Work Instruction PUI Supplier Request for Nonconforming Material (Rev 2)

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1.0 Purpose To provide Insitu suppliers a method to request Insitu s authority to supply/ship nonconforming material (NCM). This document defines how the Supplier Nonconforming Material Request (NCMR) is received, reviewed and processed. 2.0 Scope Supplier NCM is a onetime temporary variance from Insitu specifications. Insitu s approval shall be obtained before the material / product is delivered to Insitu. 3.0 Definitions 3.1 Nonconformance Failure to comply with requirements. 3.2 Non-conforming Material (NCM) materials or products that do not meet specified requirements. 4.0 References 4.1 PUF-83-001: Supplier Request for Nonconforming Material Form (NCMR) 4.2 PUF-83-002: Supplier Weight Tracking Form 4.3 QAP-83-005: Control of Non-conforming Material 4.4 QAI-82-002: Material Inspection Process 5.0 Responsibilities 5.1 Supplier 5.1.1 Supplier shall submit completed PUF-83-001, Supplier Request for Nonconforming Material Form and internal supporting documentation to SupplierManagement@insitu.com and cc their respective Insitu Supply Chain Analyst and/or Procurement Agent. 5.1.2 Hold shipment until Insitu s approval is received in writing from SM&P. 5.1.3 Approved Supplier NCMRs shipment paperwork requirements: 5.1.3.1 Approved copy of PUF-83-001. 5.1.3.2 Shipment tracker indicates material is NCM. 5.1.3.3 Provide list of all affected serial numbers / lot IDs, when assigned. 5.1.3.4 Internal supporting documentation submitted with corresponding approved PUF-83-001. 5.1.3.5 PUF-83-002, Supplier Weight Tracking form for weight related NCMR requests. 5.1.4 Additional data required, supplier shall deliver requested documentation. 5.1.5 Rejected NCMRs the material shall not be shipped to Insitu. Page 1 of 6

5.2 SM&P NCM Administrator 5.2.1 Review NCMR for completeness. 5.2.2 Enter NCMR into the tracking database. Work Instruction 5.2.3 Send NCMR and supporting documentation for approval. 5.2.4 Track status of NCMR. 5.2.5 Send dispositioned NCMR to the supplier. 5.2.6 Close Supplier NCMR after all reviews are complete and notification has been sent. 5.3 Supply Chain Analyst / Procurement Agent 5.3.1 Review the NCMR and respond to SM&P NCM Administrator noting approval, additional data required, or rejection. 5.3.1.1 If approved, the Procurement Agent checks the QC Inspection flag on the affected PO line(s). 5.4 Design Engineering 5.4.1 Review the NCMR and respond to SM&P NCM Administrator noting approval, additional data required, or rejection. 5.4.1.1 Provide justification for Use As Is determinations. 5.5 Manufacturing Engineering / Quality Engineering 5.5.1 Review the NCMR and respond to SM&P NCM Administrator noting approval, additional data required, or rejection. 5.6 Incoming Receiving 5.6.1 Identify NCMR by QC Inspection Flag on PO line and/or Supplier s NCM shipment paperwork delivered with the material. NOTE: See paperwork requirements in section 5.1.3. 5.6.2 Deliver parts and all paperwork received with the material to Quality Technicians for processing. 5.7 Quality Technicians 5.7.1 Inspect NCMR and supporting documentation. 5.7.2 Scan the NCMR documentation received with the material and log a record in the NCM Database. 5.7.3 Process material according to Incoming Inspection Process per QAI-82-002, Material Inspection Process. 6.0 Process Steps Page 2 of 6

6.1 Supplier performs internal NCM evaluation and determines need to request NCMR acceptance from Insitu. 6.2 Supplier completes a PUF-83-001 and submits with supporting documentation to SM&P for processing to _SupplierManagement@insitu.com. NOTE: The final disposition shall be determined by Insitu before the supplier ships or takes action on the material. 6.3 Supplier shall identify the specific variance to Insitu specification(s) and submit the supporting documentation with a completed PUF-83-001. 6.3.1 Supporting documents include but are not limited to: 1) Functional Product Specifications and Marked Up Drawings. 2) Test results, product measurements, material certificate of conformity. 3) PUF-83-002 for any weight related requests. 4) Historical records or other technical data as appropriate. 6.4 SM&P NCM Administrator reviews the incoming NCMR for completeness and supporting documentation. 6.4.1 If request is incomplete, supplier is notified and request status is pending until the information is received from the supplier. 6.4.2 If request is complete, the request is entered into the NCMR database, assigned an tracking ID number, and submitted for approval. Required Approvals Supply Chain Analyst/Procurement Agent Manufacturing Engineer Quality Engineering Design Engineer NOTE: Customer approval will be requested in accordance with QAP-83-005 Control of NCM Procedure. The number assigned by the SM&P NCM Administrator will be used to track the variance request. 6.5 Approvers review the NCMR and notify SM&P NCM Administrator of approval, additional data required, or rejection. 6.5.1.1 Rejections shall include the reason for rejection. 6.5.1.2 Use As Is shall include justification. 6.6 SM&P NCM Administrator notifies the supplier of the final disposition. 6.6.1 If approved, supplier attaches a copy of the approved PUF-83-001 and supporting documentation to the shipment and indicates on the shipment tracker that the delivery is NCM. 6.6.2 If rejected, the material shall not be delivered to Insitu. The material shall be dispositioned per Insitu s instructions by the supplier. 6.6.3 If additional data is required, SM&P NCM Administrator notifies the supplier that additional documentation / information is required to process the request. Page 3 of 6

NOTE: The final disposition shall be determined by Insitu before the supplier ships or takes action on the material. 6.7 Incoming Receiving performs incoming receiving and forwards the material and all NCM paperwork to Quality Technicians for processing. 6.8 Quality Technician receives the material and performs a receipt. 6.8.1 Review the material and NCMR documentation to ensure Insitu s final disposition has been properly implemented. 1) If acceptable, the material and paperwork are accepted and the material is returned to inventory. 2) If an issue is found, process the material according the QAP-83-005, Control of Nonconforming Material. Page 4 of 6

7.0 Process Flowchart Supplier NCM Request Supplier SM&P NCM Admin Approvers Incoming Receiving Quality Perform internal MRB Complete PUF- 83-001 / attach supporting docs Review submission for completeness Accept? YES Review Supplier NCM Request Send requested information / data NO Request information from Supplier Additional Data Required Disposition product per Insitu instructions REJECTED Approved? Mark shipping tracker and ship product PA checks QC Inspect flag on PO Line YES Receive product and send to QA Enter receipt Return material to inventory YES Accept? NO Follow NCM Process QAP-83-005 Page 5 of 6

8.0 Revision History Revision History Rev Date Description Revised By 1 06/24/2014 Initial release Audrey Dickenson, Patti Sherwin, Duane Purcell 2 09/01/2016 Published for Document Ownership Change Doc Control Page 6 of 6