Layered Process Audit Checklist

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Select date

  Date

Communication

• Does the employee know the quality policy?

  Yes

  No

  N/A

• Are employees aware of quality requirements?

  Yes

  No

  N/A

• Are employees aware of any recent Formal Customer Complaints (FCC's) / Quality issues?

  Yes

  No

  N/A

Workplace Organization & Environment

• Is in-process & and outgoing material properly identified?

  Yes

  No

  N/A

• Add media

  Media

• Is traceability in place?

  Yes

  No

  N/A

• Is nonconforming or suspect product identified and placed in designated area? Do you know where this is located?

  Yes

  No

  N/A

• Add media

  Media

• Is all scrap identified properly or in the proper container?

  Yes

  No

  N/A

• Add media

  Media

• Are proper containers used in production, including outgoing material?

  Yes

  No

  N/A

• Are all containers properly marked for use in production?

  Yes

  No

  N/A

• Add media

  Media

• Is containment information documented when the product is nonconforming?

  Yes

  No

  N/A

• Are all chemical bottles labeled correctly?

  Yes

  No

  N/A

• Add media

  Media

Set Up

• Are set up instructions available?

  Yes

  No

  N/A

• Are set up instructions followed?

  Yes

  No

  N/A

• Are change over instructions available?

  Yes

  No

  N/A

• Are change over instructions followed?

  Yes

  No

  N/A

Operator Standardized Work

• Are operators following standardized work orders or control plans?

  Yes

  No

  N/A

Control Plans / Work Instructions

• Are control plan / work instruction checks made at proper frequency, with the correct sample size and on the correct form?

  Yes

  No

  N/A

• Are product / process checks within specification? If not are reaction plans being followed?

  Yes

  No

  N/A

First Time Quality

• Are operators aware of when a run has to go through 1st pc inspection?

  Yes

  No

  N/A

• Is reaction plan available and being followed?

  Yes

  No

  N/A

Measurement Systems

• Are error proofing devices, gauges, and fixtures verified if available?

  Yes

  No

  N/A

• Are all gauges (required by the control plan / work instructions) available at the work station? Are all gauges numbered, calibrated?

  Yes

  No

  N/A

• What is / are the gauge number(s)?

  Yes

  No

  N/A

• Is the calibration up to date and what is the date of certification?

  Yes

  No

  N/A

5S / Health & Safety

• Are 5S activities complete to schedule?

  Yes

  No

  N/A

• Add media

  Media

• Are designated work areas neat and tidy?

  Yes

  No

  N/A

• Is the floor free from obstruction, waste and spillages?

  Safe

  At Risk

  N/A

• Are all parts stored correctly and safely?

  Safe

  At Risk

  N/A

• Mandatory PPE in use? (Safety boots, ear defenders etc.)

  Yes

  No

  N/A

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