Medtronic XOMED. Top Level Procedure for General Inspection and Testing

Transcription

1 Medtronic XOMED S.O.P. 360 Rev. AD Ref Page 1 of PURPOSE: 1.1 The purpose of this procedure is to provide a system instructions, and responsibility assignments for performing and recording the receiving and subsequent inspections of purchased products, in-process inspections, and final inspections. 2.0 SCOPE: 2.1 This procedure applies to materials, components, and other products that are purchased or are received from customers for incorporation into the final products sold by Medtronic Xomed, purchased finished products, subassemblies, and finished products. 2.2 This procedure directly concerns the Receiving, Quality Assurance, and Production functions, and is indirectly relevant to the Purchasing, R&D, and Storage functions. 3.0 ASSOCIATED DOCUMENTS: 3.1 Applicable Documents: SOP Third Party Laboratory Analysis of Material SOP Top Level Procedure for Control of Non-Conforming Product SOP Division Procedure for Record Retention SOP Receiving Procedure SOP Division Procedure for Product Identification and Traceability SOP Sampling Plans DOC Supplier Owned Quality QCFM 085 ECR Checklist QCFM Quality Assurance Audit Form QCFM Supplier Certificate of Conformance QCFM Inspection Data Sheet ACCEPTED Sticker 3.2 Reference Documents: N/A 4.0 GENERAL: 4.1 The essential requirements of MDD are considered during inspection planning and applicable requirements are incorporated in the inspection procedures relative to specific raw materials, in process products and subassemblies, and finished products. 4.2 Use of employee initials as referenced here-in is allowable, provided that employee initials are traceable to signature and/or identifiable person who conducted the testing/inspection. Records for this traceability/identification are kept on file in Human Resources. 4.3 The Sampling Plan used during inspection of raw materials, in-process manufacturing, or finished goods is indicated in the individual and/or family component or product specification. The procedure for sampling plans is found in SOP The procedure for third party testing (i.e. NAMSA, Cytotoxicity, etc.) is found in SOP All nonconforming materials are processed and documented on an NCMR per SOP PROCEDURE: 5.1 Receiving: The receiving clerk performs the visual inspection and checks identification of the received goods. Upon unloading of deliveries, the receiving clerk counts the number of delivered units, checks labeling and identification of packages, and inspects all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, the delivery receipt is signed by the inspector. If not, any shortages or damages are noted on all copies of the delivery receipts and the inspector notifies the responsible buyer. Hold bins are used for any shortage/damaged receipts Received goods are moved to the designated receiving area. All non-qa inspection required goods (provided they do not have a yellow DAMAGED sticker) as identified on the computer system and go directly to entrance. Reference SOP The product packages are labeled with the product/part and lot number For goods in the computer system requiring QA inspection, a label is printed and attached to the goods for QA inspection and placed in QA Inspection (INS). The label serve as the notification that product is awaiting inspection.

2 Rev. AD Ref Page 2 of QA Inspection: QA Inspectors perform received goods inspections. For parts that are under the supplier owned quality (SOQ) program (reference DOC) as referenced in the SAP system, the QA Inspector follows the instruction in Section 5.6. Parts under supplier owned quality are received into SLOC1060. If the part is not under the supplier owned quality program the QA inspector follows the instruction in this section First, the inspector assembles and reviews all the technical documentation, such as drawings, specifications, referenced standards, etc. that may be needed to determine the inspection scope and acceptance criteria. For assistance regarding the scope or the acceptance criteria, the inspector contacts QA Management and/or R&D At a minimum, the scope of receiving QA inspections comprises: Review of material certificates, source inspection records, compliance certificates, and other such documentation delivered with the product Confirm that the product was produced to the current revision of the specifications/drawing per SAP. A Certificate of Conformance (CoC) for the shipment can be used for this verification If a CoC is not required as part of the receipt/shipment (refer to the material spec/drawing), then the part inspection will be used to verify that it meets the current spec revision If a CoC is provided to a revision prior to the current revision in the system, the QA inspector will review the part s completed engineering change package(s) to determine if the section affecting Disposition of Product/ Material allows for the use up of previous revisions or that there is no affect to supplier inventory. If a Use Up is indicated or there is no impact to supplier material, then the CoC is acceptable If the CoC does not match the current rev or there is no allowance for previous revisions called out within the applicable completed engineering change packages, then an NCMR will be generated per SOP To view the disposition information for the engineering change, refer to the Inventory/Material Disposition section of the Affected Items tab of the ECR Visual inspection to detect any damage or other visible quality problems Perform measurements and testing as required Where pin gages are used, verify pin gage diameter before each use using a tool having a resolution of not less than In the note field for Inspection Description for Characteristics section of SAP, indicate that the pin gage diameter was verified per SOP Additional inspection of product with a yellow DAMAGED sticker to ensure integrity of the material inside the damaged shipping container. If the material inside the damaged container is not affected, a green ACCEPTED (see attachment A) sticker is affixed to the product and the product is stamped with the QC Acceptance stamp. If damage does affect contents, refer to SOP199 for the process for concealed damage Use QCFM 745 or the imbedded SAP detailed inspection plan to document the inspection results for all samples tested When using QCFM 745, enter the traceability information needed for the inspection (i.e. part number, revision, batch number and inspection lot number) Identify the inspections to be performed in the row identified by Requirement / Dimension & Tolerance. If additional space is needed, use additional sheets as necessary Under SAMPLE #, identify the number of samples to be inspected per SAP. Label each row sequentially until the sample size is reached. If additional space is needed, use additional sheets as necessary Enter the data into the sheets as the inspections are conducted If the requirement is an attribute inspection, (i.e. visual, cleanliness, presence of, etc.) then record with Pass or Fail. Pass may be abbreviated as P and Fail as F If the requirement is a variable inspection (i.e. a measurement is taken), record the measurement taken in the space provided.

3 Rev. AD Ref Page 3 of 7 NOTE: If using pin gages, record the value of the pin gauge for the feature being inspected. NOTE: Make sure to use correct significant digits when recording data Upon completion of the inspections verify if the data collected meets / satisfies the inspection requirement. Complete the Pass / Fail columns and rows appropriately Within the Inspection Tool column, document the calibration ID # for the measurement equipment used to inspect the part. If none is required, mark as N/A Upon completion of the data collection, the operator will sign and date the record. (The operator MAY also attach a scanned copy of the record into SAP to reside with inspection record) Accepted/Conforming Material/Products: Material/product that passes all the reviews, inspections, and testing shall have an accept label affixed to the receiving label The bar code label shall be affixed to the box/container prior to release and the box/container shall be placed in the appropriate storage location Finished Good products identified with a Finished Good label are not required to have the receiving label The test results, including the equipment used, are then entered in ERP system Test and measurement equipment used will be logged in the section by the calibration I.D. number, fixture, and/or fixture nomenclature Rejected/Non-Conforming Material/Product: The QA inspector initiates an NCMR for any material/product that does not conform to requirements or if the enclosed certificates and other quality records are missing or incomplete A copy of the NCMR is attached to the product and the product is moved to a designated quarantine hold area Product is dispositioned in accordance with SOP For material that requires Cytotoxicity testing, the Inspector shall review the Cytotoxicity Test File to determine when the previous test for that material has been performed. If it has been greater than 1 year since the last test performed, then Cytotoxicity testing shall be initiated per the specification QA Incoming Cleanliness and Control of Materials: Workstations, fixtures, and equipment shall be cleaned to effectively maintain a safe, orderly, and relatively clean work environment Materials that are not part of the incoming inspection process shall not be located in the Incoming QA Areas Boxes and carts shall be located only in designated labeled areas or workstations All labeling and signage on boxes, carts, and floors shall be securely attached Materials with expiration QA inspectors shall verify that the entire lot has the same expiration date. If there are different expiration dates mixed within the lot, efforts should be made to split the lot so that each different expiration date is grouped into an individual lot In cases where it is not possible to separate the lot, the shortest date of expiration shall be used Expiration labels shall be applied to all individual containers within a lot / batch prior release to inventory (refer to SOP 359) Record Archiving When the inspection is completed and processed to closure, the QA technician will collect all the supplier provided documentation (CofCs, etc.) and the QCFM 745 (if applicable) and place them in an inspection file folder identified with the inspection lot number, Medtronic batch lot number and Item Part Number This file will be added to an Iron Mountain Data Record box, and retained per SOP Manufacturing Operator Inspections (Process Checks and Acceptance Activities): Process Checks and Acceptance Activities can occur at various points throughout the manufacture of a

4 Rev. AD Ref Page 4 of 7 sub-assembly or finished product. Acceptance Activities usually occur right before the packaging step and/or right after the packaging step. Process Checks and Acceptance Activities are performed to verify that an operation or a process was performed satisfactorily and to prompt appropriate action. Results are documented as part of the Device History Record Process Checks and Acceptance Activities are generally the responsibility of trained/authorized manufacturing personnel. The scope of inspections is communicated to operators through work instructions which may refer to additional documents (such as drawings) as needed If inspection requires the use of measuring or test equipment, the operators are provided with, and are instructed in the use of, controlled and calibrated measuring equipment suitable for carrying out the inspection. The operator must verify calibration status prior to use Space is provided in the record associated with the work instruction (for example XPI-DS or PR) to record variable or attribute results as needed. The section must be completed, signed and dated by the operator responsible for performing the step (or by an approved designee) In-process use of QCFM Use QCFM 745 when: There is not adequate space on the Data Sheet to complete an inspection identified in the work instructions. There is a sampling inspection that requires a variables measurement, but adequate space has not yet been added to the Data Sheet. There are AQLs on the drawings for components manufactured in-house (for example: molding or machining) and the sampling inspection has not yet been identified on the work instructions and corresponding data sheet Enter XPI step number in the space provided in the header along with the required drawing (if applicable). NOTE: The highest level step may be used for the inspections documented on the form. Document the requirement and related tolerance in the row marked Requirement / Dimension & Tolerance. Complete as indicated and attach to the Production / DHR record. 5.4 QA Audits: QA in-process audits are performed on random selected Production Orders Random or selected Production Orders are audited daily by manufacturing area. The audit criteria are comprised and documented using QCFM 294. QA is responsible for attaching the QCFM to the Production Order audited. The form becomes part of the Production Order history If a quality event is identified during the audit, a QA technician initiates an NCMR per SOP Certificates of Conformance for Puerto Rico: Each shipment of components, sub assemblies, and raw materials shipped to Medtronic Puerto Rico (MPROC) facilities requires a certificate of conformance that follows the format in QCFM 698, Supplier Certificate of Conformance Distribution personnel complete the certificate for each shipment of components and subassemblies manufactured in Jacksonville up through the Certification of Functional Testing section of the QCFM. Then they provide the certificate to Quality Assurance for completion of the remainder of the certificate Quality Assurance personnel complete the entire certificate for any purchased components, subassemblies, or raw materials Quality Assurance personnel scan the certificate and post it to the appropriate folder on the MPROC site once a certificate of conformance is completed All paper records are placed in individual files for each shipment and placed in Iron Mountain boxes for record retention per SOP 040.

5 Rev. AD Ref Page 5 of Processing of SOQ Material Log-in to the SQM Web Portal using your username and password Once logged-in, First click on Queries Then click on Latest Shipments Then click on the Filter icon.

6 Rev. AD Ref Page 6 of Then click on the empty white box above Lot Id Then enter the supplier lot id in the Filter input. The supplier lot id will be located on the Packing Slip that accompanies the material. Then click Apply. (If packaging slip has not been provided by receiving then QA inspectors request a copy of packing slip from receiving) This will filter data for the supplier lot number within scope. Verify Results and Flag columns. If there is only row with a column with Success in the Result Column and N under the Flag column, process the parts as per site receiving procedure to transfer parts directly to Unrestricted Stock. 5.7 If there are no lots with Success under Result and N under Flag column, contact the appropriate Supplier Quality Engineer (SQE) or Sourcing Engineer to resolve the issue. 5.8 If for any reason the material cannot be processed, leave the parts in SLOC 1060 and contact the appropriate SQE or Sourcing Engineer. If the issue cannot be resolved then a NCMR will be generated per SOP037.

7 .5 5. S.O.P. 360 Rev. AD Ref Page 7 of 7 ATTACHMENT A: APPROVED STICKER

8 Medtronic XOMED S.O.P. 360 Rev. AC AD Ref Page 1of PURPOSE: 1.1 The purpose of this procedure is to provide a system instructions, and responsibility assignments for performing and recording the receiving and subsequent inspections of purchased products, in-process inspections, and final inspections. 2.0 SCOPE: 2.1 This procedure applies to materials, components, and other products that are purchased or are received from customers for incorporation into the final products sold by Medtronic Xomed, purchased finished products, subassemblies, and finished products. 2.2 This procedure directly concerns the Receiving, Quality Assurance, and Production functions, and is indirectly relevant to the Purchasing, R&D, and Storage functions. 3.0 ASSOCIATED DOCUMENTS: 3.1 Applicable Documents: SOP Third Party Laboratory Analysis of Material SOP Top Level Procedure for Control of Non-Conforming Product SOP Division Procedure for Record Retention SOP Receiving Procedure SOP Division Procedure for Product Identification and Traceability SOP Sampling Plans DOC Supplier Owned Quality QCFM 085 ECR Checklist QCFM Quality Assurance Audit Form QCFM Quality Event Form QCFM Supplier Certificate of Conformance QCFM Inspection Data Sheet ACCEPTED Sticker 3.2 Reference Documents: N/A 4.0 GENERAL: 4.1 The essential requirements of MDD are considered during inspection planning and applicable requirements are incorporated in the inspection procedures relative to specific raw materials, in process products and subassemblies, and finished products. 4.2 Use of employee initials as referenced here-in is allowable, provided that employee initials are traceable to signature and/or identifiable person who conducted the testing/inspection. Records for this traceability/identification are kept on file in Human Resources. 4.3 The Sampling Plan used during inspection of raw materials, in-process manufacturing, or finished goods is indicated in the individual and/or family component or product specification. The procedure for sampling plans is found in SOP The procedure for third party testing (i.e. NAMSA, Cytotoxicity, etc.) is found in SOP All nonconforming materials are processed and documented on an NCMR per SOP PROCEDURE: 5.1 Receiving: The receiving clerk performs the visual inspection and checks identification of the received goods. Upon unloading of deliveries, the receiving clerk counts the number of delivered units, checks labeling and identification of packages, and inspects all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, the delivery receipt is signed by the inspector. If not, any shortages or damages are noted on all copies of the delivery receipts and the inspector notifies the responsible buyer. Hold bins are used for any shortage/damaged receipts Received goods are moved to the designated receiving area. All non-qa inspection required goods (provided they do not have a yellow DAMAGED sticker) as identified on the computer system and go directly to entrance. Reference SOP The product packages are labeled with the product/part and lot number For goods in the computer system requiring QA inspection, a label is printed and attached to the goods for QA inspection and placed in QA Inspection (INS). The label serve as the notification that product is

9 Rev. AC AD Ref Page 2 of 8 awaiting inspection. 5.2 QA Inspection: QA Inspectors perform received goods inspections. For parts that are under the supplier owned quality (SOQ) program (reference DOC) as referenced in the SAP system, the QA Inspector follows the instruction in Section 5.6. Parts under supplier owned quality are received into SLOC1060. If the part is not under the supplier owned quality program the QA inspector follows the instruction in this section First, the inspector assembles and reviews all the technical documentation, such as drawings, specifications, referenced standards, etc. that may be needed to determine the inspection scope and acceptance criteria. For assistance regarding the scope or the acceptance criteria, the inspector contacts QA Management and/or R&D At a minimum, the scope of receiving QA inspections comprises: Review of material certificates, source inspection records, compliance certificates, and other such documentation delivered with the product Confirm that the product was produced to the current revision of the specifications/drawing per SAP. A Certificate of Conformance (CoC) for the shipment can be used for this verification If a CoC is not required as part of the receipt/shipment (refer to the material spec/drawing), then the part inspection will be used to verify that it meets the current spec revision If a CoC is provided to a revision prior to the current revision in the system, the QA inspector will review the part s completed engineering change package(s) to determine if the section affecting Disposition of Product/ Material allows for the use up of previous revisions or that there is no affect to supplier inventory. If a Use Up is indicated or there is no impact to supplier material, then the CoC is acceptable If the CoC does not match the current rev or there is no allowance for previous revisions called out within the applicable completed engineering change packages, then an NCMR will be generated per SOP To view the disposition information for the engineering change, refer to the Inventory/Material Disposition section of the Affected Items tab of the ECR Visual inspection to detect any damage or other visible quality problems Perform measurements and testing as required Where pin gages are used, verify pin gage diameter before each use using a tool having a resolution of not less than In the note field for Inspection Description for Characteristics section of SAP, indicate that the pin gage diameter was verified per SOP Additional inspection of product with a yellow DAMAGED sticker to ensure integrity of the material inside the damaged shipping container. If the material inside the damaged container is not affected, a green ACCEPTED (see attachment A) sticker is affixed to the product and the product is stamped with the QC Acceptance stamp. If damage does affect contents, refer to SOP199 for the process for concealed damage Use QCFM 745 or the imbedded SAP detailed inspection plan to document the inspection results for all samples tested When using QCFM 745, enter the traceability information needed for the inspection (i.e. part number, revision, batch number and inspection lot number) Identify the inspections to be performed in the row identified by Requirement / Dimension & Tolerance. If additional space is needed, use additional sheets as necessary Under SAMPLE #, identify the number of samples to be inspected per SAP. Label each row sequentially until the sample size is reached. If additional space is needed, use additional sheets as necessary Enter the data into the sheets as the inspections are conducted If the requirement is an attribute inspection, (i.e. visual, cleanliness, presence of, etc.) then record with Pass or Fail. Pass may be abbreviated as P and Fail as F If the requirement is a variable inspection (i.e. a measurement is taken), record

10 Rev. AC AD Ref Page 3 of 8 the measurement taken in the space provided. NOTE: If using pin gages, record the value of the pin gauge for the feature being inspected. NOTE: Make sure to use correct significant digits when recording data Upon completion of the inspections verify if the data collected meets / satisfies the inspection requirement. Complete the Pass / Fail columns and rows appropriately Within the Inspection Tool column, document the calibration ID # for the measurement equipment used to inspect the part. If none is required, mark as N/A Upon completion of the data collection, the operator will sign and date the record. (The operator MAY also attach a scanned copy of the record into SAP to reside with inspection record) Accepted/Conforming Material/Products: Material/product that passes all the reviews, inspections, and testing shall have an accept label affixed to the receiving label The bar code label shall be affixed to the box/container prior to release and the box/container shall be placed in the appropriate storage location Finished Good products identified with a Finished Good label are not required to have the receiving label The test results, including the equipment used, are then entered in ERP system Test and measurement equipment used will be logged in the section by the calibration I.D. number, fixture, and/or fixture nomenclature Rejected/Non-Conforming Material/Product: The QA inspector initiates an NCMR for any material/product that does not conform to requirements or if the enclosed certificates and other quality records are missing or incomplete A copy of the NCMR is attached to the product and the product is moved to a designated quarantine hold area Product is dispositioned in accordance with SOP For material that requires Cytotoxicity testing, the Inspector shall review the Cytotoxicity Test File to determine when the previous test for that material has been performed. If it has been greater than 1 year since the last test performed, then Cytotoxicity testing shall be initiated per the specification QA Incoming Cleanliness and Control of Materials: Workstations, fixtures, and equipment shall be cleaned to effectively maintain a safe, orderly, and relatively clean work environment Materials that are not part of the incoming inspection process shall not be located in the Incoming QA Areas Boxes and carts shall be located only in designated labeled areas or workstations All labeling and signage on boxes, carts, and floors shall be securely attached Materials with expiration QA inspectors shall verify that the entire lot has the same expiration date. If there are different expiration dates mixed within the lot, efforts should be made to split the lot so that each different expiration date is grouped into an individual lot In cases where it is not possible to separate the lot, the shortest date of expiration shall be used Expiration labels shall be applied to all individual containers within a lot / batch prior release to inventory (refer to SOP 359) Record Archiving When the inspection is completed and processed to closure, the QA technician will collect all the supplier provided documentation (CofCs, etc.) and the QCFM 745 (if applicable) and place them in an inspection file folder identified with the inspection lot number, Medtronic batch lot number and Item Part Number This file will be added to an Iron Mountain Data Record box, and retained per SOP Manufacturing Operator Inspections (Process Checks and Acceptance Activities):

11 Rev. AC AD Ref Page 4 of Process Checks and Acceptance Activities can occur at various points throughout the manufacture of a sub-assembly or finished product. Acceptance Activities usually occur right before the packaging step and/or right after the packaging step. Process Checks and Acceptance Activities are performed to verify that an operation or a process was performed satisfactorily and to prompt appropriate action. Results are documented as part of the Device History Record Process Checks and Acceptance Activities are generally the responsibility of trained/authorized manufacturing personnel. The scope of inspections is communicated to operators through work instructions which may refer to additional documents (such as drawings) as needed If inspection requires the use of measuring or test equipment, the operators are provided with, and are instructed in the use of, controlled and calibrated measuring equipment suitable for carrying out the inspection. The operator must verify calibration status prior to use Space is provided in the record associated with the work instruction (for example XPI-DS or PR) to record variable or attribute results as needed. The section must be completed, signed and dated by the operator responsible for performing the step (or by an approved designee) In-process use of QCFM Use QCFM 745 when: There is not adequate space on the Data Sheet to complete an inspection identified in the work instructions. There is a sampling inspection that requires a variables measurement, but adequate space has not yet been added to the Data Sheet. There are AQLs on the drawings for components manufactured in-house (for example: molding or machining) and the sampling inspection has not yet been identified on the work instructions and corresponding data sheet Enter XPI step number in the space provided in the header along with the required drawing (if applicable). NOTE: The highest level step may be used for the inspections documented on the form. Document the requirement and related tolerance in the row marked Requirement / Dimension & Tolerance. Complete as indicated and attach to the Production / DHR record. 5.4 QA Audits: QA in-process audits are performed on random selected Production Orders Random or selected Production Orders are audited daily by manufacturing area. The audit criteria are comprised and documented using QCFM 294. QA is responsible for attaching the QCFM to the Production Order audited. The form becomes part of the Production Order history If a quality event is identified during the audit, a QA technician initiates an NCMR per SOP 037. and processes QCFM 686, Quality Event Form per SOP Certificates of Conformance for Puerto Rico: Each shipment of components, sub assemblies, and raw materials shipped to Medtronic Puerto Rico (MPROC) facilities requires a certificate of conformance that follows the format in QCFM 698, Supplier Certificate of Conformance Distribution personnel complete the certificate for each shipment of components and subassemblies manufactured in Jacksonville up through the Certification of Functional Testing section of the QCFM. Then they provide the certificate to Quality Assurance for completion of the remainder of the certificate Quality Assurance personnel complete the entire certificate for any purchased components, subassemblies, or raw materials Quality Assurance personnel scan the certificate and post it to the appropriate folder on the MPROC site once a certificate of conformance is completed All paper records are placed in individual files for each shipment and placed in Iron Mountain boxes for record retention per SOP Processing of SOQ Material Log-in to the SQM Web Portal using your username and password.

12 Rev. AC AD Ref Page 5 of Once logged-in, First click on Queries Then click on Latest Shipments Then click on the Filter icon.

13 Rev. AC AD Ref Page 6 of Then click on the empty white box above Lot Id Then enter the supplier lot id in the Filter input. The supplier lot id will be located on the Packing Slip that accompanies the material. Then click Apply. (If packaging slip has not been provided by receiving then QA inspectors request a copy of packing slip from receiving) This will filter data for the supplier lot number within scope. Verify Results and Flag columns. If there is only row with a column with Success in the Result Column and N under the Flag column, process the parts as per site receiving procedure to transfer parts directly to Unrestricted Stock.

14 Rev. AC AD Ref Page 7 of If there are no lots with Success under Result and N under Flag column, contact the appropriate Supplier Quality Engineer (SQE) or Sourcing Engineer to resolve the issue. 5.8 If for any reason the material cannot be processed, leave the parts in SLOC 1060 and contact the appropriate SQE or Sourcing Engineer. If the issue cannot be resolved then a NCMR will be generated per SOP037.

15 .5 5. S.O.P. 360 Rev. AC AD Ref Page 8 of 8 ATTACHMENT A: APPROVED STICKER