15. Process sign-off
WIKA carries out process sign-offs based on the WIKA checklist in the premises of the suppliers. 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. Optionally, WIKA will carry out a process audit according to VDA 6.3 (see element series delivery, point 7 (6), process audit).
16. Material data acquisition
If 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)
REACH is an EU chemicals regulation which came into force on 1 June 2007. Being an EU regulation, REACH is equally and directly applicable in all member states.
RoHs (Restriction of the Use of Certain Hazardous Substances)
The EC Directive 2002/95/EC 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.
17. 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. This is meant to guarantee that the products manufactured by the supplier meet all WIKA requirements in accordance with the drawings and specifications. C sample (zero series) = sample that has been manufactured exclusively by means of the equipment and procedures provided for series production under the respective boundary conditions. Components with a revision index of 01 and more. The first article inspection is free of charge for WIKA.
First article inspection report
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.
Basically, WIKA reserves the right to decide on the submission stage. Level 3 indicated in the PPF procedure (VDA volume 2) is regarded as standard.
Sending documents and approval of parts
The complete documents must be stored in a folder which is to be sent by e-mail to EMPB-undSerienreport@wika.de. The first article parts must be marked sufficiently before sending them to WIKA since marking ensures that the parts can be assigned to the inspection 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.
18. 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 for each cavity of a tool or process.
19. 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 acceptance test certificate must be available to WIKA in electronic form on receipt of the goods at the latest.
Packaging takes effect on the product quality and must therefore be chosen together with WIKA before starting the series production. If necessary, transport and packaging tests must be scheduled in order to check that the packaging is suitable.
21. 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.
Requalification is a periodic check of the component in question. Where appropriate, requalification will be made via self-certification (VDA 2,4.10). The extent and frequency of requalification are to be agreed with the responsible WIKA SQE.
23. Standard and catalogue parts and materials
- Sampling inspections of standard parts and materials => first article inspection is not required
- Sampling inspections of catalogue parts and materials => only on special request by WIKA