4. SPLITTING QUANITITES OF DEFECTIVE MATERIAL IN CAMSTAR

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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 90E F F F DEFINITIONS Camstar Visual Aid for Inspection nconforming Material Product Service Safe Handling and Cleaning Procedures for LifeVest System Hardware 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. SPLITTING QUANITITES OF DEFECTIVE MATERIAL IN CAMSTAR 4.1 Lot Controlled and n-serial/n-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 not be split.

4 ZOLL Document Number: 90F1087 Page 4 of 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). te: 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. 4.2 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. 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.

5 ZOLL Document Number: 90F1087 Page 5 of 18 Appendix A Split Qty Transactions

6 ZOLL Document Number: 90F1087 Page 6 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.

7 ZOLL Document Number: 90F1087 Page 7 of 18 Appendix B Rework Transactions

8 ZOLL Document Number: 90F1087 Page 8 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.

9 ZOLL Document Number: 90F1087 Page 9 of 18 Appendix C Label Printing

10 ZOLL Document Number: 90F1087 Page 10 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. te: 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.

11 ZOLL Document Number: 90F1087 Page 11 of 18 Appendix D Generating a Rework Order

12 ZOLL Document Number: 90F1087 Page 12 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.

13 ZOLL Document Number: 90F1087 Page 13 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.

14 ZOLL Document Number: 90F1087 Page 14 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.

15 ZOLL Document Number: 90F1087 Page 15 of Right click on Operation and select Add Operation. 16. Select Service from the drop down menu. 17. Right click on Materials

16 ZOLL Document Number: 90F1087 Page 16 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.

17 ZOLL Document Number: 90F1087 Page 17 of Enter comments and select ok. The order will automatically be sent to Camstar at this point.

18 90F1087 A01 nconforming Materials MES/ERP Transaction Flow Identification of nconformance MRB Scrap Rework Use As Is Engineering Investigation Return to Vendor Incoming Inspection Defect Identified Record Defects on II Report PO or Rework Order? PO Record defective Qty in Camstar Lot or Serial Controlled? Lot Perform Split Qty to move defective material to a new container. Print and Attach Reject Label Move defective container(s) to MRB path Process MRB in Database/Docuclass Quarantine? Perform Hold Transaction Perform Release when Quarantine Release form is signed Assign move path based on disposition in Camstar Epicor automatically performs transactions based on disposition RW Serial Stock Defect Identified Generate UCR Lot or Serial Controlled? Lot Transfer to MES Warehouse in Epicor Mat Generate Rework Order in Epicor Mat MRB indicates that a possible defect is associated with the RW order Print and Attach Reject Label Serial Rework Order Defect Identified Generate UCR Item associated with RW or component issued to it? Item associated with RW Lot or Serial Controlled? Lot Perform split qty per from original container Serial Perform Rework transaction to send to MRB or MFG Print and Attach Reject Label or MFG Component Defect Identified Generate UCR Is the order already complete (in the FGI workflow)? Process MRB in Database/Docuclass Lot Controlled or Serial Controlled Serial Process MRB and indicate disposition and move in Camstar What was the disposition? Return to Vendor Engineering Investigation Use As Is Rework Scrap Perform Hold Transaction for hold reason Eng_Inv Forward to RMA processor Service POU Materials Manufacturing Defect Identified Generate UCR Defect Identified Device or Component? Device Add nconformance to Service Report or Mfg Device/Sub Assy or Component Component Has the component been issued? Component Device/Sub Assy Perform Rework Transaction to Send to Production Control What level has the component been issued to? or Mfg Lot or Serial Controlled? Lot Perform Split qty for the defective qty Accepted Click move to send accepted material to inventory. 2 or higher (issued to a subasembly) Can the component be reworked or RTV offline? Scrap? 1 (current container) Serial Perform Rework transaction to send to MRB Perform Component Remove (removes to the container it came from)* Was the component issued during this service cycle? (new) Defective Perform Component Remove to remove subassembly* Answer Routing Questions and route for service Mfg Mfg Mfg or MFG Print and Attach Reject Label or MFG * Replacement components must be issued to the subassembly and the subassembly must be reissued to the top level. Print and Attach Reject Label, Mfg Discard Component ( Transactions) Mfg Is the item associated with an order? Generate Rework Order in Epicor MRB indicates that a possible defect is associated with the RW order Lot Were multiple dispositions assigned? Perform Split Qty per 90F0030 for each disposition Quarantine/ Engineering Hold? Perform Release after Quarantine Release form is signed Perform Hold Transaction Financial Scrap Identified Is the item associated with an order? Is the order already complete (in the FGI workflow)? Perform Scrap transaction in Epicor System Perform Change Qty to trigger order completion in Camstar, Mfg or Mat Camstar Transaction Epicor Transaction Incoming Inspection Database/ Docuclass UCR Database/Docuclass Service Database/Docuclass Database/Docuclass Move to Production Control for Routing Key Responsibility Quality Mfg Manufacturing/Service Mat Material Control Select appropriate path to move to inventory or production control for routing. Perform Release transaction for release reason Inv_Comp Does Engineering recommend scrapping? Move to production control for routing. CAD FILE DRAWING NO. Enter the vendor in Camstar and move to holding step using Procedure nconforming Materials Transaction Flow Chart 90F1087 A01_revfi.vsd 90F1087 A01 ZOLL MANUFACTURING CORPORATION 121 GAMMA DRIVE PITTSBURGH, PA REVISION FI SHEET 1 Mat OF C.O. NA 1