TO ISO/TS 16949 TRAINING ISO/TS 16949 TRAINING PROGRAM PROGRAM
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 : [email protected] : [email protected]
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.