·¢²¼Ê±¼ä : ÐÇÆÚÎå ÎÄÕÂISO9001-2015²»ºÏ¸ñÆ·´¦Àí³ÌÐò(ÖÐÓ¢ÎÄ)¸üÐÂÍê±Ï¿ªÊ¼ÔĶÁ48a179cd77232f60dccca160
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Management of Nonconforming Product
£¨ISO9001£º2015£©
1.0 Ä¿µÄPurpose:
±¾³ÌÐò¶Ô²»ºÏ¸ñÆ·µÄ±êʶ¡¢¸ôÀë¡¢ÆÀ¹À¡¢´¦ÖᢼǼÌṩָÒý¡£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 ·¶Î§Scope:
ÊÊÓÃÓÚ±¾³§ËùÓв»ºÏ¸ñÀ´ÁÏ£¬°ë³ÉÆ·¼°³ÉÆ·¡£ Apply to all non-conforming incoming materials, semi-products and finished products.
3.0 ¶¨ÒåDefinition:
3.1 3.2 3.3 3.4 3.5 3.6
DXC: DXCµÄ¼ò³Æ£ºDXC is short for DXC.
UAI£ºÌزɣ¬Ò²³ÆÈò½½ÓÊÜ¡£UAI is short for use as it is, also calling concession. PM/PA: ÏîÄ¿¾Àí/ÏîÄ¿ÖúÀí Program manager / Program Assistant. QE: Æ·Öʹ¤³Ìʦ Quality Engineer ME: ÖƳ̹¤³Ìʦ Manufacturing Engineer
²»ºÏ¸ñÆ·£º²»·ûºÏ¼È¶¨µÄÆ·Öʱê×¼/ÒªÇó»ò¿Í»§ÒªÇóµÄËùÓÐÀ´ÁÏ¡¢°ë³ÉÆ·¡¢³ÉÆ·¡£Nonconforming Product: All incoming materials, WIP, finished products are non-compliant with established quality standard/requirements or customers¡¯.
3.7 ¿ÉÒÉÎïÆ·/ÎïÁÏ£º¼ìÑé»òÊÔÑé״̬±êʶ²»Ã÷È·»òûÓбêʶ£¬»ò´¢´æ³¬¹ý±£´æÆÚÏÞ»òÓÉÓÚ°ü×°ÊÜËðµÈÔÒò¿ÉÄÜÒýÆðÆ·ÖʱäÒì»ò½µµÍµÄÎïÁÏ/°ë³ÉÆ·/³ÉÆ·¡£
Suspicious products/materials£ºThe 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.
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3.8 3.9
WIP£º°ë³ÉÆ·Work In-Process.
PFMEA£º¹ý³ÌʧЧģʽ¼°Ó°Ïì·ÖÎöProcess Failure Modes and Effect Analysis
3.10 IQC II: À´ÁϼìÑé×÷ÒµÖ¸µ¼Êé Incoming Quality Control Inspection Instruction. 3.11 QC II: Æ·ÖʼìÑé×÷ÒµÖ¸µ¼Êé Quality Control Inspection Instruction
3.12 MRB£ºÎïÁÏÆÀÉóίԱ»á£¬Ò²³Æ²»ºÏ¸ñÆ·ÆÀÉóίԱ»á£¬Ö°ÔðÊÇ£º¶¨ÆÚ»ò½ô¼±×´Ì¬Ï£¬ÆÀÉó¼°
´¦Àí²»ºÏ¸ñÀ´Áϼ°Éú²úÏß·¢ÏֵIJ»Á¼°ë³ÉÆ·¼°³ÉÆ·¡£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 MRB³ÉÔ±ÈçÏÂMRB member for incoming material as below£º
LEVEL I:
IQC (½öÊÊÓÃÓÚ²»Á¼À´ÁÏ´¦ÖÃOnly for nonconforming incoming material) Planner (PPC)
Buyer (Purchasing) (½öÊÊÓÃÓÚ²»Á¼À´ÁÏ´¦ÖÃOnly for nonconforming incoming material) QE (as necessary)
ME (as necessary)
QC Supervisor (½öÊÊÓÃÓÚ²»Á¼°ë³ÉÆ·/³ÉÆ·µÄ´¦ÖÃonly for nonconforming WIP/Finished Product)
Production Supervisor(½öÊÊÓÃÓÚ²»Á¼°ë³ÉÆ·/³ÉÆ·µÄ´¦ÖÃonly for nonconforming WIP/Finished Product) LEVEL II: QA Manager ME Manager
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Purchasing Manager (½öÊÊÓÃÓÚ²»Á¼À´ÁÏ´¦ÖÃOnly for nonconforming incoming material)
PPC Manager
Production Manager (as required) Program Manager (as required) Plant Manager (as required)
4.0 Ö°ÔðResponsibility:
4.1 IQC/IPQC/FQC
4.1.1 °´¹æ¶¨µÄ¼ìÑé±ê×¼¼ìÑéÀ´ÁÏ/Éú²úµÄ°ë³ÉÆ·¼°²úÆ·£¬ÕýÈ·µØÅж¨À´ÁÏ/Éú²úµÄ²úÆ·ÊÇ
·ñºÏ¸ñ£¬²¢¶Ô²»ºÏ¸ñÆ·½øÐбêʶ¡£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 ¶Ô²»ºÏ¸ñÀ´ÁÏ/°ë³ÉÆ·/³ÉÆ·µÄ´¦Àí½á¹û½øÐиú×ٺͼǼ¡£Following up and
recording the disposition of nonconforming incoming materials/WIP/finished products.
4.2 IQCÖ÷¹Ü/¹¤³Ìʦ¸ºÔ𽫷¢ÏÖµÄÀ´Áϲ»Á¼ÎÊÌ⼰ʱͨ¸æÏà¹ØµÄMRB³ÉÔ±£¬ÈôÓбØҪʱ°²ÅÅ
²¢Ö÷³ÖMRB»áÒé¡£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 QCÖ÷¹Ü/QE¸ºÔð¶ÔÖƳ̡¢Öռ졢³ö»õ¼ì²éÖеIJ»ºÏ¸ñÆ·Ìá³ö´¦ÀíÒâ¼û¡£µ±³öÏֵIJ»ºÏ¸ñ°ë
³ÉÆ·/³ÉÆ·ÑÏÖØÓ°Ïìµ½Éú²ú½ø¶È»ò½»»õʱ£¬Ð뼰ʱ½«Éú²ú¹ý³ÌÖвúÉúµÄ²»ºÏ¸ñ°ë³ÉÆ·/³ÉÆ·ÐÅϢͨ¸æ¸øÉú²ú²¿»òPPC£¬»òME£¬»òÏîÄ¿¾ÀíºÍÆ·Öʲ¿¾Àí£¬²¢½ô¼±ÕÙ¼¯Éú²ú²¿£¬PPC»òME»òÏîÄ¿¾Àí¹²Í¬ÌÖÂÛ¶Ô²»ºÏ¸ñ°ë³ÉÆ·/³ÉÆ·µÄ´¦Öð취¡£QC Supervisor / QE are responsible for determining the disposition method for nonconforming products which found by in-process & final inspection & out-going inspection. When
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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 manger 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 QA¾Àí QA Manager£ºÖ÷³Ö²»ºÏ¸ñÆ·ÆÀÉó»áÒé Chairing MRB meeting.
4.5 Éú²ú²¿ºÍÏà¹Ø²¿ÃÅ£¨°üÀ¨²É¹º£¬PPC£¬²Ö¿â£¬°ë³ÉÆ·²Ö£¬ME£¬ÏîÄ¿²¿£©Ö´Ðв»ºÏ¸ñÆ·´¦ÖÃ
¾ö¶¨¡£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 ÌزÉÌõ¼þ£ºThe prerequisites for UAI/Concession
5.1 ¶Ô²»Ó°ÏìʹÓÃÒªÇóµÄ²»ºÏ¸ñÀ´ÁÏ/°ë³ÉÆ·/³ÉÆ·½øÐÐÈò½Ê¹Óûò·ÅÐУ¬Ðè¾MRBÊÚȨÈËÔ±µÄ
Åú×¼£¬²¢ÇÒ²»µÃÎ¥±³·¨¹æÒªÇó¡£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 Õë¶ÔÒ½ÁƲúÆ·µÄÌزɣ¬±¾¹«Ë¾±ØÐë·¢³ö¡¶²»ºÏ¸ñÆ·´¦Öñ¨¸æ¡·QF-QC-005¸ø¿Í»§ºË×¼£¬ÇÒ
ÒÔ¿Í»§ºË×¼µÄÒâ¼ûΪ×îÖÕ´¦Öþö¶¨¡£For medical product concession, Flex GongMing Site must send the ¡¶Nonconforming Materials / WIPs / Finished-goods Disposition Report¡·QF-QC-005 to customer for approval. Customer¡¯s disposition decision prevails.
6.0 ³ÌÐòProcedures:
6.1 À´Áϲ»ºÏ¸ñÆ·¹ÜÖÆ Control of nonconforming incoming materials
6.1.1 IQC³éÑù¼ìÑéʱ£¬Èç·¢ÏÖ²»Á¼ÇéÐ㬳ö¿É½ÓÊÕ±ê×¼£¬IQC½«·¢ÐС¶²»ºÏ¸ñÆ·´¦Öñ¨¸æ¡·
QF-QC-005²¢Ìá½»MRBÌÖÂÛ¡£Èç¹ûÀ´Áϲ»Á¼Îª¹¦ÄÜʧ³£»ò°²È«ÎÊÌâ»òÔÚÏß²»Á¼Âʳ¬¹ý3%»òÁ¬Ðø3ÅúÀ´ÁÏͬÑùÎÊÌâ·¢Éú£¬ÔòÐè·Ö·¢¡¶8D Report¡·QF-QC-022¸ø¹©Ó¦ÉÌ·ÖÎöÔÒò¼°¸ÄÉÆ´ëÊ©£¬²¢ÓÉIQC²¿ÃŸú½ø¸ÄÉƽá¹û¡£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
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