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ZOLL Document Number: 90F1087 Page 3 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
Proprietary of ZOLL ®
1. 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 90E1263.
2. APPLICABLE DOCUMENTS
90E1263 Camstar Visual Aid for QA Inspection 90F0030 Nonconforming Material 90F0072 Product Service 90F0112 Safe Handling and Cleaning Procedures for LifeVest System Hardware
3. 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. SPLITTING QUANITITES OF DEFECTIVE MATERIAL IN CAMSTAR
4.1 Lot Controlled and Non-Serial/Non-Lot Controlled Material
4.1.1 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.
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4.1.2 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.
4.1.3 Multiple Dispositions for Lot Controlled Material on a Single UCR or II
4.1.3.1 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 Container Name Return to Supplier (UCR# or II#)_RTV Scrap (UCR# or II#)_Scrap Use As Is (UCR# or II#)_UAI Use For (a special purpose) Only (UCR# or II#)_SPO Rework to Specification (UCR# or II#)_RW Other (UCR# or II#)_Other Multiple (UCR# or II#)_Mult
4.1.3.2 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.
ZOLL Document Number: 90F1087 Page 5 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
Proprietary of ZOLL ®
Appendix A
Split Qty Transactions
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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 90F0030. 2. 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.
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Appendix B
Rework Transactions
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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.
ZOLL Document Number: 90F1087 Page 9 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
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Appendix C
Label Printing
ZOLL Document Number: 90F1087 Page 10 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
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Appendix C
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.
ZOLL Document Number: 90F1087 Page 11 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
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Appendix D
Generating a Rework Order
ZOLL Document Number: 90F1087 Page 12 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
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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.
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5. 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.
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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 1. 14. Click Save. Operations and Materials will appear in “Job Details” window. By default,
this is located on the left of the Job Entry screen.
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15. Right click on Operation and select “Add Operation”.
16. Select Service from the drop down menu.
17. Right click on Materials
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18. 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.
ZOLL Document Number: 90F1087 Page 17 of 18 MES/ERP Nonconforming Material Transaction Instructions REV FI ________________________________________________________________________________________
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21. Enter comments and select ok. The order will automatically be sent to Camstar at this
point.
90F1087‐A01 ‐ Nonconforming Materials MES/ERP Transaction FlowIncoming
Inspectio
nStock
Rework Order
Service
POU M
aterials
Manufacturin
g
Return to VendorIdentification of Nonconformance MRB Scrap Rework Use As Is Engineering Investigation
Record Defects on II Report
Record defective Qty in Camstar
Perform Split Qty to move defective material to a new
container.
Move defective container(s) to MRB
pathLotLot or Serial
Controlled?
Serial
Print and Attach Reject Label
Process MRB in QA Database/Docuclass Quarantine? Yes 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
No
Generate Rework Order in Epicor
MRB indicates that a possible defect is
associated with the RW order
Print and Attach Reject Label
Process MRB in QA Database/Docuclass
Device/Sub Assy or Component
Component
LotLot or Serial Controlled?
Transfer to MES Warehouse in Epicor
Serial
Perform Rework transaction to send
to MRB
Print and Attach Reject Label
Is the item associated with an
order?
Is the order already complete (in the FGI workflow)?
Yes No
No Perform Scrap transaction in Epicor
YesYes
Perform Hold Transaction
Perform Release after Quarantine Release
form is signedNo
Perform Change Qty to trigger order
completion in Camstar
Device or Component?
Device
Was the component issued during this service cycle? (new)
Component No Discard Component (No Transactions)
Add Nonconformance to Service Report
Perform Rework Transaction to Send to Production Control
Scrap?
No
Yes
Financial Scrap Identified
Scrap
Rework
Return to Vendor
Move to Production Control for Routing
Is the item associated with an
order?
Is the order already complete (in the FGI workflow)?
Yes
No
Yes
Generate Rework Order in Epicor
MRB indicates that a possible defect is
associated with the RW order
No Forward to RMA processor
Enter the vendor in Camstar and move to holding step using
Procedure
POPO or Rework Order?
RW
Select appropriate path to move to inventory or production control
for routing.
Use As Is
Answer Routing Questions and route
for service
Item associated with RW or
component issued to it?
Component
Perform split qty per from original
container
Perform Rework transaction to send
to MRBLot
Serial
Print and Attach Reject Label
Item associated with RW
Lot or Serial Controlled?
Has the component been issued?
Perform Component Remove
(removes to the container it came
from)*
No
Can the component be reworked or RTV
offline?
Yes
Yes Print and Attach Reject Label
Device/Sub Assy
Perform Split qty for the defective qty
Lot or Serial Controlled? Serial
Lot
Defective
Click move to send accepted material to
inventory.
Accepted
Perform Hold Transaction for hold reason “Eng_Inv”
Engineering Investigation
What was the disposition?
Perform Release transaction for release reason “Inv_Comp”
Move to production control for routing.
DRAWING NO.
REVISION C.O.CAD FILE
SHEET OF
Nonconforming Materials Transaction Flow Chart
90F1087‐A01
FI90F1087‐A01_revfi.vsd NA
ZOLL MANUFACTURING CORPORATION121 GAMMA DRIVE
PITTSBURGH, PA 15238‐2919
11
What level has the component been
issued to?1 (current container)
Perform Component Remove to remove
subassembly*
* Replacement components must be issued to the subassembly and the subassembly must be reissued to the top level. 2 or higher (issued to a subasembly)
Does Engineering recommend scrapping?
No
Yes
Process MRB and indicate disposition and move in Camstar
No
Were multiple dispositions assigned?
Perform Split Qty per 90F0030 for each
disposition
Quarantine/Engineering Hold?
No
Yes
KeyCamstar Transaction
Epicor Transaction
Defect Identified
Defect Identified – Generate UCR
Incoming Inspection Database/Docuclass
UCR Database/Docuclass
Service Database/Docuclass
QA Database/Docuclass
Defect Identified – Generate UCR
Defect Identified – Generate UCR
Defect Identified – Generate UCR
Defect Identified
Lot Controlled or Serial Controlled
Lot
Serial
System Responsibility
QA – QualityMfg – Manufacturing/ServiceMat – Material Control
QA
QA, Mfg
QA QA QA QA QA QA QA
QA
QA
QAMatMat
QA or MFGQA or MFGQA
QA or MFG QA or MFG
QA
QA
QA QA
QA QA
QA
QA QA
QA
QA, Mfg or Mat
QA
QA
QA
Mat
QA
Mfg
Mfg
Mfg
QA or MfgQA or Mfg
Mfg