Management of Nonconforming Product（ISO 9001-2015) 2 of 3
6.1.6.1 The incoming material that is passed by IQC, if a mass of nonconforming incoming material or badly effect on product quality on line or safety issue, Production informs IQC through issuing <Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005 of confirming nonconforming status. After confirming it is true, IQC will submit it to MRB for discussing disposition method. （Note: The Serial No. of <Nonconforming Materials / WIPs / Finished-goods Disposition Report> shall be numbered by IQC as per item 6.15 ---- The numbering method of <Nonconforming Materials / WIPs / Finished-goods Disposition Report>）. IQC must re-inspect the same lot/kind incoming material in the material warehouse in order to confirm whether the same defect exists. If yes, IQC must submit it to MRB for discussing disposition method. Warehouse handles the incoming material according to its label. If the label indicates returned to vendor or sorting/reworking, then the material should be moved to nonconforming area in the warehouse. If the label indicates scrap, then the material should be moved to scrap area in the warehouse.
6.1.6.2 For reject incoming material which is judged by MRB, Purchasing contact the supplier to make up the good material/parts.
6.1.7 When rework/sort/process is determined to done by DXC, Production shall make statistics of person and time those throw into nonconforming incoming material and fill it in the <Nonconforming Materials / WIPs / Finished-goods Disposition Report> and submit it Purchasing dept. and accounting dept. Purchasing contact the supplier and take the fee of sorting & processing from the supplier.
6.1.8 Disposition of nonconforming parts from previous process found during production：
6.1.8.1 If few nonconforming parts is found during production and NG rate is below the defective rate stated in BOM, the workshop of the second process mark the status of nonconforming and makes statistics and classify. When nonconforming parts are confirmed by IPQC, the workshop packs it and scraps it by itself. Second Process shall fill out <Inventory Scrap Form> QF-PM-016 and sent it for QC for confirmation before each scrap.
6.1.8.2 If a mass of nonconforming parts (NG rate is over the acceptable rate of BOM) or nonconforming parts from previous process badly influence on the product quality is found during production, the workshops of the second process informs QC through issuing <Nonconforming Materials / WIPs / Finished-goods Disposition Report> of confirming nonconforming status.（Note: The Serial No. of <Nonconforming Materials / WIPs / Finished-goods Disposition Report> shall be numbered by QC as per item 6.15 ---- The numbering method of <Nonconforming Materials / WIPs / Finished-goods Disposition Report>）. After confirm that it is true, QC submit it to QC leader /supervisor / QE for discussing disposition method. If Production is in urgent need, QC supervisor / QE must timely inform the defective status to Production, PPC, ME or PM (if need) and hold a meeting with all concerned parties for discussing the disposition methods. QC shall mark the non-conforming products status as per MRB disposition method, and inform QC of previous process of check whether there are same lot/kind parts in WIP store. If yes, QC must re-inspect them in order to confirm whether the same defect exists. If the same defect is detected, QC must inform QC leader / QC supervisor / QD to determine the disposition method. QC marks the non-conforming WIPs status according to MRB disposition.
6.2 Control for nonconforming product found by in-process & final inspection
6.2.1 In injection process, the operators carry out self-inspection and put the rejected product into the red box as the grinding material, as well as recording the reject quantity and items in <Nonconforming Product from Self-Inspection Record> QF-PM-014. Production leader and QC perform sampling check randomly. If found reject rate is more than 5%, immediately inform relevant responsibility for disposition for that Qty in a certain period.
6.2.2 Inspection requirements in the second process are same as 4.2.1 but some more different points:
Assembly QC should mark the defect detected on the reject WIP/finished goods.
6.2.3 Both IPQC and FQC should carry out sampling inspection according to 《In-Process Inspection procedure》 FQP-PQC01, IF any nonconforming products found during their sampling inspection, they should analysis and trace time and defect quantity. If non-conformance confirmed, defect samples shall be identified and the “Rejected” identification labels shall be attached with the product, rejected parts should be segregated from the accepted parts, QC leader/supervisor/QE will determine the disposition method and QC have to issue < Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005 to production. The report and rejected samples have to be passed to Production dept for disposal. (e.g. rework/sort, scrap etc.). The Production dept. records the results of disposition and takes the relevant improvement action, IPQC and FQC should follow up until all items closed. Special Notice:
(1) When Second Process find that all plastic parts from Injection Molding Process need to be lot rejected, QC supervisor from Injection Molding Process shall confirm how to dispose off them together with the Molding QC supervisor. If the initial disposition is rework/sort/repair/reprocess by 1st process, then QC supervisor from Second Process must inform Injection Molding Manager/supervisor of participating in making the final disposition. If no molding supervisor/manager involvement, the disposition of rework/sort/processing by Molding is invalid.
(2) Special Note: After finishing rework/sort, the “rework done” label need to be attached to each carton box outside by production so that special control must be taken when these parts re-inspected by QC.
6.2.4 When FQC find quality issues, QC leader / supervisor / QE will decide the disposition methods. QC will issue 《Process Discrepancy Requisition》QF-QC-005A/B to production and followed up.
6.3 Suspicious Materials/Products Handling Process: If any suspicious materials/WIP/finished products are detected, detectors need to notify IQC or QC of re-inspection (Remark: IQC is responsible for incoming material, IPQC/FQC is for WIP and finished products). If the re-inspection result is passed, for those without inspection status marking, then IQC/QC shall stamp the passed chop; for those beyond shelf life, then update the label, For those package damage, shall re-pack and re-label on it. After finishing repack, inform IQC/QC of re-inspection. If re-inspection final result is OK, then IQC/QC will chop the “PASS” stamp. If NG, then take it as non-conforming materials/WIP/finished products. The <Nonconforming Materials / WIPs / Finished-goods Disposition Report》QF-QC-005 shall be filled out by IQC/QC.
6.4 Customer return product.
If there are customer returning product, according to <Customer Returning Product Handling Control>FQW-CFR02 to perform controlling
6.5 When IPQC in the in-process inspection or FQC in the final inspection detect a large quantity of nonconforming or badly defect, or customer complaint and customer returns occur, IPQC and FQC must re-check whether there are the same lot/kind products in the warehouse. If yes, QC must re-inspect them. If the same defect detected, must informed QC Leader/QE head/QC head of confirming the disposition and stick the red nonconforming label, also fill in <Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005.
6.6 Once receiving <Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005, Warehouse transfers the nonconforming to the nonconforming area.
6.7 Once receiving the Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005, Production will issue <Material Requisition Form>QF-MW-001 to dept head/manager for approval and take back from warehouse, disposal the nonconforming according to nonconforming disposition method.
6.8 The disposition of nonconforming product produced by our company is as below:
6.8.1 rework/sort
6.8.2 Base on consideration of the cost and lead time, if nonconforming products can meet applicable regulatory requirement and have been verified that its defect do not affect the function of customer product by ME, then it can be UAI, and the requestor of UAI must clearly state the UAI reason in the <Nonconforming Materials / WIPs / Finished-goods Disposition Report> QF-QC-005 and sent it to PM/PA and QD manager or his deputy for approval. If customers require that any concession of nonconforming products must got his written permission before shipment, the requestor of concession must notify the customers of concession in written form before making concession decision. Or when ME can not give a clear judgment whether the defect shall affect the function of customer product, the nonconforming product can’t be concessive accepted before obtaining customer approval. QC need to stamp “Waiver” chop or mark with “Waiver” words on outer box of Concessive acceptance products.