Management of Nonconforming Product（ISO 9001-2015) 1 of 3
This procedure provides the instructions for the identification, quarantine, evaluation, disposition, documentation of non-conformance associated with incoming materials, in-process incoming materials, semi-product, finished product.
2.0 Scope:
Apply to all non-conforming incoming materials, semi-products and finished products.
3.0 Definition:
3.1 DXC: DXC：DXC is short for DXC.
3.2 UAI：UAI is short for use as it is, also calling concession.
3.3 PM/PA: Program manager / Program Assistant.
3.4 QE: Quality Engineer
3.5 ME: Manufacturing Engineer
3.6 Nonconforming Product: All incoming materials, WIP, finished products are non-compliant with established quality standard/requirements or customers’.
3.7 Suspicious products/materials：The status of inspection or testing isn’t indicated/marked or the quality of materials/semi-products/finished products may have deteriorated because of package damaged or over shelf life.
3.8 WIP： Work In-Process.
3.9 PFMEA： Process Failure Modes and Effect Analysis
3.10 IQC II: Incoming Quality Control Inspection Instruction.
3.11 QC II: Quality Control Inspection Instruction
3.12 MRB：Material Review Board，also calling non-conforming product review board, is responsible for reviewing and disposing non-conforming incoming material / WIP / finished products on a regular or urgent basis..
3.13 MRB member for incoming material as below：
LEVEL I:
IQC (Only for nonconforming incoming material)
Planner (PPC)
Buyer (Purchasing) (Only for nonconforming incoming material) QE (as necessary)
ME (as necessary)
QC Supervisor (only for nonconforming WIP/Finished Product)
Production Supervisor (only for nonconforming WIP/Finished Product)
LEVEL II:
QA Manager
ME Manager
Purchasing Manager (Only for nonconforming incoming material)
PPC Manager
Production Manager (as required)
Program Manager (as required)
Plant Manager (as required)
4.0 Responsibility:
4.1 IQC/IPQC/FQC
4.1.1 Inspecting/measuring/testing incoming materials or WIP/Finished products produced as per the approved quality control inspection instruction (QC II), and judge whether the incoming material / WIP/Finished products is pass or fail, and marking the non-conforming incoming material lot or WIP or finished products with the established label.
4.1.2 Following up and recording the disposition of nonconforming incoming materials/WIP/finished products.
4.2 IQC Supervisor/Engineer is responsible for handling nonconforming incoming materials and informs the related MRB member of the nonconformance. If necessary, IQC should arrange the MRB meeting.
4.3 QC Supervisor / QE are responsible for determining the disposition method for nonconforming products which found by in-process & final inspection & out-going inspection. When nonconforming WIP/finished products will badly affect production progress or delivery, QC Supervisor / QE need to timely inform production or PPC or ME or Program manager and quality manager of non-conforming WIP or finished products status, and call an urgent meeting for deciding how to dispose of these non-conforming WIP or finished products.
4.4 QA Manager：Chairing MRB meeting.
4.5 Production and related departments (including Purchasing, PPC, Warehouse, WIP store, ME, Program) carry out the disposition of nonconforming incoming materials/WIP/finished products.
5.0 The prerequisites for UAI/Concession
5.1 The conditions for concession/UAI: Only meet the regulatory and statutory requirements and have no effect on product intended use and approved by the MRB members, then the non-conforming products/materials are accepted and released by concession。
5.2 For medical product concession, Wovam Technology Limited must send the 《Nonconforming Materials / WIPs / Finished-goods Disposition Report》QF-QC-005 to customer for approval. Customer’s disposition decision prevails.
6.0 Procedures:
6.1 Control of nonconforming incoming materials
6.1.1 IQC performs the sampling inspection to incoming materials and issue a《Nonconforming Materials / WIPs / Finished-goods Disposition Report》QF-QC-005 which submitted to MRB for discussion if nonconformity status beyond accepted standard. If the defect is functional failure or safety issue or on-line defective rate more than 3% or the same defect recurs successively more than 3 lots for the incoming part, IQC will issue <8D Report> QF-QC-022 to the vendor for improvement and followed up until closed.
6.1.2 If need to held a meeting, IQC should prepare NG samples and corresponding report before MRB meeting.
6.1.3 Disposition method of nonconforming incoming material determined by MRB members together will be fill in 《Nonconforming Materials / WIPs / Finished-goods Disposition Report》QF-QC-005 by IQC/IQC Supervisor and MRB member will sign on it for approval. For the disposition principles of nonconforming incoming material, please see the <Disposition Guideline for Incoming Material> FQWIQC04.
6.1.4 Disposition status label should be attached to the relevant incoming material by IQC immediately.
6.1.5 Warehouse handles the incoming material according to its label. If the label marks returned to vendor or sorting/reworking, then the material should be moved to nonconforming area in the warehouse. If the label marks scrap, then the material should be moved to scrap area in the warehouse.
6.1.6 Disposition method of nonconforming material (including sub-out parts) on line：
6.1.6.1 If few non-conforming incoming materials is found on line, Production makes statistics and classify (The material that is damaged in our production is taken as scrap). When nonconforming material is confirmed by IQC, Production Dept. packs it and returns it to the warehouse regularly. Production shall issue the <Nonconforming Materials / WIPs / Finished-goods Disposition Report>QF-QC-005 and <Material Return Form (MRTF)> QF-MW-004B to IQC for each return. Warehouse can accept the returned incoming material until accompanying the approved the <Nonconforming Materials / WIPs / Finished-goods Disposition Report>QF-QC-005. In such case, the <Nonconforming Materials / WIPs / Finished-goods Disposition Report>QF-QC-005 only need to be signed for confirmation by Production Supervisor and IQC. The Serial No. of <Nonconforming Materials / WIPs / Finished-goods Disposition Report> shall be numbered by Production as per item 6.15 ---- The numbering method of <Nonconforming Materials / WIPs / Finished-goods Disposition Report>.