vda 6.3 based supplier assessment

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  • Supplier: 48

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    Are the customer requirements available?

    TS: 4.2.3.1, 7.2.1, 7.2.3

    Has feasibility been determined on the

    basis of all current requirements?

    TS: 7.2.2, 7.2.2.2, 7.2.3

    Is a Product Development Plan available

    and are the prescribed aims [targets]

    adhered to?

    TS: 7.1, 7.1.1

    Has the Design FMEA been prepared and

    are the improvement actions defined?

    TS: 7.3.1.1, 7.3.2.3, 7.3.3.1, 7.3.3.2

    The known requirements must be checked for feasibility through interdisciplinary cooperation,

    here the customer requirements have special significance. Requirements to the following

    points, for example, are to be considered:

    - Design/Engineering

    - Quality

    - Process equipment, resources

    - Special characteristics

    - Company objectives

    - Directives, standards, legislation

    - Environmental aspects

    - Delivery dates/Time frames

    - Cost frame.

    The product development plan is an integral part of the project plan and stands in correlation

    with the process development plan. All activities, including those for suppliers, are to be

    established until start of series [after job1, full, after PPAP] production. The targets must be

    derived from the requirements and maintained at the established project phases. The following

    points, for example, are to be considered:

    - Customer requirements

    - Costs

    - Deadlines: Planning/Purchasing release, modification stoppages [design freeze]

    - Prototype/Pilot production, start of series production [after job1, full, after PPAP]

    - Resources (manning, equipment, tooling) studies

    - Setting and monitoring the target

    - Regular information to the company management

    - Simultaneous Engineering Teams (SET) [Concurrent Engineering]

    The product risks are to be pointed out and continually reduced with appropriate measures,

    through interdisciplinary cooperation, also with the customer and suppliers. For complex parts

    or complete function systems, the use of a system FMEA is sensible (see VDA Volume 4, Part 1

    and 2, [System FMEA references have been removed from AIAG FMEA 4th edition]). Other

    comparable analysis techniques are to be agreed with the customer. The following points, for

    example, are to be considered:

    - Customer requirements/performance specifications

    - Function, safety, reliability, maintainability, important characteristics

    - Environmental aspects

    - Involvement of all affected areas

    - Trial and test results

    - Product-specific measures from [to] the process FMEA.

    2. Process Development

    Open Questions:

    Answered:

    A. Product Development Process

    A. Product Development Process

    1.2

    1.3

    1.1

    Score

    Score Distribution:

    All customer requirements for the product to be developed must be known and included in the

    development. The following points, for example, are to be considered:

    - Drawings, standards, specifications, performance specification

    - Logistic concepts

    - Technical specifications, test specifications

    - Quality agreements, target agreements

    - Important product/process characteristics

    - Purchase order documents with parts lists and delivery dates

    - Legislation/Directives

    - Waste management plans, environmental aspects.

    VDA 6.3 based supplier

    assessment

    Guidance / Suggestions for objective evidence

    1. Process / Product Development Planning

    1.4

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    Guidance / Suggestions for objective evidence

    Has the Design FMEA been updated during

    the Project Course and have the defined

    actions been implemented?

    TS: 7.3.4

    Are all the necessary releases planned

    and/verification available?

    TS: 7.3.2.1, 7.3.3, 7.3.3.2, 7.3.5

    Has a pre-production run been carried out

    prior to full scale production, under full

    scale production conditions?

    TS: 7.3.6.3

    Are the procuction and inspection

    documents available and complete (PPAP)?

    TS: 7.3.3.1, 7.3.6.3, 7.5.1.2, 7.5.3.2

    Amendments to the product and process must be evaluated by the project management. In

    agreement with the FMEA Team, a new analysis, if necessary, is to be initiated. An update is

    also necessary after realization of measures (Design Review). The following points, for

    example, are to be considered:

    - Customer requirements

    - Important parameters/characteristics, legal requirements

    - Function, fitting measurements

    - Material

    - Environmental aspects

    - Transport (internal/external)

    - Product-specific measure from the process FMEA.

    2.1

    2.2

    2.3

    The releases/qualification records of all individual parts, subassemblies and purchased parts are

    to be proven. The following points, for example, are to be considered:

    - Product trials (e.g. fitting inspections [do parts fit in assembly/application], functional tests,

    durability checks, environmental simulations)

    - Status of the prototype parts

    - Pilot series model

    - Production/inspection, measuring and test equipment in experimental installation.

    A pre-production is required to be able to evaluate and, if necessary, correct all production

    factors and influences at an early stage. In serial production [after job 1, after PPAP, full],

    bottlenecks and quality impairment [scrap and rework], shall become avoidable [corrective

    actions are effective]. The following points, for example, are to be considered:

    - Customer requirements

    - Establishing minimum numbers of production pieces

    - Process capability analysis

    - Measuring equipment capability

    - Readiness of the production materials and equipment for series [after job1, after PPAP, full]

    (measuring records,[evidence]

    - First sample inspection

    - Handling, packaging, marking and storage

    - Personnel qualification

    - Work/Inspection instructions

    - Arrangement of work/inspection stations.

    2.4

    Process parameters/inspection characteristics are always to be given with tolerances, the

    production and inspection documents must be available at the work/inspection station. The

    implemented corrective actions for nonconformities are to be documented. Details are, for

    example:

    - Process parameters (e.g. pressures, temperatures, times,speeds)

    - Machine/tool/auxiliary means data

    - Inspection requirements (important characteristics, inspection, measuring and test

    equipment, methods, inspection frequencies)

    - Intervention limits in process control charts [control limits]

    - Machine and process capability records

    - Operating instructions

    - Work instructions

    - Inspection instructions

    - Information on the current nonconformities. [non conforming material is documented and

    tracked]

    - [PPAP]

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    Guidance / Suggestions for objective evidence

    Are the required resources available?

    TS: 6.2.2, 6.3

    Are only approved and qualified suppliers

    used?

    TS: 7.4.1, 7.4.1.2

    Is the quality of the purchased parts

    assured?

    TS: 7.4.3, 7.4.3.1

    Is the quality performance evaluated and

    are corrective actions introduced when

    there are deviations from the

    requirements?

    TS: 7.4.3, 7.4.3.2

    Are the necessary releases available for all

    the supplied products and are the

    necessary improvement actions converted

    into practice?

    TS: 7.3.5, 7.3.6

    B. Production Process

    2.5

    The required resources are to taken from the quotation calculation and the preplanning. They

    must be available, or planned and provided at the respectively appointed [appropriate] time.

    The required means for this must be included in the project. The following points, for example,

    are to be considered:

    - Customer requirements

    - Qualified personnel

    - Lost time through absenteeism [controllable and uncontrollable]

    - Through put/Processing time

    - Buildings, premises

    - Experimental installation

    - Prototype construction

    - Tools/Equipment

    - Test/Inspection/Laboratory equipment.

    3. Supplier Management

    The supplier must have established criteria for selection and re-evaluation of their sub-

    suppliers. Sub-suppliers must be qualified to meet the suppliers' customer requirement.

    Records of assessment results, if any, corrective actions and quality performance must be

    kept.

    3.1

    3.2

    3.3

    The following points, for example, are to be considered:

    - Sufficient inspection and test possibilities (capabilities, lab scope) Laboratory and measuring

    equipment)

    - Internal/external inspections and tests

    - Supplied gauges/surveys

    - Drawings/order details/specifications

    - Quality assurance agreements [ppm, delivery]

    - Coordination of inspection and testing procedures, proceedings and frequencies [control plan]

    - Analysis of nonconformity focal points [scrap analysis]

    - Capability evidence. [reviewed and analyzed]

    The capabilities and performances of a supplier are to be checked at defined intervals and

    recorded and evaluated in a part-specific listing (supplier catalog) [supplier score card].

    Qualification programs [supplier remedial activities and monitoring] are to be established when

    negative results are found. The implementation [and effectiveness] is to be proven [validated].

    The following points, for example, are to be considered:

    - Records about quality meetings [minutes and action item list]

    - Agreements [supplier buy-in] about and monitoring of improvement programs

    - Inspection and measuring records of improved components [e.g PPAP]

    - Analysis of nonconformity focal points/problem suppliers.

    3.4

    The releases/qualification records of all individual parts, subassemblies and purchased parts,

    production, inspection , measuring and test equipment, are to be proven. The following points,

    for example, are to be considered:

    - Product trials (e.g. fitting inspection (dimensional, into assembly/application), functional test,

    durability check, environmental simulations)

    - Pilot production parts

    - First sample

    - Capability records of important product/process characteristics

    - Logistic concept (e.g. checking suitability of packaging by a test dispatch)

    - Tools, machines, equipment, inspection, measuring and test equipment.

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    Guidance / Suggestions for objective evidence

    Are the stock levels of purchased material

    suited to the production requirements?

    TS: 7.5.1.6

    Are purchased materials/internal surpluses

    delivered and stored according to their

    purpose?

    TS: 6.2.1, 6.2.2, 7.5.5.1

    Is the personnel qualified for the individual

    tasks?

    TS: 6.2.2.2

    Are the employees given responsibility and

    authority for monitoring the

    product/process quality?

    TS: 5.5.1.1

    Are the personnel responsible for

    production equipment and the production

    environment?

    TS: 6.2.2.4

    4.1 Production - Personnel - Qualifications

    The following points, for example, are to be considered:

    - Cooperation on improvement programs (participation)

    - Worker self assessments (self audit, operator TPM)

    - Process approval/release

    - Set up release/First/last production piece testing / inspection)

    - Process control (Interpretation of control charts)

    - Authority to stop production.

    The following points, for example, are to be considered:

    - Tidiness and cleanliness [housekeeping, 5S]

    - Carrying out or ordering repair and maintenance work

    - Providing parts/storage

    - Carrying out/ordering the installation and calibration of inspection, measuring and test

    equipment.

    B. Production Process

    The required stock levels must already be determined and considered during process planning.

    When requirements change, the analyzed stock levels, if necessary, are to be updated. The

    following points, for example, are to be considered:

    - Customer requirements

    - KANBAN/Just in time

    - Storage costs

    - Emergency strategy when input material bottlenecks occur [contingency plan, expedited

    shipments]

    - FIFO (first in/first out).

    3.5

    3.6

    3.7

    The following points, for example, are to be considered:

    - Packaging

    - Storage administration system [Warehouse management, MRP/ERP system]

    - FIFO (first in/first out)

    - Tidiness and cleanliness [housekeeping, 5S]

    - Climatic conditions [ambient conditions]

    - Protection against damage/contamination [preservation]

    - Identification

    - (Traceability/Inspection status/Sequence of operations/Application status)

    - Safety against mix ups [prevention]

    - Secure storage (fitted and used). [finished goods, WIP]

    Personnel responsible for the following areas, for example, are to be considered:

    - Supplier selection, evaluation, qualification

    - Product inspection, measuring and testing

    - Storage/Transport

    - Logistics.

    Knowledge must be available, for example, about:

    - Product/specifications/special customer requirements

    - Standards/legislation

    - Packaging

    - Processing

    - Evaluation methods (e.g. audits, statistics)

    - Quality techniques (e.g. 8D-Method, Cause/Effect diagram)

    - Foreign languages.

    4.1.2

    4.1.1

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    Are the employees suitable to perform the

    required tasks and is their qualification

    maintained?

    TS: 6.2.2.2, 6.2.2.3

    What is the plan to substitute personnel in

    case of absence?

    TS: 6.2.2.2

    Are techniques for increasing employee

    motivation effectively used?

    TS: 6.2.2.4

    Are the product related quality

    requirements guaranteed using the

    production equipment/tools?

    TS: 8.2.2.3

    Can the quality requirements be monitored

    effectively during serial production with the

    implemented inspection, measuring and

    test equipment?

    TS: 8.2.3.1

    Is there a Gage Management System and

    Measurement System Analysis for

    production equipment and devices ? Do

    they execute it and is it effective?

    The following points, for example, are to be considered:

    - Introduction/Training/Qualification records about the process

    - Knowledge of the product and nonconformities which have occurred

    - Instructions in health and safety at work/Environmental aspects [MSDS, OSHA, ISO 14001]

    - Instructions for the handling of components with special verification requirements [special

    characteristics]

    - [Operator] Qualification records (e.g. Welder certificates, sight tests [vision, color], driving

    license for industrial trucks).

    When planning personnel, the absentee figures (illness/holidays/[vacation]/training courses)

    are to be considered. The required qualifications of replacement personnel are also to be

    ensured. The following points, for example, are to be considered:

    - Shift plan ([Union] contract related)

    - Qualification records (Qualification matrix) [compentency]

    - Work analyses/Time and motion studies.

    The willingness to work [morale, commitment] must be promoted through targeted information

    and thereby, the quality awareness increased. [information sharing] The following points, for

    example, are to be considered:

    - Quality information (Specified/Actual values)

    - Improvement suggestions

    - Voluntary activities (Training courses, quality circles, [first responder]

    - Low illness frequency rate

    - Contribution to quality improvement

    - Self assessments.

    Comment: The question also stands in connection with question 7.5. [see question 5.5]

    4.2 Production Machinery / Equipment

    The following points, for example, are to be considered:

    - Machine/Process capability evidence important characteristics / process parameters

    - Compulsory control/regulation of important parameters [process control of special

    characteristics]

    - Warnings when deviations from specified values occur (e.g. lamps, sirens, shutdown) [andon

    lights, r/y/g status lights]

    - Feed and delivery equipment [conveyors and transfer mechanisms, loading/unloading

    equipment]

    - Maintenance and repair status of tools/plants/machines (including scheduled maintenance).

    The following points, for example, are to be considered:

    - Reliability, function and corrosion resistance tests [preservation]

    - Measuring accuracy/inspection, measuring and test equipment capabilities

    - Data acquisition [Quality records, process data] and analysis

    - Calibration records.

    B. Production Process

    4.2.3

    4.2.1

    4.2.2

    4.1.3

    4.1.5

    4.1.4

    The following points are to be considered:

    - MSA manual latest revision available,

    - MSA study results (R&R, Linearity, Bias, Stability) are available,

    - MSA results are analyzed and corrective action are initiated,

    - Criteria for frequency of study are defined.

    - Equipment is calibrated with traceable standards

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    Guidance / Suggestions for objective evidence

    TS: 7.6, 7.6.1

    Are the work places, inspection areas and

    test areas suited to the requirements?

    TS: 6.4, 6.4.2

    Are the relevant details fully completed and

    adhered to in the production and inspection

    documents?

    TS: 7.5.1.2, 8.2.4, 8.3, 8.3.1

    Is the appropriate equipment and tooling

    available to support product changeover?

    TS: 7.5.1.5

    Has a preventive maintenance plan been

    established? Is it monitored and followed?

    TS: 7.5.1.4

    Has a list with critical equipment and

    critical parts been established and up to

    date?

    TS: 7.5.1.4

    4.2.4

    4.2.5

    The following points are to be considered:

    - list of critical equipment,

    - is there a plan and is plan followed?

    The folloing points are to be considered:

    - critical equipment has a list with repair parts

    4.2.6

    - Equipment is calibrated with traceable standards

    - Use of equipment with expired calibration dates is prevented

    The environmental conditions (also for repairs/rework) are to be tuned [appropriate] to the

    work contents and the products, to avoid contamination, damage and mix up /

    misinterpretation. The following points, for example, are to be considered

    - Ergonomics

    - Lighting

    - Tidiness and cleanliness [housekeeping]

    - Environmental protection [work area, noise, contamination]

    - Surroundings/Handling of the components

    - Health and safety at work.

    Process parameters and inspection and testing characteristics are always to be given with

    tolerances. Manufacturing and inspection documents must be available at the work/inspection

    stations. Nonconformities and implemented corrective actions must be documented.

    The following points, for example, are to be considered:

    - Process parameters (e.g. pressures, temperatures, times, speeds)

    - Machine/tool/auxiliary means [perisable tooling] data (Tool and machine numbers)

    - Inspection requirements (important characteristics, inspection, measuring and test

    equipment, methods, frequencies)

    - Intervention limits [Control limits] in process control charts

    - Machine and process capability records

    - Operating instructions

    - Work instructions

    - Inspection instructions

    - Information on the current nonconformities [log, check list]

    The following points, for example, are to be considered:

    - Tooling plans

    - Tool setting aids/comparison aids [checking aids]

    - Flexible tool change equipment

    - Limits patterns [SPC out of control conditions]

    4.2.7

    4.2.8

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    Is an approval for production starts issued

    and are adjustment details, as well as

    deviations recorded?

    TS: 7.5.1.3

    Are the corrective actions implemented and

    checked for effectiveness?

    TS: 8.5.2

    Are the quantities/ production lot volumes

    matched to demand and are they conveyed

    in a targeted manner?

    TS: 7.5.1.6

    Are products/ components stored according

    to their purpose and are the transport

    method/ packaging equipment matched to

    the special characteristics of the products/

    components?

    4.3 Production - Transport / Production Handling / Storage / Packaging

    The following points, for example, are to be considered:

    - Sufficiently suitable transport means [internal, between processes, to/from warehouse]

    - Defined storage areas

    - Minimal/no intermediate store [minimize WIP]

    - KANBAN

    - Just in time

    - First in/first out

    - Storage administration [inventory management]

    - Modification status [Rework / in-process status identified]

    - Only transfer of satisfactory parts [only good parts go downstream]

    - Recording production pieces numbers/evaluation [production and inspection results]

    - Information flow.

    Comment: When material/purchased parts are delivered directly to the respective production

    plants, the requirements according to question 3.7 are also to be considered.

    The following points, for example, are to be considered:

    - Stock levels

    - Protection against damage

    - Parts positioning

    - Tidiness, cleanliness, [housekeeping, 5S] overstocking (storage areas, containers)

    - Monitoring of the storage time [shelf life monitoring]

    - Environmental influences, air conditioning. [storage conditions]

    Comment: When material/purchased parts are delivered directly to the respective production

    plants, the requirements according to question 3.5 and 3.6 are also to be considered.

    B. Production Process

    4.2.9

    4.2.10

    Release to serial production (first piece inspection, set-up inspection) is the contract-related

    first and re-release for the start of the production. The release is necessary for product and

    process and must be carried out, in writing, by authorized employees with the help of

    acceptance criteria. At this point, known problems in the product / process planning and/or

    previous serial production must be eliminated. The release inspection and tests must be made

    according to clear inspection instructions, to ensure their reproducibility. Here, the use of a

    checklist is recommended. If production is continued after the extraction of test pieces, the

    products must be placed on hold until release of the test pieces. Reworked products are to be

    included in the release process. The following points, for example, are to be considered:

    - New, changed product

    - Standstill of the equipment/process interruption

    - Repair, tool change

    - Material change (e.g. Batch/heat change)

    - Changed production parameters

    - First production piece testing with documentation

    - Topicality of the parameters

    - Tidiness and cleanliness at the work station [housekeeping, 5S]

    - Packaging

    - Release /modification status of tools and inspection, measuring and test equipment

    Corrective actions relate to the entire process chain, from input material through to use by the

    customer. The effectiveness of corrective actions carried out, must be checked and proven. The

    following points, for example, are to be considered:

    - Risk analyses (Process FMEA) Fault analyses

    - Improvement programs from audits

    - Information to the responsible party

    - Interface discussions internal/external

    - Internal complaints

    - Customer complaints

    - Customer surveys

    4.3.2

    4.3.1

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    TS: 7.5.5.1

    Are reject, re-work and setup parts

    conscientiously separated and identified?

    TS: 8.3, 8.3.2, 8.3.3

    Is the material and parts flow secured

    against mix-up/confusion and is traceability

    guaranteed?

    TS: 7.5.3, 7.5.3.1, 8.3

    Are tools/ equipment and test and

    inspection equipment stored appropriately?

    TS: 7.5.1.5, 7.6

    Is the Packaging is according customer

    requirements?

    TS: 7.2.1, 7.2.2

    Is quality and process data recorded in a

    manner that can be analysed?

    TS: 8.2.3.1, 8.2.4

    plants, the requirements according to question 3.5 and 3.6 are also to be considered.

    The following points, for example, are to be considered:

    - Holding store, holding areas

    - Marked containers for rejects, rework parts and adjustment parts

    - Nonconforming products and nonconformity characteristics

    - Identification/marking

    - Defined transfer/rework stations in the production department.

    Appropriate to the product risk, the traceability along the entire process chain from supplier to

    customer, must be guaranteed. The following points, for example, are to be considered:

    - Identification/Marking of parts

    - Identification/Marking of the operational, inspection and test and application status

    - Batch/heat numbering

    - Expiry date

    - Removal of invalid identification/marking

    - Working documents with parts/production data.

    Tools, machinery, inspection, measuring and test equipment, not in use and not released, must

    also be correctly stored and administrated. The following points, for example, are to be

    considered:

    - Storage without risk of damage

    - Tidiness and cleanliness [housekeeping, 5S]

    - Defined storage location

    - Administered issue [controlled release from storage]

    - Environmental influences [on storing of tools, machinery, etc]

    - Identification/Marking

    - Defined release and revision status.

    The following items should be considerd:

    - does the supplier have a copy of the customer's packaging requirements?,

    - are the requirements being followed?

    - does supplier have an access to the latest D13 specification?

    4.4 Non-conformity / corrective action analysis / continuous improvement

    Quality and process data must be completely available to prove the compliance with

    requirements. They must be able to be evaluated. Special events are to be documented

    (Logbook). The following points, for example, are to be considered:

    - General charts [inspection logs, run charts]

    - Nonconformity lists

    - Control charts

    - Data acquisition

    - Recorders for process parameters (e.g. temperature, time, pressure)

    - Plant standstill [planned shutdowns]

    - Parameter changes [process settings]

    - Power cuts. [power outage]

    B. Production Process

    4.3.5

    4.3.6

    4.3.4

    4.3.3

    4.4.1

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    assessment

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    Are the quality and process data

    statistically analysed and improvement

    programmes introduced?

    TS: 8.1, 8.4, 8.4.1, 8.5.1.2

    Are the causes analysed and the corrective

    actions checked for effectiveness in the

    case of deviations from product and

    process requirements?

    TS: 8.3, 8.5.1.2, 8.5.2, 8.5.2.1

    Are the processes and products regularly

    audited?

    TS: 8.2.2, 8.2.2.2, 8.2.2.3, 8.2.2.4,

    8.2.2.5

    Are the product and process subject to

    continuous improvement?

    TS: 8.5.1, 8.5.1.2

    4.4.2

    4.4.3

    Findings and problem points are to be related [forwarded] to the responsible departments,

    which must then work out and implement improvements. The following points, for example,

    are to be considered:

    - Process capabilities

    - Failure modes/failure frequencies

    - Nonconformity costs

    - Process parameter

    - Rejects/rework

    - On hold notifications/Sorting actions

    - Cycle, through put/processing times

    - Reliability/Failure conduct.

    The following, for example, can be used:

    - SPC

    - Pareto Analysis

    - Cause/effect diagrams

    When product/process failures have occurred, appropriate immediate actions (such as placing

    on hold, sorting, informing, [containment]) must be carried out, to ensure compliance with the

    requirements, until the cause of the failure has been removed and the effectiveness of

    corrective actions has been proven. The following points, for example, are to be considered:

    - Additional dimensional, material, functional, endurance tests

    - Cause/effect diagram

    - Taguchi, Shainin

    - FMEA/Fault analysis

    - Process capability analysis

    - Quality Circle

    - 8D-Method.

    4.4.4

    4.4.5

    Audit plans for the product and its manufacturing process must be available. Audit reasons

    are, for example:

    - New projects/processes/products

    - Nonconformity with quality requirements (internal/external)

    - Maintaining records of the compliance with quality requirements

    - Identifying improvement potentials.

    Nonconformity reports (NCRs) are to be distributed to the responsible parties, the

    improvement measures are to be monitored. The following points, for example, are to be

    considered:

    - Customer requirements

    - Important characteristics

    - Function

    - Process parameters/capabilities

    - Marking/identification, Packaging

    - Established processes/procedures.

    The improvement potential must be determined from previous findings about quality, costs and

    service [delivery] The following points, for example, are to be considered:

    - Cost optimization

    - Reduction of waste (e.g. rejects and rework)

    - Improving of process safety [variation reduction] (e.g. process analysis)

    - Optimizing set-up times, raising plant availability [uptime]

    - Reducing through-put/processing times

    - Reducing stock levels.

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    Are targets set for the product and process

    and are these monitored?

    TS: 8.2.3.1, 8.2.4

    Are the customer requirements fulfilled

    before delivery?

    TS: 8.2.2.3, 8.2.4, 8.2.4.1

    Is the customer service fulfilled?

    TS: 7.1.4, 7.2.3, 7.5.1.7, 8.2.1, 8.2.1.1,

    8.5.2.4

    Are documented emergency plans/

    strategies in place?

    TS: 6.3.2

    Are all non conformities analysed and

    improvement actions instigated?

    TS: 8.2.3.1, 8.5.2, 8.5.2.1

    The following points, for example, are to be considered:

    - Analysis possibilities [capabilities] (Laboratory, inspection/test equipment, personnel)

    - PARETO Analyses of failure characteristics (internal/external)

    - Involvement of all affected departments (internal/external)

    - Use of problem solving methods (e.g. 8D Report)

    - Correction of sampling deviations

    - Revision of the specifications

    - Check [verification] of effectiveness.

    B. Production Process

    4.4.6

    5.1

    Target parameters must be agreed and feasible, the topicality [current and correct version] is

    to be guaranteed. Special measures required are to be established and implemented, if

    necessary. The following points, for example, are to be considered:

    - Presence and absence of personnel

    - Number of production pieces produced

    - Quality indices (e.g. failure rates, audit results)

    - Through-put/processing times

    - Nonconformity costs

    - Process characteristic values (e.g. process capability).

    5. Customer Care / Customer Satisfaction

    All requirements are considered, especially those which go into the supplier evaluation by the

    customer.

    The following points, for example, are to be considered:

    - Quality agreements

    - Dispatch audits [dock audits]

    - Endurance testing (Investigating failure conduct)

    - Storage/Call off processing/parts provision/dispatch [shipping]

    - Functional testing

    - Suitability of inspection, measurement and test equipment

    - Agreed inspection and testing procedures

    - Topicality [correct and latest version] of the specifications.

    5.2

    It is to be guaranteed, that competent contact people for the various organization departments

    of the customer are available. Customer support is also a measure of active cooperation. The

    sub-supplier has the duty to observe and, if necessary, improve, his products across all

    development and application phases. The following points, for example, are to be considered:

    - Records of customer visits, if necessary, deriving measures [corrective actions]

    - Knowledge of product application

    - Knowledge of product problems

    - Implementation of new requirements

    - Notification of improvement measures

    - Notification of product/process changes/redeployments, (also of suppliers)

    - First/repeat samplings (Trial/Series)

    - Information about nonconformities.

    The following items should be considered:

    - contingency plans for product/equiment/utilities/manning issues,

    - capability of and reaction to containment activities

    5.4

    5.3

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    Are the personnel qualified for the

    individual tasks?

    TS: 6.2.1, 6.2.2, 6.2.2.2

    Responsible personnel, for example, for the following areas are to be considered:

    - Customer service

    - Product inspection and testing

    - Storage/Transport

    - Logistics

    - Fault analysis.

    Knowledge [Compentency] of the following, for example, must be available:

    - Product/specifications/special customer requirements

    - Standards/Legislation

    - Processing/Application

    - Evaluation methods (e.g. audit, statistics)

    - Quality techniques (e.g. 8D Method, Cause/effect diagram)

    - Foreign languages.

    5.5

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