Welcome

Presentation on ISO/TS 16949:2002 by Qual-Tech Associates (India)
7/26/2010 show 1

ISO/TS 16949:2002

AN OVERVIEW

7/26/2010

show

2

Historical Evolution
Pre-Industrial Inspection Statistical Quality Control Organisational & National QA Standards ISO 9000:1987, 1994, 2000 QS 9000 ISO/TS 16949:1999, 2002 Composite Standard 7/26/2010 show

3

WHY CHANGE ISO 9000 NOW?
ISO requirement to review standards every 5 years International survey of ISO 9000 users identified problem areas New standard equally relevant to nonmanufacturing industries Standard structure in line with business processes in an organisation
7/26/2010 show 4

Key Points of Revision ISO 9000

Focus on processes Focus on customer satisfaction Focus on continual improvement Numbering scheme revised Language improved Application of 8 quality management principles
7/26/2010 show 5

Quality Management Principles
1 Customer focussed organisation 2 Leadership 3 Involvement of people 4 Process approach 5 System approach to management 6 Continual improvement 7 Factual approach to decision making 8 7/26/2010 Mutually beneficial show supplier relationships6

ISO 9000:2000 vs. ISO 9000:1994
Total number of standards and guidelines reduced There is only ISO 9001 in the 2000 version for certification ISO 9002 & 9003 discarded ISO 9000:2000 gives concepts and vocabulary ISO 9004: 2000 gives guidelines on 7/26/2010 show quality management systems

7

TS 16949 vs. ISO 9001
ISO 9001 is generic and applies to any kind of business TS 16949 is for automobile suppliers ISO 9001 is a standard, TS is a spec All clauses of 9001 apply plus additional requirements TS requires efficiency and effectiveness whereas ISO requires only effectiveness
7/26/2010 show 8

TS 16949 vs. QS 9000
QS is a private standard of US auto majors TS is an international document QS based on ISO 9001:1994 TS based on ISO 9001:2000 Eventually TS would replace QS

7/26/2010

show

9

Benefits of ISO 9001
High assurance of product quality Eliminates organisational slack and more profitability Emphasis on customer focus and satisfaction leads to more repeat orders Greater confidence of customer on organisation; its own on employees Greater clarity in operations reduces 7/26/2010 show 10 wastage

Benefits (Cont)
Apart from direct benefits, application of QMS makes an important contribution to managing costs and risks whose consideration has beneficial impacts on customer loyalty, business growth, operational results, flexible and fast response, motivation & involvement of people, optimal use of resources and ability to create value to organisation & 7/26/2010 show 11 suppliers

What ISO 9000 Is Not
It is not a product standard Product specs are determined by market or customer needs Applies equally to higher grade and lower grade products. Does not mean Rolls It identifies the problems, but solutions with management 7/26/2010 show 12 Assurance only if QMS implemented

Scope ISO 9001:2000
Specifies QMS requirements to demonstrate ability to consistently provide product that meet customer & regulatory reqmts Aims to enhance customer satisfaction through*Effective implementation of system*Continual improvement of system*Assurance of conformity to customer and regulatory requirements 13 7/26/2010 show

Scope TS 16949
In conjunction with ISO 9001:2000 defines the QMS requirements for automotive-related products Applicable to sites where customer specified parts and/or service are manufactured Off-site support functions HO and R&D centre are also to be covered 7/26/2010 14 Applies throughout show supply chain

Exclusions ISO 9001
Where a requirement does not apply due to nature of orgn or product, exclusions can be made Exclusion applicable only to Clause No 7 (Product realisation) Exclusions permissible only if they don t affect ability to supply conforming products
7/26/2010 show 15

Exclusions TS 16949
Exclusions permitted only in Clause 7.3 where organisation is not responsible for product D&D Permitted exclusion does not include manufacturing process design

7/26/2010

show

16

Supply Chain
Supplier-----> Organisation------> Customer > The standard applies to the Organisation . This can be a firm, company, corporation, institute, office, establishment or any other commercial and non commercial entity that adopts the standard 7/26/2010 show 17

General Layout 9001:2000
> Contains 5 main causes as under: 4 Quality management system (2) 5 Management responsibility (6) 6 Resource management (4) 7 Product realisation (6) 8 Measurement, analysis and improvement(5) > 7/26/2010 Contains 23 sub-clauses as indicated in 18 show brackets

Definitions
Premium Freight: Extra costs or charges incurred additional to contracted delivery Error proofing:Product and manufacturing process D&D to prevent manufacture of NCP Predictive maintenance:Based on process data to avoid mtce.problems by prediction of likely failure modes 7/26/2010 show 19

4
Quality Management System
7/26/2010 show 20

4.1 General Requirements
Identify processes and their application Determine their sequence and interaction Determine criteria to ensure effectiveness Provide resources and monitor, measure & analyse processes Take actions to achieve planned results and continual improvement of processes Mange processes as per std reqmts Ex control over out-sourced processes 7/26/2010 show 21

4.1.1 General Requirements
Ensuring control over outsourced processes does not absolve organisation responsibility for conforming to customer requirements

7/26/2010

show

22

4.2 Documentation Requirements
4.2.1 General Requirements Documented quality policy and objectives Quality manual and procedures as per standard Needed by the organisation for effective plg, control & operation of processes Records required as per the standard
7/26/2010 show 23

4.2 (Cont)
4.2.2 Quality Manual A quality manual to be established and maintained. To include: Scope of QMS incl. exclusion details and their justification Documented procedures or their reference Description of interaction between QMS 7/26/2010 show 24 processes

4.2 Documentation Requirements
4.2.3 Control of Documents Documented procedure Procedure to ensure documents are:
Adequate, clear and legible Updated, revised and re-issued. Revision status identified Available where required External documents controlled 7/26/2010 show Prevent usage of obsolete documents

25

4.2.3.1 Engineering Specs
To have a process for timely review, distribution and implementation of customer engineering specs/standards and changes based on customer required schedules. Timely review should be ASAP and not exceed two weeks.
7/26/2010 show 26

4.2 Documentation Requirements
4.2.4 Control of Records Procedure to define identification, storage, protection, retrieval, retention time and disposition Records to:
Provide evidence of conformity and effective operation of QMS Be legible, readily identifiable and retrievable 7/26/2010 show

27

5 Management Commitment
7/26/2010 show 28

5.1 Management Commitment
Top management to provide evidence of its commitment for development, implementation and continual improvement of QMS by:
Communicating to Org importance of meeting customer and regulatory requirements Establishing quality policy & objectives Conducting management reviews Ensuring availability of resources
7/26/2010 show 29

5.1.1 Process Efficiency
Top management to review the product realization processes and the support processes to ensure effectiveness and efficiency

7/26/2010

show

30

5.2 Customer Focus
Top management to ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction >This must not only be present but seen to be present >Represents orientation of the Organisation and must be manifest in all activities and processes 7/26/2010 show 31

5.3 Quality Policy
Top management to ensure it: Is appropriate to organisation s purpose Includes a commitment to comply with requirements and continually improve QMS effectiveness Provides framework to establish and review quality objectives Is communicated and understood 7/26/2010 show 32 Reviewed for continuing suitability

5.4 Planning
5.4.1 Quality Objectives Measurable quality objectives at relevant functions and levels incl. those for meeting product requirements Quality objectives to be consistent with the quality policy

7/26/2010

show

33

5.4.1.1 Q Objectives
To define quality objectives and measurements for inclusion in business plan and used to deploy quality policy Should address customer expectations and be achievable in a defined time period

7/26/2010

show

34

5.4.2 QMS Planning
Planning of QMS to meet requirements given in Clause 4.1 and quality objectives Integrity of QMS is to be maintained when changes in QMS are planned

7/26/2010

show

35

5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority Top management to ensure that the responsibilities, authorities and their interrelation are defined and communicated within the organisation > Ground rules are to be laid regarding division of labour to avoid confusion > Chains of command to be defined
7/26/2010 show 36

5.5.1.1 Responsibility for Quality
Mgt. with R&A for CA to be promptly informed about product & process NC Personnel responsible for product quality to have authority to stop production to correct quality problems Production operations in all shifts to have personnel in-charge of, or with delegated responsibility for ensuring product quality 7/26/2010 show

37

5.5.2 Management Representative
Member of management to ensure QMS processes are established, implemented and maintained Report QMS performance and improvement needs to top management Ensuring promotion of awareness of customer needs in organisation Nominated by top management
7/26/2010 show 38

5.5.2.1 Customer Representative
Top management to designate personnel with R&A to ensure that customer requirements are met This includes selection of special characteristics, setting quality objectives and related C&PA, product D&D

7/26/2010

show

39

5.5.3 Internal Communication
Top management to ensure that appropriate communication processes are established within the organisation and that communication takes place regarding the effectiveness of the QMS > Meant to ensure involvement of all > Must be up-down, down-up and lateral > Essential to ensure unity of purpose
7/26/2010 show 40

5.6 Management Review
5.6.1 General Management review of QMS to be conducted at planned intervals: To ensure its continuing suitability, adequacy and effectiveness To assess opportunities for improvement To assess need for changes to the QMS 7/26/2010 show including quality policy and objectives 41

5.6.1.1 QMS Performance
Mgt. Rev to include all requirements of the QMS and its performance trends To include monitoring of quality objectives and regular reporting and evaluation of cost of poor quality To record the achievement of quality objectives given in business plans and customer satisfaction with products supplied 7/26/2010 show 42

5.6.2 Review Input
Results of audits & customer feedback Process performance & product conformity Status of P & C Actions Changes that could affect QMS Recommendations for improvements Follow-up actions on previous reviews
7/26/2010 show 43

5.6.2.1 Review Input
Input to management review to include an analysis of actual and potential field failures and their impact on quality, safety and environment

7/26/2010

show

44

5.6.3 Review Output
To include decisions and actions related to: Improvement in the effectiveness of the QMS and its processes Improvement of products related to customer requirements Resource needs
7/26/2010 show 45

6 Resource Management
7/26/2010 show 46

6.1 Provision of Resources
To determine and provide resources to Implement & maintain QMS and continually improve its effectiveness Enhance customer satisfaction by meeting customer requirements > Resources should include human and infrastructure > Provision of resources can be in-house 7/26/2010 show 47 or contracted

6.2 Human Resources
6.2.1 General Personnel performing work affecting product quality to be competent on the basis of education, skills, training and experience > Meant to ensure that there are no square pegs in round holes as far as the work-force is concerned
7/26/2010 show 48

6.2.2 Competence, Awareness and Training
Determine necessary competence of those doing quality-related work Provide training or take other actions to satisfy needs and maintain records Evaluate effectiveness of actions Ensure awareness about relevance & importance of activities
7/26/2010 show 49

6.2.2.1 Product Design Skills
To ensure personnel with product design responsibility are competent and are skilled in applicable tools and techniques Applicable tools and skills to be identified by the organisation

7/26/2010

show

50

6.2.2.2 Training
To have documented procedure to identify training needs and achieving competence of personnel performing activities affecting product quality Personnel performing specific tasks to be qualified as required by customer This applies to all personnel whose work affects quality
7/26/2010 show 51

6.2.2.1 Training on the Job
To provide on-job training to personnel, including contract labor, on any new or modified job affecting product quality Personnel whose work affects quality to be informed of consequence to the customer of any nonconformity to quality requirements
7/26/2010 show 52

6.2.2.4 Employee Motivation & Empowerment
To have a process to motivate employees to achieve Q objectives, to make continual improvement and to create an environment to promote innovation and to include promotion of quality and technological awareness To have process to measure extent of personnel awareness of importance of their activities and contribution to Q 7/26/2010 show 53

6.3 Infrastructure
Determine, provide and maintain infrastructure needed to provide product conformity to incl. : Buildings, workspace and associated utilities Process equipment including hardware and software Supporting services ( such as transport 7/26/2010 54 or communication) show

6.3.1 Plant, Facility and Equipment Planning
To use Multi-disciplinary teams (MDT) for developing plant, facility and equipment plans Plant layout to optimize material travel, handling and floor space use and synchronous material flow To develop and implement methods to evaluate and monitor effectiveness of existing operations show 7/26/2010 55

6.3.2 Contingency Plans
To prepare contingency plans to satisfy customer requirements in the event of emergency such as: ¶ Utility interruptions ¶ Labor shortages ¶ Key equipment failures ¶ Field returns
7/26/2010 show 56

6.3 Work Environment
Determine and manage the work environment needed to achieve product conformity > It should consider all aspects that can impact product quality e.g. Light, Ambience, Environment, Housekeeping, Worker Safety, Ergonomics
7/26/2010 show 57

6.41 Personnel Safety
At the product design stage to ensure product safety and safety of employees while developing manufacturing processes

7/26/2010

show

58

6.4.2 Cleanliness of Premises
To maintain premises in a state of order, cleanliness and repair consistent with product and process needs

7/26/2010

show

59

7 Product Realization
7/26/2010 show 60

7.1 Planning of Product Realization
Plan & develop processes for product realisation & determine as appropriate Q objectives & requirements for pdcts Need for processes & documents and provide pdct specific resources Verification, validation, monitoring, inspection and test arrangements and acceptance criteria for products 7/26/2010 show Records for conformity evidence

61

7.1.1 Planning for Product Realization
To include customer requirements and reference to their technical specs as part of quality plans

7/26/2010

show

62

7.1.2 Acceptance Criteria
Acceptance criteria to be defined and where required approved by customer Zero defect for attribute sampling acceptance criteria

7/26/2010

show

63

7.1.3 Confidentiality
To ensure confidentiality of customer contracted products and projects under development and related product information

7/26/2010

show

64

7.1.4 Change Control
To have process to control and react to changes that impact product realization Effect of changes incl. those caused by supplier to be assessed Verification and validation activities to be defined to ensure compliance to customer requirements Changes to be validated before 7/26/2010 show 65 implementation

7.1.4 Change Control (Cont.)
For proprietary designs, effect of changes to be reviewed with customer When required by customer, additional requirements by customer for verification/validation to be met Any product realization changes affecting customer requirements only after customer agreement 7/26/2010 66 Applies to productsshow processes and

7.2 Customer-Related Processes
7.2.1 Determination of Product Requirements Determine product specs, delivery and post-delivery requirements: Specified by the customer Those necessary for use Regulatory and statutory Those determined by Organisation
7/26/2010 show 67

7.2.1 (Notes) Determination of Product Requirements
Post-delivery activities incl. after-sales service as per contract Requirement includes recycling recycling, environmental impact and characteristics based on product and process Includes compliance to all government regulations on safety and environment on storage, handling etc on materials 7/26/2010 show

68

7.2.1.1 Special Characteristics
To demonstrate compliance to customer requirements of designation, documentation and control of special characteristics

7/26/2010

show

69

7.2.2 Review of Requments related to Product
Review product requirements prior to make commitments (incl. tenders) to ensure they are defined, differences with those expressed previously are resolved and organisation has the ability to meet Ensure changes are communicated to all concerned Note:7/26/2010 In some cases e.g. internal sales show review may only be reference to catalog

70

7.2.2.1 Review of Requments related to Product
Waiving of the requirement for a formal review as provided in the ISO clause note only after customer approval

7/26/2010

show

71

7.2.2.2 Manufacturing Feasibility
To investigate, confirm and document the manufacturing feasibility of the proposed product during the contract review process including risk analysis

7/26/2010

show

72

7.2.3 Customer Communication
Determine and implement effective arrangements for communication with customer related to: Product information Enquiries, contracts or order handling and amendments Feedback incl. customer complaints
7/26/2010 show 73

7.2.3.1 Customer Communication
To have the ability to communicate necessary information including data in a customer specified language and format (e.g. CAD data and electronic data exchange)

7/26/2010

show

74

7.3 Design and Development (D&D)
7.3.1 D&D Planning Plan and control product D&D and determine D&D stages, the review, verification and validation at each stage, responsibilities and authorities for D&D Manage interfaces between groups including communications & clear cut responsibilities and show authorities 7/26/2010

75

7.3.1.1 Multidisciplinary Approach
To use multidisciplinary approach to prepare for product realization including
Development/finalization of special characteristics Development and review of FMEA including action to reduce potential risks Develop and review control plans Note: MDT typically includes design, QA production, engineering and other relevant 7/26/2010 show 76 functions

7.3.2 D&D Inputs
-Determine & include: Functional & performance requirements Applicable statutory & regulatory reqmts Info from previous similar designs Other reqmts essential for D&D -Inputs to be reviewed for adequacy.Reqmts be complete, 7/26/2010 show 77 unambiguous and not conflicting

7.3.2.1 Product Design Input
To identify, document and review product design input requirements incl.: Customer requirements like special characteristics, identification, packing Use of info: To have process to deploy info gained from previous design projects, competitor analysis, supplier feedback, internal input etc 7/26/2010 Targets for productshow life, reliab. etc 78 Q,

7.3.2.2 Manufacturing process design input
To identify, document and review the mfg. process design input requirements including: Product design output data Targets for productivity, process capability and cost Customer requirements if any Experience from previous developments
7/26/2010 show 79

7.3.2.3 Special Characteristics
To identify special characteristics and: Include them in control plans Comply with customer specified definition and symbols Identify process control documents incl. Drg, FMEA, control plans and operator instructions. Use customer defined symbols at the process steps that affect 7/26/2010 show 80 special characteristics

7.3.3 D&D Outputs
To be in a form that enables verification against input and to be approved before release. They shall: Meet input reqmts for D&D & provide info for purchase, production etc Contain or refer product acceptance norms Specify product characteristics for its 7/26/2010 & proper use show safe

81

7.3.3.1 Product Design Output
To be expressed in terms that can be verified against input requirements incl: Design FMEA, reliability results Special characteristics and specs Error-proofing, product definition incl math-based data, design review results and diagnostic guidelines where applicable
7/26/2010 show 82

7.3.4 D&D Review
-At suitable stages, systematic review of D&D as per planned arrangements To evaluate ability of results of D&D to meet requirements To identify problems & propose actions -Participants to incl. reps of functions concerned with D&D stages being reviewed 7/26/2010 show -Records of reviews & necessary actions 83

7.3.4.1 Monitoring
Measurement at specified stages of D&D to be defined, analyzed and reported with summary results as an input to management review

7/26/2010

show

84

7.3.5 D&D Verification

To be as per planned arrangements To ensure that D&D outputs meet D&D input requirements Records of verification & any necessary actions to be kept

7/26/2010

show

85

7.3.6 D&D Validation
To be as per planned arrangements To ensure resulting pdct capable of meeting specified application or intended usage requirements where known Where practical, done before delivery or implementation of pdct Records of validation & necessary 7/26/2010 show 86 actions

7.3.6.1 D&D Validation
When required by customer, to have a prototype program and control plan To use same suppliers, tooling and mfg.process during production All testing to be monitored for timely completion and compliance To control outsource services with technical leadership
7/26/2010 show 87

7.3.6.3 Product approval process
To conform to a product and manufacturing process approval procedure recognized by customer This procedure to also apply to suppliers

7/26/2010

show

88

7.3.7 Control of D&D Changes
D&D changes to be identified and records maintained Changes to be reviewed, verified, validated and approved before implementation Review of D&D changes to incl. evaluation of effect on constituent parts and already delivered products 7/26/2010 show 89 Records of review and actions

7.4 Purchasing
7.4.1 Purchasing Process To ensure purchased product conforms to specified purchase requirements Control on supplier & purchased product dependent upon effect on final product and subsequent product realization Evaluate & select suppliers on their 7/26/2010 show ability to meet purchase requirements 90

7.4.1 Purchasing Process (Cont.)
Criteria for selection, evaluation & reevaluation to be established. Records of evaluation and follow-up action to be kept

7/26/2010

show

91

7.4.1.1 Regulatory Conformity
All purchased products or materials used in products supplied to customer to meet applicable regulatory requirements

7/26/2010

show

92

7.4.1.2 Supplier QMS Development
To perform supplier QMS development with the goal of supplier acquiring TS Conformity with ISO 9001:2000 first step in achieving this goal Unless waived by customers, ISO 9001:2000 third party registration mandatory
7/26/2010 show 93

7.4.1.3 Customer-approved sources
Where specified by customer, to purchase products, materials and services from approved sources This does not absolve supplier from the responsibility for quality of purchased products

7/26/2010

show

94

7.4.2 Purchasing Information
To describe product to be purchased and include where applicable requirements for approval of products, procedures, processes and equipment; for personnel qualification and QMS To ensure adequacy of specified purchase requirements before communication
7/26/2010 show 95

7.4.3 Verification of Purchased Product
To establish & implement inspection & other activities to ensure conformance Where applicable requirements of own or customer verification and arrangements thereof to be defined > Requirement of inspection if any is part of the purchase process
7/26/2010 show 96

7.4.3.1 Incoming product quality
To have a process to assure the quality of purchased product using one or more of the following: Receipt & evaluation of statistical data Receipt inspection and testing Second and third party audit Part evaluation in a designated lab Another method agreed by customer
7/26/2010 show 97

7.4.3.2 Supplier monitoring
Supplier performance to monitored through following indicators: Delivered product quality Customer disruptions incl. field returns Delivery schedule performance incl. incidents of premium freight Special status customer notification related to quality or delivery issues 7/26/2010 show 98 To promote sup montrng of mfg. process

7.5 Production & Service Provision
7.5.1 Control of Production & Service Provision To be performed under controlled conditions that include as applicable: Availability of WI, MMD & information on product characteristics Use of suitable equipment Implement M&M; release, delivery and 7/26/2010 show 99 post-delivery activities

7.5.1.1 Control plan (CP)
To develop CP of system, sub-system, component and/or material level for product supplied To have CP for pre-launch and production taking into account design and process FMEA outputs CP to include control of process and special characteristics 7/26/2010 show To be reviewed and updated

100

7.5.1.2 Work Instructions
To prepare documented WI for all employees having responsibilities for operation of processes impacting product quality WI to be accessible at work station WI to be derived from sources like quality plan, control plan and product realization process
7/26/2010 show 101

7.5.1.3 Verification of job set-ups
Job set-ups to be verified whenever performed such as initial run of a job, material change over or job change WI to be available for set-up personnel To use statistical method where applicable

7/26/2010

show

102

7.5.1.4 Preventive and predictive maintenance
To identify key process eqpt and provide for mtce and develop total preventive mtce system System to incl. planned mtce activities, packaging and preservation of eqpt, tooling and gauges; availability of spares and documenting, evaluating and improving mtce objectives To use predictive mtce methods to 7/26/2010 show 103 enhance efficiency and effectiveness

7.5.1.5 Tooling Management
To provide resources for tooling design,fabrication and verification To establish system for tooling management to include mtce and repair facility, storage and recovery, set-up, change program for perishable tools, modification and revision to docs and identification and status indication System to monitor if out-sourced 7/26/2010 show 104

7.5.1.6 Production scheduling
Production to be scheduled in order to meet customer requirements such as JIT Supported by information system entailing access to production info at key stages Order driven
7/26/2010 show 105

7.5.1.7 Feedback from service
To establish a process for communication of information on service concerns to manufacturing, engineering and design activities Note: meant to ensure no NC from external sources

7/26/2010

show

106

7.5.1.8 Service agreement
When a service agreement with customer exists, to verify effectiveness of: Any organization service centers Any special purpose tools and measurement systems Training of service personnel

7/26/2010

show

107

7.5.2 Validation of Processes
Validate processes where output cannot be verified by subsequent M&M or the deficiency manifests in usage. To incl. as applicable: Criteria for review & approval of processes Approval of eqpt & qualification of pers Requirements of records 7/26/2010 show 108 Revalidation

7.5.2.1 Process Validation
Requirement of 7.5.2 shall apply to all production and service provision processes

7/26/2010

show

109

7.5.3 Identification & Traceability
Where appropriate, identify product suitably throughout realization process Identify status w.r.t. monitoring & measurement requirements (Essentially means indicate inspection status) Where traceability is required, control and record unique identification
7/26/2010 show 110

7.5.3.1 Identification and traceability
The words where appropriate in 7.5.3 shall not apply

7/26/2010

show

111

7.5.4 Customer Property
Includes intellectual property Take care while in control or use Where incorporated in product; to verify, identify and safeguard To inform customer in case of loss, damage or found unsuitable To keep records
7/26/2010 show 112

7.5.4.1 Customer-owned production tooling
Customer-owned tools, manufacturing, test, inspection tooling and equipment to be permanently marked so that the ownership can be visible and determined

7/26/2010

show

113

7.5.5 Preservation of Product
To preserve product conformity during internal processing and delivery to destination Preservation to include: Identification, Handling, Packaging, Storage and Protection To also cover constituent parts
7/26/2010 show 114

7.5.5.1 Storage and inventory
To periodically assess stock condition to detect deterioration To use inventory management system to optimize inventory turnover time and assured rotation such as FIFO Obsolete products to be controlled likewise
7/26/2010 show 115

7.6 Control of MMD
To determine M&M required & MMD needed for evidence of product conformity and establish processes to ensure conformity of product with requirements Where necessary to ensure valid results, measuring MMD to be calibrated
or verified at specified intervals or before use against MMD traceable to national std. Where 7/26/2010 show these not available, cal basis to be defined 116

7.6 Control of MMD (Cont)
Adjusted or readjusted as necessary and identified to enable cal status to be determined Safeguarded against unauthorised adjustments and protected from damage and deterioration during handling, maintenance and storage Assess and record result validity if not conforming and where used software to be confirmed prior to use and show later 7/26/2010

117

7.6.1 Measurement System Analysis
To conduct stat studies to analyze variations in each type of MMD To apply to measurement system referred in control plan Analytical method and acceptance criteria in customer reference manuals Other methods acceptable if approved by customer
7/26/2010 show 118

7.6.2 Calibration/verification records
Records of calibration/verification of gauges and other MMD to include: Eqpt identification incl standard against which calibrated Revisions following eng changes Out-of-spec (OOS) readings Assessment of impact of OOS condition Conformity statement after calibration 7/26/2010 show 119 Customer notification for suspects

7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory
Internal lab to have a defined scope including its capability. Its documentation to be part of QMS Lab to specify and implement tech requirements for adequacy of procedures, competence of personnel, testing of products, capability to perform services correctly, traceability to process standards and review of 7/26/2010 show 120 related records

7.6.3.2 External laboratory
External labs to defined scope covering our products and their inspection test etc Evidence that it is acceptable to customer Accredited to ISO 17025 or equivalent (NABL)
7/26/2010 show 121

8
Measurement, Analysis and Improvement (MM&I)
7/26/2010 show 122

8.1 General
-Plan and implement MM&I to: Demonstrate product conformity Ensure QMS conformity Continually improve QMS effectiveness -To include determination of methods like statistical techniques and their use

7/26/2010

show

123

8.1.1 Identification of Statistical tools
Appropriate statistical tools for each process to be determined during advance quality planning and include in the control plan

7/26/2010

show

124

8.1.2 Knowledge of basic statistical concepts
Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment to be understood and utilized throughout the organization

7/26/2010

show

125

8.2 Monitoring & Measurement
8.2 Customer Satisfaction To monitor information relating to customer perception as to whether his requirements have been met Method of obtaining & using this information to be determined > Customer whose satisfaction is measured must be clearly identified. 7/26/2010 be internal show 126 Can

8.2.1.1 Customer satisfaction
Customer satisfaction to be monitored through continuous evaluation through defined processes Performance indicators based on objective data such as: Delivered quality*Customer disruptions incl field returns*Delivery schedule performance (incl premium freight)* Customer notification on Q&Q 7/26/2010 show 127 Monitor mfg process for customer E&Q

8.2.2 Internal Audit
At planned intervals to determine QMS conformity implementation & maintenance Audit program to be planned. Define criteria,scope, frequency and method Independence of auditors Corrective actions & follow-up verification 7/26/2010 show 128 Documented procedure

8.2.2.1 QMS Audit
To audit QMS for compliance to TS and additional QMS requirements

7/26/2010

show

129

8.2.2.2 Manufacturing process audit
To audit each manufacturing process to determine effectiveness

7/26/2010

show

130

8.2.2.3 Product audit
To audit products at appropriate stages of production and delivery to verify conformity to all specified requirements such as product dimensions, functionality, packaging and labeling at a defined intervals (dock audit)

7/26/2010

show

131

8.2.2.4 Internal audit plan
Internal audits to cover all QMS related processes, activities and shifts, and to be scheduled according to an annual plan When an NC or customer complaint occurs, frequency to increased appropriately
7/26/2010 show 132

8.2.2.5 Internal auditor qualification
To have internal auditors who are qualified to conduct TS audit

7/26/2010

show

133

8.2.3 Monitoring and measurement of processes
Suitable methods. Need for criteria To demonstrate process ability to achieve planned results Take correction & CA to ensure pdct conformity where plnd results not achieved

7/26/2010

show

134

8.2.3.1 M&M of Mfg Processes
To perform process studies on new manufacturing processes Results of study to be documented Docs to incl objectives for mfg process capability, maintainability, availability and acceptance criteria To maintain mfg process capability defined by customer 7/26/2010 show 135 To implement CP and flow chart

8.2.3.1 M&M of Mfg Processes (Cont.)
Significant process events to be recorded To initiate a reaction plan from CP for unstable or incapable characteristics. RP to incl containment and 100 % check A time-bound CAP to be completed to make process able and stable CAP to be approved by customer if req. 7/26/2010 show 136 To record process change dates

8.2.4 M&M of Products
To verify product conformance At appropriate stages as per planned arrangements Evidence of conformity Records of release authority Further processing and delivery only after planned M&M gives desired results
7/26/2010 show 137

8.2.4.1 Layout inspection and functional testing
Layout inspection i.e. complete measurement of characteristics shown in design records and functional verification to be performed on each product as per CP Results to be made available to customer
7/26/2010 show 138

8.2.4.2 Appearance items
For customer defined appearance items to provide: Resources incl proper lighting Masters for colour, grain, gloss, texture and distinctness of image etc Control of appearance masters and evaluation equipment Verification of competence and 7/26/2010 show 139 qualification of personnel

8.3 Control of NCP
All NCP to be identified to prevent unintended use or delivery Documented procedure NCP to be disposed off by repair, rework etc; concessions or alternate use Maintain record of the nature of NC and subsequent actions including 7/26/2010 show concessions

140

8.3 Control of NCP (Cont.)
All corrected NCP to be re-verified If NCP detected after delivery, take appropriate actions considering impact of the NC

7/26/2010

show

141

8.3.1 Control of NCP
Products with unidentified and suspect status to be classified as NCP

7/26/2010

show

142

8.3.2 Control of reworked product
Instruction for rework including reinspection to be accessible and utilized by concerned personnel

7/26/2010

show

143

8.3.4 Customer waiver
To obtain customer concession or deviation permit before proceeding if variation from P&P approvals To record expiration date or quantity To revert to original on expiry To identify all shipped concession items Also applies to purchased products Reference to customer with 7/26/2010 show 144 organization recommendation

8.4 Analysis of Data
Determine, collect and analyse data to : - Demonstrate suitability and effectiveness of QMS -Evaluate where improvement is possible Analysis to provide info relating to *Customer satisfaction *Conformity of product requirements * Characteristics & trends in products and processes incl145 7/26/2010 show PA opportunities *Suppliers

8.4.1 Analysis and use of data
Trends in quality and operational performance to be compared with objectives and lead to following: Prioritize customer problem solutions Determine key customer trends Information system for prompt reporting of product information arising from usage
7/26/2010 show 146

8.5 Improvement
8.5.1 Continual Improvement Continually improve QMS effectiveness through use of quality policy, quality objectives, audit results, analysis of data, C&PA and management reviews > Key clause that addresses one of the objectives of the standard > Improvement should be pro-active show > 7/26/2010 Identify opportunities for improvement 147

8.5.1.1 Continual improvement of organization
To define process for continual improvement

7/26/2010

show

148

8.5.1.2 Manufacturing process improvement
To focus on control and reduction in variation in product and manufacturing process characteristics Notes: 1 Controlled characteristics in CP 2 CI is implemented once mfg process is capable and stable or product characteristics are predictable and meet 7/26/2010 show 149 customer requirements

8.5.2 Corrective Actions
To prevent recurrence of NC CA to be appropriate to the effect of NC Documented procedure to define: Review of NCs incl customer complaints Determine NC causes & evaluate CA need Take CA and record their results Review result of CAshow 7/26/2010 150

-

8.5.2.1 Problem solving
To have process for problem solving and root cause identification and elimination

7/26/2010

show

151

8.5.2.2 Error proofing
To use error-proofing method in corrective action process

7/26/2010

show

152

8.5.2.4 Corrective action impact
To apply to other similar products and processes the corrective action and controls implemented to eliminate cause of nonconformity

7/26/2010

show

153

8.5.2.4 Rejected product test/analysis
To analyze parts rejected by customer To minimize cycle time of process Record of analysis to be made To perform analysis and initiate CA to prevent recurrence

7/26/2010

show

154

8.5.3 Preventive Actions
Prevent occurrence of potential NC PA appropriate to effect of problem Documented procedure. To address: Determine potential NC & causes Evaluate need for PA Determine & implement PA Record and reviews of results of PA
7/26/2010 show 155

-

Definitions
Quality: degree to which specified requirements are fulfilled System: set of interrelated and interacting elements Quality management system: system to establish quality policy and objectives and to achieve those objectives Quality objective: something sought or 7/26/2010 show 156 aimed for related to quality

Definitions
Process: system of activities which uses resources to transform inputs into outputs Product: results of processes. Can be software or service also Service: intangible product that is the result of at least one activity performed between the supplier and customer
7/26/2010 show 157

Definitions
Nonconformity: non-fulfillment of a requirement Defect: non-fulfillment of a requirement related to an intended or specified use Preventive action: action taken to eliminate the cause of a potential nonconformity or potentially undesirable situation
7/26/2010 show 158

Sources of Info:Customer Satisfaction
Customer complaints Comm with customer Questionnaires and surveys Collection & analysis of data Focus groups Reports from consumer organisations Media reports Sector & industry studies 7/26/2010 show

159

Process Approach
Understanding & fulfilling requirements Consider processes in terms of value addition Obtain results of process performance and effectiveness Continual improvement based on objective measurement
7/26/2010 show 160

Effectiveness vs. Efficiency
Effectiveness Measure of the extent to which planned activities are realized and planned results achieved Efficiency Relationship between the results achieved and resources used
7/26/2010 show 161

Process Approach
To function effectively org has to identify & manage numerous interlinked processes Often output from one process is direct input to another The systematic identification and management of the processes employed within an orgn and particularly their interaction is referred 162 7/26/2010 show to as process approach

Sign up to vote on this title
UsefulNot useful