This printed document is an UNCONTROLLED COPY - Check B.O.S.

to verify validity prior to use

Date printed: Monday, March 03, 2008

SOP-0012 Control of Non-conforming Product & Materials

Start
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
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) 4.5.3 Nonconformance and Corrective & Preventive Action

Notification by Supplier of defective Shipped Parts

Receiving Insp/ Supplier Qualification

Third Party Sort

Lab Inspections

Assembly

Environmental/Health & Safety Audits/ Housekeeping

External Returns

Upon notification from Supplier, Supplier Quality Analyst / Q.A. Analyst initiate action to trace, identify & segregate suspect/nonconforming 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

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

3rd Party identifies & segregates suspect or known nonconforming materials and returns to Customer (accumulation returns)

Lab testing/ inspection results in identification of nonconformances See F-0595 ABCs Test Matrix for complete listing of Laboratory testing & Inspections

WI-0150 Third Party Sort

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

Unidentified, unlabelled or nonconforming materials or products found during environmental or health & safety audits, or by housekeeping are segregated and identified as nonconforming WI-0073 Written Hazard Communication Program WI-0391 Health, Safety & Environmental Audit

Customer returns nonconforming 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

Engineering Periodic Layout, Functional & Dock Audits & Testing 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 Engineering Design change results in obsolete materials which must be identified and segregated

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
4.2.4 Control of Records 4.1.1 Records Retention 4.2.1.16 Forever Requirements Extended Enterprise (L. 147, 152, 153, 154)

SOP-0007 Change Control

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

Processing Non-conformances

4.5.4 Records

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 - 3rd 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) Process Output: -

4) maintains records of the nature of all nonconformities, (including suspected nonconformities which are subsequently approved, and any actions taken, including concessions obtained)

Go to

A
Patricia Ravanello, Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 1 Page: 1 of 3 pages