process control of nonconforming product & corrective · 4.3 supplier non conformance reports...

Process Control of Nonconforming Product & Corrective

& Preventive Action Process Process No: STA-P08-02

ISO 9001, ISO 14001 & OHSAS 18001 8. Measurement Analysis & Improvement

Stauff UK Ltd 500 Carlisle St East Sheffield S4 8BS Tel: +44(0)1142 518518 Fax: +44(0)1142 518534 Sub Clause Number 8.3 & 8.5.2; 8.5.3, 4.5.3

Author:

S Fearnley Approved by: J Morris

Revision Level: 03 Date of Issue: October 2014 This document is UNCONTROLLED if printed

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Scope

• Supplier Returns/ Rejects • WIP Nonconforming Material/ Subcomponents/Customer Owned Materials • Customer Returns/Warranty • Customer Supplied Material • Concessions • Scrap Control • Corrective Action • Corrective Action Review • Corrective Action Impact • Preventive Action

Key Performance Indicators – See KPI Matrix





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Process Flow Procedure

1 Identification of Nonconforming Product

1.1 Any product or material that is found to be suspect or nonconforming at any point during the manufacturing process is removed from WIP, and will be clearly identified with a REJECT Label (STA-F08-02-02). The product or material will either be held on the area or in the Quarantine Area awaiting disposition.

1.2 Non-conforming product will either be:

• Reworked • Accepted by Concession • Scrapped • Customer Owned Materials • Returned to supplier

2 Rework

2.1 The Departmental Manager will review the method of rework with the Quality Manager. If it is agreed that the product can be reworked the HOLD Label (STA-F08-02-01) is joined by a REWORK Label (STA-F08-02-03), and the part placed into the quarantine or other area.

2.2 If the proposed rework method involves a process not approved for manufacturing, the Quality Manager must seek customer approval before continuing (See STA System Concession Request STA-F08-02-04). When the rework method has been agreed, the Manufacturing/production Manager will arrange for all rework to be carried out & a rework operation is planned on SAP System.

2.3 When the rework has been completed the product is re-inspected by the Inspector & Departmental Manager verifying the work is complete and meets the specification. The Supervisor will verify that any scrap is disposed of and that any revised quantity is entered onto SAP with the difference being scrap Qty.

3 Scrap

3.1 Known scrap materials are placed in the Scrap Bins or designated area for recycling.

3.2 The Supervisor is responsible for recording all rejects (Reject Label STA-F08-02-02), by entering the data and the rejection details onto the Scrap / Reject sheet (STA-F08-02-05).These will be passed to QA to enter on the Non conforming database. SAP transaction MB1A will be used to call for parts to allow rejected parts to be replaced to allow the customers order quantity to be satisfied. Reject entries shall include;

• STA Number • Quantity Rejected • Reason for Rejection

3.3 This data will be reviewed, analysed, and reduction plans supported by appropriate corrective actions implemented through the Continuous Improvement Programme.

4 Return to Supplier

4.1 If the product is to be rejected against the supplier the Quality Manager will review such rejections and determine whether to raise a Supplier Non Conformance Report via Non Conforming Database

4.2 The Quality Manager will return product to Supplier using SAP & a credit note / FOC replacements requested from the supplier].A report will be requested from the supplier in an 8D format.

4.3 Supplier Non Conformance Reports will be discussed at meetings between the departments involved.

4.4 Some Quality Problem items will need a Supplier visit to confirm Corrective Actions taken.

5 Customer Owned Materials

5.1 Customer owned materials either damaged/lost or nonconforming on receipt or during processing will be processed using STA System as previously defined.

5.2 Such materials will be notified to the customer.





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6 Accepted By Concession

6.1 Internal

6.1.1 The STA System Concession Request (STA-F-08-02-04) is used when it is considered that a product has been manufactured outside specified limits but meets the customer specification, and can be used without reworking.

6.1.2 The Quality Manager will review the nature of the Concession Request with the Departmental Manager, who will determine the validity of each request. If the request is accepted the Quality Manager will allocate a Concession request to the customer. Brief details of the Concession request must be recorded on a concession request log STA-F08-02-10

6.1.3 The description of the Concession must be concise and accurate. The period or quantities to be covered must be accurate.

6.1.4 The Quality Manager will consider the Concession Request. Remarks will be made and approvals given if appropriate. If the request impacts on the Customer the Quality Manager will apply for a Customer Concession. (On customer designated documentation where appropriate).

6.1.5 Once final approval has been given by the appropriate signatories the Concession will be distributed to the following as appropriate: • QA Manager • Technical Sales • Departmental Manager

6.1.6 All product manufactured under this Concession must be accompanied by a Concession Request form and a valid Concession number. The master is retained by the Quality Manager on the central file.

6.2 Supplier

6.2.1 When a supplier requests a Concession, the Quality Manager will review the request and decide whether to proceed. If the decision is made to reject the request the Quality Manager will inform the Supplier of the decision to reject and disposition any material affected.

6.2.2 If the Concession request is initially accepted, Quality Manager the will raise a Concession Request. If the Concession is accepted all material will supplied under a Concession label (STA-F08-02-06) and a valid Concession number must accompany the product.

6.3 Customer

6.3.1 In both cases defined above customer approval will be required if the product is outside customer specification. In such instances the Quality Manager will approach the customer using the appropriate customer Concession Request.

6.3.2 Upon approval the Customer Concession will be appended to the original Concession request and the request will be annotated with the customer Concession number, this shall be entered on STA System so it can appear on any delivery documentation.

6.3.3 The approved customer Concession request will be filed by the Quality Manager and copies distributed along with the original Concession are issued as per internal request.

6.3.4 No product will be shipped until customer approval has been received. All Shipping documentation must quote the customer Concession number where customer approval prior to shipment is necessary. In all cases (Internal/Supplier/Customer) all material processed under the Concession will be identified with a Concession label (STA-F08-02-06).

6.3.5 A Non Conformance Report will be raised whenever a customer Concession is requested, whether the customer accepts the request or not.

6.3.6 A concession log will be held to summarise the status of all concessions by the Quality Manager. This will be held on the central file.





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7 Corrective & Preventive Action

7.1 Corrective & Preventive Action can be taken as a result of:

• Customer Concerns/Complaints/Returns • Nonconforming product received from Suppliers • In-Process Concerns

• Accidents or incidents

• Environmental incidents

8 Customer

8.1 Customer Concern/Complaint/Warranty

8.1.1 When a customer Concern/Complaint is received by STA, the person notified will inform Customer Services or the QA dept who will fill in the Non conformance data base.

8.2 Customer Return

8.2.1 On receipt of product rejected by the Customer, the Goods Inwards Department will pass the product and the paperwork onto the Quality Manager for review and disposition. Parts will be placed in the returns bay & The Quality Manager or Inspector will identify the parts with a Reject Tag (STA-F08-02-02).

8.2.2 The product will be identified with the Reject Tag (STA-F08-02-02). and placed in the Quarantine Area prior to its disposition and the details are entered onto STA Non Conformance database. The paperwork will stay with the QA dept referenced to the Reject Tag (STA-F08-02-02).number until the final report has been written.

8.2.3 The QA Manager will determine liability with the support of product specialists.

8.2.4 If the liability is determined to be that of STA, the QA Manager will open a formal Customer Complaint Report and will form an appropriate cross-functional team to investigate and resolve the problem. An 8D Process Checklist to be followed for the complaint investigation (STA-W08-02-02)

8.2.5 Should the customer require a report STA will raise an 8D report (STA-F08-02-08). This report will be kept in the customer file located on the central file. A report on the customer own paperwork can be completed if required using the 8D report as support.

8.2.6 Should the customer request a site visit to discuss problems, a visit will be arranged to support any actions taken.





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9 Nonconforming Product Received from Suppliers

9.1 Any product found to be defective due to manufacture with nonconforming purchased material is identified with a Reject Tag (STA-F08-02-02 and placed in the Quarantine Area or other suitable place whilst it is being reviewed by the Quality Manager. The outcome of the investigation may result in:

• Rework • Accept under concession • Rejection to the supplier

9.2 If Inspection is required at STA for the problem STA will sort the problem or a Sorting Cost is sent to the Supplier.

9.3 If the product is to be rejected against the supplier the Quality Manager will review such rejections and determine whether to raise Supplier Non Conformance Report (STA-F08-02-09) via STA System.

9.4 Finance will request a credit note and product will be returned. This will be done using STA System.

9.5 Supplier Non Conformance Report are discussed at the monthly Management Meeting.

9.6 Some Quality Problem items will need a Supplier visit to confirm Corrective Actions taken.

10 In-Process Nonconforming Product

10.1 Design Problems

10.1.1 Where design problems exist the Technical Sales Department will bring it to the attention of the Customer. All such request for any changes should only be accepted in writing from the customer.

10.2 Manufacturing Problems

10.2.1 Manufacturing problems will be to the attention of the Quality Manager Via the Initial Sample Inspection report carried out by the QA dept who in turn review the problem & implement any process changes necessary using the specialists required.

11 Corrective Action

11.1 The Quality Manager will decide if an issue should be logged on the Non Conformance database (STA-F08-02-07). All such entries will be reviewed by the Departmental Managers affected. If required a multi-functional team will be assembled to prevent further re-occurrence. If required an 8D report will be written outlining the results of any investigation.

12 Corrective Action Impact

12.1 Where applicable any corrective action taken and controls implemented to eliminate the cause of nonconformity will be applied to other similar processes and products. This will be controlled through the Quality Manager

• Significant actions will be entered onto the Non Conformance Database.





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13 Corrective Action Review

13.1 Senior Management will be actively involved in any Major corrective actions making sure that all actions agreed by any multi-functional teams are carried out fully. Major corrective actions/ improvements will be placed onto the Continual improvement programme & reported on at senior management meetings.

14 Preventive Action

14.1 All appropriate sources of records will be analysed and reviewed by the appropriate functional responsibilities.

14.2 All such actions will be documented, and the preventive action agreed will be controlled through the appropriate mediums as defined previously.

The eventual close out of significant actions will be presented to the Management Review Meeting to be closed out.

15 OHS Nonconformity Reporting

15.1 In the event of an accident or incident involving serious harm, potential serious harm or a near miss, it will be managed in accordance with the Accident & Incident Investigation Process STA=P08-04.

15.2 If the investigation concludes that the management system is deficient, it will be recorded as a nonconformity and wherever appropriate, the root cause will be established to enable effective action to be established and taken.

16 EMS Nonconformity Reporting

16.1 In the event of an environmental accident or incident (e.g. a spillage), it will be managed in accordance with the Accident & Incident Investigation Process STA=P08-04.

16.2 If the investigation concludes that the management system is deficient, it will be recorded as a nonconformity and wherever appropriate, the root cause will be established to enable effective action to be established and taken.

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