Does Your Layered Process Audit Checklist Include Everything It Should?

Layered Process Audits

By EASE
October 20, 2015

Layered process audit checklist

When many of us think of a road map we envision an unwieldy, impossible-to-fold item that our parents or grandparents used for navigating the family’s vacation route before the days of GPS. But, according to Webster’s online dictionary, a road map is also a detailed plan to guide progress toward a goal. If your goal is to conduct layered process audits (LPAs) that not only meet customer requirements but also enhance the culture of quality in your organization, then you need a comprehensive road map or checklist to reach your destination.

A Road Map to Reach Your Goals

LPAs involve various levels of plant leadership assessing adherence to procedures, work instructions, control plans, etc. and, if detected, correcting nonconformances on a real-time basis. Whether using a paper-based system or streamlined LPA software, auditors rely on checklists as their road map for the LPA. Do your LPA checklists include everything necessary for you to accomplish your goals?

Creating the Well-Balanced Checklist

To ensure a thorough and balanced checklist, it should be developed with input from a cross-functional team. Well-designed checklists will likely contain the following topics:

  • Review of error-proofing verification records—example question: Are error-proofing devices, gauges, and fixtures verified at XYZ setting?
  • Review of first-time quality tracking, reporting, and reaction—example question: Are alarm limits set at XYZ frequency?
  • Verification that the operator is following standardized work procedures—example question: Does the operator have version XYZ of the standardized work instruction and is it in plain sight?
  • Verification that the operator is trained/certified for the task at hand—example question: Does the operator possess a current certification for the task being performed?
  • Review of the workplace organization/environment—example question: Is trash, scrap, waste, etc. being placed in labeled bins for Trash, Scrap, or Waste?
  • Verification of control plans—example question: Is the operator conducting control plan checks at X frequency with Y sample sizes and using the XYZ form?

Focusing on Risk

Other items should be included in the checklist based on your quality system or customer satisfaction issues. Examples might include:

  • Rework or repair instructions
  • Issues identified through process failure modes effects analyses (PFMEA)
  • Processes highlighted through risk analysis reports, and in particular, those elements in the report which scored the highest risk priority numbers
  • Preventive maintenance activities
  • Gauge calibration

You will want to create checklists for all critical processes in your organization, but make certain that each process is:

  • In its final state
  • Fully documented
  • Covers an approved process
  • Critical to your customer’s satisfaction, satisfying government regulations, or vital to the performance of the organization

Other Details to Consider

Because they are a road map for the success of your LPA system, also ensure that your checklists:

  • Note the prescribed frequency of the audit
  • Consider craftsmanship and building technique checks for those specific tasks that are highly dependent on people
  • Provide instructions on what should happen if a nonconformance is detected and what must be done to correct the nonconformance
  • Contain enough detail for an auditor who is unfamiliar with the process being audited
  • Cover all customer-specific requirements
  • Include a defined purpose for questions and a response that would be expected from the auditee

Your checklist should also provide space so that an auditor can note a brief description of any non-conformances. If a non-conformance has the potential to place your product quality at risk, immediate action must be taken to correct the situation. Issues that cannot be mitigated immediately should be tracked through your corrective action process or escalated as required.

Finally, remember that checklists are like road maps in that updates are needed periodically to keep you on track to your destination. Think of your LPA checklists as living, not static documents, and encourage management to stay involved with updating your checklists.

EASE