TO

ISO/TS 16949 TRAINING ISO/TS 16949 TRAINING PROGRAMPROGRAM

NATHAN & NATHAN CONSULTANTS PVT LTDNATHAN & NATHAN CONSULTANTS PVT LTD

TRAINING PROGRAMME TRAINING PROGRAMME

ON ON

ISO/TS 16949ISO/TS 16949

No. 36, MUKTA BUILDINGS, 8th MAIN, 18th CROSS, MALLESWARAM, No. 36, MUKTA BUILDINGS, 8th MAIN, 18th CROSS, MALLESWARAM,

BANGALORE - 560 055, INDIABANGALORE - 560 055, INDIA

PHONE - 91-080-3440703, 3311622PHONE - 91-080-3440703, 3311622

E-MAIL : rcnathan@blr.vsnl.net.inE-MAIL : rcnathan@blr.vsnl.net.in

Website : WWW.NNCPL.COMWebsite : WWW.NNCPL.COM

CONTENTSCONTENTS•EVOLUTION OF ISO9000•EVOLUTION OF QS-9000•EVOLUTION OF ISO/TS16949•CORRECT UNDERSTANDING OF A SYSTEM•KEY QUALITY MANAGEMENT PRINCIPLES•PROCESS APPROACH•ISO/TS 16949 STANDARD REQUIREMENTS

EVOLUTION

ISO-9000-1987ISO-9000-1994ISO-9000-2000QUALITY ASSURANCE CHANGED TO QUALITY MANAGEMENTBASED ON 8 QM PRINCIPLESCONTINUAL IMPROVEMENT FOCUSSEDSIMPLIFIED TERMINOLOGIESREDUCED DOCUMENTATIONBASED ON PROCESS APPROACHCOMPATIBLE TO OTHER STANDARDS

ISO9000 VS QS9000DEVELOPED BY ISO BODY

GENERIC IN NATURE

SUITABLE FOR ANY ORGANISATION

DEVELOPED BY BIG 3 ( GM,FORD,CHRYSLER)

SPECIFIC REQMTS, CLARIFYING WHAT IS SUITABLE

APPLICABLE FOR MASS PRODUCTION MFG INDUSTRY, ESPECIALLY FOR AUTO INDUSTRY

QS9000 EVOLUTION

QS-9000 = ISO9001-1994 + SALIENT ADDITIONS

FROM BIG THREE SUPPLIER DEVELOPMENT MANUALS REVISED IN 1995 FEBRAUARY REVISED IN 1998 MARCH ( THIS WILL DIE SOONER AS

ISO9001-1994 IS VALID TILL DEC15,2003) INITIALLY IT MEANT FOR THEIR SUPPLIERS NOW ANY ORGANISATION CAN GET ACCREDITED

PROVIDED THEY IMPLEMENT FULLY EXCEPT 4.4 &4.19

TS16949 EVOLUTION

QS-9000 NOT ACCEPTED BY EUROPEANS ( GERMAN,ITALY,..)

HENCE IT REQUIRES MULTIPLE CERTIFICATION AGANIST VDA 6.1, EAQF94 &AVSQ94

TO AVOID MULTIPLE CERTIFICATION AND TO CREATE THE GLOBAL STANDARD FOR AUTOMOBILE SUPPLIERS

HENCE IATF IS FORMED, WHICH INCLUDES REP FROM BIG3, VDA,ANFIA,CCFA & ISO/TC176

THEY RELEASED IN THE FORM OF TECHNICAL SPECIFCATION IN 1999 WHICH REQUIRES ONLY APPROVAL OF 2/3 OFTHE MEMBERS VOTE ( AS IT REQUIRES URGENTLY)

THIS IS IN LINE WITH ISO-9000-1994 MODEL WITH ADDITIONAL REQUIREMENT OF AUTOMOBILE SECTOR

TS16949 EVOLUTION

AS OF NOW IN INDIA, AROUND 10 COMPANIES GOT CERTIFIED TO ISO/TS-16949

NNCPL HAS HELPED THE FIRST ORGANISATION TO ACHIEVE THE SAME IN 2000 (M/S. Roots inds, CBE)

THIS IS QUALITY SYSTEMS STANDARD FOR AUTOMOTIVE SUPPLIERS WHICH REPLACES ALL QS9000, VDA6.1, EAQF94 & AVSQ94 STANDARDS

THIS TECHNICAL SPECIFICATION WILL BECOME INTERNATIONAL STANDARD AFTER ITS 3 YEARS OF USE

TS16949 EVOLUTION

AS ISO9000-2000 STANDARD IS RELEASED, THIS IS REVISED INLINE WITH THE 2000 VERSION

INTENT AND GOAL OF STANDARD IS MAINTAINED AND TRIED TO MIMIMISE “ HOW”

THIS HAS 189 ADDITIONAL SHALL/SHOULD REQUIREMENTS OVER ISO9000-2000 REQUIREMENTS

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.

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.

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 Focus

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

Nathan & Nathan Consultants Pvt. Ltd.

14

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

duc

t R

ealiz

atio

n

Process ModelISO 9001:2000

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 7.3

4. QUALITY MANAGEMENT SYSTEM (QMS)

4.1 GENERAL REQUIREMENTS

4.2 DOCUMENTATION REQUIREMENTS 4.2.2 QUALITY MANUAL

4.2.3 CONTROL OF DOCUMENTS

4.2.3 CONTROL OF DOCUMENTS - CONTD.

4.2.3.1 ENGINEERING SPECIFICATIONS• HAVE A PROCESS FOR TIMELY REVIEW, DISTRIBUTION AND

IMPLEMENTATION

• MAINTAIN RECORD OF DATE ON WHICH CHANGE IS

IMPLEMENTED

NOTE :

• DISPOSITION INCLUDES DISPOSAL

• INCLUDES CUSTOMER SPECIFIED RECORDS

4.2.4 CONTROL OF RECORDS 4.2.4.1 RECORDS RETENTION

5. MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT 5.1.1 PROCESS EFFICIENCY

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

5.2 CUSTOMER FOCUS5.3 QUALITY POLICY

5.4 PLANNING 5.4..1 QUALITY OBJECTIVES

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

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

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 QUALITY

5.5.2 MANAGEMENT REPRESENTATIVE

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

5.6 MANAGEMENT REVIEW

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

5.6.2.1 REVIEW INPUT – SUPPLEMENTALINCLUDESANALYSIS OF FIELD FAILURES THEIR IMPACT ON QUALITY, SAFETY OR THE ENVIRONMENT

5.6.3 REVIEW OUTPUT

6 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES

6.2 HUMAN RESOURCES

6.2.1 GENERAL6.2.2.1 PRODUCT DESIGN SKILLS

IDENTIFY REQUIRED DESIGN SKILLS

QUALIFY DESIGN PERSONNEL ON THE REQUIRED SKILLS

6.2.2 COMPETENCE, AWARENESS AND TRAINING

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

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 ENVIRONMENT6.4.1 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

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 PRODUCT7.2.1.1 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 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 7.2.3.1 CUSTOMER COMMUNICATION – SUPPLEMENTAL

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

7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING.

7.3.1.1 MULTIDISCIPLINARY APPROACH

USE A MULTIDISCIPLINARY APPROACH FOR PRODUCTREALISATION

DEVELOPMENT/ FINALISATION AND MONITORING OFSPECIAL CHARACTERISTICS

DEVELOPMENT AND REVIEW OF FMEA’s DEVELOPMENT AND REVIEW OF CONTROL PLANS

7.3.2 DESIGN & DEVELOPMENT INPUTS

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 DEVELOPMENT

7.3.3 DESIGN AND DEVELOPMENT OUTPUTS 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

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

7.3.6 DESIGN & DEVELOPMENT VALIDATION

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

7.3.6.3 PRODUCT APPROVAL PROCESS

COMPLY WITH A PRODUCT AND PROCESS APPROVALPROCEDURE RECOGNISED BY THE CUSTOMER

7.4 PURCHASING

7.4.1 PURCHASING PROCESS 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

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

7.4.3 VERIFICATION OF PURCHASED PRODUCT

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

7.5.1.1 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 PRODUCT AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

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 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 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

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

7.5.4 CUSTOMER PROPERTY

7.5 PRODUCTION AND SERVICE PROVISION(CONTD..)

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

7.5.5.1 STORAGE AND INVENTORY

CONDITION OF PRODUCT IN STOCK TO BE ASSESSED AT PLANNED INTERVALS

USE AN INVENTORY MANAGEMENT SYSTEM OBSOLETE PRODUCT TO BE CONTROLLED IN A MANNER TO SIMILAR TO

NONCONFORMING PRODUCT7.6 CONTROL OF MEASURING AND MONITORING DEVICES

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

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 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION 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

8.2.2 INTERNAL AUDIT

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 IMPROVEMENT

8.2.3 MEASUREMENT AND MONITORING OF PROCESSES

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

8.2.4.1 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..2.4 MONITORING AND MEASUREMENT OF PRODUCT

8.3 CONTROL OF NONCONFORMING PRODUCT 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 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

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

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

SUMMARY•ADDITIONS ARE BASED ON GOALS

•DEFECT PREVENTION

•REDUCTION IN WASTE/VARIATION IN THE ENTIRE SUPPLY

CHAIN

•CONTINUOUS IMPROVEMENT

SUMMARY•MORE EMPHASIS ON NEW PRODUCT DEVELOPMENT PLANNING WITH THE STRUCTURED METHODOLOGY

•ADDITIONAL DOCUMENTATION SUCH AS PROCEDURE FOR TRG, DFMEA, PFMEA, CONTROL PLAN, ETC.,

•EMPLOYEE MOTIVATION AND EMPOWERMENT

REQUIREMENTS ARE ADDED

•CONTINGENCY PLANS TO PROTECT DELIVERY

•QUALITY POLCY SHOULD ADDRESS TECHNOLOGY, PRODUCT SAFETY, RISKS TO EMPLYEES,ETC.,

SUMMARY•DEFINE SPECIAL CHARECTERISTICS

•PROCESS DESIGN INPUT/OUTPUT IS ADDRESSED

•PRODUCT APPROVAL PROCESS IS ADDRESSED

•SUPPLIER QUALITY SYSTEM DEVPT. IS ADDED

•SUPPLIERS COMPLIANCE TO REGULATORY REQUIREMENTS

MUST BE ENSURED

•CONTROL PLANS MUST BE MADE FOR ALL STAGES

•USE OF MULTI DISCIPLINARY TEAM APPROACH

•USE OF PREDICTIVE MAINTENANCE METHODS

•ADDRESS TOOLING MANAGEMENT SYSTEM

•INVENTORY MANAGEMENT SYSTEM IS REQUIRED

SUMMARY•MEASUREMENT SYSTEMS MUST BE VALIDATED

USING STATISTICAL STUDIES

•ISO/IEC17025 COMPLIANCE IS RECOMMENDED FOR

INHOUSE LABORATORY AND IT IS MANDATORY FOR

ALL EXTERNAL LABORATORIES

•STATISTICAL TOOLS MUST BE UTILISED FOR EACH

PROCESSES

•BASIC STATISICAL CONCEPT KNOWLEDGE ACROSS

THE ORGANISATION

•SYSTEM FOR CAPTURING CUSTOMER SATISFACTION

SUMMARY•SYSTEM AUDIT, PROCESS AUDIT & PRODUCT AUDIT IS INCLUDED

•MONITOR SUPPLIER PERFORMANCE

•GET PPAP FROM SUPPLIERS

•FOLLOW DISCIPLINED PROCESS FOR CORRECTIVE ACTION

•UTILISE MISTAKE PROOFING METHODOLOGY FOR CORRECTIVE ACTION/ PREVENTIVE ACTION

Thank You

NATHAN & NATHAN CONSULTANTS PVT. LTD.