Transcription of Equipment/Process Validation Checklist ME 3.9.4-1
1 Equipment/Process Validation Checklist ME In addition, ME must be completed at supplier and Mfg floor runoffs DBS ME Page 1 of 6 Issue Date: 10-17-06 Revision Date: 8-20-10 SECTION I General information & Plan Equipment Name Part numbers by family, which are currently in the manufacturing plan. Family Part name Part number Operation Number Target Department Number supplier Name Manufacturing Plan For Each Family Of Parts Family Required Tact Time Planned Cycle Time Required Equipment FTTQ to Meet System FTTQ Required Throughput (8hr Shift) Number of Hours or Pieces for Machine Qualification Required at supplier Qualification Team Name Function QCIs, KPCs or KCC identified Measurement technique Other Validation Requirements Identified: Mfg.
2 Eng Quality Eng Mfg Eng Mgr Approval & Date Equipment/Process Validation Checklist ME In addition, ME must be completed at supplier and Mfg floor runoffs DBS ME Page 2 of 6 Issue Date: 10-17-06 Revision Date: 8-20-10 SECTION II supplier Runoff- Checklist Check One (X) This Section Applicable- Equipment made at Non-Delphi supplier This Section Not Applicable- Equipment made at Delphi (skip to Section III) Item Requirement Pass Fail Not Applicable 2-1 Perform a 20-hour dry run of the equipment; if the equipment stops during the test, the test is restarted. The equipment must be set to run at the manufacturing planned speed.
3 2-2 Validate all error proofing that is called out on the PFMEA 2-3 Obtain safety approval of the equipment (approved ME Checklist ) 2-3A Verify that each interlock and light curtain operates per the design intent in the affected area. 2-3B Verify that all light curtains and Safety mats are mounted to comply with minimum safe distance requirements indicated in Design In Health and Safety Specification. 2-4 Obtain ergonomic approval of the equipment 2-5 MSA must be complete on all gages that relate to control plan features or characteristics. 2-6 Demonstrate and time all changeovers that are required per the existing manufacturing plan.
4 The changeovers should be completed with the planned number of people. 2-7 Primary parts going through the process should be varied to the spec limits and serialized to enable correlation of primary part measurements to equipment and final product performance. This run should consist of a minimum of 50 pieces. 2-8 Perform a supplier Validation run with the following conditions: 8 hour run is preferred; lesser durations need to be manager approved prior to the run. Equipment must run at planned cycle times Parts fed into the equipment must demonstrate FULL range of the acceptable spec.
5 (If this is not feasible at a minimum, parts from different lots or set-ups from the previous process.) The equipment should be varied through its range of acceptable parameters throughout the run (as defined in the prelaunch control plan) 2-9 Acceptable Ppk of all previously determined KPCs, KCCs and QCIs when the process is running at nominal, and no out of spec parts when the process is run at its extremes. (determine appropriate sample size and resulting Ppk from ppap manual ) 2-10 Does the supplier Validation run FTTQ meet the manufacturing system design from Page 1? 2-11 Does the machine operational availability (OA) meet the manufacturing system requirements ?
6 NOTE- all downtime must be documented during the supplier Validation run 2-12 ALL equipment settings during the supplier Validation run must be documented. (Including air ) 2-13 Is the method of shipment adequate to protect the equipment 2-14 Install property asset tag on control panel prior to shipment. 2-15 Energy control devices identified and tagged 2-16 Lockout placard is installed on control panel 2-17 Recommended spare parts list available (Incl. In design) 2-18 Recommended PM plan Equipment/Process Validation Checklist ME In addition, ME must be completed at supplier and Mfg floor runoffs DBS ME Page 3 of 6 Issue Date: 10-17-06 Revision Date: 8-20-10 SECTION II supplier Runoff - Approvals Document failed items or items not applicable from SECTION II supplier Runoff - Checklist Item No.
7 Reason Failed or Not Applicable Check One APPROVED All items/criteria from supplier Runoff Checklist successfully completed. APPROVED Some items/criteria from supplier Runoff Checklist not met, not completed or not applicable as indicated above. Approvals Below Authorize Shipment of Equipment: Mfg. Engineer Date Mfg. Engineering Supervisor Date Equipment/Process Validation Checklist ME In addition, ME must be completed at supplier and Mfg floor runoffs DBS ME Page 4 of 6 Issue Date: 10-17-06 Revision Date: 8-20-10 SECTION III Manufacturing Floor Runoff - Checklist Item Requirement Pass Fail Not Applicable 3-1 Perform a 20-hour dry run of the equipment; if the equipment stops during the test, the test is restarted.
8 The equipment must be set to run at the manufacturing plan speed. 3-2 Validate all error proofing that is called out on the PFMEA 3-3 Obtain safety approval of the equipment (approved ME Checklist ) and associated hoists / cranes. Sign off of the safety tag. 3-3A Verify that each interlock and light curtain operates per the design intent in the affected area 3-3B Verify that all light curtains and safety mats are mounted to comply with minimum safe distance requirements indicated in Design In Health and Safety Specification. 3-4 Obtain ergonomic approval of the equipment 3-5 Demonstrate and time all changeovers that are required per the existing manufacturing plan.
9 The changeovers should be completed with the planned number of people. 3-6 Train manufacturing personnel on the equipment. 3-7 Five samples per hour should be taken of the primary parts going through the process during the in-house Validation run to enable correlation of primary part measurements to equipment and final product performance. The samples taken should be appropriately labeled and saved for 6 months. One final assembly per hour should also be appropriately labeled and saved for 6 months. 3-8 Perform an 8 hour in-house Validation run with the following conditions: 8 hour run is preferred; lesser durations need to be manager approved prior to the run.
10 Equipment must run at planned cycle times Parts fed into the equipment must demonstrate FULL range of the acceptable spec. (If this is not feasible at a minimum, parts from different lots or set-ups from the previous process.) During this run the equipment is to be run by manufacturing personnel 3-9 Acceptable Ppk of all previously determined KPCs, KCCs and QCIs (determine appropriate sample size and resulting Ppk from ppap manual ) 3-10 Does the in-house Validation run FTTQ meet the manufacturing system design from page 1? 3-11 Does the machine uptime meet the manufacturing system requirements?