Purpose
This document describes how FlexLink PSD, Product Quality and Testing Department operates to secure that the need for approval of new items or change of already existing items are performed in a structured and controlled way and in correct timing. This apply only for customer Zollner items which need customer FAI documents.
Scope
The process is applicable to Product Quality and Testing Department belonging to PSD Operation and covers:
- Official approval of new item or approval of change of already existing item at FlexLink supplier.
- Creating customer Zollner FAI documents.
Definitions
- OMS: Operational Management System. Link: http://oms.flexlink.se/oms/
- CORAL: PDM (Product Data Management System) for documentation of drawings and other documents.
- IDC: FlexLink International Distribution Center in Poland.
- FAI: First Article Inspection report to customer Zollner.
Process
Product Quality & Testing department, Product Quality Engineer, is notified by design department that there is need for new item, change of existing item, change of supplier or any other reason for change. Product quality engineer does Quality Reviews of specifications and gives feedback to design department trough Red Folder Process and also comments if new initial samples from existing or new supplier is needed or not. Description of Red Folder process is available in FlexLink Knowledge base, link: https://kbpsd.flexlink.com/help/coral-instructions
Quality review available at: https://kbpsd.flexlink.com/help/quality-reveiw
In case Product Quality engineer decide that new initial sample is required then it must be communicated to the design department trough Red Folder Process. Design department contacts Purchasing and the Initial Samples are ordered and sent to Product Quality Engineer for approval.
In case it is decided that no new physical Initial Sample is required then Product Quality Engineer makes an Inspection Record anyway and sends it to supplier to inform about approved change. Inspection record can require only documents (e.g. measurement protocol) from supplier but no physical items.
Upon receiving the Initial Samples, Product Quality Engineer makes analysis of the part, cross check dimensions if needed, investigates if the Initial sample is according to the specifications. If the sample is meeting specification, Product Quality Engineer approves the item by making Inspection Record which is documented in FlexLink PDM system CORAL and sends a copy of approved Inspection Record to responsible Purchaser at FlexLink so Inspection Record can officially be communicated to supplier.
FAI documentation to customer Zollner is required on all items which are delivered to customer Zollner for first time. Also, FAI documentation is required if item is changed and is going to be delivered to customer Zollner for first time with the change.
FAI documents to customer Zollner contain:
- Inspection record (FlexLink to Zollner)
- Product Approval Document (FlexLink to Zollner), Zollner representative inspect items and documentation and states if approved or not. This document is to be signed by Zollner representative and sent back to FlexLink for archiving in PDM system CORAL.
- Measurement report made by FlexLink, of the parts which are sent to customer Zollner.
- Drawing to which measurement report refers to.
Any information about FlexLink suppliers such as supplier names, contact persons, or other info about supplier’s identity is not allowed to be shown on the documents in any way to customer Zollner, or any other customer.
After customer Zollner receive first items and FAI documentation sent by FlexLink and are approved by Zollner representative, the customer need so send back copy of FAI with signature and statement if FAI is approved or not. Upon receiving of approved and signed FAI document from Zollner representative, FlexLink Product Quality Engineer archive the documentation in FlexLink PDM System CORAL.
Deviations can occur on both initial samples and on the items which are already approved with FAI documentation from customer Zollner.
In case of deviation is found on approved items or initial samples, found by FlexLink or its suppliers it is mandatory to create “Request for concession” according to Zollner document FQ1305H and to be presented to customer Zollner for formal approval. If customer accepts deviation then it is allowed to use the items with deviation. “Request for concession” must be signed and returned by customer. Signed and approved “Request for concession” shall be archived in FlexLink PDM system CORAL for that specific part number.
In case the deviation is caused by FlexLink or FlexLink´s Supplier, it is mandatory to create FlexLink DAR (Deviation Approval Request). Supplier must submit FlexLink DAR (document template can be found in FSA at supplier side) to FlexLink. FlexLink responsible (Product Quality Engineer and Design Engineer) decide if the DAR is accepted or rejected. If accepted, FlexLink Product Quality Engineer shall “Request for consession” according to Zollner document FQ1305H and send it to responsible Zollner contact directly or through responsible person for Zollner at FlexLink. Only after signed approval of “Request for consession” is received it is allowed to deliver items to customer Zollner. “Request for consession” document FQ1305H can be found in FlexLink system CORAL with document number: to be added when we get CORAL number of this document. Benjamin Magnusson and Björn Tibblin working on uploading it to CORAL but will take some time (2020-02-26).
Approved and signed “Request for concession” shall be archived in CORAL for that specific item number.