DOCUMENT REVISION HISTORY PAGE. Revision History Of Document. CO Number Description of Change Author Effective Date FI NA First Issue CJM

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2 DOCUMENT REVISION HISTORY PAGE Document Number: Rev: Page: 90F1087 Title: ERP/MES Nonconforming Material Transaction Instructions C 2 of 28 Rev Revision History Of Document CO Number Description of Change Author Effective Date FI NA First Issue CJM A 4279 Updated the system used for printing reject labels in incoming CJM inspection to Camstar. B 4428 Added section 7 to accommodate exceptions to the process. CJM Added 90F1087-A01 to applicable documents. Separate 90F1087-A01 into separate document. Added section 3 to identify responsibilities. C 4635 Appendix B - Modified step 6 regarding entering UCR, SR, or PE EMH number into the UCR/SR/PE field, updated screenshot. Updated instruction in step 8 regarding forwarding defective material based on order type as it will be routed according to the system, included screenshots. Appendix D - Added in Epicor to title for clarification. Added Appendix E - Defect Processing, Added Appendix F Logging Troubleshoot Information, Added Appendix G Recording Rework and In- Process Inspection Activities, Added Appendix H Investigation - Recording Causes Added Section 8 Alternate Process to support phased MES defect tracking implementation. Updated Section 3 Responsibility to support addition of flow chart in Section 8. In response to CAR-1291, added screenshot to section on where to check in Camstar if a Mfg Order is associated with a container Added clarification to section for handling of material not in an MES warehouse already. Updated screenshot and instructions in Appendix B to include UCR/SR/PE field. ZOLL Form Number: 90A0001-A03 Form REV Level: J

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-A01 and within the Alternate Defect Tracking Transaction Flow in section 8 of this procedure. 4. 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. Example: No Mfg Order associated with this container in Camstar 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). Defective material from stock that is not already in a MES warehouse, must be sent to Camstar for the quantity to be reworked otherwise an Order Download Failure will occur due to insufficient quantity. Use the Production Bin Refill and Inventory Transfer transactions in Epicor according to the 90F1087-A01 flowchart. Note: Any point of use material that has been issued must be removed from that container before the rework order is generated in Epicor.

5 ZOLL Document Number: 90F1087 Page 5 of 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 90F1087-A01 for the appropriate transactions. 6. 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 ALTERNATE PROCESS 8.1 A revised process for recording defects in the Camstar MES is being implemented in phases. An alternative process has been defined in 90F0030 and within the associated documents referenced in 90F0030. As device specific workflows are revised and validated, those products will begin using the alternate process. The process transaction flows are as follows:

7 ZOLL Document Number: 90F1087 Page 7 of 28 Appendix A Split Qty Transactions

8 ZOLL Document Number: 90F1087 Page 8 of 28 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.

9 ZOLL Document Number: 90F1087 Page 9 of 28 Appendix B Rework Transactions

10 ZOLL Document Number: 90F1087 Page 10 of 28 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 associated UCR, SR, or PE number in the UCR/SR/PE 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 or Troubleshoot/Rework as directed by the system message below. Note: A green success message will appear at the bottom of the window and includes the workflow destination of the container. Physically route the material to the appropriate Rework/Troubleshoot or MRB location. If the above message is not seen, reload the E Procedure page, and click the green arrow next to the Container box, the Status tab is displayed as default, the workflow is displayed. Physically route the material to the appropriate Rework/Troubleshoot or MRB location.

11 ZOLL Document Number: 90F1087 Page 11 of 28 Appendix C Label Printing

12 ZOLL Document Number: 90F1087 Page 12 of 28 Instructions for Printing Labels 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.

13 ZOLL Document Number: 90F1087 Page 13 of 28 Appendix D Generating a Rework Order in Epicor

14 ZOLL Document Number: 90F1087 Page 14 of 28 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.

15 ZOLL Document Number: 90F1087 Page 15 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.

16 ZOLL Document Number: 90F1087 Page 16 of 28 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.

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

18 ZOLL Document Number: 90F1087 Page 18 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.

19 ZOLL Document Number: 90F1087 Page 19 of Enter comments and select ok. The order will automatically be sent to Camstar at this point.

20 ZOLL Document Number: 90F1087 Page 20 of 28 Appendix E Defect Processing

21 ZOLL Document Number: 90F1087 Page 21 of 28 Component Level Defect Processing 1. Print and fill out a Reject label per Appendix C. 2. Physically route the defective material to MRB location. Record a Production Event 1. Ensure that the container is moved in if the current step is configured to require one. WARNING! Failing to move in will result in the container being stuck in its current location until the event is resolved. 2. Record the defect in Camstar by clicking the Record Production Event button found within the container information header of the E Procedure page. 3. The Record P/E page will load as a separate tab. a. Select an appropriate Failure Mode Group from the drop down, then select a corresponding Failure Mode from the drop down according to the defect found. b. The Qty Rejected field defaults to 1, update the quantity if necessary. c. Enter applicable information in the Failure Comment box. d. Click the Add Failure button, the entry is added to the Event>Failure Modes grid. e. Select a Resource Group and Resource from the drop down menu. f. Click the Record Production Event button in the bottom right corner. Enter your credentials in the ESig Popup window and click Submit. g. Print and attach a reject label per Appendix C. 4. Perform the Rework transaction per Appendix B.

22 ZOLL Document Number: 90F1087 Page 22 of 28 Appendix F Logging Troubleshoot Information

23 ZOLL Document Number: 90F1087 Page 23 of 28 Logging Troubleshoot Information 1. Open E procedure and enter the container, click the Move button. 2. The container will automatically move to the appropriate workflow. 3. Reload the E Procedure page. 4. Click the green arrow next to the container, select the Events tab (see above example) 5. Click to open the Event with the most recent Creation Date. 6. The Manage P/E page will load. a. Click the Set Edit Mode button in the upper right corner of the window to allow updates to be made to the Event. b. Click the Log tab. c. Select a Failure Mode as shown in the Failures tab. d. Select the appropriate Comment Type and enter applicable instructions in the Comment box. e. Click the Add Comment button, your comment will now display in the Comment Log grid. f. Click the Save button in the bottom right corner. Enter your credentials in the ESig Popup window and click Submit. g. Physically route the container to the appropriate Rework location.

24 ZOLL Document Number: 90F1087 Page 24 of 28 Appendix G Recording Rework and In-Process Inspection Activities

25 ZOLL Document Number: 90F1087 Page 25 of 28 Recording Rework and In Process Inspection Activities 1. Open E Procedure and enter the container. 2. Click the green arrow next to the container, select the Events tab. 3. Click to open the Event with the most recent Creation Date. 4. The Manage P/E page loads as a separate tab. a. Click the Log tab. b. Perform any Rework activities listed within the Comment Log grid. c. Click the Set Edit Mode button in the upper right corner of the window to allow updates to be made to the Event. d. Select the entry for which Rework was performed in the Comment Log grid e. Click the Mark Selected as Completed button f. Click the Save button in the bottom right corner. Enter your credentials in the Esig Popup window and click Submit. 5. If an in process or IPC inspection is required by the rework recorded in the Event Log, complete the following: a. Perform Inspection for listed Rework activities within the Comment Log grid. b. Select the appropriate entry in the Comment Log grid c. Click the Mark Selected as Inspection Complete button. d. Click the Save button in the bottom right corner. Enter your credentials in the Esig Popup window and click Submit. e. In E Procedure, complete all work instructions presented in the task lists.

26 ZOLL Document Number: 90F1087 Page 26 of 28 Appendix H Investigation Recording Causes

27 ZOLL Document Number: 90F1087 Page 27 of 28 Investigation Recording Causes 1. Open E Procedure and enter the container. 2. Click the green arrow next to the container, select the Events tab. 3. Click to open the Event with the most recent Creation Date. 4. The Manage P/E page will load. a. Click the Set Edit Mode button in the upper right corner of the window to allow update to be made to the Event. b. Click the Investigation tab. c. The Event>Failure Mode>Cause Code grid will display all Failure Mode entries within the Event, select a Failure Mode from the grid. d. Select an appropriate Cause Code Group from the drop down, then select a corresponding Cause Code from the drop down. e. Check the Is Root Cause checkbox, if applicable. f. Select the Product from the drop down, enter the Lot/SN information, if applicable. g. Enter applicable information within the Cause Comment box. h. Click the Add Cause to Selected Failure(s) button to add it the Failure Mode within the grid i. Click the Save button in the bottom right corner. Enter your credentials in the Esig Popup window and click Submit. j. Ensure each defect has been addressed and has a Cause Code associated.

28 ZOLL Document Number: 90F1087 Page 28 of 28 k. In E Procedure I. Execute the TS Close task II. Execute the Production Control task III. Click the Move button to move the container to the appropriate path based on answers in previous task. l. Physically route the container to the appropriate location.