This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Medtronic XOMED

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. N Ref. 7.5.3 Page 1 of 5

1.0 PURPOSE: 1.1 The purpose of this procedure is to provide for a system and instructions, to assign responsibilities and to meet

the requirements of Corporate Policy 017 of the Corporate Quality and Regulatory Affairs Policy for: 1.1.1 Product identification and traceability 1.1.2 Allocating part and serial numbers 1.1.3 Product marking

2.0 SCOPE: 2.1 This procedure applies to all materials, components, and subassemblies intended for incorporation into the final

products sold by Medtronic Xomed and to the final products themselves. 2.2 This procedure applies to the Jacksonville and Mystic facilities.

3.0 ASSOCIATED DOCUMENTS: 3.1 Applicable Documents:

3.1.1 SOP 037 - Top Level Procedure for Control of Non-Conforming Product 3.1.2 SOP 040 - Division Procedure for Record Retention 3.1.3 QCFM 293 - Lot Traceability Decision Tree 3.1.4 Corporate Procedure 035-P295 - United States FDA Unique Device Identification (UDI)

3.2 Reference Documents: 3.2.1 Corporate Policy 017 Product Identification and Traceability Policy

4.0 GENERAL: N/A 5.0 PROCEDURE:

5.1 Parts and Product Identification: 5.1.1 All purchased materials and parts intended for incorporation into the company's products are assigned

and their packaging marked with a part number. 5.1.2 Receiving (Jax)

5.1.2.1 SAP generates a standard receiving label that will indicate the type of inspection to be performed by incoming inspection. This is based upon the inspection history of the part within SAP history or based upon the master data set-up. The following are different statuses that can be reflected on the Receiving Label: (refer to Appendix A for examples) • Inspection Required (QI Stock) • Normal Inspection • Reduced Inspection • Tightened Inspection • No Inspection Required Note: SAP will place numbers behind the inspection note. These numbers are logic levels that SAP uses to manage the switching rules between Normal, Reduced and Tightened inspection. The numbers have no bearing on the inspection to be performed. Note: SAP inspection levels are to be verified against the manual Part File. Any discrepancies should between the part history file and SAP will be adjusted to match the part history file. SAP will be adjusted accordingly.

5.1.2.2 If shipping damage is found during receiving, the box or pallet will be identified with a DAMAGE label (see appendix A).

5.1.3 Incoming Inspection: (JAX) 5.1.3.1 After incoming inspection is performed, the status of the product will be identified in 1 of 3

ways: refer to Appendix A for examples. 5.1.3.2 QA Stamp - A green QA Accepted stamp will be placed on the receiving label. The stamp will

include the number assigned to the inspector and the date stamped. The presence of this stamp will indicate to the material handlers that the material has been released to inventory and is acceptable for use in production.

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. N Ref. 7.5.3 Page 2 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

5.1.3.3 ACCEPTED (OK) - SAP post move to inventory will generate a label stating Accepted (OK). This indicates that the material is released to inventory. This is equivalent and interchangeable with the green QA stamp. The presence of this ACCEPTED (OK) on the SAP label indicates to the material handlers that the material has been released to inventory and is acceptable for use in production. Labels reprinted from SAP after QA release should have this indication.

5.1.3.4 NCMR - If a product is rejected, the product will be identified with a copy of the NCMR per SOP 037.

5.1.3.5 If a box has external damage, but is marked with an “Accepted, damage does not effect product” sticker” (See appendix A), then it has been reviewed by inspection / engineering found not to be impacting the internal contents or customer facing packaging. The damage is acceptable and may be moved to inventory as is or be repacked by material handling.

5.1.4 If raw material needs to be removed from the primary package and it has a QA acceptance stamp, an additional label (small label) must be produced indicating the part number, lot number, and expiration date (if applicable). This includes materials such as adhesives, lubricants, and chemicals or fluids. The primary package with the QA acceptance sticker will remain in the raw material area. 5.1.4.1 The quantity printed on the label of the primary package cannot be revised (marked through

with initials and date) to reflect the remaining contents of the primary package. 5.1.4.2 Refer to Appendix A for examples of JAX in-house labels and expiration date labels. 5.1.4.3 Adhesives that are purchased in point-of-use containers (hand held tubes, bottles, guns,

etc.) must be labeled by QA personnel with the part number, lot number, and expiration date. See Appendix A for an example. In-process handwritten or downstream printed labels are not permitted for these items.

5.1.5 Prior to making additional labels (i.e. smaller labels) the Material Handlers must verify that the QA acceptance label is present. R&D department is responsible for assignment of part numbers. Marking is done by the receiving clerk. In-house manufactured parts likewise are identified with a part number and lot number. Whenever possible the same number identifies drawings and specifications pertaining to the part.

5.1.6 Finished products are assigned and labeled with a lot number. The Operations department is responsible for assigning lot numbers. The work order, inspection records, and all other documents and records created during manufacturing, assembly, inspection, and testing of a product are identified with its lot number. Each product is labeled with its lot number after it has passed the final inspection.

5.1.7 Some products, primarily electro-mechanical capital products, are also assigned and labeled with a serial number. Operations controls and issues these numbers.

5.2 Identification and Traceability Record: 5.2.1 Raw material analysis files contain the record for each component part number and lot number. 5.2.2 Traceability to the materials, component, subassemblies, etc. used to manufacture other subassemblies or

finished products is maintained by recording the corresponding part and lot numbers and quantity of the materials, component, subassemblies, etc. that are used on the Bill of Material (BOM) and the Materials Issued Report that accompany each Work Order (WO). If lot traceability for any material, component, or subassembly is determined as not necessary, QCFM 293 Lot Traceability Decision Tree must be completed to document this decision. The completed/approved form will be filed in DHR department.

5.2.3 The company has overall responsibility for traceability of distributed finished products. The traceability record includes the following minimum information: product number, lot or serial number, customer name, and quantity and date shipped. 5.2.3.1 For finished products sold to independent distributors, Medtronic Xomed will have

contracts/agreements with distributors that will include their responsibility to maintain traceability of product sold to customers and cooperate with company requested field actions.

5.2.3.2 For devices labeled with a Unique Device Identifier (see Corporate Procedure 035-P295, United States FDA Unique Device Identification (UDI) for rules on which devices are labeled with a UDI), the DHR includes or refers to the location of the UDI information.

5.2.4 R&D and Document Control departments maintain records correlating each issued part number to corresponding drawings, specifications, technical data, and other documentation defining the part. The record is maintained while the part is in use, and is preserved in accordance with SOP 040.

5.2.5 Quality Assurance department maintains configuration records for each product. The records correlate lot and/or serial numbers of products with the parts lists used in their manufacture. Storage location and retention period for the identification and traceability records are specified in SOP 040.

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. N Ref. 7.5.3 Page 3 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Appendix A

Receiving Inspection Labels General Inspection Required Normal Inspection Required

Reduced Inspection Required Tightened Inspection Required

No Inspection Required

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. N Ref. 7.5.3 Page 4 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Acceptance Labels Receiving Label with Green QA Accept Stamp Inventory Label - Accepted (OK)

In-Process Labels In-Process Mini Label In-Process Handwritten Label

Expiration Label Expiration Label on Adhesive in Point-of-Use Container

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. N Ref. 7.5.3 Page 5 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Shipping Damage Labels

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Medtronic XOMED

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. M N Ref. 7.5.3 Page 1 of 5

1.0 PURPOSE: 1.1 The purpose of this procedure is to provide for a system and instructions, to assign responsibilities and to meet

the requirements of Corporate Policy 017 of the Corporate Quality and Regulatory Affairs Policy for: 1.1.1 Product identification and traceability 1.1.2 Allocating part and serial numbers 1.1.3 Product marking

2.0 SCOPE: 2.1 This procedure applies to all materials, components, and subassemblies intended for incorporation into the final

products sold by Medtronic Xomed and to the final products themselves. 2.2 This procedure applies to the Jacksonville and Mystic facilities.

3.0 ASSOCIATED DOCUMENTS: 3.1 Applicable Documents:

3.1.1 SOP 037 - Top Level Procedure for Control of Non-Conforming Product 3.1.2 SOP 040 - Division Procedure for Record Retention 3.1.3 QCFM 293 - Lot Traceability Decision Tree 3.1.4 Corporate Procedure 035-P295 - United States FDA Unique Device Identification (UDI)

3.2 Reference Documents: 3.2.1 SOP 524 - Division Procedure for Good Documentation Practices for Quality Records 3.2.2 Corporate Policy 017 Product Identification and Traceability Policy

4.0 GENERAL: N/A 5.0 PROCEDURE:

5.1 Parts and Product Identification: 5.1.1 All purchased materials and parts intended for incorporation into the company's products are assigned

and their packaging marked with a part number. 5.1.2 Receiving (Jax)

5.1.2.1 SAP generates a standard receiving label that will indicate the type of inspection to be performed by incoming inspection. This is based upon the inspection history of the part within SAP history or based upon the master data set-up. The following are different statuses that can be reflected on the Receiving Label: (refer to Appendix A for examples) • Inspection Required (QI Stock) • Normal Inspection • Reduced Inspection • Tightened Inspection • No Inspection Required Note: SAP will place numbers behind the inspection note. These numbers are logic levels that SAP uses to manage the switching rules between Normal, Reduced and Tightened inspection. The numbers have no bearing on the inspection to be performed. Note: SAP inspection levels are to be verified against the manual Part File. Any discrepancies should between the part history file and SAP will be adjusted to match the part history file. SAP will be adjusted accordingly.

5.1.2.2 If shipping damage is found during receiving, the box or pallet will be identified with a DAMAGE label (see appendix A).

5.1.3 Incoming Inspection: (JAX) 5.1.3.1 After incoming inspection is performed, the status of the product will be identified in 1 of 3

ways: refer to Appendix A for examples. 5.1.3.2 QA Stamp - A green QA Accepted stamp will be placed on the receiving label. The stamp will

include the number assigned to the inspector and the date stamped. The presence of this stamp will indicate to the material handlers that the material has been released to inventory and is acceptable for use in production.

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. M N Ref. 7.5.3 Page 2 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

5.1.3.3 ACCEPTED (OK) - SAP post move to inventory will generate a label stating Accepted (OK). This indicates that the material is released to inventory. This is equivalent and interchangeable with the green QA stamp. The presence of this ACCEPTED (OK) on the SAP label indicates to the material handlers that the material has been released to inventory and is acceptable for use in production. Labels reprinted from SAP after QA release should have this indication.

5.1.3.4 NCMR - If a product is rejected, the product will be identified with a copy of the NCMR per SOP 037.

5.1.3.5 If a box has external damage, but is marked with an “Accepted, damage does not effect product” sticker” (See appendix A), then it has been reviewed by inspection / engineering found not to be impacting the internal contents or customer facing packaging. The damage is acceptable and may be moved to inventory as is or be repacked by material handling.

5.1.4 If raw material needs to be removed from the primary package and it has a QA acceptance stamp, an additional label (small label) must be produced indicating the part number, lot number, and expiration date (if applicable). This includes materials such as adhesives, lubricants, and chemicals or fluids. The primary package with the QA acceptance sticker will remain in the raw material area. 5.1.4.1 The quantity printed on the label of the primary package cannot be revised (marked through

with initials and date) to reflect the remaining contents of the primary package. 5.1.4.2 Refer to Appendix A for examples of JAX in-house labels and expiration date labels. 5.1.4.3 Adhesives that are purchased in point-of-use containers (hand held tubes, bottles, guns,

etc.) must be labeled by QA personnel with the part number, lot number, and expiration date. See Appendix A for an example. In-process handwritten or downstream printed labels are not permitted for these items.

5.1.5 Prior to making additional labels (i.e. smaller labels) the Material Handlers must verify that the QA acceptance label is present. R&D department is responsible for assignment of part numbers. Marking is done by the receiving clerk. In-house manufactured parts likewise are identified with a part number and lot number. Whenever possible the same number identifies drawings and specifications pertaining to the part.

5.1.6 Finished products are assigned and labeled with a lot number. The Operations department is responsible for assigning lot numbers. The work order, inspection records, and all other documents and records created during manufacturing, assembly, inspection, and testing of a product are identified with its lot number. Each product is labeled with its lot number after it has passed the final inspection.

5.1.7 Some products, primarily electro-mechanical capital products, are also assigned and labeled with a serial number. Operations controls and issues these numbers.

5.2 Identification and Traceability Record: 5.2.1 Raw material analysis files contain the record for each component part number and lot number. 5.2.2 Traceability to the materials, component, subassemblies, etc. used to manufacture other subassemblies or

finished products is maintained by recording the corresponding part and lot numbers and quantity of the materials, component, subassemblies, etc. that are used on the Bill of Material (BOM) and the Materials Issued Report that accompany each Work Order (WO). If lot traceability for any material, component, or subassembly is determined as not necessary, QCFM 293 Lot Traceability Decision Tree must be completed to document this decision. The completed/approved form will be filed in DHR department.

5.2.3 The company has overall responsibility for traceability of distributed finished products. The traceability record includes the following minimum information: product number, lot or serial number, customer name, and quantity and date shipped. 5.2.3.1 For finished products sold to independent distributors, Medtronic Xomed will have

contracts/agreements with distributors that will include their responsibility to maintain traceability of product sold to customers and cooperate with company requested field actions.

5.2.3.2 For devices labeled with a Unique Device Identifier (see Corporate Procedure 035-P295, United States FDA Unique Device Identification (UDI) for rules on which devices are labeled with a UDI), the DHR includes or refers to the location of the UDI information.

5.2.4 R&D and Document Control departments maintain records correlating each issued part number to corresponding drawings, specifications, technical data, and other documentation defining the part. The record is maintained while the part is in use, and is preserved in accordance with SOP 040.

5.2.5 Quality Assurance department maintains configuration records for each product. The records correlate lot and/or serial numbers of products with the parts lists used in their manufacture. Storage location and retention period for the identification and traceability records are specified in SOP 040.

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. M N Ref. 7.5.3 Page 3 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Appendix A

Receiving Inspection Labels General Inspection Required Normal Inspection Required

Reduced Inspection Required Tightened Inspection Required

No Inspection Required

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. M N Ref. 7.5.3 Page 4 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Acceptance Labels Receiving Label with Green QA Accept Stamp Inventory Label - Accepted (OK)

In-Process Labels In-Process Mini Label In-Process Handwritten Label

Expiration Label Expiration Label on Adhesive in Point-of-Use Container

S.O.P. 359 Division Procedure for Product Identification and Traceability

Rev. M N Ref. 7.5.3 Page 5 of 5

This document is electronically controlled. Printed copies are considered uncontrolled. Refer to the Document Management System for the controlled version of this document.

Shipping Damage Labels