Management of Nonconforming Product（ISO 9001-2015) 3 of 3

6.8     The disposition of nonconforming product produced by our company is as below:

6.8.1      rework/sort

6.8.2      The process for returning NG parts produced by DXC to WIP store：When Second Process return NG parts to WIP Store, if there is stock, WIP store shall issue the equivalent good parts to Second Process. If no stock, PPC shall decide how to do it and communicate the final disposition with Second Process.

6.8.3      Rework / repair / processing：

①     If necessary, ME need to work out and provide the rework/repair/processing instruction to production for operator’s reference according to the《Rework Control Procedure》FQP-NCP05.

②     For medical products, ME need to review any adverse impact on product caused by rework/repair/process. When necessary, ME need to updated the corresponding PFMEA.

③     If the customers require that any rework/repair/processing disposition decision must be notified them or/and obtain their written permission in advance, then PM or ME/QE authorized by PM must inform customer of rework/repair/processing disposition decision and get the customer’s written permission before carrying out rework/repair/processing.

6.8.5      Scrap (as grinding material or scrap)

6.9           Nonconforming product judged to rework/sort/process can’t be released until re-inspected by QC is Pass.

6.10        Grinding Room grinds all scrap plastic parts, if there is not any contamination, re-use it. If they can’t be reused, pack them and move them into the scrap area of store.

6.11   For every phase nonconforming product of pending disposition or disposed, get them rightly identified and placed according to status identification requirement of each phase. Yellow pending labels represent that the final conclusion on inspected parts is still uncertainty at present and waiting for decision after further discussing with customers or insiders. Red label represent that the inspected parts is absolutely non-conforming.

6.12   8D release：When the following conditions occurs, QC need to release 《8D Report》QF-QC-022 to production or related department for taking corrective actions.

6.12.1        The same defect of a part/product recurs successively more than 3 lots and cause a large scrap.

6.12.2        The whole lot will be scrapped due to our internal quality issue.

6.12.3        Customer feedback that the defective rate is more than 3% or badly defect detected by customer and customer didn’t release the written 8D report or the equivalents to us, after confirming that it is true,  QE will release 8D to QC department or Production department and the related departments.

6.12.4        Nonconformance trend of SPC control chart indicates the continuous ascending or descending. 

6.13      For medical products, when the nonconformance occurs, QC need to track all affected WIP, Finished goods. If found the same non-conforming finished products has been shipped to customer, then QE need to immediately find out the lot no, qty of shipment, delivery date of the non-conforming products and notify the customer by e-mail or telephone and handle according to customer’s instruction.

6.14      If the corrective & preventive actions taken for eliminating the non-conformances recurrence result in permanently changing specification/construction/drawing of product/material, or suppliers, or manufacturing method, or packing method, or manufacturing process and so on, then follow the <Engineering Change Control> procedure FQP-ECR01. 

6.15      Nonconforming Materials / WIPs / Finished-goods Disposition Report and 8D Coding practice is as below：

6.16        Each department/Process shall appoint one special person to number the <Nonconforming Materials / WIPs / Finished-goods Disposition Report> and <8D Report> in order that the repeated/missing number do not occur.

6.0    Relevant document and data﹕

6.1         FQP-CFR02 <Customer Return Product Handling Control>

6.2         FQP-CAR01 <Corrective & Preventative Action Control>

6.3         QE001<Customer Requirement & FQC Control Method>

6.4         FQP-PQC01 <In-process Inspection>

6.5         FQP-FQC01<Final Inspection Procedure >

7.0    Quality Records﹕

8.0          Flow Chart: See the below page.