NONCONFORMING MATERIAL CONTROL & REVIEW 1.0 2.0 PURPOSE AND SCOPE 1.1 To establish the requirements for the control and disposition of nonconforming Product. 1.2 This procedure applies to nonconforming product found in incoming inspection, WIP, finished products, in service, customer sites, and customer returned products. DEFINITIONS 2.1 Advisory notice: A notice issued upon detection of nonconforming material/ product after delivery or use by end Customer has started. It includes the relevant information regarding the effects or potential effects of the nonconformity. 2.2 Customer: Company or organization that has contracted services of XXXX Medical Division to manufacture product per specifications defined by customer. 2.3 Customer Concession: The authorization by customer to use or release product that does not conform to specified requirements. 2.4 Deviation: Authorization for use or acceptance of product that does not conform to drawing or specification. 2.5 Material Review Board (MRB): Consists of members from Quality Assurance, Manufacturing Engineering, Purchasing and customer when signature approval is required on an NCMR to authorize disposition of the product or to approve the request for variance, and the assignment of corrective action responsibility). 2.6 MRB Coordinator: Designated representative from Quality will manage MRB program and chair MRB meeting. 2.7 Nonconforming Product: specifications. 2.8 Nonconforming Material Report (NCMR): The document used in recording the occurrence of a nonconformance or to request a specification variance (SV), the disposition of that product or request, and initiate the requirement for corrective action, as required. 2.9 Nonconforming Material Disposition: The conclusion reached after reviewing and considering all aspects of the nonconformance. The Any product that does not meet specified Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW conclusion results in a decision to use as is, sort, rework, repair scrap, return to vendor, or deviate. 2.9.1 Use as is: Product that has been verified not to cause nonconformance of the top assembly to issued specifications. 2.9.2 Return to Vendor (RTV): Product that has been rejected and is to be returned to the source for credit, replacement, rework, or sorting. 2.9.3 Sort: Separation of conforming from nonconforming Product:. 2.9.4 Rework: means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. An example of rework would be taking a down revision product that must be upgraded to match current specifications. Generally, routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device. 2.9.5 Repair: Action on a nonconforming product to make it acceptable for intended use. Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance. Unlike rework, repair can affect or change parts of the nonconforming product. 2.9.6 Scrap: Nonconforming product that cannot be processed for technical, safety, or economic reasons and is to be destroyed or otherwise removed from the manufacturing system. 2.9.7 Deviate: Allows acceptance of a product to authorized specifications that are different from issued specifications. 3.0 2.10 Product: means components, manufacturing materials, in- process devices, finished devices, and returned devices. 2.11 Specification: Any requirement with which a product, process, service, or other activity must conform. 2.12 Supplier: Provider of any product used or consulting services provided for manufacture of XXXX Medical products. GENERAL Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 3.1 This procedure is used in conjunction with SOP-3-MD8000-A Corrective and Preventive Action procedure for Internal or Supplier corrective actions pertaining to nonconforming product. 3.1.1 Customer complaints related to nonconforming devices are handled according to Complaint Handling and Reporting procedure, SOP-3-MD8002-A. 3.2 Product with unidentified or suspect status shall be classified as nonconforming product. 3.2.1 Non-conforming product shall be segregated immediately from production. If product is moved from the production floor to a segregated staging area for MRB disposition, then this product must be transferred to MRB within 24 hours, both physically and electronically in Oracle. No disposition shall be performed until completing the transfer to MRB and NCMR form is initiated. 1 3.3 If the product cannot physically fit in defined MRB area, then this product shall be moved away from the regular production area, segregated, and clearly identified as non-conforming. 3.4 Identified product nonconformance shall be documented for evaluation and investigation result (if applicable) by using a Non-Conforming Material Report (NCMR). The nonconformance should be quantified by defect type, identified, and segregated for proper disposition. The description of nonconformance should be in specific terms, not generalities that don’t adequately describe the nonconformance. 3.5 The evaluation of nonconformance shall include a notification of the persons or functions directly responsible for the nonconformance and/or assuring the quality of such product and the determination of the need for an investigation and/or a CAPA. The aim is to prevent further reoccurrence of the problem. 3.6 When nonconforming product is dispositioned as Use-As-Is (UAI), a justification of use and the signature of the individual(s) authorizing the use shall be documented in the MRB record1. 3.7 When nonconforming product is dispositioned as rework to be performed internally by XXXX or via an outside supplier, rework instructions shall be attached to the NCMR and approved by the customer. Use log, minutes, or terminology that is consistent with existing Sanmina procedures. Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 3.8 The function responsible for coordinating the nonconforming product disposition process shall ensure that an NCMR is completed in accordance with this procedure. 3.9 Nonconforming product pending disposition shall be segregated or clearly identified as nonconforming product in order to prevent unintended use. 3.10 Material Purge shall be conducted according to SOP-3-MD7012-A. Records related to product purge shall be attached with the NonConforming Material Report, SOP-4-MD7045-A. 3.11 The Material Review Board (MRB) is responsible for the review and disposition of nonconforming products. Authorized signatures are to be compatible with the department organization but shall include a minimum of two functional disciplines of which one shall be from Quality Assurance. 3.11.1 MRB can assign a disposition of “Use-As-Is” if use of nonconforming product will NOT adversely affect part, system or product performance, safety, reliability, appearance, manufacturing processes, or any other quality, performance or cost requirement known to MRB members. The justification of “Use-As-Is” shall be documented with documented customer approval. 3.12 When an agreement cannot be reached concerning the disposition of nonconforming product, involved members of the MRB must escalate the problem progressively to the next higher level of management until the issue is resolved. 3.13 Nonconforming product shall be handled according to SOP-3-MD7023A, Handling, Storage, Packaging, Preservation, and Delivery. 3.14 When returning/shipping nonconforming product to suppliers or for failure analysis it shall be packaged in its original packaging (if available) or in a compatible packaging to prevent damage or deterioration. 3.15 When nonconforming product is detected after delivery or use has started by end user, XXXX shall notify and work with Customer (OEM) who is responsible to take appropriate action such as issuing advisory notice to end user appropriate to the effects, or potential effects, of the nonconformity. Records of action taken shall be maintained. Reference SOP-3-MD8009-A Medical Device Reporting (MDR) SOP for details. Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 4.0 3.16 Trend Analysis of discrepancies found in nonconforming product shall be performed and reported on a monthly and quarterly basis. 3.17 When automated data processing system is used in the management and control of the nonconforming product, it shall be validated. RESPONSIBILITIES 4.1 VP of RA & QA, Medical Division or designee is responsible for maintaining and revising this document. 4.2 Department Manager(s) or Supervisor(s) are responsible for: 4.2.1 Ensuring that personnel are trained and certified to all aspects of this document and this procedure is followed. 4.3 Facility Quality Manager or designee is responsible for: 4.3.1 Ensuring that identified nonconforming product is properly documented, labeled, or segregated pending review by the Material Review Board. 4.3.2 Ensuring timely disposition of nonconforming product. 4.3.3 Ensuring that scrapped product is properly disposed. Finished devices or working electronic sub-assemblies are to be made inoperable as well as in a state that cannot be made operable and the Device Label MUST ALSO BE REMOVED prior to sending outside XXXX for disposal. 4.3.4 Acting as or appointing a Material Review Board coordinator. 4.3.5 Ensuring customer complaints are handled in a timely manner. 4.3.6 Ensuring CAPAs or investigations are initiated where appropriate from the review of nonconforming product. 4.3.7 Conducting a trend analysis on discrepancies found in nonconforming product and utilizing the analysis as input for Corrective & Preventive Action. 4.3.8 Reviewing and approving NCMR’s with “Use-As-Is” depositions to ensure product has been properly qualified. 4.4 Quality Inspectors, Test Technicians, or trained individuals are responsible for: Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 4.4.1 Documenting identified nonconformance, quality, or technical problem in local electronic NCMR database system, or by using Nonconforming Material Report SOP-4-MD7045-A. 4.4.2 Labeling or disposition. segregating nonconforming product pending 4.4.3 Re-inspecting and/or re-testing reworked and repaired product to specified inspection criteria or test plans. 4.4.4 Documenting results of inspection after rework or repair. 4.5 Material Review Board, under the guidance of the Facility Quality Manager or designated chairperson, is responsible for: 4.5.1 Timely review and disposition of identified nonconformance. The frequency for MRB to convene is established at the facility level. 4.5.2 Documenting Material Review nonconforming material report. Board disposition on the 4.5.3 Requesting investigation of problems when deemed necessary. 4.5.4 Assignment of CAPA for quality and/or technical problems when deemed necessary. 5.0 4.6 Materials or Production Control is responsible for the purge and quarantine of discrepant product at work in process, finished goods inventory, pending MRB review, and disposition following Material Purge Control Procedure, SOP-3-MD7012-A. 4.7 Facility Quality Manager and Material Manager are responsible for the recall and quarantine of discrepant product in field following the Product Recall Procedure SOP-3-MD7036-A. PROCEDURE 5.1 Documenting Identified Nonconformance 5.1.1 When product does not conform to specified requirements, the discrepancy is recorded in local electronic NCMR database system, or on a Nonconforming Material Report, SOP-4-MD7045A. Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 5.1.2 Nonconforming product is segregated and taken to the appropriate designated nonconforming product location for storage and disposition by the MRB. 5.2 Material Review Board process 5.2.1 The designated MRB coordinator guides the Material Review Board members in the review of each pending NCMR in order to reach a disposition. 5.2.1.1 If disposition cannot be reached at the time of the review because further investigation is required, a mutually agreed time for completion of disposition will be established between the MRB members. 5.2.1.2 If disposition cannot be reached after further investigation, the MRB chairperson must escalate the problem to appropriate functions for consideration and resolution. 5.2.2 When a disposition is reached by the MRB members, they approve the NCMR under the appropriate functions they are representing to denote concurrence with the NCMR disposition.5.2.3 If the disposition requires customer response, the Program/Account Manager is notified by the MRB coordinator to obtain any of the following Customer concession dispositions. 5.2.3.1 Accept as is 5.2.3.2 Accept with rework 5.2.3.3 Reject 5.2.4 The customer contact is recorded on the NCMR, including the response received from the Customer. 5.2.5 If the nonconforming product is dispositioned for rework, a rework instruction is generated and approved by Customer, Manufacturing Engineering, and Quality Assurance. Adverse effect of the rework shall be determined to be inconsequential before the commencement of the rework activity. All reworks are subjected to the same acceptance test or inspection procedure as specified in the quality plan. Results of inspection or test are recorded on the NCMR or Rework Traveler (as appropriate). Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 5.2.6 If MRB determines the need to put production or shipment on hold, the decision is noted on the NCMR and the program manager is notified. In cases where the customers input is required to restart production or shipment, written decisions for approval/deviation from the customer shall be required. 5.3 Implementation of the Material Review Board Disposition 5.3.1 The discrepant product is processed based on the MRB disposition. 5.4 5.3.1.1 Discrepant product requiring rework, are reworked in accordance with approved rework instruction. Reworked product is subject to the same inspection and/or test as required. 5.3.1.2 Discrepant product disposition for scrap is disposed of in accordance with an established facility procedure for handling scrap. 5.3.1.3 Discrepant product requiring “Return to Vendor” is sent back to the Supplier in accordance with established facility procedure for handling parts to be returned to supplier. Discrepant Product Containment 5.4.1 Concurrent with the MRB activity is the containment of discrepant product for work-in process, finished goods inventory or product in the field, if applicable. 5.4.2 Recalled discrepant product shall be recorded on the NCMR and forwarded to the QA Department for identification, control, and disposition. 5.5 Investigation/Failure Analysis and Corrective Action 5.5.1 If the Material Review Board determines that the nonconformity needs further investigation/failure analysis, it will be noted on the NCMR form. 5.5.2 If the Material Review Board determines that the situation warrants issuance of a Corrective Action Request, a Corrective Action Request shall be processed in accordance with SOP-3MD8000-A, Corrective and Preventive Action procedure. Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 6.0 QUALITY RECORDS 6.1 7.0 8.0 9.0 SOP-4-MD7045-A Nonconforming Material Report (or Local Electronic NCMR Database system) ASSOCIATED DOCUMENTS 7.1 SOP-3-MD7012-A, Material Purge Control Procedure 7.2 SOP-3-MD7036-A, Product Recall Procedure 7.3 SOP-3-MD7023-A, Handling, Storage, Packaging, Preservation and Delivery SOP 7.4 SOP-3-MD8000-A, Corrective and Preventive Action 7.5 SOP-3-MD8002-A, Complaint Handling and Reporting Procedure 7.6 SOP-3-MD8009-A, Medical Device Reporting (MDR) Procedure. REFERENCE DOCUMENTS 8.0 21 CFR Part 820 – Quality System Regulation 8.1 (EN) ISO 13485 - Quality Management Systems – Medical Devices – System Requirements for Regulatory Purposes 8.2 SOR-98-282: May 7, 1998, Canadian Medical Device Regulation MISCELLANOUS 9.1 The following table specifies the minimum signature requirements on NCMRs. Quality Mfg Eng Materials Program Mgr Customer Material (Supplier Related Issues) X X (optional) X X2 X1,2 Assembly Level (Process Related Issues) X X X (optional) X2 X1,2 Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW 9.2 If NCMR forms are electronically initiated using a database, a print out of the form will be made for taking customer signatures and kept on file as record of objective evidence. Notes: 1) If customer has contractual obligation to have representation during MRB, signature is required. 2) If MRB committee has determined that non-conformance needs to be elevated to customer level, product manager is notified and customer is brought in for review and signature is also required. 10.0 REVISION LOG Rev. Section Date Released See Agile See Agile See Agile A B C None 4.4.1 & 5.1.1 4, 7 D E 6.1 3.0, 4.0, 5.0, 6.0, 8.0, and 9.0 See Agile See Agile F G ALL 2.0 3.5, 3.9.1, 4.3.8, 7.0 See Agile See Agile H 4.3.3 See Agile J All All 3.2 3.6 10-Oct-2014 Description Of Change Initial Release Allow use of NCMR database Corrected ref to Recall proc & added to assoc docs Correct 4.4.1, 5.1.1, 6.1 to SOP-4-MD7045-A Corrected procedure names, and added quality records. Incorporated complaint handling, initiation of investigations, and material purge processes to define a closed loop CAPA/Investigation process. Clarified minimum signature requirements. Revised the “superseded documents” sub-heading to “Reference Documents” Updated to new SOP format Added back definitions. Reference to Rework SOP, SOP-3-MD-7055-A, Added requirement for QA manager to approve all UAI, Include SOP-3-MD7055-A –Rework Procedure Updated footer Updated the responsibility of QA Manager to ensure finished devices that are being scrapped are made inoperable before disposal. Updated company logo and name change Updated procedure to clarify product also means material. Added immediate containment requirement Removed reference to Rework SOP and added Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile NONCONFORMING MATERIAL CONTROL & REVIEW K 3.2 3.2.1 12-Mar-2016 7.1 L 10-Oct-2017 2.1 3.4 3.5 3.15 M 7.6 3.5 5.2.5 23-Oct-18 rework instructions in place. Added definition for Rework and Repair. Updated procedure to include product that with unidentified or suspect status be classified nonconforming material. Removed obsolete SOP-3-MD4014-A. Updated to meet requirements of ISO 13485:2016. Added definition of advisory notice. Added documentation of investigation result in NCMR. Modified text for correct sequence of follow-up actions addressing nonconforming products detected. Added requirement for advisory notice in response to nonconforming product detected after delivery. Added associated MDR procedure. Highlighted the requirement to notify persons or functions directly responsible for the nonconformance to prevent further reoccurrence of the problem. Added requirement to determine and ensure no adverse effect before commencement of rework activity. Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use. Official document and revision history is available on Agile