SOP-0012 Control of Non-Conforming Product & Materials
1
4.2.4 Control of Records 4.5.4 Records 4.1.1 Records Retention 4.2.1.16 “Forever Requirements” - Extended Enterprise (L. 147, 152, 153, 154) Process Input: Receiving Inspection List Supplier Rating Report F-0243 Stock on Hold Pending Disposition F-0252 F-0516 F-0633 F-0682 F-0780 F-1034 F-1093 Quality Cage Disposition Codes SOP-0012 Control of Non-conforming Product & Materials Start Processing Non-conformances Supplier Quality Specialist/Q.A. Analyst per applicable Work Instruction 1) assesses suspected or identified non-conforming materials/products 2) Determines & assigns disposition of one of the following: - Return to Source - Scrap - 3 rd Party Sort - Rework/reuse - Send to Lab for testing - Hold - Customer/Internal Waiver 3) communicates disposition status as applicable to ensure that customers are promptly informed of issues which might impact them (Materials Manager notifies customer of any actual or potential supplier issues, or potential supply or capacity issues and Q.A. Manager notifies customer of any actual or potential non-conforming product which may have been shipped) 4) maintains records of the nature of all nonconformities, (including “suspected nonconformities” which are subsequently approved, and any actions taken, including concessions obtained) Process Output: - 3 rd Party identifies & segregates suspect or known non- conforming materials and returns to Customer (accumulation returns) WI-0150 Third Party Sort Unidentified, unlabelled or non- conforming materials or products found during environmental or health & safety audits, or by housekeeping are segregated and identified as non- conforming WI-0073 Written Hazard Communication Program WI-0391 Health, Safety & Environmental Audit Identification & Segregation As applicable, Supplier Quality Specialist or Quality Assurance Supervisor ensures suspect or known non-conforming materials are clearly identified & segregated or moved to designated HOLD/Quarantine area Customer returns non- conforming product to ABC Company returns product subsequent to Annual Verification and Validation (where applicable) WI-0153 Processing of Returns from Assembly WI-0157 Rework & Disposition of Customer Returns WI-0158 Purging the System for Defects WI-0347 Analysis of Warranty Return Parts Go to A Upon notification from Supplier, Supplier Quality Analyst / Q.A. Analyst initiate action to trace, identify & segregate suspect/non- conforming materials WI-0151 Processing of Supplier Defects WI-0158 Purging the System for Defects WI-0314 Disposition of Suspect Material WI-0435 In-house Repair Report WI-0479 Returning Product to the Supplier Notification by Supplier of defective Shipped Parts Third Party Sort Lab Inspections External Returns Engineering Design change results in obsolete materials which must be identified and segregated SOP-0007 Change Control Assembly Engineering Environmental/Health & Safety Audits/ Housekeeping Respective Test/Audit results in identification of non-conforming product WI-0094 Dock Audit - Assembly Q.A., WI-0044 Function Audit WI-0097 B.S.R. Testing Periodic Layout, Functional & Dock Audits & Testing SQA/Q.A. Analyst identify suspect or non-conforming materials during inspection of incoming material or supplier qualification WI-0154 Nonconforming Purchased Product WI-0090 Receiving Inspection WI-0465 Supplier Annual Part Verification and Validation Receiving Insp/ Supplier Qualification 5.2 Customer Focus 7.2.3 Customer Communication 7.4.3 Verification of Purchased Product 7.4.3.1 Incoming Product Quality 7.4.3.2 Supplier Monitoring 7.5.5.1 Storage & Inventory 7.5.3 Identification & Traceability 8.2.1.1 Customer Satisfaction - Supplemental 8.3 Control of Non-conforming Product 8.3.1 Control of Non-conforming Product - Supplemental 8.3.3 Customer Information 4.1.1 Records Retention (L. 63) 4.1.5 Certification Body/Registrar Notification (L. 80) Lab testing/ inspection results in identification of nonconformances See F-0595 ABCs Test Matrix for complete listing of Laboratory testing & Inspections Plant Personnel identify & segregate known or suspected non-conformances Applicable Operation Work Instructions WI-0156 Quarantine Area (Assembly) WI-0160 Re-work Front Line Assist straps WI-0158 Purging the system for Defects Assembly WI-0221 Assembly Rework Instructions WI-0070 Utility Person Assembly 4.5.3 Nonconformance and Corrective & Preventive Action Incidents of known or suspected product or process non-conformances may arise or be identified during the implementation of any of the activities identified below (blue boxes). The respective controls, responsibilities, and authority are detailed in the applicable Work Instructions (red text) identified under each of the individual scenarios This printed document is an UNCONTROLLED COPY - Check B.O.S. to verify validity prior to use Date printed: Monday, March 03, 2008 Patricia Ravanello, Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 1 Page: 1 of 3 pages
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Transcript of SOP-0012 Control of Non-Conforming Product & Materials
4.2.4 Control of Records
4.5.4 Records
4.1.1 Records Retention4.2.1.16 “Forever Requirements” -Extended Enterprise (L. 147, 152, 153, 154)
Process Input:Receiving Inspection ListSupplier Rating ReportF-0243 Stock on Hold Pending DispositionF-0252 F-0516 F-0633 F-0682 F-0780 F-1034 F-1093 Quality Cage Disposition Codes
SOP-0012 Control of Non-conforming Product & Materials
Start
Processing Non-conformancesSupplier Quality Specialist/Q.A. Analyst
per applicable Work Instruction1) assesses suspected or identified non-conforming materials/products 2) Determines & assigns disposition of one of the following:
- Return to Source - Scrap - 3rd Party Sort - Rework/reuse - Send to Lab for testing - Hold - Customer/Internal Waiver
3) communicates disposition status as applicable to ensure thatcustomers are promptly informed of issues which might
impact them (Materials Manager notifies customer of any actual or potential supplier issues, or potential supply or capacity issues and Q.A. Manager notifies customer of any actual or potential non-conforming product which may have been shipped)4) maintains records of the nature of all nonconformities, (including “suspected nonconformities” which are subsequently approved, and any actions taken, including concessions obtained)
Process Output:-
3rd Partyidentifies & segregates suspect or
known non-conforming
materials and returns to Customer
(accumulation returns)
WI-0150 Third Party Sort
Unidentified, unlabelled or non-
conforming materials or products found
during environmental or health & safety
audits, or by housekeeping are segregated and
identified as non-conforming
WI-0073 Written Hazard Communication ProgramWI-0391 Health, Safety & Environmental Audit
Identification & SegregationAs applicable, Supplier Quality Specialist or Quality Assurance Supervisor
ensures suspect or known non-conforming materials are clearly identified & segregated or moved to designated HOLD/Quarantine area
Customer returns non-conforming product to ABC Company returns product
subsequent to Annual Verification and Validation
(where applicable)
WI-0153 Processing of Returns from AssemblyWI-0157 Rework & Disposition of Customer ReturnsWI-0158 Purging the System for DefectsWI-0347 Analysis of Warranty Return Parts
Go to A
Upon notification fromSupplier,
Supplier Quality Analyst /Q.A. Analyst initiate action
to trace, identify & segregate suspect/non-
conforming materialsWI-0151 Processing of Supplier Defects WI-0158 Purging the System for DefectsWI-0314 Disposition of Suspect MaterialWI-0435 In-house Repair ReportWI-0479 Returning Product to the Supplier
Notification by Supplier of defective Shipped Parts
Third Party Sort Lab Inspections External Returns
Engineering Design change results in
obsolete materials which must be identified and segregated
SOP-0007 Change Control
Assembly
Engineering
Environmental/Health & Safety Audits/Housekeeping
Respective Test/Audit results in identification of non-conforming product
WI-0094 Dock Audit -Assembly Q.A.,WI-0044 Function AuditWI-0097 B.S.R. Testing
Periodic Layout, Functional & Dock Audits & Testing
SQA/Q.A. Analyst identify suspect or
non-conforming materials during
inspection of incoming material or supplier
qualification
WI-0154 Nonconforming Purchased ProductWI-0090 Receiving Inspection WI-0465 Supplier Annual Part Verification and Validation
Receiving Insp/ Supplier Qualification
5.2 Customer Focus7.2.3 Customer Communication7.4.3 Verification of Purchased Product7.4.3.1 Incoming Product Quality7.4.3.2 Supplier Monitoring7.5.5.1 Storage & Inventory7.5.3 Identification & Traceability8.2.1.1 Customer Satisfaction - Supplemental8.3 Control of Non-conforming Product 8.3.1 Control of Non-conforming Product - Supplemental8.3.3 Customer Information
4.1.1 Records Retention (L. 63)4.1.5 Certification Body/Registrar Notification (L. 80)
Lab testing/inspection results in identification of nonconformances
See F-0595 ABCs
Test Matrix for complete
listing of Laboratory testing & Inspections
Plant Personnel identify & segregate known or suspected non-conformances Applicable Operation Work InstructionsWI-0156 Quarantine Area (Assembly)WI-0160 Re-work Front Line Assist strapsWI-0158 Purging the system for Defects AssemblyWI-0221 Assembly Rework InstructionsWI-0070 Utility Person Assembly
4.5.3 Nonconformance and Corrective & Preventive Action
Incidents of known or suspected product or process non-conformances
may arise or be identified during the implementation of any of the activities identified
below (blue boxes). The respective controls, responsibilities, and
authority are detailed in the applicableWork Instructions (red text) identified under each of the individual scenarios
This printed document is an UNCONTROLLED COPY - Check B.O.S. to verify validity prior to use Date printed: Monday, March 03, 2008
Patricia Ravanello, Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 1 Page: 1 of 3 pages
