Professional Documents
Culture Documents
VDA 6.2
Purpose of use
Self assessment Pre-audit Certification audit Surveillance audit Extension audit Subsequent audit Date: Date: Date: Date: Date: Date: Date:
Organization
Name Address Postal Code, town/city Certified area Area of activity Contact person Phone/fax E-mail
Auditor team
1. Auditor (audit
manager):
2. Auditor: Observer:
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Notes:........................................................................................................................ 5 Processes and components in ISO 9001:2000........................................................... 6 Standard-ogramm .................................................................................................... 6 Management process ................................................................................................. 9 Obligation of management (provision of resources) ................................................. 10 Quality management system .................................................................................... 11 Document Control..................................................................................................... 13 Quality records control.............................................................................................. 15 Training, competence, awareness............................................................................ 17 Internal audit............................................................................................................. 19 Corrective measures ............................................ Fehler! Textmarke nicht definiert. Preventive actions .................................................................................................... 23 Improvement process ............................................................................................... 25 Customer-related processes..................................................................................... 27 Development ............................................................................................................ 29 Production / service provision................................................................................... 31 Planning of the product implementation ................................................................... 32 Management of the resources (infrastructure, working environment.)...................... 33 Procurement ............................................................................................................. 35 Measuring and test equipment monitoring................................................................ 37 Measuring, analysis and improvement ..................................................................... 38 Process assessment according to the VDA 6.2 ............................................... 39 (Summary taking account of the objectives) .................................................. 39
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
c.) The classification of audit activities according to priority and taking account of:
d.) The completion of the audit program including the sequences / process steps, time management, interview partners and the application of rules for recognition by the VDA-QMC.
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Strengths/weaknesses + Standar d points 4.1 4.2.1 4.2.2 4.2.3 Short name General requirements General Quality Management Handbook Controlling of documents Controlling of quality records Management obligations Customer orientation Quality policy Quality objectives Planning of the quality management system General information Inputs for the evaluation Results of the evaluation Responsibility and authority Authorized representative of top management Internal communication Provision of resources General information Capability, awareness and training Infrastructure Working environment General information Customer satisfaction Internal audit Monitoring and measuring of processes Monitoring and measuring of the product Control of non -conforming products Data analysis Continuous improvement Corrective measures Preventive measures Planning and product implementation Establishing the requirements reg the product Evaluating the requirements reg. the product Communication with the customer Development planning Development inputs Development results Development evaluation Development verification Development validation Controlling of development changes Procurement process Procurement data Verification of procured products Controlling of the product/service provision Validation of the product/service provision Identification marking and traceability Customer property Product maintenance Control of monitoring and measurement
P* WW*
Document control
4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1
Internal Communication
Customer orientation
6. Management of Resources
Internal audits
Customer satisfaction
8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
Product / service
Provision of resources
Personnel resources
Analysis of data
Infrastructure
Workingenvironment
7. Product implementation
Improvement measures
Preventive measures
Corrective measures
Development
Test equipment
Procurement
Planning
7.5.5 7.6
Key
*P = Priority, *WW = Interaction, = Processes, = Components, = Components relating to a process
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Processes and components in the ISO 9001:2000 system and in VDA 6.2
Management
Chapter / crossreference VDA 6.2 Document second edition 2004
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Is a clear definition of the structure and process organization given? Are all interest partners taken into reasonable account? Does top management take up issues such as: o the business plan o business results o comparable performance internal / external data o employee satisfaction o customer satisfaction and deal with them in an integrated manner? Are aspects such as product liability, the recognition of risks, hazards at the workplace given reasonable account? Are there business plans containing all the following aspects: o cost aspects o sales aspects o overall corporate aspects o development aspects o process and quality aspects taking account of time data and of the customer and employee expectations? Is the efficiency of all value creation and support processes evaluated by top management? Is there a process for establishing customer requirements, (customer representative) have measurable targets been established for this? Have measurable and achievable quality targets (continuously) been established? Performance of the quality management system (monitoring of the Q- targets / evaluation of the quality related internal / external losses (periodic tracking) Information flow, transparency, monitoring of effectiveness Improvement process general.
Goals
Section 5.1
Strategy
Planning Sub-targets
Section 5.7
Section 5.1.1.
Section 5.1.2.
Review
Section 5.5
Improvement
Systemmodification
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Discussion partner:
5.4.2-01 The planning of the quality management system is done in a manner so as to fulfill the specifications given in section 4.1 and to achieve the quality objectives? 5.4.2-02 The functionality of the quality management system is maintained, when changes to the quality management system are planned and implemented?
5.6 Management review 5.6.1 General 5.6.1-01 Does the top management evaluate the quality management system of the organization at planned intervals in order to ensure its continuing suitability, applicability and effectiveness? 5.6.1-02 Does this review of the evaluation of possibilities for improvements and the change requirement for the quality management system also include the quality policy and the quality objectives? 5.6.1-03 Are the notes made concerning the management review adhered to? 5.6.2 Input for evaluation Does the input for the management review contain information about the following issues: 5.6.2-01 Results of audits? Feedback from customers? Process performance and product conformity?
Notes, recommendations:
5.6.2-02 5.6.2-03
5.6.2-04 The status of preventive and corrective measures? 5.6.2-05 Measures to be taken as a consequence of preceding management evaluations? 5.6.2-06 Planned changes that could have an effect on the quality management system? 5.6.2-07 Recommendations for improvements? 5.6.3 Results of the management review Doe the results contain all the decisions and measures from the review on the following issues:
5.6.3-01 Improvement of the effectiveness of the quality management systems and its processes? 5.6.3-02 Product improvement in regard to customer requirements? 5.6.3-03 Resources requirements?
Please note: Requirement in accordance with the QA general terms and conditions and/or EN 45012 Are complaints also dealt with and documented in the scope of this evaluation in regard to the QM system?
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Discussion partner:
Can it prove that the effectiveness of the QMS is being continuously improved in that: 5.1-02 The organization is actually conveying the significance of fulfillment of customer requirements and the statutory authority requirements? 5.1-03 The establishment of quality policy? 5.1-04 Assuring that quality objectives have been established? 5.1-05 Management reviews have been carried out and the availability of resources assured? 5.2 Customer orientation 5.2-01 Has top management assured that the issue of customer requirements has been communicated and fulfilled with the objective of increasing customer satisfaction?
5.5.1 Responsibility and authority 5.5.1-01 Top management assures that die responsibilities and authorities and their interactions within the organization have been defined and have been made known?
5.5.2 Representative of the top management Has top management appointed a member, who independent of all other responsibilities, has responsibility and authority including the following points:
5.5.2-01 to ensure that the required processes are introduced, implemented and maintained for the quality management system? 5.5.2-02 That top management is reported to on the performance of the quality management system along with each necessity for improvement? 5.5.2-03 that awareness about customer requirements is promoted and assured throughout the entire organization?
Notes, recommendations:
5.5.3-01 Does top management assure that suitable processes for communication are introduced throughout the organization and that a communication about the effectiveness of the quality management system takes place?
6.1 Provision of resources Does the organization determine the resources and provide them for: 6.1-01 Implementing the quality management system and for continuously improving its effectiveness 6.1-02 Increasing customer satisfaction through fulfillment of the customer requirements?
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Discussion partner:
4.2 Documentation requirements 4.2.1 General Does the documentation for the quality management system contain: 4.2.1-01 a documented quality policy and quality objectives? 4.2.1-02 a quality management handbook? 4.2.1-03 documented procedures that are required by this international standard?
Notes, recommendations:
4.2.1-04 documents that are required by the organization for assuring the effective planning, implementation and controlling of all its processes? 4.2.1-05 The quality notes specified by this international standard? EXPLANATORY NOTE 1: When the designation "documented procedure" is used, this means that the relevant procedure is defined, documented, realized and maintained. EXPLANATORY NOTE 2: The extent and scope of the quality management system documentation can be different from organization to organization as a result of: a) the size of the organization and the type of its activities, b) the complexity and the interaction of the processes, and c) the capabilities of the personnel. EXPLANATORY NOTE 3: The documentation can be implemented in any form or type of medium. 4.2.2 Quality Management Handbook Does the Quality Management Handbook contain: 4.2.2-01 the application area of the quality management system including the details about and reasons for every exclusion? 4.2.2-02 the documented procedures created for the quality management system or indicators to it? 4.2.2-03 a description of the interaction of processes in the quality management system?
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Document control
Chapter / crossreference VDA 6.2 Document second edition 2004
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000 Is the timely evaluation / distribution / implementation in compliance with the customer scheduling assured? Have all changes been consistently documented? Is there a clear presentation of all documents? Is exclusion of abuse ensured?
Creating, maintaining
Section 4.2.3.1
Checking releasing
Publish update
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Discussion partner:
4.2.3-09 to prevent the unintentional use of outdated documents and to mark them in an appropriate manner, in the event that they have to be preserved for any reason?
Notes, recommendations:
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Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Control of quality records
Chapter / crossreference VDA 6.2 Document second edition 2004
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Section: 4.2.4.1
Does the control of the records comply with statutory, authority and customer requirements? Are aspects taken into account such as:
o o o protection against fire, water archiving media (files, micro-film, computer). if necessary additional security files (double archiving, safety copy etc.)
Releasing distributing
Storing securing
Protect keep
Destroy
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Discussion partner:
Notes, recommendations:
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Resources, training, competence, awareness
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Are measures for training, qualification and motivation of the employees planned and implemented at all levels in all areas and is the implementation evaluated? Is the qualification of the employees established in appropriate requirement profiles, job descriptions, functional or process descriptions? Has a sustained improvement in management / management behaviour been achieved (keyword employee attitude survey) Are there procedures for: o Attracting new employees o Job familiarization/instruction o Regular employee discussions with comparison of target achievement o Regular establishing of the personnel and function related training requirements of all employees? Is there an adequate employee training given at the workplace? Keywords to this: o New / changed work processes o Effects of faults / nonfulfilment on the customer Establishing of employee motivation (continuous improvement of environment / innovation). Are all activities traceable to terms of maintenance / improvement of the infrastructure? Have all the criteria for a fulfilment of the services according to requirements been established (e.g. ergonomics, quality, schedules, costs) Are there emergency plans? Has it been assured that all the requirements from planning for the working environment have been maintained in relation to the provision of the service? Do the works, the environment comply with the statutory requirements in respect to safety, order, and hygiene?
Section 6.2.1.
Section 6.2.1.1.
Section 6.2.2.
Coordination implementation
Evaluating use
Section 6.2.2.1
Section 6.2.2.2/3
Section 6.3
Section 6.3.1.
Section 6.4
Section 6.4.1.
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Discussion partner:
Notes, recommendations:
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Internal audit
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Does the system audit your QM system in accordance with the VDA 6.2 specifications, along with all other QM system requirements (taking account of customer specific specifications)? Is each service process audited in order to establish its effectiveness? Do the internal audits take account of all the service processes listed in the handbook and are these audited in an adequate manner? Is there an annual plan for the carrying out of audits? Does the internal audit planning take into account at least: o auditing issues o reference documents o processes to be audited o audit sequence o questions complex (check list) o schedules o audit team (contact partners) o reporting and distribution Are all the auditors sufficiently qualified in accordance with the customer / industry requirements / (also see Basic Requirements from VDA 6 ) Are all the auditors trained in regard to the requirements of methods, quality techniques, standards etc? Do the auditors comply with the requirements in terms of personal characteristics (also see ISO 19011 see Basic Requirements for Auditors)?
Section 8.2.2.1
Section 8.2.2.2
Section 8.2.2.3
Reporting
Section 8.2.2.4
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Discussion partner:
8.2.2-01 fulfils the planned rules of this international standard and the requirements on the quality management system as established by the organization? 8.2.2-02 is effectively realized and maintained? 8.2.2-03 Is an audit program created in which the significance of the processes to be audited and the areas as well as the results of earlier audits are taken into account? 8.2.2-04 Are the audit criteria, the extent of the audit, the audit frequency and the audit method defined? 8.2.2-05 Does the selection of auditors and the carrying out of the audits ensure the objectivity and impartiality of the audit process? 8.2.2-06 Is it assured that the auditors are not auditing their own activities? 8.2.2-07 Are the responsibilities and requirements for the planning and implementation of audits together with reporting on their results and the keeping of record notes established in a documented procedure? 8.2.2-08 Has the management responsible been assured for the area to be audited so that measures for dealing with faults and their causes that have been recognized can be taken without delay? 8.2.2-09 Do the follow-up measures contain provisions for the verification of these measures and for reporting on the verification?
Notes, recommendations:
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Corrective measures
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Are appropriate methods for solving problems systematically applied by the organization in order to do away with the basic causes (e.g. 8 Steps, 5 Steps, 5 M or similar)? Are deeper root causes established by these methods, in particular in regard to quality and problems with customer satisfaction (inclusion of those involved in the process such as service providers and service receivers / record documents covering this)? Are problem solving methods specified by the customer applied? Is the knowledge gained from problems also taken into account in similar cases / processes on a preventive basis? Are processes that promote customer oriented thinking and acting and rule out repetitions of faults established? Are appropriate techniques used, e.g.: o working in a control cycle (PDCA) o working according to cycle plans, check lists or similar o risk analyses (FMEA) Are services analyzed about which customers have complained? Is the analysis of data for internal and external complaints a purposeful / planned procedure with the objective of systematically excluding the causes of faults? Is the time for diagnostics (analysis of causes of faults / derivation of measures / checking of effectiveness) recorded and minimized? Are the record notes on this available?
Section 8.5.2.1
Analyse causes
Section 8.5.2.3
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Discussion partner:
8.5.2-01 Have corrective measures been made for dealing with the causes of faults to prevent reoccurrence? 8.5.2-02 Corrective measures must be appropriate to the effects of the faults that have occurred. Is this the case?
Does an introduced documented procedure exist to establish specifications for the: 8.5.2-03 Evaluation of faults (including customer complaints)? 8.5.2-04 Establishing the causes of faults? 8.5.2-05 Assessment of the requirement for action, to prevent the renewed occurrence of faults? 8.5.2-06 Establishing and realization of the required measures? 8.5.2-07 Recording of the results of the measures introduced? 8.5.2-08 Evaluation of the corrective measures taken?
Notes, recommendations:
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Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Preventive measures
Chapter / crossreference VDA 6.2 Document second edition 2004
Identifying weighting evaluating possible, but not yet existent problems / risks
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Basic requirements for the automobile industry are to be taken into account
(For further examples on this see contract verification / project handling / FMEA)
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Discussion partner:
8.5.3-01 Have preventive measures for dealing with the causes of potential faults been defined to prevent these from occurring? 8.5.3-02 Preventive measures must be appropriate to the effects of the potential problems that have occurred. Is this the case?
Does an introduced documented procedure exist to establish specifications for the: 8.5.3-03 Establishing of potential faults and their causes? 8.5.3-04 Assessment of the requirement for action, to prevent the renewed occurrence of faults? 8.5.3-05 Establishing and realization of the required measures? 8.5.3-06 Recording of the results of the measures introduced? 8.5.3-07 Evaluation of the preventive measures taken?
Notes, recommendations:
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Improvement process
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000 Is the service improvement constantly aligned to reducing the quality fluctuations? o Improvement of the quality level for services o Optimizing of processes o Risk analysis for the service provision o Increasing efficiency (costs reduction for processes, increasing customer value) o Improving customer support and customer relations Have steps and activities such as e.g.: o Systematic diagnosis and implementation of the knowledge that has been obtained (inclusion of those concerned, optimizing) o Establishing of responsibilities and authorities o Selection of improvement projects according to established criteria o Monitoring of the separate improvement projects o Results evaluation (customer value, economy, comparison with objective targets) o Use of reporting systems, benchmarks, audits, customer reports been taken into account?
Defining the improvement potential of the system, the processes, the products, the services, the communication, the information, and setting priorities
Section 8.5.1.1
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Discussion partner:
8.5.1-01 Is the effectiveness of the quality management system continuously improved through the application of quality policy, quality objectives, audit results, data analysis, correction and preventive measures plus management evaluation?
Notes, recommendations:
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Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Requirements
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Is quality planning done across all departments? Does the quality future planning include concepts for avoiding faults? Are the processes / activities described in an appropriate manner, - as e.g.: o establishing and marking of the significant characteristics of the service o provision of equipment, processes and controlling measures o updating of processes and equipment o timely, forward looking provision of measuring techniques and methods o testing of purposeful positions for service implementation o clarification of acceptance criteria o monitoring of changes including verification and validation Has a check been made prior to the provision of the service, which applicable specifications, standards and drawings are to be taken into account? Is there a process for market research as the basis for the development / provision of services? Is it a management task to monitor these processes in regard to their effectiveness? Has the extent of the service to be provided been adequately clarified? o clarification of the extent of the service and its feasibility o limiting of the expected costs in the provision of the service o defining the quality requirements Can a systematic market development be documented? Are advertising claims fulfilled in a manner that can be verified? Is the effectiveness evaluated? Is a Corporate Identity maintained? Is the acceptance of and affect on/through the customer observed through the entire period of the warranty/guarantee? Is the knowledge gained in this made of use of in the sense of the KVP?
Section 7.2.1
Section 7.2.3.1
Follow-up activity
Section 7.2.3.2
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Discussion partner:
7.2.2-03 That the specifications made on the product are defined? 7.2.2-04 That the differences between the specifications in the contract or order and the specifications as these were previously formulated have been disposed of? 7.2.2-05 That the organization is in a position to fulfil the defined specifications?
Notes, recommendations:
7.2.2-06 That records are made of the evaluation results and their follow-up measures? 7.2.2-07 That the customer requirements prior to acceptance are confirmed by the organization when the customer has not previously presented documented specifications? 7.2.2-08 Does the organization ensure when product requirements change that the relevant documents are also changed and that the responsible personnel are made aware of the changed specifications? EXPLANATORY NOTE: In a number of cases e.g. Internet sales, a formal evaluation of each separate order is not practicable. Instead of this, the evaluation can refer to relevant product information such as catalogues or advertising material for example. 7.2.3 Communication with the customer Does the organization have effective regulations for communication with the customer that have been established to cover the following points and have these been implemented: 7.2.3-01 Product information? 7.2.3-02 Inquiries, contracts or order processing including changes? 7.2.3-03 Feedback from the customer including customer complaints?
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Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Development
Chapter / crossreference VDA 6.2 Document second edition 2004
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000 Is an inter-departmental approach assured? Have special characteristics and their monitoring been established within the scope of the project planning? Have appropriate methods and tools been used in the planning phase (e.g.: FMEA)? Have all the characteristics/requirements for the product development been established, documented and evaluated?
o o o o customer demands contract document specifications agreed delivery obligations taking into account of previous experience (market research, competition, supplier feedback,...) Have targets been established for the product quality/service life/reliability/shelf life etc. been established? Is there a time management and cost overview for this?
Specification
Section 7.3.1.
Design / development
Section 7.3.2.1
Design / Reviews
Section 7.3.2.2
Verification
Validation
Section 7.3.7
Section 7.3.8
Are all the requirements for the production process development known? Have the special characteristics been established (customer requirement or internal)? Are the results of the service process development available? Is the development of appropriate evaluations performed in established phases? Have processes and responsibilities for changes been suitably established? Is there a procedure for the checking and release after completion of the service preparation?
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22, Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com, E-mail: office@qualityaustria.com
Discussion partner:
N
7.3.2-04 Where applicable, information derived from earlier similar developments? 7.3.2-05 Other specifications important for the development? 7.3.2-06 Are these inputs evaluated on the basis of their appropriateness? 7.3.2-07 Are the specifications complete, clear and free from contradictions? 7.3.3 Development results
7.3.3-01 Are the development results provided in a form which make their verification possible over and against the development inputs, and are they subject to approval before release? Is it ensured that: 7.3.3-02 the development results fulfil the development specifications? 7.3.3-03 reasonable information levels for the procurement, production and provision of service are prepared? 7.3.3-04 Acceptance criteria for the product are contained or reference made to them?
Notes, recommendations:
7.3.3-05 Those characteristics of the product are established that are essential for a safe use and the intended the purpose? 7.3.4 Development evaluation Are systematic reviews carried out in suitable phases in order to: 7.3.4-01 Assess the suitability of the development results for the fulfilment of the specifications? 7.3.4-02 To recognize all problems and to suggest necessary measures? 7.3.4-03 Do the participants of reviews of this kind include representatives of the functional areas that are affected by the evaluated development phase or the evaluated development phases. 7.3.4-04 Are notes taken about the results of the reviews and about essential measures? 7.3.5 Development verification 7.3.5-01 Is a verification is carried out in order to assure that the development results fulfil the development specifications? 7.3.5-02 Are notes taken about the results of the verification and about essential measures? 7.3.6 Development validation 7.3.6-01 Has a development validation been carried out in accordance with the planned regulations (see 7.3.1), to ensure that the resulting product is in a position to fulfil the specifications for the defined or the known intended use? 7.3.6-02 Has the validation been completed where possible before the delivery or the introduction of the products? 7.3.6-03 Are notes taken about the results of the reviews and about essential measures? 7.3.7 Steering of development changes 7.3.7-01 Are development changes marked and recorded?
7.3.7-02 Are changes evaluated, verified and validated and also approved before their introduction insofar as it is reasonable to do so? 7.3.7-03 Does the evaluation of the development changes include the assessment of the effects of the changes on the components and the delivered products? 7.3.7-04 Are notes taken about the results of the reviews and about essential measures?
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Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000 Is there a steering plan for the provision of the service?
o o o o
Specifications
Planning availability of: information instructions check lists measuring test equipment resources Identification und taceability
Section 7.5.1.1.
indicators for quality steering? testing and treatment of customer property defined characteristics information requested immediate measures for Qproblems
Section 7.5.1.2
Are there appropriate process- / procedural instructions for the completion of the contract? Are all the working instructions required up-to-date and available at the workplaces? Are the requirements for servicing / maintenance of tools fulfilled to terms of the requirement (availability / planned maintenance / key equipment / resources / qualification etc.)? Is there a coordination and schedule planning for the provision of the service? Are agreements with the customer available and are these taken into account? Is there a process in respect to feedback from the customer? Is there a real process for service and customer support? Are all production and service processes validated? Is the entire service traceable at all times (participating employees / records)? Are the requirements for the products / tools that have been provided (customer property) fulfilled? Is the state of the warehouse checked at reasonable planned intervals? Are the FIFO requirements fulfilled and are the storage areas optimally used?
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Customer property
Section 7.5.1.5
Discussion partner:
7.5.1-05 The availability and use of monitoring and measuring equipment? 7.5.1-06 The implementation of monitoring and measurements? 7.5.1-07 The implementing of release and delivery activities and activities subsequent to the delivery? 7.5.2 Validation of the production and service provision processes 7.5.2-01 Are all the production and service provision processes validated, whose the results cannot be verified by the following monitoring or measurement? 7.5.2-02 Does this also apply to all processes where the inadequacy of was first seen only after either the product had gone into use or the service had been provided? 7.5.2-03 Does this validation demonstrate the capability of these processes for the achievement of the planned results? Have regulations been established for these processes insofar as this is relevant, containing: 7.5.2-04 Established criteria for the evaluation and approval of the processes? 7.5.2-05 Approval of the equipment and the qualification of the personnel? 7.5.2-06 7.5.2-07 7.5.2-08 Use of specific methods and processes? Requirements for records? Renewed validation?
Notes, recommendations:
7.5.3-01 Is marking of the products with suitable means during the entire product realization performed insofar as this is reasonable? 7.5.3-02 Is a marking made of the product status in respect to the monitoring and measurement requirements? 7.5.3-03 Is a clear marking of the product steered and recorded when traceability is demanded? EXPLANATORY NOTE: In some industrial branches configuration management is a means for marking and traceability. 7.5.4 Property of the customer 7.5.4-01 Does the organization handle customer property carefully for as long as it is within the controlling orbit of the organization or while it is used by it? 7.5.4-02 Does the organization mark, verify and protect the customer property that is entrusted to it for use or for inclusion in the product? 7.5.4-03 Are cases of loss, damage or otherwise nonsuitability for use in respect to customer property reported to the customer and are records maintained of this? EXPLANATORY NOTE: intellectual property. Customer property can also include
7.5.5 Product maintenance 7.5.5-01 Is the conformity of the product maintained during the internal processing and delivery to the specified location as foreseen? 7.5.5-02 Does this maintenance include marking, handling, packing, storage and protection? 7.5.5-03 Does this maintenance apply in an analogue manner for the components of a product?
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EXPLANATORY NOTE 1: A document that establishes both the processes of the quality management system (including the product implementation processes) and the resources that are to be used for a specific product, project or for a specific contract, can be named quality management plan. EXPLANATORY NOTE 2: The organization may apply the requirements given in Section 7.3 also on the development of product realization processes.
Notes, recommendations:
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Notes, recommendations:
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Processes and components in the ISO 9001:2000 system and in ISO /TS 16949
Procurement
Chapter / cross-reference VDA 6.2 Document second edition 2004
Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000
Specifications
Section 7.4.1.
Procurement information
Section 7.4.2
Do all the products, materials and services procured comply with the relevant applicable official regulations? Does the supplier QM system comply with automobile industry requirements and is there at least a valid (accredited) ISO 9001:2000 certificate available? Has it been ensured that the organization uses only supply sources that have been approved by the customer, insofar as this has been contractually agreed? Have all the details relevant to the procuring of the products / services been coordinated with suppliers / sub-contractors? Is the supply quality adequately monitored? o receipt and evaluation of o o o
statistical data goods arrivals tests evaluation / auditing of suppliers other methods coordinated with the customer
Section 7.4.3.1
Section 7.4.3.2
Is the supplier service monitored according to appropriate indicators (product quality, delivery performance, additional freight costs)?
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Discussion partner:
Notes, recommendations:
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Additional requirements / focal points VDA 6.2 compared with ISO 9001:2000 Is all calibration, testing, measuring equipment that is required for verification of conformity monitored?
Specifications
Verification
Section 7.6.1.
Stock
Calibration
Issue
Steering
Withdrawal
Proof of at least the following has to be made: Marking of the measuring equipment including traceability to the Calibration and Measurement Standard. Re-processing on the basis of development and constructional changes. All measured values outside of the specification that are found during calibration or verification. Evaluation of the effects of the defective state Confirmation of compliance with the specification after the calibration or verification and Reporting to the customer on delivery and/or installation of products suspects of being defective or materials or in the case of services suspected of being faulty.
Calibration
Follow-up measures, stock, disposal, depreciation evaluation of required activities or products / services
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7.6-06 Is measuring equipment adjusted or readjusted if required? 7.6-07 Are they marked so that the calibration status can be recognized? 7.6-08 Are they secured against wrong adjustments that would make the measuring result invalid? 7.6-09 Are they protected against damage or deterioration during handling, maintenance and storage?
Notes, recommendations:
7.6-10 Does the organization assess the validity of previous measuring results and are these recorded when it has been established that the measuring equipment does not fulfil the requirements. 7.6-11 Are suitable measures being taken in respect to the measuring equipment and all the products affected? 7.6-12 Are notes taken about the results of calibration and verification? 7.6-13 When computer software is used for monitoring and measuring compliance with the defined specifications, is the suitability of this software confirmed as regards the intended application ? 7.6-14 Is this done before the first use and when necessary later?
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8.2.4-01 Are the characteristics of the product monitored and measured, in order to verify the fulfillment of the specifications in the product? 8.2.4-02 Is this done in suitable phases in the product implementation process and in compliance with the planned activities? 8.2.4-03 Is a proof of conformity carried out with the acceptance criteria? 8.2.4-04 Do these record notes state who is or who are the person/s responsible for the release of the product? 8.2.4-05 Is a product release and service provision only made after the satisfactory completion of all the defined activities, insofar as this is not done otherwise by a responsible body and, to the extent that this is required, with the permission of the customer? 8.3 Control of non-conforming products 8.3-01 Is it assured that a product that does not fulfill the specifications is appropriately marked and controlled to ensure that its unintentional use or its delivery are prevented? 8.3-02 Are the control measures and the responsibilities and authorities allocated to them for dealing with non-conforming products established in a documented procedure? Are non-conforming products dealt with in one or more of the following ways: 8.3-03 Introduce measures to deal with the established fault? 8.3-04 Approval for use, for release or acceptance after special release by a responsible position and, where appropriate, by the customer? 8.3-05 Introduce measures to rule out the originally intended use or application? 8.3-06 Making record notes of the type of faults and the subsequent measures resorted to including the special releases that have been obtained? 8.3-07 When a non-conforming product has been improved is this verified once again to demonstrate conformity with the specifications? 8.3-08 If a non-conforming product is discovered after the delivery or in use, are measures introduced that are appropriate for the consequences or the potential consequences? 8.4 Data analysis 8.4-01 Are suitable data established, recorded and analyzed in order to present and assess the suitability and effectiveness of the quality management system where continuous improvement of the quality management system can be made? 8.4-02 Does this also include data that is obtained from monitoring and measuring and from other relevant sources? Does the data analysis supply data about: 8.4-03 8.4-04 8.4-05 8.4-06 8.4-07 Customer satisfaction? The fulfillment of the specifications for the product? Process and product characteristics and their trends? Possibilities for preventive measures? Suppliers?
Notes, recommendations:
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practice
Specification and verification documentation Points assessment to VDA 6.2 Traffic-light logic / effects for certification procedures
Completely fulfilled
Predominately given
Given in fragments
Evaluated processes
Corporate strategy
Management including corporate culture, personnel / safety Process landscape (responsibility for development and sequence organization) Management system (also QM system) Controlling (also financial evaluation of non-quality costs) Market and customer requirements are defined? Develop service (product) Develop service processes Marketing Sell service Provide service Service and customer support Procurement / logistics / binding of suppliers
Summary taking account of the objectives (focal points for the audit report)
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Potentials:
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