Equipment/Process Validation Checklist ME 3.9.4-1

Equipment/Process Validation Checklist ME 3.9.4-1

In addition, ME 3.9.4-2 must be completed at Supplier and Mfg floor runoffs

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

Family

Manufacturing Plan For Each Family Of Parts

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

Name

Qualification Team Function

QCIs, KPCs or KCC identified

Measurement technique

Other Validation Requirements Identified:

Mfg. Eng DBS ME 3.9.4-1

Quality Eng Page 1 of 6

Mfg Eng Mgr Approval & Date

Issue Date: 10-17-06 Revision Date: 8-20-10

Equipment/Process Validation Checklist ME 3.9.4-1

In addition, ME 3.9.4-2 must be completed at Supplier and Mfg floor runoffs

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

2-1

2-2 2-3 2-3A 2-3B 2-4

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. Validate all error proofing that is called out on the PFMEA Obtain safety approval of the equipment (approved ME 3.9.4-2 checklist) Verify that each interlock and light curtain operates per the design intent in the affected area. 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. Obtain ergonomic approval of the equipment

Pass Fail

Not

Applicable

2-5 2-6

2-7

2-8

2-9

2-10 2-11

2-12 2-13 2-14 2-15 2-16 2-17 2-18

MSA must be complete on all gages that relate to control plan features or characteristics. Demonstrate and time all changeovers that are required per the existing manufacturing plan. The changeovers should be completed with the planned number of people. 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. 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. (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) 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) Does the supplier validation run FTTQ meet the manufacturing system design from Page 1? Does the machine operational availability (OA) meet the manufacturing system requirements ? NOTE- all downtime must be documented during the supplier validation run ALL equipment settings during the supplier validation run must be documented. (Including air pressures...) Is the method of shipment adequate to protect the equipment Install property asset tag on control panel prior to shipment. Energy control devices identified and tagged Lockout placard is installed on control panel Recommended spare parts list available (Incl. In design) Recommended PM plan

DBS ME 3.9.4-1

Page 2 of 6

Issue Date: 10-17-06 Revision Date: 8-20-10

Equipment/Process Validation Checklist ME 3.9.4-1

In addition, ME 3.9.4-2 must be completed at Supplier and Mfg floor runoffs

SECTION II ? Supplier Runoff - Approvals

Document failed items or items not applicable from SECTION II ? Supplier Runoff -Checklist

Item No.

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

DBS ME 3.9.4-1

Page 3 of 6

Issue Date: 10-17-06 Revision Date: 8-20-10

Equipment/Process Validation Checklist ME 3.9.4-1

In addition, ME 3.9.4-2 must be completed at Supplier and Mfg floor runoffs

Item 3-1 3-2 3-3 3-3A 3-3B 3-4 3-5 3-6 3-7

3-8

3-9 3-10 3-11 3-12 3-13 3-14 3-15 3-16 3-17 3-18 3-19 3-20 3-21 3-22 3-23 3-24 3-25 3-26

SECTION III ? Manufacturing Floor Runoff - Checklist

Requirement

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 plan speed. Validate all error proofing that is called out on the PFMEA Obtain safety approval of the equipment (approved ME 3.9.4-2 checklist) and associated hoists / cranes. Sign off of the safety tag. Verify that each interlock and light curtain operates per the design intent in the affected area

Pass Fail

Not Applicable

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. Obtain ergonomic approval of the equipment

Demonstrate and time all changeovers that are required per the existing manufacturing plan. The changeovers should be completed with the planned number of people. Train manufacturing personnel on the equipment. Five samples per hour should be taken of the primary parts going through the process during the inhouse 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. 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.

? 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 Acceptable Ppk of all previously determined KPCs, KCCs and QCIs (determine appropriate sample size and resulting Ppk from PPAP manual) Does the in-house validation run FTTQ meet the manufacturing system design from page 1? Does the machine uptime meet the manufacturing system requirements? NOTE- all downtime must be documented during the in-house validation run ALL equipment settings during the in-house validation run must be documented. (Including air pressures...) Are machine detail prints available (with common designation of components) Spare parts and a machine specific spare parts reference list must be readily available. (crib set-ups complete for frequent use items and infrequent use items ordered). Are the up-to-date machine logic programs and documentation available with a back-up disk in the panel? Can the maintenance department (on all 3 shifts) access all equipment programmable devices with necessary instructions, cables, hardware, and software? Is all documentation in place (operator instructions, check sheets, gage instructions, control plan, PFMEAs...)? All material handling and part presentation devices must be in place and utilized during the in-house validation. Are all hazardous and non hazardous waste storage areas clearly identified on a layout and visually controlled on the plant floor? MSA must be complete on gages that relate to control plan features or characteristics. Applicable gages, controllers, transducers, etc included in gage calibration system. Verify asset tag has been installed to all equipment. Notify Mexico Property Accounting that asset is to be capitalized using the "Fixed Asset Information Document" (DBS Form FIN 8.4.1-1). (Ref. DBS Financial Procedure 8.4.1) Provide physical plant location, cost center and asset tag using the Tool & Equipment Tracking Application's "Equipment Move Order" form (DBS Form FIN 8.4.1-2). FOR GM ONLY: Complete the "Create Tooling Information for VTAM Process" VTAM link and e-mail completed form to: Thermal ME VTAM Process Owner, with pictures of the tools.

Finalize lock-out / tag-out / energy source tags.

DBS ME 3.9.4-1

Page 4 of 6

Issue Date: 10-17-06 Revision Date: 8-20-10

Equipment/Process Validation Checklist ME 3.9.4-1

In addition, ME 3.9.4-2 must be completed at Supplier and Mfg floor runoffs

SECTION III ? Manufacturing Floor Runoff - Approvals

IIIA. Production Acceptance

Document failed items or items not applicable from SECTION III ? Manufacturing Floor Runoff Checklist

Item No.

Reason Failed or Not Applicable

APPROVED for Production Acceptance

Approvals Below Indicate Equipment May Begin Production at Site:

Some Manufacturing Floor Runoff Checklist requirements may not be met at this time as indicated above

Mfg. Engineer

Date

Quality Engineer

Date

Mfg. Engineering Supervisor

Date

Manufacturing Management

Date

DBS ME 3.9.4-1

Page 5 of 6

Issue Date: 10-17-06 Revision Date: 8-20-10

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