17. Process sign-off
WIKA carries out process sign-offs / process audits on supplier premises with the aid of WIKA's own checklist. This is based on the specifications in accordance with VDA 6.3. The process sign-off is planned in coordination with the responsible department of the supplier.
WIKA can carry out the process sign-off within the scope of the first article inspection (e.g. new supplier). When the sign-off is finished, the supplier will be informed on the audit result within one working week, but usually the information is given on the visiting day. If the result requires improvement measures, the supplier must elaborate an action plan and send it to the WIKA lead auditor within the agreed period of time. The process sign-off includes the capacity studies, the observance of delivery periods, documents for the first article inspection and an Advanced Product Quality Planning.
18. Material data acquisition
f requested by WIKA, material data acquisition will be part of the sampling inspection. The supplier will input the necessary data into the system and will make them available to WIKA free of charge. Furthermore, the supplier must present a disposal or recycling concept.
IMDS (International Material Data System)
The term IMDS describes an archiving, exchange and management system for the automotive industry. On the basis of this system, a material data sheet is created indicating all materials used for a component together with the proportional material components as well as all data necessary for later recycling the vehicle part.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
This is an EU Directive on chemical substances that came into force on 1 June 2007. As an EU Regulation, REACH is equally and directly valid in all member states.
RoHs (Restriction of the Use of Certain Hazardous Substances)
The current EC directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment regulates the use of hazardous substances in instruments and components. This directive and its transposition into national law are designated with the abbreviation RoHS.
19. First article inspection
The first article inspection is the last step of the pilot lot phase and leads to series production. It includes the final inspection and approval of the components for use in series production. First articles are products which have already been manufactured by means of series production equipment at the intended site and under series process conditions. These initial samples are also designated as C samples. This is meant to guarantee that the products manufactured by the supplier meet all WIKA requirements in accordance with the drawings and specifications.
Initial sample test report (FAI, First Article Inspection)
WIKA makes the form available to the supplier immediately after placing the order. The supplier will complete this report. If multiple-cavity tools are used, a first article inspection will be carried out for each cavity.
Submission stages
Basically, WIKA reserves the right to decide on the submission stage.
Sending documents and approval of parts
The complete documents must be stored in a folder which is to be sent by e-mail to WIKA. The initial sample delivery must be marked as such (FAI - initial sample) on the delivery note. The marking secures the assignment of the parts to the initial sample test report. The supplier may not deliver any series parts to WIKA until they have been approved in written form.
Second sample inspection
WIKA reserves the right to charge the supplier for the costs of a second sample inspection if the first article approval cannot be given due to an insufficient preparation on the part of the supplier.
20. Reference sample
A reference sample should help to achieve the required quality level, which is particularly important when the available data is insufficient or not clear and consequently the parts cannot be approved. WIKA recommends the supplier to keep at least one reference sample together with the first article inspection documents for the required time period. The reference sample must be marked as such and have the same dimensions as the delivered parts. Unless agreed otherwise, the supplier must keep a reference sample from the supplier for each cavity of a tool or process.
21. Acceptance test certificates
If required by WIKA in the order documents or in the technical documentation, the latest version of the inspection certificate according to DIN EN ISO 10204 must be established. Exceptions from this rule must be negotiated separately and must be documented in the order. The inspection results will be certified by a department which is independent from the manufacturing department and confirmed by an expert designated by the manufacturer. Inspection results on the basis of specific tests, i.e. tests according to the technical conditions specified in the order are part of the inspection certificate. To determine whether the parts meet the requirements specified in the order, the nominal and actual values must be clearly indicated. The nominal values will be taken from the technical documentation. The inspection certificate must be available to WIKA in electronic form on receipt of the goods at the latest.
22. Packaging
The selection of the packaging has an impact on the product quality and must therefore be determined in cooperation with WIKA prior to serial production.
f necessary, transport and packaging tests must be scheduled to test the suitability of the packaging.
23. Retention periods
In view of the limitation periods for product liability claims, it is recommended that the supplier retains the material up to 30 years.
24. Requalification
Requalification is a periodic check of the component in question. Where appropriate, requalification will be made via self-certification (e.g. VDA 2, 4.10). The extent and frequency of requalification are to be agreed with the responsible WIKA-SQE.
25. Standard and catalogue parts and materials
- Sampling of standard parts/materials => initial sampling omitted
- Sampling of catalogue parts/materials => only in case of special request by WIKA