TS 16949 Presentation
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Transcript of TS 16949 Presentation
04/11/23 show 1
Welcome
Presentationon
ISO/TS 16949:2002by
Qual-Tech Associates (India)
04/11/23 show 2
ISO/TS 16949:2002
AN OVERVIEW
04/11/23 show 3
Historical Evolution
Pre-IndustrialInspection
Statistical Quality ControlOrganisational & National QA Standards
ISO 9000:1987, 1994, 2000QS 9000
ISO/TS 16949:1999, 2002Composite Standard
Presentationon
ISO 9000:2000by
Qual-Tech Associates (India)
04/11/23 show 4
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 non-manufacturing industries
• Standard structure in line with business processes in an organisation
04/11/23 show 5
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
04/11/23 show 6
Quality Management Principles
1 Customer focussed organisation2 Leadership3 Involvement of people4 Process approach5 System approach to management6 Continual improvement7 Factual approach to decision making8 Mutually beneficial supplier relationships
04/11/23 show 7
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
quality management systems
04/11/23 show 8
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
04/11/23 show 9
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
04/11/23 show 10
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
wastage
04/11/23 show 11
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 & suppliers
04/11/23 show 12
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
• Assurance only if QMS implemented
04/11/23 show 13
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
04/11/23 show 14
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
• Applies throughout supply chain
04/11/23 show 15
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
04/11/23 show 16
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
04/11/23 show 17
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
04/11/23 show 18
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)>Contains 23 sub-clauses as indicated in
brackets
04/11/23 show 19
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
04/11/23 show 20
4
Quality Management System
04/11/23 show 21
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
04/11/23 show 22
4.1.1 General Requirements
Ensuring control over outsourced processes does not absolve organisation responsibility for conforming to customer requirements
04/11/23 show 23
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
04/11/23 show 24
4.2 (Cont)
4.2.2 Quality ManualA 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
processes
04/11/23 show 25
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– Prevent usage of obsolete documents
04/11/23 show 26
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.
04/11/23 show 27
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
04/11/23 show 28
5
Management Commitment
04/11/23 show 29
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
04/11/23 show 30
5.1.1 Process Efficiency
Top management to review the product realization processes and the support processes to ensure effectiveness and efficiency
04/11/23 show 31
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
04/11/23 show 32
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• Reviewed for continuing suitability
04/11/23 show 33
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
04/11/23 show 34
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
04/11/23 show 35
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
04/11/23 show 36
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and AuthorityTop 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
04/11/23 show 37
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
04/11/23 show 38
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
04/11/23 show 39
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
04/11/23 show 40
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
04/11/23 show 41
5.6 Management Review
5.6.1 GeneralManagement 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
including quality policy and objectives
04/11/23 show 42
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
04/11/23 show 43
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
•
04/11/23 show 44
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
04/11/23 show 45
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
04/11/23 show 46
6
Resource Management
04/11/23 show 47
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 or
contracted
04/11/23 show 48
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
04/11/23 show 49
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
04/11/23 show 50
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
04/11/23 show 51
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
04/11/23 show 52
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
04/11/23 show 53
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
04/11/23 show 54
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 or communication)
04/11/23 show 55
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
04/11/23 show 56
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
04/11/23 show 57
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
04/11/23 show 58
6.41 Personnel Safety
At the product design stage to ensure product safety and safety of employees while developing manufacturing processes
04/11/23 show 59
6.4.2 Cleanliness of Premises
To maintain premises in a state of order, cleanliness and repair consistent with product and process needs
04/11/23 show 60
7
Product Realization
04/11/23 show 61
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
• Records for conformity evidence
04/11/23 show 62
7.1.1 Planning for Product Realization
To include customer requirements and reference to their technical specs as part of quality plans
04/11/23 show 63
7.1.2 Acceptance Criteria
• Acceptance criteria to be defined and where required approved by customer
• Zero defect for attribute sampling acceptance criteria
04/11/23 show 64
7.1.3 Confidentiality
To ensure confidentiality of customer contracted products and projects under development and related product information
04/11/23 show 65
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 implementation
04/11/23 show 66
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
• Applies to products and processes
04/11/23 show 67
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
04/11/23 show 68
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
04/11/23 show 69
7.2.1.1 Special Characteristics
To demonstrate compliance to customer requirements of designation, documentation and control of special characteristics
04/11/23 show 70
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: In some cases e.g. internal sales review may only be reference to catalog
04/11/23 show 71
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
04/11/23 show 72
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
04/11/23 show 73
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
04/11/23 show 74
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)
04/11/23 show 75
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 authorities
04/11/23 show 76
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 plansNote: MDT typically includes design, QA
production, engineering and other relevant functions
04/11/23 show 77
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, unambiguous and not conflicting
04/11/23 show 78
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
• Targets for product Q, life, reliab. etc
04/11/23 show 79
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
04/11/23 show 80
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 special characteristics
04/11/23 show 81
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 safe & proper use
04/11/23 show 82
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
04/11/23 show 83
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
-Records of reviews & necessary actions
04/11/23 show 84
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
04/11/23 show 85
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
04/11/23 show 86
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 actions
04/11/23 show 87
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
04/11/23 show 88
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
04/11/23 show 89
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
• Records of review and actions
04/11/23 show 90
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 ability to meet purchase requirements
04/11/23 show 91
7.4.1 Purchasing Process (Cont.)
• Criteria for selection, evaluation & re-evaluation to be established.
• Records of evaluation and follow-up action to be kept
04/11/23 show 92
7.4.1.1 Regulatory Conformity
All purchased products or materials used in products supplied to customer to meet applicable regulatory requirements
04/11/23 show 93
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
04/11/23 show 94
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
04/11/23 show 95
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
04/11/23 show 96
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
04/11/23 show 97
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
04/11/23 show 98
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 issuesTo promote sup montrng of mfg. process
04/11/23 show 99
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
post-delivery activities
04/11/23 show 100
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
• To be reviewed and updated
04/11/23 show 101
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
04/11/23 show 102
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
04/11/23 show 103
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 enhance efficiency and effectiveness
04/11/23 show 104
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
04/11/23 show 105
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
04/11/23 show 106
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
04/11/23 show 107
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
04/11/23 show 108
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• Revalidation
04/11/23 show 109
7.5.2.1 Process Validation
Requirement of 7.5.2 shall apply to all production and service provision processes
04/11/23 show 110
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
04/11/23 show 111
7.5.3.1 Identification and traceability
The words ’where appropriate’ in 7.5.3 shall not apply
04/11/23 show 112
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
04/11/23 show 113
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
04/11/23 show 114
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
04/11/23 show 115
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
04/11/23 show 116
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 these not available, cal basis to be defined
04/11/23 show 117
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 later
04/11/23 show 118
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
04/11/23 show 119
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• Customer notification for suspects
04/11/23 show 120
7.6.3 Laboratory requirements7.6.3.1 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 related records
04/11/23 show 121
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)
04/11/23 show 122
8
Measurement, Analysis and Improvement (MM&I)
04/11/23 show 123
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
04/11/23 show 124
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
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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
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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. Can be internal
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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
• Monitor mfg process for customer E&Q
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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• Documented procedure
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8.2.2.1 QMS Audit
To audit QMS for compliance to TS and additional QMS requirements
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8.2.2.2 Manufacturing process audit
To audit each manufacturing process to determine effectiveness
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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)
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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
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8.2.2.5 Internal auditor qualification
To have internal auditors who are qualified to conduct TS audit
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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
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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
• To implement CP and flow chart
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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.• To record process change dates
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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
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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
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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
qualification of personnel
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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 concessions
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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
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8.3.1 Control of NCP
Products with unidentified and suspect status to be classified as NCP
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8.3.2 Control of reworked product
Instruction for rework including re-inspection to be accessible and utilized by concerned personnel
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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 organization
recommendation
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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 incl PA opportunities *Suppliers
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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
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8.5 Improvement
8.5.1 Continual ImprovementContinually 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>Identify opportunities for improvement
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8.5.1.1 Continual improvement of organization
To define process for continual improvement
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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 CP2 CI is implemented once mfg process is
capable and stable or product characteristics are predictable and meet customer requirements
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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 CA
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8.5.2.1 Problem solving
To have process for problem solving and root cause identification and elimination
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8.5.2.2 Error proofing
To use error-proofing method in corrective action process
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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
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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
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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
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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 aimed for related to quality
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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
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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 non-conformity or potentially undesirable situation
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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
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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
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Effectiveness vs. Efficiency
• EffectivenessMeasure of the extent to which planned activities are realized and planned results achieved
• EfficiencyRelationship between the results achieved and resources used
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Process Approach
• To function effectively org has to identify & manage numerous inter-linked 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 to as ‘process approach’