VDA 6.3audit Guidelines [PDF]

Zitiervorschau

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 1

Assessment element

A

Product Development Process Product Development (Design)

M1

Product Development Planning

M1.1

Are the customer requirements available? Are drawings, standards, specifications and customer requirements available? Was the required logistics concept taken into account? Are the technical delivery conditions and test specifications clearly defined? How is the (contract) review documented? Are there product quality agreements, ppm targets? Are important product/process characteristics described? Are customer ordering documents including parts lists/deadlines available? (usually not relevant for automotive divisions UBK) Were applicable laws and legal standards considered? Were recycling plans and environmental aspects considered? Are there quality management and/or organizational requirements? Were they considered?

M1.2

Is a product development plan available and are the targets maintained? Does it contain the customer requirements? Were cost targets considered? Are deadlines defined for planning/purchasing release, design freeze, preproduction, start of mass production (e.g. general deadline schedule and detailed project deadline schedules)? Was a capacity analysis performed? Are quality targets defined and are they tracked? (cost see above) Is recurring information to management planned (e.g. QB's, reviews, releases)? Are simultaneous engineering teams (SET) used?

M1.3

Are the resources for the realization of the product development planned? Have customer requirements been considered? Is the personnel adequately qualified? Is additional training necessary? Are processing times taken into account? Are suitable buildings available (for making test and prototype samples)? Are suitable tools and equipment available? Is the laboratory and test equipment suitable and available? Is CAD, CAM and CAE used to a suitable extent?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M1.4

Page 2

Assessment element Have the product requirements been determined and considered? Have customer requirements and market expectations been adequately considered? Has an internal specification been developed from the customer specification which was agreed to? Are the requirements compatible with the company's targets? Has the design goal robust design/capable processes been considered? How is available know-how used; for example, are there design rules? Are regular customer/supplier discussions planned? Have important characteristics and legal requirements been considered? Have functional dimensions, installation dimensions and materials been determined and defined?

M1.5

Has the feasibility been determined based on the available requirements? Has the feasibility of the design been determined? Can the quality requirements be maintained? Can the process equipment be made and the capacity requirements met? Can the applicable standards, rules and laws be complied with? Can the environmental compatibility requirements be met? Can the deadlines and overall time schedule be met? Can the cost target be met?

M1.6

Are the neccessary personnel and technical conditions for the project process planned/available? Are the project management and the project planning team, and their responsibilities, defined? Are communications means available (e.g. data transfer via networks)? Is communication to and from the customer during the planning phase possible (regulare meetings, conferences)?

M2

Realizing Product Development

M2.1

Is the design FMEA raised and are improvements measures established? Have customer requirements/specifications been considered? Have function, safety, reliability, serviceability and other important factors been considered? Have environmental aspects been considered? Are all relevant departments involved? Are test results considered? Have product-specific actions from the process FMEA been considered?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M2.2

Page 3

Assessment element Is the design FMEA updated in the project process and are established measures realized? Have customer requirements been considered? Have important parameters/characteristics and legal requirements been considered? Have function, installation dimensions and material been considered? Have environmental aspects been considered? Has internal and external shipping been considered? Have product-specific actions from the process FMEA been considered?

M2.3

Is a quality plan prepared? Are significant characteristics defined and identified? Are test sequence plans made for the prototype phase and for the preproduction phase? Are the necessary equipment and supplies available? Was advanced planning of the necessary measurement equipment performed, and is timely availability ensured? Are tests at suitable stages of the product development planned? Were the acceptance criteria (customer specification) employed?

M2.4

Are the required releases/qualifications records available at the respective times? Has product testing been performed (e.g. installation tests, functional tests, endurance tests, environmental simulation tests)? Have individual prototype parts and pre-production parts (hardware) been tested and released? Are manufacturing and test equipment, and measuring and test equipment in the sample shop, included in the release process?

M2.5

Are the required resources available? Have the sample shop capacity and processing times been considered? Is the personnel qualified for their tasks? Note: If M1 and M2 are rated during the audit, then the following questions can be ignored, since they are considered in question M1.3. If M2 is used itself (without M1) then the following questions should be considered: Are suitable buildings available? Are suitable tools and equipment available? Is the laboratory and test equipment suitable and available? Is CAD, CAM and CAE used to a suitable extent?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 4

Assessment element

M3

Process Development Planning

M3.1

Are the product requirements available? Is the current specification available? Are the currently valid drawings and test specifications available? (For projects in an early phase: are current customer or development documents available (e.g. drawings, specifications) and how is updating/exchange of documents ensured?) Which standards or legal regulations are applicable (e.g. DIN, Bosch Norm, …)? Is the current edition available? Are packaging requirements known (e.g. one-way or returnable packaging, special inserts or labeling)? How are product-related quality agreements (e.g. ppm upper limits) made known, and how are they achieved? Are special characteristics (important, significant, critical) agreed upon and identified in the documentation? Are dangerous materials used? Are results from environmental compatibility/recycling tests available? Which special actions does this result in?

M3.2

Is a process development plan available and are the targets maintained? Are activities for process planning defined and dated (e.g. general deadline schedule, project deadline schedule)? Do the deadlines correspond to the newest overall project deadline schedule (e.g. QB/review, release deadlines, pre-production, SOP, component release/availability)?

Have costs been determined (investment calculation with material, production area, equipment, … costs)? Is time allotted for -checking available production capacity, writing the (equipment) specification -procuring and releasing equipment (including tooling/measuring equipment/software) -preparing manufacturing and process documentation -procuring packaging -starting Production -training personnel M3.3

Are the resources for th realization of serial production planned? Has a capacity analysis been performed, and a comparison of predicted sales volume (VPS) to the technical equipment capacity (TEK)? Is this analysis used to determine the equipment (including laboratory equipment, measuring and test equipment), production area, personnel, etc. needed, and if necessary, is an investment request made? Is an order specification made for new equipment? (including requirements for power/cycle time/% up-time, machine capability, maintenance, legal requirements, deadlines, acceptance criteria, ...)

Is enough returnable packaging/containers planned or available, including corresponding areas for storage and for use in production?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 5

Assessment element Are planning tools such as CA-tools or standardized planning processes (diagrams, checklists, …) available, and are they used?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M3.4

Page 6

Assessment element Have the process requirements been determined and considered? Is production planning personnel involved in the use of quality management methods (e.g. QFD, DOE, …) at an early stage of product development, in order to ensure that previous process experience and requirements are considered? How is experience from comparable equipment/tooling/measuring equipment analyzed and used when planning new equipment, to ensure that it is suitable from the start?

Are the departments for work and test station design involved in the planning process, and how are the layout suggestions and requirements implemented? How are special handling, packaging, storage and labeling requirements for materials, components and finished products determined, and how is compliance with these requirements ensured (e.g. dangerous materials, limited storage time, ESD protection, clean

M3.5

Are the necessary personnel and technical preconditions for the project process planned/available? Is there a project team with clearly defined responsibilities (e.g. responsibility for process planning/implementation, if necessary sub- teams or partial teams as part of the overall project)? Are reporting paths and cycle times (who reports what to whom) defined and known to all team members? Are the communication interfaces to the customer (personnel and technical) defined (e.g. sales, development, … CAD data transfer)? Are the Bosch-internal requirements/directives available, and are they complied with (e.g. during data exchange)? Are documents available for estimating the number of personnel needed?

Are documents available for estimating the technical feasibility (e.g. difficulty, equipment for planning, installing process equipment: CAD, machine construction, …)? Is the technical capacity available (e.g. degree of use of machines and equipment), or are the orders confirmed? M3.6

Is the process FMEA raised and are the improvement measures established? Do all relevant departments (e.g. production planners, manufacturing personnel, development, quality assurance) participate in performing the process FMEA? Are technical specifications complied with (e.g. test specification, drawings, special characteristics (customer requirements) with special symbols, etc.)? Have all manufacturing stages and process steps been considered in the FMEA? Is follow-up on comments from the design FMEA concerning manufacturing activities performed? Have environmental influences (e.g. temperature, vibration) and environmental protection aspects been considered? How have suppliers been involved (can be rated in M5): Are suppliers informed of the function and of potential risks/defects in components (e.g. from the design FMEA)? Is the supplier familiar with the process FMEA and process capability measures?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 7

Assessment element Have internal and external shipping risks, and (if required) traceability risks been considered?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

M4 M4.1

Page 8

Assessment element

Realizing Process Development Is the process FMEA updated when amendments are made during the project process and are the established measures implemented? Is the FMEA updated for changes of components, the finished product or processes, and are all process steps analyzed regarding possible changes or additions? Are affected suppliers involved? Are changes implemented on time, and are they documented in the FMEA in an understandable manner? Are changes and updates of the FMEA clearly understandable (FMEA change history/resum?)?

M4.2

Is a quality plan prepared? Note: Quality plan for equipment planning and implementation activities see above in questions M3.2/3.3. The following questions deal with SOP and mass production. Is there a control plan (see QSP0403)? If pre-production or pilot series were manufactured: is there a corresponding pre-production control plan? Is the control plan in agreement with other manufacturing documents (e.g. work flow plan, drawings, manufacturing and test/work station instructions), or is it clear that the documents have been verified to agree with each other? Is there a corresponding process layout/flow chart? Are special characteristics (important, significant, critical) identified in the PQP (control plan)? Does the PQP or its supplemental documents include information on ensuring the capability of equipment (cyclical tests of proper and capable function)? Are actions defined in the process FMEA included in the PQP and implemented? Is the control plan updated when process changes or additions are made (e.g. due to additional CIP or defect prevention activities), and can the changes and modifications be clearly traced (PQP change history/resum?)?

M4.3

Are the required release/qualification records available at the respective times? Has an acceptance qualification release according to the specification for equipment (machines, equipment, tooling, measurement equipment) been performed and documented (including corresponding machine and measurement system capabilities)?

Are there deadlines for items still open, and are they finished according to the schedule? Are all of the purchased parts, materials and operating supplies for mass production available (i.e. has the initial sampling been successfully completed)? Are reliability tests according to the test specification performed and completed on time? Are additional tests (of finished products, components, materials) planned/performed/completed (e.g. installation tests, environmental tests, driving tests)?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 9

Assessment element How has the logistic concept been validated (e.g. shipping tests, are the results documented and have corrective actions been introduced, if necessary)?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M4.4

Page 10

Assessment element Is a pre-production carried out under serial conditions for the serial release? Is an initial series production with the necessary number of parts performed, analyzed and documented, together with possibly needed corrective actions? Is initial sampling performed and documented according to customer requirements (e.g. PPAP)? Has the required process capability been analyzed and fulfilled? If it is not fulfilled: are the necessary additional quality assurance activities defined and implemented? Is delivery performed according to the packaging parts list? Have general parts flow requirements (e.g. FIFO, labeling, …) been considered? Is the personnel trained, and is the necessary documentation of this training available?

M4.5

Are the production and inspection documents available and complete? Are the manufacturing and test documents controlled copies, or how can the personnel check whether they have the current and valid version (e.g. with a master list on the computer network)? Are all of the required/planned process, test and manufacturing instructions (test specifications indicating the characteristic, test method, test frequency, test equipment) available and up-to-date? Are all of the required set-up instructions for current machine/process parameters available (e.g. quantities for pressure, temperature, time, speed, machine program, …), and are the permissible tolerances indicated?

Have set-up charts been prepared for replaceable tooling and fixtures, and are they being used? Are operating manuals available if needed? Are all of the SPC charts specified in the control plan, including the necessary test information, in place, and are they being used? Are manufacturing defects (also from final testing) systematically registered and analyzed? Are the responsibilities defined? Are clear maintenance specifications available (indicating the activity, frequency of performance and responsibility), and is performance of this activity documented? M4.6

Are the required resources available? Has the capacity (as planned, see question M3.3) been installed? If there are capacity problems: are actions defined and are they being completed according to schedule? Has a capacity analysis been performed, and a comparison of predicted sales volume (VPS) to the technical equipment capacity (TEK)? Have subassemblies and purchasing of materials and components been included in the analysis? Is this used to determine the equipment needed (including laboratory equipment, measuring and test equipment), production area, personnel, etc., and if necessary, was an investment request filled out? Is an order specification made for new equipment? (including requirements for power/cycle time/% up-time, machine capability, maintenance, legal requirements, deadlines, acceptance criteria, ...)

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 11

Assessment element Is enough returnable packaging/containers planned or available, including corresponding areas for storage and for use in production?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 12

Assessment element

B M5

Serial Production Suppliers/Input Material

M5.1

Are only approved quality capable suppliers used? Is there a formal release of all relevant suppliers? Are there meetings with suppliers and regular contacts? Is a quality capability assessment performed (self assessment, audit from other customers, certificate)? Is the quality of delivered products rated (quality, cost, service)?

M5.2

Is the agreed quality of the purchased parts guaranteed? Is there adequate test equipment (laboratory and measurement equipment)? Are there internal/external tests? Are there customer-supplied gages or fixtures? Are they included in the calibration system? Are they according to the latest revision level? Are drawings/order specifications/specifications according to the latest revision level? Are there quality assurance agreements (general delivery agreements, quality assurance agreements, ship-to-stock agreements, specific requirements for the components, ramp-up schedule, quality assessment of new parts)? Are the test methods, test procedures and test frequencies agreed? Are the most commonly occuring defects analyzed? Is there proof of capability?

M5.3

Is the quality performance evaluated and are corrective actions introduced when there are deviations from the requirements? Are there meeting minutes for quality meetings? Are agreed improvement programs tracked? Are there test and measurement records for corrected/modified components? Are there special support programs for problem suppliers?

M5.4

Are target agreements for continual improvement of products and process made and implementaded with the suppliers?

Are workshops (interdisciplinary work teams) performed? Are measurable targets for quality, price and service defined? …Reduction of the amount of testing, while at the same time increasing process capability …Reduction of scrap (internal/external) …Reduction of in-process inventory …Increasing customer satisfaction

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M5.5

Page 13

Assessment element Are the required releases for the delivered serial products available and the required improvements measures implemented? Are there production model releases (by authorities)? Are there test releases? Are these releases up-to-date? Are there initial sample reports according to VDA or comparable standards? Has capability been proven for important characteristics? Are safety data sheets and EC guidelines complied with? Has the reliability been analyzed? Are there requalification test reports, and do these result in improvement activities?

M5.6

Are the procedures agreed with the customer, regarding customer-supplied products, maintained? Customer-supplied products can be: services, tooling, test equipment, packaging, products. Are there agreements on handling and on the procedure for customersupplied products with quality defects (rework, guarantee)?

How does control, verification, storage, shipping, and maintenance of quality and characteristics occur? What information paths exist for deficit or lost products? Is the quality documented (quality status, quality history)? M5.7

Are the stock levels of input material matched to production needs? Which customer requirements exist, and how are they implemented? Which inventory system is used (KANBAN, Just in Time), and how is it implemented? Are storage costs and inventory costs tracked? Are there emergency strategies for material shortages? How is the FIFO principle implemented? …during initial addition to stock, ….when returning items to stock?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M5.8

Page 14

Assessment element Are input materials/internal residues delivered and stored according to their purpose? Are packaging requirements defined (type, size, material) defined and complied with? Does the inventory management system support FIFO? Are component/finished product-specific requirements for orderliness and cleanliness defined and maintained? (Mix-ups?)

Are the climatic conditions for storage defined and maintained? Are components/finished products protected from damage? Are requirements for orderliness and cleanliness defined and maintained?

Are labeling requirements defined and maintained (traceability, test status, process step, use status)? Is there a containment storage area for bad parts or parts on hold, and is it used? Who is responsible for it? M5.9

Is the personnel qualified for the respective tasks? Are there qualification records for specific tasks? Are special qualifications/knowledge needed to perform some tasks? Is there proof of this (e.g. for forklift drivers, x-ray testers, etc.)

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 15

Assessment element

M6 M6.1

Production Personnel/Qualification

M6.1.1

Are the employees given responsibility and authority for the monitoring the product/process quality? Who performs the process release? Who tests the first piece off the line? Who performs the necessary tests (are they done by production personnel themselves)? Who fills out the SPC cards? Who evaluates and analyzes? Who is authorized to put products on hold? Who works on improvement projects (involvement in CIP, etc.)?

M6.1.2

Are the employees given responsibility and authority for the production equipment and environment? Does production personnel perform repairs and preventive maintenance themselves, and are there records of this? Who is responsible for furnishing, storing and labelling parts at the work stations? Who is responsible for using and functional adjustment of the necessary test and measurement equipment? Is the production personnel responsible for orderliness and cleanliness of the work stations?

M6.1.3

Are the employees suitable to perform the required tasks and is their qualification maintained? Does production personnel have proof of initial instruction/training/qualification for the process? …for mistakes that can occur? How was the personnel informed of on-the-job safety and environmental aspects? How was the personnel informed of how to handle components which require "special retention of records"? Does the personnel have the necessary qualification records (e.g. forklift driver's license, welding certificate, vision test, hearing test, etc.)?

M6.1.4

Is there a personnel plan with a replacement ruling? Are there qualification records (soldering certificate, etc.) for performing the necessary process steps? Is there a qualification matrix? Are work station analyses/time studies (e.g. MTM, REFA) performed?

M6.1.5

Are instruments to increase employee motivation effectively implemented? Are employees aware of the current quality level? Is this information up-to-date? How are employees involved in CIP and workshops, and are quality topics covered (is there an overview of the topics)? Who is responsible for updating the shop floor display areas?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 16

Assessment element Is there an employee suggestion program? Is it actively used? How are employee suggestions at the shop floor level processed? Is there feedback to the employees?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

M6.2 M6.2.1

Page 17

Assessment element

Production Material/Equipment Are the product-specific quality requirements fulfilled with the production equipment/tools? Were machine and process capability studies performed for manufacturing equipment and tooling, and are they capable? How are the process and component parameters controlled? Is there an in-process warning when the process is out of tolerance (e.g. lamp, horn, shut-down, etc.), and is its correct function regularly tested? Do the feeder devices and product conveyor devices affect the product quality, and how are these maintained? Does the repair and maintenance status of tooling/equipment/machines affect the quality of manufactured parts?

M6.2.2

Can the quality requirements be monitored effectively during serial production with the implemented inspection, measuring and test equipment? Does this process step manufacture characteristics affecting reliability, function or corrosion? Are these items monitored during product audit tests? Is the measurement accuracy of the test equipment used adequate (test equipment capability)? Are test equipment capability analyses performed for the equipment used? How is the necessary data registered and analyzed? Is there proof of calibration for the measurement equipment used (e.g. test sticker)? If test equipment is found to be defective or damaged, what is the procedure for this situation, and how are possible effects on finished products evaluated and, if necessary, the required actions defined (e.g. informing customers, retrieving products)?

M6.2.3

Are the work and inspection stations appropriate to the needs? Ergonomics, lighting, orderliness and cleanliness, environmental protection, surroundings/handling of components, on-the-job safety

M6.2.4

Are the relevant details in the production and inspection documents complete and maintained? Are the process parameters available and complete? Is the data for machines/tooling/fixtures (tool and machine number) named in, for example, the work sequence plan, control plan, test instruction? Are test characteristics, equipment, methods, and frequencies defined and complied with? Are the control plan, work sequence plan, and manufacturing specifications available and complied with? Are test and quality specifications available and complied with? Are control limits specified in SPC cards?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Assessment element Are operating instructions available? Is information on recent problems available and known?

Page 18

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M6.2.5

Page 19

Assessment element Are the necessary auxiliary means available for adjustments? Are set-up plans (set-up data, programs, etc.) and product-specific changeover plans available? Are there set-up fixtures and comparison devices available? Are flexible tooling change fixtures used? Are there test and limit samples available and in use?

M6.2.6

Is an approval for production starts issued and are adjustments details, as well as deviations recorded? Is there a procedure for initial release and for re-releasing production, and is it specified when this is necessary? Is there a checklist for the initial release and for re-releasing, is it complete, and is it being used? How, where and by whom is documentation done?

M6.2.7

Are the required corrective actions carried out on schedule and checked for effectiveness? Are activities defined in the process FMEA implemented? Are additional activities due to corrective actions implemented? Are improvements from audits implemented, and is their effectiveness checked? Is there feedback of information to the source/machine operator? Is there an inter-disciplinary flow of information between shifts and production areas, and does it function well? How are internal/external complaints processed, corrective actions implemented and tracked (e.g. product resum?, list of corrective actions)?

Do internal customer questionnaire responses lead to corrective actions, and are they implemented?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 20

Assessment element

M6.3

Transport/Parts Handling/Storage/Packaging

M6.3.1

Are the quantities/production lot sizes matched to the requirements and are they purposefully forwarded to the next station? Are parts forwarded with suitable transport means to defined storage areas without, or with minimal, intermediate storage? Are process logistics controlled (KANBAN, Just in Time, FIFO)? Is product identification for different change revision levels defined? How is forwarding of good/rework/scrap parts identified, and how is the return of parts no longer needed defined? How are quantities determined and analyzed?

M6.3.2

Are the products/components appropriately stored and are the transport means/packaging equipment tuned to the special properties of the product/components?

Can information on in-stock and available stock quantities be retrieved? Are components protected from damage? Is the component positioning suitable for safe handling? Are the storage areas and containers clean and orderly? Overfilled? Are the specified storage times monitored (maximum and minimum storage times, specified intermediate storage time)? Are the components protected from environmental and climatic influences?

M6.3.3

Are rejects, rework and adjustment parts, as well as internal residues strictly separared and identified? Is there a containment storage area for bad parts or parts on hold? Are containers for scrap, rework, set-up parts and recyclable materials labelled? Are defective parts and defect characteristics identified? Are there defined reject and rework stations?

M6.3.4

Is the material and parts flow secured against mix ups/exchanges by mistake and traceability guaranteed? Are there enough containers and components, suitably and clearly identified? Is the processing status or test status apparent, if necessary? Are lots identified, if necessary? Is the expiration date/maximum storage time adhered to, if necessary? Are invalid labels removed?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M6.3.5

Page 21

Assessment element Are tools, equipment and inspection, measuring and test equipment stored correctly? Do the storage conditions protect the equipment from damage? Are the storage conditions in line with orderliness and cleanliness requirements? Are the storage locations defined? Is the procedure for issuing defined? Is the storage location protected from damaging environmental influences? Is stored equipment identified? Is the release and change revision level status of tools/equipment/test equipment identified/indicated?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 22

Assessment element

M6.4

Fault analysis/Correction/Continual Improvement

M6.4.1

Are the quality and process data recorded complete and ready to be evaluated? Are SPC cards/control cards/tracking cards used? Are they filled out as specified? Is process data automatically recorded? Are process disruptions recognized, and if necessary are corrective actions (action plan) initiated and documented?

M6.4.2

Are the quality and process dada statistically analyzed and are improvement program derived from this? Is process capability determined (cpk-value)? Is defect type and frequency recorded, analyzed and are corrective actions defined? Are defect costs recorded according to the correct source of the costs (number of scrap, rework and replacement parts), and are corrective actions defined? Are process parameters analyzed? What is the reaction to messages about products on hold/sorting activities? Are deviations from standard cycle times recognized? How are corrective actions defined from the results of reliability testing?

M6.4.3

Are the causes of product and process nonconformities analyzed and the corrective actions checked for their effectiveness? Which methods are used to perform cause analysis? Is the 8D method used? Does this lead to corrective actions, and are the control plan, process FMEA etc. updated if necessary? Is the effectiveness of corrective actions monitored?

M6.4.4

Are process and products regularly audited? Which type of audits are performed? Is the improvement potential identified in audits used for additional process improvement? Are audit reports sent to the responsible managers? Are employees informed of the audit results and of possibly necessary improvement activities?

M6.4.5

Are the procduct and process subject to continual improvement? Which process-specific CIP activities are performed (costs, scrap, rework, increasing process capability, changeover time optimization, equipment uptime, reducing process time, reducing storage time)?

M6.4.6

Are the target parameters available for the product and process and is their compliance monitored?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 23

Assessment element Which process-specific targets have been defined (quantity produced, quality indicators such as defect rates, audit results, process times, defect costs, process indicators such as cpk)?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No.

Page 24

Assessment element

M7

Customer Service, Customer Satisfaction, Service

M7.1

Are the customer requirements fulfilled at delivery? Were quality assurance agreements made with customers? Is the customers' supplier rating system known? Are customer requirements audited (e.g. dock audit)? Is product put on hold if necessary, is the customer informed? Are endurance tests performed according to the test specification? In case of delivery stops, is it clearly defined who will inform the departments storage/delivery planning/component supply/shipping, and the customer if necessary? Are only products which have been tested good shipped to the customer? Is the suitability of test and measurement equipment controlled? Is customer-owned test and measurement equipment used? Has the customer agreed to the test methods? Are only valid specifications used?

M7.2

Is the customer service guaranteed? Is customer service responsibility defined? Do customer evaluations lead to improvement activities, and is their effectiveness checked? Is the customer service personnel knowledgeable of product operating conditions and product problems? Are new customer requirements implemented? Are improvement activities, resulting from customer complaints or evaluations, communicated to the customer? Are changes (e.g. product and process changes, production relocations also at suppliers) reported to the customer? Is initial and repeated sampling agreed with the customer? Are customers informed of nonconformities?

Quality Assurance Process Audit Internal audit according to VDA 6.3 Auditor Checklist Revision 1 dated 02/99

No. M7.3

Page 25

Assessment element Are the complaints quickly reacted to and the supply of parts secured? Is the supply of parts and meeting of delivery deadlines ensured? Are deviations from delivery requirements recognized and reported, and which corrective actions are initiated? Are emergency plans used when delivery bottlenecks occur? Are the resources and reaction time for sorting activities planned and implemented (e.g. for 100% checks of inventory, possible rework)? Is it ensured that non-predictable changes of equipment, special operating supplies and tooling will not cause a delivery bottleneck or delivery stop? Are external resources used (e.g. requests for temporary manpower, service companies)? Is there a data back-up (emergency) system used for the possibility that the the computer system data transfer fails (if the customer has an electronic system of data transfer for early reporting of deliveries to the supplier)?

Is the supplier's production planning oriented toward customer orders (e.g. daily/weekly comparison of orders with the customer)? Is there a procedure for reporting delivery bottlenecks to management?

Is there a procedure for reporting delivery bottlenecks to management?

M7.4

Are fault analysis carried out when there are deviations from the quality requirements and are improvement measures implemented?

Are internal/external defect characteristics analyzed (e.g. Pareto analysis, laboratory, test equipment, personnel), improvement actions implemented and their effectiveness checked? Are all relevant departments (internal/external) involved?

Are sampling nonconformities/specifications reworked? Are problem-solving methods (e.g. 8D report) used? M7.5

Is the personnel qualified for each task? Is the personnel qualified for their tasks (for example): customer service, product testing, storage and transportation, shipping and defect analysis? Is the personnel knowledgeable of (for example): -products/specifications/special customer requirements -standards/laws -processing/use -quality techniques (e.g. 8D method, cause/effect diagram) -foreign languages?

Does the personnel have the necessary qualification records (e.g. records of product training, seminars on quality techniques)?