ZOLL Document Number: 90F1087 Page 3 of 18 MES/ERP Nonconforming Material Transaction Instructions REV B

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3 ZOLL Document Number: 90F1087 Page 3 of INTRODUCTION The purpose of this document is to provide instruction for when and how to perform the ERP and MES transactions required to process nonconforming material. Execution of transactions per the instructions contained in this document ensure that nonconforming material can be properly identified and quantities in the system of record are accurately maintained. All defective material shall be processed per 90F0030, flowchart 90F1087- A01 and 90E APPLICABLE DOCUMENTS 90F1087-A01 90E F F F RESPONSIBILITIES MES/ERP Nonconforming Material Flowchart Camstar Visual Aid for QA Inspection Nonconforming Material Product Service Safe Handling and Cleaning Procedures for LifeVest System Hardware Responsibilities for performing transactions are identified in the bottom right hand corner of flowchart steps within flowchart 90F1087-A DEFINITIONS Container Camstar s primary method for identifying what is being processed in the system. System generated container names may be a lot number, serial number, inspection request parent identifier, inspection request child identifier, or a rework identifier. Other manually assigned container naming conventions are identified in this document. Work In-Process(WIP) The status of material identified as the part being built on an open manufacturing order, serviced on a service order, or reworked on a rework order. Split Qty The Camstar transaction used to divide a portion of an existing container into a new identical container that is named by the user. Naming conventions are defined in the instructions in this procedure Remove The Camstar transaction used to un-issue material from the container it was issued to. By default, the material is returned to the container that it was issued from. Rework Transaction The rework transaction is the Camstar transaction used to move defective material to a predefined step that has been configured to process nonconforming material.

4 ZOLL Document Number: 90F1087 Page 4 of SPLITTING QUANITITES OF DEFECTIVE MATERIAL IN CAMSTAR 5.1 Lot Controlled and Non-Serial/Non-Lot Controlled Material Material Status: WIP In order to send accepted material to inventory and defective material to the MRB for disposition, the defective quantity must be split into a new container. When performing the Split QTY transaction, the UCR or II number (e.g. UC-12345, II-12345) shall be used as the container name for the defective material. If the full quantity associated with the order is defective, the container should be split to maintain naming consistency Material Status: In-Stock, Point of Use Defective lot controlled or non-serial/non-lot controlled material that is not associated with an order in Camstar shall have a rework order generated in Epicor prior to MRB processing. Any quantity specified on the rework order that is available in Camstar will be automatically split by the system into a rework container using the rework numbering rule (RWxxxxxxxx). Note: Any point of use material that has been issued to another container should be removed from that container before the rework order is generated in Epicor Multiple Dispositions for Lot Controlled Material on a Single UCR or II Camstar requires that each disposition for lot controlled material is processed individually. When splitting material into a new container for this purpose, the following naming conventions should be used: Disposition Return to Supplier Scrap Use As Is Use For (a special purpose) Only Rework to Specification Other Multiple Container Name (UCR# or II#)_RTV (UCR# or II#)_Scrap (UCR# or II#)_UAI (UCR# or II#)_SPO (UCR# or II#)_RW (UCR# or II#)_Other (UCR# or II#)_Mult Any single piece of material can only exist in a single MES container at once. If any single piece of lot controlled material has multiple failure modes with different dispositions for each, use the naming convention for multiple dispositions. 5.2 Serial Controlled Material Serial Controlled items shall never be split into a new container to process a nonconformance. Reference flowchart 90F1097-A01 for the appropriate transactions.

5 ZOLL Document Number: 90F1087 Page 5 of REPLACEMENT OF SUBASSEMBLY COMPONENTS All components issued to subassemblies on a manufacturing order must be removed from that subassembly in order to be processed. In order to accomplish this, the subassembly must first be removed from any upper level assembly it is issued to. Once the defective component has been replaced, the subassembly must be reissued to the upper level assembly. Reference flowchart 90F1087-A01 for all required transactions. 7. EXCEPTIONS In the event that large quantities of material must be transacted, the standard process in this document may result in a significant contribution of non-value added transactional labor time that could potentially be eliminated or significantly reduced. In these situations, exceptions to the process may be made. The process used for an exception must be assessed by Quality Assurance, Manufacturing Systems, Enterprise Applications, and Finance to ensure compliance, data accuracy, and financial records are properly maintained. The process used for the exception shall be clearly documented per 95A0002.

6 ZOLL Document Number: 90F1087 Page 6 of 18 Appendix A Split Qty Transactions

7 ZOLL Document Number: 90F1087 Page 7 of 18 Instructions for Executing the Split Qty Transaction 1. Generate an Unsatisfactory Condition Report (UCR) or add a nonconformance to the Incoming Inspection (II) report per 90F Log into Camstar and enter the station ID. 3. Select the Split Qty transaction from the container menu. 4. Enter the name of the container being processed into the Container field. 5. In the To Container field, enter the container name using the instructions in the Splitting Defective Quantities in Camstar section of this document. 6. Enter the quantity to be split into the Quantity field. 7. Click the Split button to complete the transaction. 8. Once the container has been split, generate a container label following the instructions in Appendix C so the material can be identified. 9. For manufacturing, service, or rework order types, perform a rework transaction per Appendix B. For incoming inspection containers, process per 90E1263.

8 ZOLL Document Number: 90F1087 Page 8 of 18 Appendix B Rework Transactions

9 ZOLL Document Number: 90F1087 Page 9 of 18 Instructions for Executing a Rework Transaction 1. Create an UCR or record a nonconformance on the Service Report(SR). 2. Log into Camstar and enter the workstation. 3. Open the Rework screen. 4. Enter the name of the container identified on the container label for the defective material. 5. Select the applicable Rework Reason from the drop down. 6. Enter the UCR or SR number/sr nonconformance item number in the UCR/SR- Number field. 7. Click Rework to complete the transaction. 8. If required by 90F1087-A01, generate a reject label per Appendix C. 9. Forward the defective material to MRB for manufacturing (W) or rework (RW) order types. Forward defective material to production control for service (SW) order types.

10 ZOLL Document Number: 90F1087 Page 10 of 18 Appendix C Label Printing

11 ZOLL Document Number: 90F1087 Page 11 of 18 Instructions for Printing Labels Appendix C 1. Log into Camstar and enter the workstation ID. 2. Open the Print Container Labels menu object. 3. Enter the container name of the material being processed. 4. Select the desired label template from the Printer Label Definition dropdown menu. 5. Select the desired printer name from the Print Queue dropdown menu. 6. Enter the desired quantity of labels. 7. Click Print Label. Note: Container labels and manufacturing labels may be applied directly to a finished good. All other labels will leave a residue when removed and contact with material surfaces should be avoided. If any other label is applied to a finished good, clean the area thoroughly using a method approved in 90F0112.

12 ZOLL Document Number: 90F1087 Page 12 of 18 Appendix D Generating a Rework Order

13 ZOLL Document Number: 90F1087 Page 13 of 18 Instructions for generating a rework order in Epicor 1. Log into Epicor and open the Job Entry Screen 2. Select new job from the drop down menu. 3. Select next job. 4. Select ok.

14 ZOLL Document Number: 90F1087 Page 14 of Enter part number in the field next to the Part button. 6. Select the Revision from the Rev: dropdown menu. Ensure that the revision selected matches the revision of the material to be reworked.

15 ZOLL Document Number: 90F1087 Page 15 of 18 WARNING: If the incorrect revision is selected the revision of the material will be changed in Camstar and when returned to inventory. This is not an approved method for converting revisions. All revision changes will take place in Camstar. 7. Select Rework Order from the Job Type: dropdown menu. 8. Enter the serial or lot number to be reworked. 9. Select today s date as the requested date. 10. Select the arrow next to the New icon. 11. Select New Demand Link from drop down. 12. Select Make to Stock. 13. Enter the quantity to be placed on the order. All serialized items must be Click Save. Operations and Materials will appear in Job Details window. By default, this is located on the left of the Job Entry screen.

16 ZOLL Document Number: 90F1087 Page 16 of Right click on Operation and select Add Operation. 16. Select Service from the drop down menu. 17. Right click on Materials

17 ZOLL Document Number: 90F1087 Page 17 of Enter part number and select revision from the dropdown menu. Ensure that the revision matches the revision of the material being reworked. WARNING: If the revision does not match the revision of the material in inventory, it will not be removed from inventory when the order is generated. 19. Check the Released box. 20. Click Save. WARNING: Clicking Save will automatically send the rework order to Camstar. Any errors identified after an order is received by Camstar shall be treated as a nonconformance and processed per 90F0030 and the rework order section of 90F1087-A01 to ensure system accuracy.

18 ZOLL Document Number: 90F1087 Page 18 of Enter comments and select ok. The order will automatically be sent to Camstar at this point.