QS 9000 Reference Manual. Initial samples. Initial samples are parts which have
been taken at random from a larger process series after completion of the.
QUALITY ASSURANCE AGREEMENT
APPENDIX 2
To the Development Framework Agreement To the Manufacturing und Supply Agreement
Quality Assurance Agreement
between
Willi Elbe Gelenkwellen GmbH & Co. KG Hofäckerstraße 10, D-71732 Tamm – hereinafter referred to as WET –
and
§1
Object
This Quality Assurance Agreement (QAA) comprises the general requirements, which shall be stipulated with selected suppliers of Willi Elbe Gelenkwellen GmbH & Co. KG (WET).
The present Quality Assurance Agreement is aimed at •
clearly defining the requirements to the suppliers’ QM systems and
•
guaranteeing the quality of the products supplied.
Deviations from the QAA which the supplier may request shall be made in writing and need to be confirmed in writing by WET.
§2
Definitions, abbreviations
APQP
Advanced Product Quality Planning QS 9000 Reference Manual
Initial samples
Initial samples are parts which have been taken at random from a larger process series after completion of the process capability study and which have been completely produced by means of series production manufacturing resources at production conditions.
EDI
Electronic Data Interchange
FMEA
Failure Mode and Effect Analysis
IMDS
International Material Data System
CIP
Continuous Improvement Process
MSA
Measurement System Analysis
QS 9000 Reference Manual PPS
Production Planning System
PCS
Process Capability Study
Gauge R&R
Gauge Repeatability and Reproducibility
PPAP
Production Part Approval Process
QS 9000 Manual Cmk, Ppk, Cpk
Short-term and long-term process capability parameters
Ppm
(Defective) parts per million
PSW
Part Submission Warrant (QS 9000 initial sample inspection report)
QM
Quality Management
QMS
Quality Management System
QAA
Quality Assurance Agreement
SPC
Statistical Process Control
PT
Production tool
VDA
Association of the German Automotive Industry
WET
Willi Elbe Group
WET parts placed at disposal Parts, which are the property of WET and made available to the supplier enabling him to meet the requirements of this contract. This may include, but is not limited to, tools and packaging. Assemblies
Assemblies
§3 3.1.
Description of Tasks General
3.1.2. Responsibility The supplier is held fully liable for the products and services supplied by him within the framework of the spheres of responsibility agreed upon prior to order placement. The supplier shall also be responsible for the proper treatment, processing, care and maintenance of WET parts placed at his disposal. In the event of damage or loss the supplier shall inform WET accordingly. As far as authorities, which are in charge of motor vehicle safety, ask to get insight into the production process and the inspection documents of the purchaser in order to review compliance with particular requirements, the supplier shall be willing, at the purchaser’s request, to grant such authorities the same rights on his premises and offer them any reasonable assistance.
3.1.3. Quality Management System In order to do justice to his responsibility the supplier undertakes to introduce and maintain a QMS in accordance with VDA 6.1 or ISO/TS 16949:2002 or equivalent.
Within the framework of the QMS efficient processes tailored to the WET product and its requirements shall be introduced. This shall apply in particular to the following processes:
•
Procurement of raw materials and purchased parts
•
Control of processes, statistical process control (SPC) and process capability
•
Tests and measures to ensure a “Zero Defects Delivery Quality”
•
Compliance with environmental requirements.
In the event that the supplier discovers that the design defined in the technical documentation or specified test methods may be replaced by more suitable, cost-effective or efficient ones, WET expects the supplier to submit appropriate recommendations to WET in this respect.
3.1.4. Targets
Product quality: Quality objectives measured in ppm are only used as an indicator. However, this shall not affect the “Zero Defects Requirements” as well as warranty claims based on this.
Delivery reliability: Recording of delivery reliability takes place in the WET PPS system. WET expects a delivery reliability of 100% as a result.
3.1.5. Legal, safety-relevant and environmental regulations The necessary processes employed in the manufacturing of parts as well as the materials used in such processes must comply with the generally recognized technical rules. All materials supplied for and used in the production of components shall meet the currently valid legal requirements and safety regulations as regards restricted, toxic and hazardous substances just as well as such materials shall comply with the requirements in terms of environmental compatibility, electricity and electromagnetic fields. In case of initial delivery and modified delivery of hazardous and auxiliary substances (oils, fats, adhesives and similar), such delivery must be accompanied by an EC safety data sheet in accordance with EG-91/155/EWG. As regards the delivery of substances and parts, which will again release hazardous substances under certain conditions, as well as the delivery of substances which are known to be difficult to be disposed of, the above shall apply accordingly, i.e. written notification and complete documentation.
3.2.
Selection of suppliers
3.2.2. Assessment of a supplier’s QMS WET reserves the right to assess the supplier’s QMS capability by means of a system audit in accordance with the current VDA 6.1 or ISO/TS 16949:2002 standards. The result obtained from the system audit will document the efficiency of the QMS under review. By arrangement, certificates issued by an accredited certification authority as well as results of a system audit may be acknowledged by other purchasers. According to VDA 6.1, the classification should be at least AB (80%).
3.2.3. Process audits, product audits, re-qualification inspections WET reserves the right to conduct process- or product audits at the supplier’s premises
•
prior to placement of an order
•
in the event of new products
•
in the event of process-relevant equipment modifications or relocation
•
in the event of persistent or repeated negative quality conditions.
Re-qualification inspections must be conducted within the sense of ISO/TS16949:2002. The results obtained must be made available for customer review purposes. Quality-related queries shall be addressed to the WET quality officer. If required, such queries may be passed on to an internal department in order to get support. Responsibility for the products’ quality shall remain in the hands of the supplier.
3.2.4. Subcontractors As far as the supplier engages subcontractors in order to meet his obligations arising from this contract the supplier undertakes to fully integrate the subcontractors’ share of supply into his QMS. The subcontractor’s QMS shall comply with the current versions of VDA 6.1, ISO/TS 16949:2002 or qualify in a similar way. The supplier shall maintain a capable system to assess, select and regularly review the subcontractors. The aforesaid shall also apply if the supplier’s subcontractors have been determined by WET.
3.3.
Purchase Order Documents
The supplier has to make sure that documents appertaining to the drawings, including technical delivery terms, quality standards or similar are available. In the event that such documents are not available, they can be ordered from the WET Purchasing Department. The supplier shall make sure via a distribution system that all relevant bodies and authorities will always receive all the necessary WET documents in their latest version. In the event that such technical documentation specifies the use of particular sources whereas the supplier wishes to use different ones, the supplier shall not use such different sources without the written approval by the WET Purchasing Department.
3.4.
Quality Planning, Advanced Product Quality Planning
3.4.2. Project progress When submitting his offer the supplier shall prepare a clearly structured process progress plan (QM plan) in terms of time from which it becomes evident that the milestones and the project completion date imposed upon will be met (please see VDA 4.3 or APQP). After consultation with WET this process control plan shall be binding and is considered to be an integral part of the quotation.
The supplier’s process progress plan shall comprise at least the following key data:
•
Preparation of a design-related FMEA (for development suppliers)
•
Final date for the design of tools
•
Process and work schedules
•
Preparation of a process-related FMEA
•
Production control plan
•
Provision of measuring and test equipment
•
Product sample phase (non-off-tool samples, if required)
•
100% reference samples from production tools
•
Pre-production series (100% process-reliable parts from production tools)
•
Product capability study (PCS), MSA
•
Supplier’s corrective-action phase
•
Date of initial sample inspection
•
Production- and system charging
Changes to the process progress plan can only be made after consultation with the WET Purchasing Department.
3.4.3. Special characteristics during the planning phase During quality planning the supplier undertakes to adhere to the special characteristics established by WET and to take into account such special characteristics when preparing FMEAs, the production control plan, during process control, the product capability study and MSA. In addition, based on his know how, the supplier shall define his own product- and process-specific special characteristics, which will be handled in the same way as the special characteristics stipulated by WET. Documents comprising special characteristics, (e. g. drawings, FMEAs, production control plans, work instructions, etc.) shall be identified with a clearly defined symbol for special features.
3.4.4. Failure Mode and Effect Analysis (FMEA) During the development phase (prototyping phase), the supplier in charge of design duties shall prepare a design-related FMEA on principle. The interfaces shall be determined in consultation with the WET project management. During product quality advance planning (process planning phase) the supplier shall establish a process-related FMEA. The interfaces shall be determined in consultation with the WET project management. VDA 4.2 or the FMEA reference manual of QS 9000 shall be used as a basis in the FMEAs’ preparation. The FMEAs worked out by the suppliers will be jointly discussed in a meeting. In justified cases a written confirmation stating that the FMEA is available in its latest version may suffice. The relevant FMEA must consider potential interfaces with addon parts, transport, assembly and the environment. The FMEAs must be maintained over the course of the entire production period and shall be updated in the event of product or process modifications. For WET preparation and maintenance of FMEAs is free of charge.
3.4.5. Production control plan A production control plan in accordance with ISO/TS 16949:2002 shall be prepared for every single part. If necessary, such a plan must be submitted to the WET Quality Control Department for inspection purposes.
3.4.6. Process Capability Prior to the conclusion of a delivery contract the supplier must verify whether he can guarantee that his deliveries are free from defects and their supply is secure. Upon conclusion of the delivery contract the supplier guarantees that process capability has been accomplished as well as provision of obvious evidence on the occasion of initial sampling.
Inspection and assessment of machine- and process capability is conducted on the basis of VDA - 4.1. As regards all functional characteristics (⊗ identification in the WET drawing) the supplier shall perform and document detailed analyses on the suitability of the machines and equipment used.
If the supplier fails to obtain a capability value of Ppk or Cmk ‡ 1.67 the supplier undertakes to introduce appropriate optimisation measures, and to avoid, by means of an elevated testing accuracy, the delivery of defective parts. With series production already in progress, the supplier shall give objective evidence and document a process capability value of Cpk ‡ 1.33 for all special characteristics over the entire production period by means of suitable procedures (e. g. SPC). If the supplier fails to reach this value, the supplier undertakes to introduce suitable optimisation measures and conduct a 100% inspection; at least until process capability will be reached.
The supplier shall be held liable for the optimization of machines and equipment and the determination of appropriate measuring and testing methods.
3.4.7. Production and assembly processes Add-on parts must be installed in a reliable and process-secure way (100% monitoring, Poka Yoke solutions). Production or assembly processes pertaining to the components’ function (operating reliability), must be safeguarded independent from machine operators or subjected to 100% inspections. Screw connections which are identified as D-specified or as a functional characteristic in a drawing, must be carried out via torque control and rotational-angle control and shall be documented in a component-related way.
3.5.
Production process- and product approval
3.5.2. Product sample inspection Initial sample inspection is used for the purpose of series production approval, provided that all dimensional, materialrelated, functional and process-related criteria have been met, which have been agreed upon between WET and the supplier in accordance with drawings and specifications. As regards all other kinds of samples such as hand specimen, samples made from auxiliary tools, samples made from production tools which have not been produced under series-production conditions, a sample inspection report must always be prepared and submitted to WET upon delivery. The sample inspection report must contain a note quoting the type of samples. For test items and other samples a measuring report should always be prepared. Identification must allow a reference to parts history. Initial samples must always be presented prior to the initial series production delivery. For sample-relevant terms see DIN 55 350 part 15. As may be agreed, approval of initial samples can be conducted in conjunction with a process audit at the supplier’s premises. Unless not otherwise agreed VDA 2, submission level 3 or PPAP /QS 9000, submission level 3 shall be used as a basis for product sampling.
3.5.3. Parts’ history The supplier undertakes to document a given part’s history right from the launch of devel-opment, in order to ensure complete traceability of all changes and modifications including their date of employment. The supplier undertakes to update this part’s history after every modification or change performed and to submit to WET an updated history if requested by WET.
3.5.4. Elements of initial sample approval
•
Dimensions: Measurement by means of target/actual comparison on at least 5 samples in accordance with all dimensions stated in the drawing. In the event of multiple-cavity moulds, multiple-processing stations at least 1 part must be measured at every equipment.
•
Material inspection: Laboratory testing of all characteristics corresponding to the relevant material specification, German Industrial Standards (DIN), WET specifications.
•
Functional testing: Product assessment depending on function, product life and other test requirements which are set forth in a WET quality instruction, in the technical terms of delivery, in a drawing or in specifications.
•
Process obvious evidence: The proof for process capability and Gauge R&R, in particular for special characteristics.
•
Material data system - IMDS: The supplier shall integrate the material data of all components into the IMDS data system. The IMDS ID no. must be shown on the EMPB report’s cover sheet.
As regards product samples consisting of several individual parts (assembly parts) sampling of individual parts is required.
3.5.5. Initial sample inspection report The inspection report sheet in accordance with VDA 2 or the PSW according to PPAP must be fully completed. After the counter-check performed the supplier will receive from the WET Purchasing Department the report’s results including the respective decision. The inspection results sheet must show the target/actual comparison. The measuring values must be clearly allocated to the drawing (identification with pointer). In addition to supplier and parts information, the WET drawing number and the index of changes must be stated on all accompanying documents. In the event that some of the required measurements or inspections cannot be conducted without outside help, an appropriate body/authority shall be commissioned with this task.
3.5.6. Obligation to report process changes Process changes of any kind shall be reported to the WET Quality Control Department in sufficient time prior to the introduction of such change, in order to ensure the introduction of resulting measures and approval.
The following information must be shown on the VDA Initial Sample Inspection Report cover sheet:
•
Risk analysis with reference to process changes
•
Objective evidence of the safeguarding process operations
•
Objective evidence of the coordination of the procedure with the relevant subcon-tractors.
The supplier’s settlement with his subcontractors shall be conducted in accordance with the stipulated procedure.
3.6.
Measuring and test equipment and Gauge R&R
To ensure the quality of the measuring and test equipment used, the supplier undertakes to continuously monitor his measuring and test equipment via a system and document the ensuing results. If WET makes measuring and test equipment available to the supplier, the supplier shall integrate such equipment into his monitoring system. As regards measuring and test equipment which is used for the monitoring of special characteristics, Gauge R&R must be continuously proven in accordance with the QS 9000 MSA reference manual. The results of the MSA must be archived in order to provide necessary objective evidence.
3.7.
Complaints
In the event of complaints the supplier undertakes to produce a supplier’s statement within 10 working days or, if specified in the complaints’ report, by way of an 8-D report. .
3.8.
Goods inwards inspection at the purchaser
The supplier shall be responsible for the pre-delivery inspection and hence also for faultless deliveries. On the basis of the above the purchaser will merely conduct receiving inspections in accordance with the skiplot procedure (without inspection), or audits as well as identity inspections and inspections on intact deliveries (loss or damage in transit). Any documents such as inspection records, acceptance certificate, etc. shall remain with the supplier, however, if requested, such documents shall be submitted to WET.
3.9.
Zero Defects Strategy and Continuous Improvement (CIP)
Within the framework of QMS the supplier shall be bound to the Zero Defects Target. Unless otherwise agreed, an action control limit of
•
† 500 ppm
shall be effective for the ramp-up curve; an action control limit of •
† 100 ppm
shall be effective for series production.
The supplier shall notify the WET Quality Control Department without delay as soon as adverse deviations from the above action control limits become foreseeable.
The afore-mentioned action control limits shall not affect the supplier’s liability as regards WET’s warranty claims and damages claims arising from defective or inadequate deliveries. In fact, due to the contractual provisions, the supplier shall also be held liable for possible defects even if the error frequency ranges within the framework of the target range.
At the same time WET expects continuous improvement of ppm values. This target can be reached by means of wellstructured improvement projects or introduction of the Continuous Improvement Process (CIP). WET reserves the right to ask the supplier to prepare an escalation scenario in the event that action control limits exceed the defined levels.
3.10.
Supplier Review
Within the framework of supplier development WET will review the services provided as well as our suppliers’ structural organisation. The results gained from this review shall be used as basis to consider our further collaboration with the supplier.
Assessment criteria: Classification status
Action control limit
Delivery reliability
Supplier’s further development
1
< 25 ppm
Delayed delivery max.2 WD
ISOTS16949:2002
2
< 50 ppm
Delayed delivery max.4 WD
VDA 6.1/QS 9000
3
< 75 ppm
Delayed delivery max.6 WD
DIN EN ISO 900X:2000
4
100 ppm
Delayed delivery > 8 WD
QMS questionnaire
The supplier review comprises the following criteria which shall be given the weighting as stated below:
• Error rate , ppm
40% monthly recording
• Delivery reliability, days
40% monthly recording
• Supplier’s further development
20% annual recording
As a rule, the Purchasing Department will contact the suppliers in writing once a year. Such a letter informs the supplier about the supplier review which is based on a full year. In the event that failure or default for which the supplier is held responsible will result or has resulted in disturbances or breakdowns at WET customers, WET will promptly issue a separate letter in which the supplier is asked to introduce action plans to prevent delays in delivery from occurring and/or action control limits. Furthermore, such adverse incidents will cause WET to increase the performance rating on the negative balance by 0.5 within a supplier’s overall assessment.
The classification status results in the following rating:
Classification status
Supplier rating
1-1.5
A
1.6-2
AB
2.1-2.5
B
2.6-3
BC
>3
C
3.11. Product liability, product safety and warranty For the above items the provisions stipulated in the manufacturing and supply agreement including the appendant annexes shall apply. Unless otherwise specifically agreed the information and certificates of VDA 6.1 and VDA 1 shall apply correspondingly.
3.12. Special characteristics – record keeping and documentation
D characteristic: the D symbol and the characteristics with a bar drawn above are clearly identified in the WET drawing. In general, D characteristics are related to material-specific requirements. F characteristic: Functional characteristics are identified by the following symbol . For functional characteristics process safety must be proved. *1
Functional characteristic checked with limit plug gauge or: functional characteristic checked with limit-ring gauge
*2
Functional characteristic checked with go-plug gauge or: functional characteristic checked with go-ring gauge
*3
Functional characteristic checked with other gauge (e. g. in accordance with drawing)
1 characteristic of functional relevance which is kept in the QM plan with increased inspection frequency. Objective evidence of process capability is not required.
All special characteristics (D+F) are subject to keeping objective evidence. Responsibility for documentation and supplierspecific product-relevant documentation shall be borne by the supplier. The supplier covenants to keep records in such a way so that airtight evidence can be given at any time that product and process specifications have been met and the relevant inspection results are available.
Unless otherwise agreed with WET, characteristics with particular archiving obligation must be retained for 15 years. The handling of documentation and their retention is based on the provisions laid down in VDA 1.
3.13.
Packaging, shipment and identification
The supplier must make sure that shipment of products to WET will not adversely affect the deliveries’ quality.
Means of transport and packaging shall be agreed with the WET Purchasing Department.
Accompanying documents shall comprise the following details: •
Purchase order no.
•
Designation / WET drawing no.
•
Change index
•
Delivery quantity
•
Batch no., to be quoted on request
A VDA material tag or adhesive label must be undetachably attached to every single packaging unit with the above details. If required, the WET Purchasing Department may specify further additional identification.
Upon delivery: •
No intermixture of batches
•
Temporary rust protection as agreed with the WET Purchasing Department
•
The required inspection certificates in accordance with EN 10204 shall accompany the delivery.
3.14. Traceability
WET keeps the supplier’s delivery tickets in the documentation. Unless otherwise agreed, the supplier shall integrate his delivery ticket no. into his documentation system. The supplier undertakes to keep a consistent traceability system.
§4
Changes
Rev.status
Date
Description of change
a
11-05-2007
New version KP06-FB-001“Quality Assurance Agreement with Suppliers” shall supersede the previous issue of QSV 001 status e including the Quality Assurance Agreement (ppm target values) as well as “Additional Requirements on QSV” form FB-QW-009.
§5
Confirmation
The supplier hereby confirms that this Quality Assurance Agreement is valid and effective:
Place, date
Signature
Please return this page to the WET Purchasing Department!
Company stamp
