Manufacturing Process Audit Checklist Rev. 03

• Auditor

• Shift

  Morning

  Afternoon

  Night
• Site
  Address

• Conducted on

  Date

• Customer/Part Number

Materials and Tools and Floorshop

• Does each workstation have the right materials and tools in the right quantity?

  Yes

  No

  N/A

• Materials include tools, supplies, personal protective equipment, tooling, racks...

• Are tools and materials in good working condition?

  Yes

  No

  N/A

• Are procedures, instructions and/or operation sheets available in the work stations?

  Yes

  No

  N/A

• Are the documents updated to their latest revision?

  Yes

  No

  N/A

Operation Process

• Can operators and personnel involved access the most recent Control Plan?

  Yes

  No

  N/A

• Is the Control Plan updated and does it reflect the audited process?

  Yes

  No

  N/A

• Can Operations Personnel access the most recent instructions, procedures, operations sheets, formats or any other support documents according to the Control Plan?

  Yes

  No

  N/A

• Do all personnel follow the same standard documented process, according to the Control Plan?

  Yes

  No

  N/A

• Are all records filled according to procedures, operation sheets or any other support documents?

  Yes

  No

  N/A

• Is process material labeled and handled properly?

  Yes

  No

  N/A

• Is the applicable Packaging Standard followed?

  Yes

  No

  N/A

Laboratory Inspection

• Are measurement equipment calibrated and verified?

  Yes

  No

  N/A

• Are inspections followed according to procedures or standardized work instructions?

  Yes

  No

  N/A

• Use at least one example of a procedure or operation sheet for this evaluation.

• Are the critical characteristics measured and do they meet the specifications?

  Yes

  No

  N/A

• Do the quality certificates show compliance with Customer requirements?

  Yes

  No

  N/A

Maintenance

• Do Operations Personnel have suitable, available and updated TPM Operation Sheets?

  Yes

  No

  N/A

• Is Operations Personnel trained in TPM?

  Yes

  No

  N/A

Quality Reporting - Product/Process

• Do Operations Personnel have suitable methods for reporting quality concerns related to the product/Process? Are the methods followed?

  Yes

  No

  N/A

• Are reported problems documented and corrected according to procedures?

  Yes

  No

  N/A

Training and Awareness

• Is Operations Personnel qualified according to the Capability Matrix?

  Yes

  No

  N/A

• Is there Objective Evidence of training?

  Yes

  No

  N/A

• Is personnel aware of the latest Quality Alert?

  Yes

  No

  N/A

• Is personnel aware of their contribution to the Customer Satisfaction, Quality and Performance?

  Yes

  No

  N/A

• Auditor's full name, position and signature.

  Sign

• Approved by (Full name, position and signature)

  Sign