMITY TO CUSTOMER REQUIREMENTS FOR DESIGNATION, DOCUMENTATION AND CONTROL OF SPECIAL CHARACTERISTICS

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

REVIEW DURING TENDERS, ORDERS AND AMENDMENTS TO ENSURE THE FOLLOWING :

•PRODUCT REQUIREMENTS ARE DEFINED.•DIFFERENCES RESOLVED•ABILITY TO MEET THE REQUIREMENTS DEFINED

•VERBAL REQUIREMENTS ARE CONFIRMED BEFORE ACCEPTANCE

7.2.2.1 ORGANISATION MANUFACTURING FEASIBILITY

•INVESTIGATE, CONFIRM AND DOCUMENT THE MANUFACTURING

FEASIBILITY OF THE PROPOSED PRODUCTS IN CONTRACT REVIEW

7.2 CUSTOMER RELATED PROCESSES

7.2.3 CUSTOMER COMMUNICATION IDENTIFY AND IMPLEMENT ARRANGEMENTS FOR COMMUNICATING TO CUSTOMERS REGARDING:

• PRODUC T INFORMATION• ENQUIRIES, CONTRACTS OR ORDER HANDLING INCLUDING

AMENDMENTS.• CUSTOMER FEEDBACK, INCLUDING CUSTOMER COMPLAINTS.

7.2.3.1 CUSTOMER COMMUNICATION – SUPPLEMENTAL

HAVE THE ABILITY TO COMMUNICATE IN A CUSTOMER SPECIFIED LANGUAGE AND FORMAT

7.3 DESIGN AND DEVELOPMENT

INCLUDES PRODUCT AND MANUFACTURING PROCESS DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING. • STAGES OF DESIGN AND DEVELOPMENT PROCESS.• REVIEW, VERIFICATION AND VALIDATION ACTIVITIES• RESPONSIBILITY AND AUTHORITY FOR DESIGN AND DEVELOPMENT ACTIVITIES• INTERFACES BETWEEN DIFFERENT GROUPS• PLANNING OUTPUT SHALL BE UPDATED, AS THE DESIGN AND DEVELOPMENT PROGRESSES.

7.3.1.1 MULTIDISCIPLINARY APPROACH USE A MULTIDISCIPLINARY APPROACH FOR PRODUCT

REALISATION DEVELOPMENT/ FINALISATION AND MONITORING OF

SPECIAL CHARACTERISTICS DEVELOPMENT AND REVIEW OF FMEA’s, INCLUDING

ACTIONS TO REDUCE POTENTIAL RISKS DEVELOPMENT AND REVIEW OF CONTROL PLANS

7.3.2 DESIGN & DEVELOPMENT INPUTS

• FUNCTIONAL AND PERFORMANCE REQUIREMENTS •APPLICABLE REGULATORY AND STATUTORY REQUIREMENTS•APPLICABLE INFORMATION DERIVED FROM PREVIOUS SIMILAR DESIGN•OTHER REQUIREMENTS ESSENTIAL FOR DESIGN & DEVELOPMENT

•INPUT SHALL BE REVIEWED FOR ADEQUACY

7.3.2.1 PRODUCT DESIGN INPUT

•IDENTIFY, DOCUMENT AND REVIEW THE PRODUCT DESIGN INPUT REQUIREMENTS INCLUDING•CUSTOMER REQUIREMENTS•USE OF INFORMATION GAINED FROM PREVIOUS DESIGN PROJECTS•TARGETS FOR PRODUCT QUALITY, LIFE, RELIABILITY, MAINTAINABILITY,TIMING, COST.

7.3.2.2 MANUFACTURING PROCESS DESIGN INPUT

IDENTIFY, DOCUMENT AND REVIEW THE PROCESS DESIGNINPUT REQUIREMENTS INCLUDING

PRODUCT DESIGN OUTPUT DATA, SUCH AS DESIGN FMEA’s

TARGETS FOR PRODUCTIVITY, PROCESS CAPABILITY ANDCOST

CUSTOMERS REQUIREMENTS

EXPERIENCE FROM PREVIOUS DEVELOPMENTS

7.3.2.3 SPECIAL CHARACTERISTICS IDENTIFY SPECIAL CHARACTERISTICS INCLUDE IN THE CONTROL PLAN COMPLY WITH SPECIFIC DEFINITIONS AND SYMBOLS OF THE

CUSTOMERS MARK THE PROCESS CONTROL DOCUMENTS WITH

CUSTOMER’S/ ORGANISATION’S EQUIVALENT SYMBOL

7.3 DESIGN AND DEVELOPMENT7.3.3 DESIGN AND DEVELOPMENT OUTPUTS •MEET THE INPUT REQUIREMENTS•PROVIDE INFORMATION FOR PURCHASING, PRODUCTION AND SERVICE PROVISION.•CONTAIN OR REFERENCE ACCEPTANCE CRITERIA FOR PRODUCT•DEFINE THE CHARACTERISTICS OF THE PRODUCT THAT ARE•ESSENTIAL FOR ITS SAFE AND PROPER USE.7.3.3.1 PRODUCT DESIGN OUTPUTS – SUPPLEMENTAL

•EXPRESS PRODUCT DESIGN OUTPUT SUCH THAT IT CAN BE VERIFIED AND VALIDATED AGAINST INPUT REQUIREMENTS

•PRODUCT DESIGN OUTPUT INCLUDES •DESIGN FMEA, RELIABILITY STUDIES•PRODUCT SPECIAL CHARACTERISTICS, SPECIFICATIONS•PRODUCT MISTAKE PROOFING•PRODUCT DEFINITION INCLUDING DRAWINGS•PRODUCT DESIGN REVIEWS RESULTS

• DIAGNOSTIC GUIDELINES, WHERE APPLICABLE

7.3.3.2 MANUFACTURING PROCESS DESIGN OUTPUT EXPRESS PROCESS DESIGN OUTPUT SUCH THAT IT CAN BE

VERIFIED AND VALIDATED AGAINST INPUT REQUIREMENTS PROCESS DESIGN OUTPUT INCLUDES SPECIFICATIONS AND DRAWINGS MANUFACTURING PROCESS FLOW CHART/ LAYOUT MANUFACTURING PROCESS FMEA’s CONTROL PLAN WORK INSTRUCTIONS PROCESS APPROVAL ACCEPTANCE CRITERIA DATA FOR QUALITY, RELIABILITY, MAINTAINABILITY AND

MEASURABILITY RESULTS OF ERROR-PROOFING ACTIVITIES METHODS OF RAPID DETECTION AND FEEDBACK OF

PRODUCT/ PROCESS NONCONFORMITIES

7.3.4 DESIGN & DEVELOPMENT REVIEW• TO EVALUATE THE ABILITY TO FULFILL REQUIREMENTS• TO IDENTIFY PROBLEMS AND PROPOSE NECESSARY ACTIONS• TO BE DONE BY CROSS FUNCTIONAL TEAM • RECORDS SHALL BE MAINTAINED.

7.3.4.1 MONITORING

•DEFINE MEASUREMENTS AT SPECIFIED STAGES OF DESIGN AND DEVELOPMENT, ANALSE AND REPORT AS AN INPUT FOR MANAGEMENT REVIEW•MEASUREMENTS INCLUDE QUALITY RISK, COST, LEAD-TIME, CRITICAL PATHS

7.3.5 DESIGN AND DEVELOPMENT VERIFICATION TO BE PERFORMED TO ENSURE THE OUTPUT MEETS THE INPUTSRECORDS SHALL BE MAINTAINED. 7.3.6 DESIGN & DEVELOPMENT VALIDATION

• TO BE PERFORMED TO CONFIRM THAT RESULTING PRODUCT IS CAPABLE OF MEETING THE REQUIREMENTS FOR THE INTENDED APPLICATION• USE IN ACCORDANCE WITH PLANNED ARRANGEMENTS.• RECORDS SHALL BE MAINTAINED.

7.3.6.1 DESIGN AND DEVELOPMENT VALIDATION – SUPPLEMENTAL

PERFORM IN CONJUNCTION WITH CUSTOMER PROGRAM TIMING REQUIREMENTS

7.3.6.2 PROTOTYPE PROGRAM•HAVE A PROTOTYPE PROGRAM AND PROTOTYPE CONTROL PLAN, IF REQUIRED BY THE CUSTOMER•USE THE SAME SUPPLIERS, TOOLING AND MANUFACTURING PROCESS AS WILL BE USED IN PRODUCTION•MONITOR ALL PERFORMANCE TESTING ACTIVITIES FOR TIMELY COMPLETION•IF SERVICES ARE SUBCONTRACTED, PROVIDE TECHNICAL LEADERSHIP

7.3.7 CONTROL OF DESIGN & DEVELOPMENT CHANGES

•CHANGES TO BE IDENTIFIED, DOCUMENTED & CONTROLLED CHANGES TO FOLLOW THE DESIGN CYCLE, AS APPROPRIATE

•THE RESULT OF THE REVIEW OF CHANGES TO BE RECORDED.

7.3.6.3 PRODUCT APPROVAL PROCESS COMPLY WITH A PRODUCT AND PROCESS APPROVAL PROCEDURE RECOGNISED BY THE CUSTOMER IT IS APPLICABLE FOR SUPPLIERS ALSO

7.4 PURCHASING

7.4.1 PURCHASING PROCESS • TYPE AND EXTENT OF CONTROL TO BE DEPENDENT ON EFFECT OF THE PURCHASED PRODUCT ON OTHER PROCESS.• EVALUATION AND SELECTION OF SUPPLIERS• CRITERIA FOR SELECTION, EVALUATION• MAINTAIN EVALUATION AND RESULTING ACTION RECORDS.

7.4.1.2 REGULATORY COMPLIANCESATISFY CURRENT APPLICABLE REGULATORY REQUIREMENTS FOR THE PURCHASED PRODUCTS OR MATERIALS

7.4.1.3 SUPPLIER QUALITY MANAGEMENT SYSTEM DEVELOPMENT

•PERFORM SUPPLIER QUALITY MANAGEMENT SYSTEM DEVELOPMENT WITH THE GOAL OF COMPLIANCE TO ISO/TS 16949

•MINIMUM, SUPPLIER SHALL BE CERTIFIED TO ISO 9001:2000 UNLESS OTHERWISE SPECIFIED BY CUSTOMER

7.4.1.4 CUSTOMER APPROVED SOURCES

PURCHASE PRODUCTS, MATERIALS OR SERVICES FROM CUSTOMER APPROVED SOURCES, IF REQUIRED BY CONTRACT.

7.4.2 PURCHASING INFORMATION

• REQUIREMENTS FOR APPROVAL OR QUALIFICATION OF PRODUCT,

PROCEDURES, PROCESSES, EQUIPMENT, PERSONNEL

•ENSURE ADEQUACY OF SPECIFIED REQUIREMENTS IN PURCHASING DOCUMENTS.

7.4.3 VERIFICATION OF PURCHASED PRODUCT

ORGANIZATION VERIFICATION CUSTOMER VERIFICATION

7.4.3.1 INCOMING PRODUCT QUALITY

• PROCESS TO ASSURE THE QUALITY OF PURCHASED PRODUCTS BY

THE FOLLOWING METHOD :• RECEIPT AND EVALUATION OF STATISTICAL DATA• RECEIVING INSPECTION/ TESTING• SECOND OR THIRD PARTY ASSESSMENT• PART EVALUATION BY DESIGNATED LABORATORY• ANY OTHER METHOD AGREED WITH THE CUSTOMER.

7.4.3.2 SUPPLIER MONITORING

• MONITORING THROUGH THE FOLLOWING INDICATORS : • DELIVERED PART QUALITY PERFORMANCE• CUSTOMER DISRUPTIONS INCLUDING FIELD RETURNS• DELIVERY SCHEDULE PERFORMANCE (INCIDENTS OF PREMIUM

FREIGHT)• SPECIAL STATUS CUSTOMER NOTIFICATION RELATED TO

QUALITY OR DELIVERY ISSUES.• PROMOTE SUPPLIER MONITORING OF THE PERFORMANCE OF

MANUFACTURING PROCESS

7.5 PRODUCT AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION OPERATIONS CONTROL TO INCLUDE : •THE AVAILABILITY OF INFORMATION THAT SPECIFIES THE CHARACTERISTICS OF THE PRODUCT.

•WHERE NECESSARY, THE AVAILABILITY OF WORK INSTRUCTIONS

•THE USE OF SUITABLE EQUIPMENT

•THE AVAILABILITY AND USE OF MEASURING AND MONITORING DEVICES.

•IMPLEMENTATION OF MEASURING & MONITORING ACTIVITIES.

•IMLEMENTATION OF RELEASE, DELIVERY AND POST - DELIVERY ACTIVITIES.

7.5.1.1 CONTROL PLAN DEVELOP CONTROL PLAN AT THE SYSTEM, SUBSYSTEM,

COMPONENT AND/ OR MATERIAL LEVEL HAVE A CONTROL PLAN FOR PRE-LAUNCH AND PRODUCTION,

TAKING DESIGN FMEA AND PROCESS FMEA OUTPUTS USE A MULTI-DISCIPLINARY APPROACH LIST ON THE CONTROL PLAN THE CONTROLS USED FOR PROCESS

CONTROL INCLUDE THE CUSTOMER REQUIRED INFORMATION INITIATE THE SPECIFIED REACTION PLAN AS A MINIMUM, INCLUDE METHODS FOR MONITORING AND

RECORDING RESULTS OF CONTROL EXERCISED OVER SPECIAL CHARACTERISTICS

REVIEW AND UPDATE THE CONTROL PLAN WHEN ANY CHANGE OCCURS AFFECTING PRODUCT, MANUFACTURING PROCESS, MEASUREMENT, LOGISTICS,, SUPPLY SOURCES OR FMEA.

7.5.1.2 WORK INSTRUCTIONS PREPARE DOCUMENTED WORK INSTRUCTIONS FOR THE

OPERATION OF THE PROCESSES TO BE ACCESSIBLE FOR USE AT WORK STATION DERIVE FROM SOURCES SUCH AS QUALITY PLAN, CONTROL

PLAN AND PRODUCT REALISATION PROCESS 7.5.1.3 VERIFICATION OF J OB SET-UPS VERIFY J OB SET-UPS J OB INSTRUCTIONS TO BE AVAILABLE FOR SET-UP

PERSONNEL USE STATISTICAL METHODS OF VERIFICATION, WHERE

APPLICABLE

7.5.1.4 PREVENTIVE AND PREDICTIVE MAINTENANCE IDENTIFY KEY PROCESS EQUIPMENT AND PROVIDE

RESOURCES FOR MAINTENANCE DEVELOP TOTAL PREVENTIVE MAINTENANCE SYSTEM,

INCLUDING PLANNED MAINTENANCE ACTIVITIES PACKAGING AND PRESERVATION OF EQUIPMENT, TOOLING

AND GAUGING AVAILABILITY OF REPLACEMENT PARTS FOR KEY

MANUFACTURING EQUIPMENT DOCUMENTING, EVALUATING AND IMPROVING MAINTENANCE

OBJ ECTIVES USE PREDICTIVE MAINTENANCE METHODS TO CONTINUALLY

IMPROVE THE EFFECTIVENESS AND EFFICIENCY OF PRODUCTION EQUIPMENT

7.5.1.5 TOOLING MANAGEMENT PROVIDE RESOURCES FOR TOOL AND GAUGE DESIGN, FABRICATION AND VERIFICATION ACTIVITIES ESTABLISH AND IMPLEMENT A SYSTEM FOR TOOLING MANAGEMENT INCLUDING: MAINTENANCE AND REPAIR FACILITIES AND PERSONNEL STORAGE AND RECOVERY SET-UP TOOL CHANGE PROGRAMS FOR PERISHABLE TOOLS TOOL DESIGN MODIFICATION DOCUMENTATION TOOL MODIFICATION AND REVISION TO DOCUMENTATION TOOLING IDENTIFICATION & STATUS IMPLEMENT A SYSTEM TO TRACK AND FOLLOW-UP ON THESE ACTIVITIES, IF OUTSOURCED.

7.5.1.6 PRODUCTION SCHEDULING TO BE SCHEDULED IN ORDER TO MEET CUSTOMER REQUIREMENTS SUCH AS SUE OF J UST-IN-TIME 7.5.1.7 FEEDBACK OF INFORMATION FROM SERVICE ESTABLISH AND MAINTAIN A PROCEDURE FOR COMMUNICATION OF INFORMATION ON SERVICE CONCERNS 7.5.1.8 SERVICING AGREEMENT WITH THE CUSTOMER VERIFY THE EFFECTIVENESS OF SERVICE CENTRES SPECIAL PURPOSE TOOLS OR MEASURING EQUIPMENT TRAINING OF SERVICING PERSONNEL

7.5 PRODUCT AND SERVICE PROVISION

7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION & SERVICE PROVISION

VALIDATE THE PRODUCTION AND SERVICE PROCESSES WHERE THE RESULTING OUTPUT CANNOT BE VERIFIED BY SUBSEQUENT MEASUREMENT OR MONITORING DEMONSTRATE THE ABILITY OF THE PROCESSES. SYSTEM TO CONSIDER:

CRITERIA FOR REVIEW AND APPROVAL OF PROCESS APPROVAL OF EQUIPMENT AND QUALIFICATION OF PERSONNEL USE OF SPECIFIC METHODS AND PROCEDURES REQUIREMENTS FOR RECORDS RE-VALIDATION

7.5.2.1 SUPPLEMENTAL

ABOVE REQUIREMENTS APPLY TO ALL PROCESSES FOR PRODUCTION AND SERVICE PROVISION

7.5 PRODUCTION AND SERVICE PROVISION

7.5.3 IDENTIFICATION AND TRACEABILITY •IDENTIFICATION AT ALL STAGES WHERE APPROPRIATE•IDENTIFICATION OF STATUS OF THE PRODUCT AFTER MEASUREMENT.•CONTROL AND RECORD THE UNIQUE IDENTIFICATIONS OF THE PRODUCT, WHERE TRACEABILITY IS A REQUIREMENT

7.5.4 CUSTOMER PROPERTY • IDENTIFICATION• VERIFICATION• PROTECTION• MAINTENANCE• REPORTING TO CUSTOMER IN CASE OF LOSS, DAMAGE OR OTHERWISE UNSUITABLE FOR USE, RECORDS.

7.5 PRODUCTION AND SERVICE PROVISION

7.5.4.1 CUSTOMER OWNED PRODUCTION TOOLING •CUSTOMER-OWNED TOOLS, MANUFACTURING, TEST, INSPECTION TOOLING AND EQUIPMENT TO BE PERMANENTLY MARKED.

7.5.5 PRESERVATION OF PRODUCT •PRESERVE CONFORMITY OF PRODUCT DURING INTERNAL PROCESSING AND DELIVERY.•PRESERVATION TO INCLUDE IDENTIFICATION, HANDLING, PACKAGING, STORAGE AND PROTECTION.

7.5.5.1 STORAGE AND INVENTORY

CONDITION OF PRODUCT IN STOCK TO BE ASSESSED AT PLANNED INTERVALSUSE AN INVENTORY MANAGEMENT SYSTEMOBSOLETE PRODUCT TO BE CONTROLLED IN A MANNER TO SIMILAR TO NONCONFORMING PRODUCT

7.6 CONTROL OF MEASURING AND MONITORING DEVICES •IDENTIFY THE MEASUREMENT TO BE MADE AND MEASURING AND MONITORING DEVICES REQUIRED INCLUDING TEST SOFTWARE.•CALIBRATION AGAINST DEVICES TRACEABLE TO INTERNATIONAL/ NATIONAL STANDARDS•CALIBRATION STATUS IDENTIFICATION•SAFEGUARD AND PROTECTION•ASSESS, RECORD VALIDITY OF MEASUREMENT WHEN EQUIPMENT IS OUT OF CALIBRATION•RECORDS OF CALIBRATION.

7.6.1 MEASUREMENT SYSTEM ANALYSIS

CONDUCT STATISTICAL STUDIES TO ANALYSE VARIATIONPRESENT IN THE RESULTS OF EACH TYPE OFMEASUREMENT AND TEST EQUIPMENT SYSTEM,REFERRED IN THE CONTROL PLAN

REFER CUSTOMER REFERENCE MANUALS FORANALYTICAL METHODS AND ACCEPTANCE CRITERIA

7.6.2 CALIBRATION RECORDS

RECORDS TO INCLUDE

REVISIONS FOLLOWING ENGINEERING CHANGES ANY OUT OF SPECIFICATION READINGS AS RECEIVED

FOR CALIBRATION/ VERIFICATION AN ASSESSMENT OF THE IMPACT OF OUT-OF-

SPECIFICATION CONDITION STATEMENTS OF CONFORMANCE TO SPECIFICATION

AFTER CALIBRATION/ VERIFICATION NOTIFICATION TO THE CUSTOMER, IF THE SUSPECT

PRODUCT OR MATERIAL HAS BEEN SHIPPED

7.6.3 LABORATORY REQUIREMENTS

7.6.3.1 INTERNAL LABORATORY

TO HAVE A DEFINED SCOPE

LABORATORY SCOPE TO INCLUDED AS PART OF QUALITY MANAGEMENT SYSTEM DOCUMENTATION

LABORATORY TO COMPLY WITH TECHNICAL REQUIREMENTS INCLUDING

ADEQUACY OF LABORATORY PROCEDURE

QUALIFICATIONS OF LABORATORY PERSONNEL

TESTING OF THE COMMODITIES

CAPABILITY TO PERFORM THE TESTS CORRECTLY, TRACEABLE TO RELEVANT PROCESS STANDARD

REVIEW OF RELATED QUALITY RECORDS

7.6.3.2 EXTERNAL LABORATORY

TO HAVE A DEFINED LABORATORY SCOPE

LABORATORY TO BE ACCREDITED TO ISO/IEC 17025 OR NATIONAL EQUIVALENT, OR

EVIDENCE THAT THE EXTERNAL LABORATORY IS ACCEPTABLE TO THE CUSTOMER.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL DEFINE, PLAN AND IMPLEMENT THE MEASUREMENT, MONITORING AND IMPROVEMENT PROCESSES INCLUDING STATISTICAL TECHNIQUES. 8.1.1 IDENTIFICATION OF STATISTICAL TOOLS

DETERMINE DURING ADVANCE QUALITY PLANNING AND INCLUDE IN CONTROL PLAN

8.1.2 KNOWLEDGE OF BASIC STATISTICAL CONCEPTS

BASIC CONCEPTS TO BE UNDERSTOOD THROUGHOUT THE ORGANISATION (VARIATION, CONTROL, PROCESS CAPABILITY AND OVER-ADJUSTMENT)

8.2.1.1 CUSTOMER SATISFACTION – SUPPLEMENTAL

•TO BE MONITORED THROUGH CONTINUAL EVALUATION OF THE PERFORMANCE•PERFORMANCE INDICATORS TO BE BASED ON OBJECTIVE DATA AND INCLUDE DELIVERED PART QUALITY PERFORMANCE•CUSTOMER DISRUPTIONS INCLUDING FIELD FAILURES•DELIVERY SCHEDULE PERFORMANCE (INCLUDING INCIDENTS OF PREMIUM FREIGHT)•CUSTOMER NOTIFICATIONS RELATED TO QUALITY OR DELIVERY ISSUES

•TO MONITOR MANUFACTURING PROCESSES’ PERFORMANCE TO DEMONSTRATE COMPLIANCE WITH CUSTOMER REQUIREMENTS FOR PRODUCT QUALITY AND EFFICIENCY OF THE PROCESSES. OPERATIONS

8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION MONITOR THE CUSTOMER SATISFACTION AND/ OR DISSATISFACTION. METHODOLOGIES SHALL BE:

8.2.2 INTERNAL AUDIT

• CONDUCT PERIODICAL INTERNAL AUDITS TO DETERMINEWHETHER THE QMS CONFORMS TO THE REQUIREMENTS OF THIS INTERNATIONAL STANDARD HAS BEEN EFFECTIVELY IMPLEMENTED AND MAINTAINED. •PLAN THE AUDIT PROGRAM TAKING INTO CONSIDERATION THE STATUS AND IMPORTANCE OF THE ACTIVITIES,AREAS TO BE AUDITED AS WELL AS THE RESULTS OF PREVIOUS AUDITS•DEFINE THE AUDIT SCOPE, FREQUENCY AND METHODOLOGIES•AUDIT TO BE CONDUCTED BY PERSONNEL OTHER THAN THOSEWHO PERFORM THE ACTIVITY BEING AUDITED.•REPORT AUDIT OBSERVATIONS.•PROPOSE AND IMPLEMENT CORRECTIVE ACTIONS•FOLLOW-UP ACTIONS TO VERIFY THE IMPLEMENTATION OFCORRECTIVE ACTION AND TO REPORT THE VERIFICATION RESULTS.

8.2.2.1 QUALITY MANAGEMENT SYSTEM AUDIT AUDIT THE QUALITY MANAGEMENT SYSTEM TO VERIFY COMPLIANCE WITH THIS TECHNICAL SPECIFICATION AND ANY ADDITIONAL QUALITY MANAGEMENT SYSTEM REQUIREMENTS. 8.2.2.2 MANUFACTURING PROCESS AUDIT AUDIT THE MANUFACTURING PROCESS TO DETERMINE THE EFFECTIVENESS 8.2.2.3 PRODUCT AUDIT AUDIT PRODUCTS AT APPROPRIATE STAGES OF PRODUCTION AND DELIVERY TO VERIFY CONFORMANCE TO PRODUCT DIMENSIONS, FUNCTIONALITY, PACKAGING & LABELLING

8.2.2.4 INTERNAL AUDIT PLANS TO COVER ALL QUALITY MANAGEMENT SYSTEM RELATED PROCESSES, ACTIVITIES AND SHIFTS AND TO BE SCHEDULED ACCORDING TO AN ANNUAL PLAN. 8.2.2.5 INTERNAL AUDITOR QUALIFICATION INTERNAL AUDITORS TO BE QUALIFIED TO AUDIT THE REQUIREMENTS OF THIS TECHNICAL SPECIFICATION.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT8.2.3 MEASUREMENT AND MONITORING OF PROCESSES

SUITABLE METHODS FOR MEASUREMENT AND MONITORING

8.2.3.1 MONITORING AND MEASUREMENT OF PROCESSES – SUPPLEMENTAL PERFORM PROCESS STUDIES ON ALL NEW MANUFACTURING PROCESSES

•DOCUMENT THE RESULTS WITH SPECIFICATIONS, FOR MEANS OF PRODUCTION, MEASUREMENT AND MAINTENANCE INSTRUCTIONS•THE DOCUMENTS TO INCLUDE OBJECTIVES FOR MANUFACTURING PROCESS CAPABILITY, RELIABILITY, MAINTAINABILITY AND AVAILABILITY, AS WELL AS ACCEPTANCE CRITERIA

•MAINTAIN MANUFACTURING PROCESS CAPABILITY OR PERFORMANCE AS SPECIFIED BY THE CUSTOMER PART APPROVAL PROCESS REQUIREMENTS•ENSURE IMPLEMENTATION OF CONTROL PLAN AND PROCESS FLOW DIAGRAM•NOTE THE SIGNIFICANT PROCESS EVENTS ON THE CONTROL CHARTS•INITIATE APPROPRIATE REACTION PLAN FROM THE CONTROL PLAN, FOR THE CHARACTERISTICS THAT ARE UNSTABLE OR NON-CAPABLE•COMPLETE THE CORRECTIVE ACTION PLAN TO ASSURE THAT THE PROCESS BECOMES STABLE AND CAPABLE•REVIEW AND APPROVE THE PLANS WITH THE CUSTOMER, IF REQUIRED•MAINTAIN RECORDS OF EFFECTIVE DATES OF PROCESS CHANGES

8..2.4 MONITORING AND MEASUREMENT OF PRODUCT

• MEASURE AND MONITOR THE PRODUCT CHARACTERISTICS AT

APPROPRIATE STAGES.

• EVIDENCE OF CONFORMITY WITH THE ACCEPTANCE CRITERIA

• RECORD SHALL INDICATE THE AUTHORITY RESPONSIBLE FOR

RELEASE OF PRODUCT.

• PRODUCT RELEASE AND SERVICE DELIVERY SHALL NOT

PROCEED UNTILL ALL THE SPECIFIED ACTIVITIES HAVE BEEN

SATISFACTORILY COMPLETE, UNLESS OTHERWISE APPROVED BY

THE CUSTOMER.

8.2.4.1 LAYOUT INSPECTION AND FUNCTIONAL TESTING PERFORM TO APPLICABLE CUSTOMER ENGINEERING

MATERIAL AND PERFORMANCE STANDARDS FOR ALL PRODUCTS AT FREQUENCY SPECIFIED IN THE CONTROL PLAN

RESULTS SHALL BE AVAILABLE FOR CUSTOMER REVIEW APPEARANCE ITEMS 8.2.4.2 APPEARANCE ITEMS FOR APPEARANCE ITEMS, PROVIDE APPROPRIATE LIGHTING

FOR EVALUATION AREAS MASTERS FOR COLOR, GRAIN, GLOSS, METALLIC BRILLIANCE,

TEXTURE, DISTINCTNESS OF IMAGE MAINTENANCE AND CONTROL OF APPEARANCE MASTERS AND

EQUIPMENT VERIFICATION THAT PERSONNEL MAKING APPEARANCE

EVALUATIONS ARE QUALIFIED TO DO SO.

8.3 CONTROL OF NONCONFORMING PRODUCT DOCUMENTED PROCEDURE TO DEFINE THE FOLLOWING•IDENTIFICATION AND CONTROL•DOCUMENTATION•CORRECTION•RE-VERIFICATION AFTER CORRECTION•RECORD OF NC's AND SUBSEQUENT ACTIONS INCLUDING• CONCESSIONS.

8.3.1 CONTROL OF NONCONFORMING PRODUCT-SUPPLEMENTAL

PRODUCT WITH UNIDENTIFIED OR SUSPECTED STTUS TO BE CLASSIFED AS NONCONFORMING PRODUCT.

8.3.2 CONTROL OF REWORKED PRODUCT

REWORK INSTRUCTIONS TO BE ACCESSIBLE AND UTILIZED BY THE APPROPRIATE PERSONNEL

8.3.3 CUSTOMER INFORMATION TO BE INFORMED PROMPTLY TO THE CUSTOMER IN THE

EVENT, NONCONFORMING PRODUCT IS SHIPPED. 8.3.4 CUSTOMER WAIVER OBTAIN CUSTOMER AUTHORISATION PRIOR TO CHANGING CUSTOMER –APPROVED PRODUCT OR PROCESSES MAINTAIN RECORDS OF EXPIRATION DATE OR QUANTITY AUTHORIZED REVERT TO ORIGINAL OR SUPERSEDING SPECIFICATIONS WHEN THE AUTHORSATION EXPIRES PROPERLY IDENTIFY ON EACH SHIPPING CONTAINER APPLIES TO PURCHASED PRODUCTS ALSO WITH RESPECT

TO REQUESTS FROM SUPPLIERS

8.4 ANALYSIS OF DATA • COLLECT AND ANALYSE DATA TO DETERMINE THE SUITABILITY AND EFFECTIVENESS OF THE QMS AND IDENTIFY IMPROVEMENTS • ANALYSE THE DATA TO PROVIDE INFORMATION ON CUSTOMER SATISFACTION• CONFORMANCE TO PRODUCT REQUIRMENTS CHARACTERISTICS, TRENDS OF PROCESSES, PRODUCT AND OPPORTUNITIES FOR PREVENTIVE ACTION SUPPLIERS

8.4.1 ANALYSIS AND USE OF DATA COMPARE TRENDS WITH PROGRESS TOWARDS QUALITY OBJ ECTIVES AND TAKE ACTION TO SUPPORT :

A. DEVELOPMENT OF PRIORITIES FOR PROMPT SOLUTIONS TO CUSTOMER-

RELATED PROBLEMS B. DETERMINATION OF KEY CUSTOMER RELATED TRENDS AND

CORRELATION TO SUPPORT STATUS REVIEW, DECISION MAKING AND LONGER TERM PLANNING

C. AN INFORMATION SYSTEM FOR THE TIMELY REPORTING OF PRODUCT INFORMATION ARISING FROM USAGE

NOTE: COMPARE WITH COMPETITORS AND/ OR BENCHMARKS

8.5 IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT

CONTINUALLY IMPROVE THE EFFECTIVENESS OF THE QMS THROUGH THE USE OF THE QUALITY POLICY, OBJECTIVES, AUDIT RESULTS, ANALYSIS OF DATA, CORRECTIVE AND PREVENTIVE ACTION AND MANAGEMENT REVIEW.

8.5.1.1 CONTINUAL IMPROVEMENT OF THE ORGANISATION• TO DEFINE A PROCESS FOR CONTINUAL IMPROVEMENT.

•8.5.1.2 MANUFACTURING PROCESS IMPROVEMENT

• FOCUS UPON CONTROL AND REDUCTION OF VARIATION IN PRODUCTS CHARACTERISTICS AND MANUFACTURING PROCESS PARAMETERS.

8.5.2 CORRECTIVE ACTION

•ACTION TAKEN TO ELIMINATE THE CAUSE OF NC's INORDER TO PREVENT RECURRENCE.•DOCUMENTED PROCEDURE TO DEFINE•REVIEWING NONCONFORMITIES (INCLUDING CUSTOMER COMPLAINTS)•DETERMINING THE CAUSES OF NONCONFORMITY•EVALUATING THE NEED FOR ACTIONS TO ENSURE THAT NONCONFORMITIES DO NOT RECUR•DETERMINING AND IMPLEMENTING THE CORRECTIVE ACTION NEEDED.•RECORDING RESULTS OF ACTION TAKEN•REVIEWING OF CORRECTIVE ACTION TAKEN

8.5.2.1 PROBLEM SOLVING HAVE A DEFINED PROCESS FOR PROBLEM SOLVING LEADING TO

ROOT CAUSE IDENTIFICATION AND ELIMINATION USE CUSTOMER PRESCRIBED SYSTEM, IF ANY 8.5.2.2 ERROR PROOFING USE IN THE CORRECTIVE ACTION PROCESS APPROPRIATE TO THE DEGREE OF THE PROBLEM AND RISKS ENCOUNTERED 8.5.2.3 CORRECTIVE ACTION IMPACT EXTEND TO OTHER SIMILAR PROCESSES AND PRODUCTS

8.5.2.4 REJ ECTED PRODUCT TEST/ANALYSIS COVER CUSTOMER’S MANUFACTURING PLANTS, ENGINEERING

FACILITIES AND DEALERSHIPS MINIMISE THE CYCLE TIME OF THIS PROCESS MAINTAIN RECORDS OF THESE ANALYSIS INITIATE CORRECTIVE ACTION TO PREVENT RECURRENCE

8.5.3 PREVENTIVE ACTION

•ACTION TAKEN TO ELIMINATE THE CAUSE OF POTENTIAL NC's INORDER TO PREVENT OCCURENCE.

•DOCUMENTED PROCEDURE TO DEFINE•IDENTIFYING POTENTIAL NONCONFORMITIES AND THEIR CAUSES•EVALUATING THE NEED FOR ACTIONS TO PREVENT OCCURRENCE OF NONCONFORMITIES. •DETERMINING AND IMPLEMENTING THE PREVENTIVE ACTION NEEDED.•RECORDING RESULTS OF ACTION TAKEN•REVIEWING OF PREVENTIVE ACTION TAKEN

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