LPA (Layered Process Audit) Checklist

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This Template was installed 3 times.

Process Definition & Documentation

1 of 10

Focuses on the clarity, completeness, and accessibility of process documentation.

Is the process flow diagram (PFD) current and accessible?

Briefly describe the process being audited.

Are process inputs clearly defined and documented?

Revision number of the process document being audited.

Date of last process document revision.

Describe any discrepancies observed between documented process and actual practice.

Is the process owner clearly identified and contact information available?

Equipment & Tooling

2 of 10

Evaluates the condition, maintenance, and calibration of equipment and tooling used in the manufacturing process.

Equipment ID/Asset Tag Number

Last Calibration Date

Next Calibration Due Date

Calibration Result (within tolerance?)

Equipment Condition (Visual Inspection)

Any observed issues/deviations from expected operation?

Maintenance Schedule Followed?

Upload Calibration Certificate (if applicable)

Raw Materials & Components

3 of 10

Assesses the receiving, storage, and handling of raw materials and components to ensure quality and traceability.

Incoming Material Rejection Rate (Last 3 Months)

Last Raw Material Supplier Audit Date

Raw Material Traceability System Used

Storage Conditions Verified (Select all that apply)

Describe any discrepancies found during raw material inspection.

Attach recent Certificate of Analysis (CoA) for critical raw material.

Material Handling Equipment Inspection Frequency

Work Instructions & Procedures

4 of 10

Verifies that work instructions are accurate, up-to-date, and followed consistently by operators.

Are work instructions readily available at the point of use?

Describe any instances where work instructions were unclear or inadequate. (If applicable)

Are work instructions reviewed and updated periodically?

How often are work instructions reviewed (in months)?

Which of the following methods are used to ensure adherence to work instructions?

Are changes to work instructions documented and communicated effectively?

Upload an example of a recent work instruction revision (if applicable).

Operator Training & Competency

5 of 10

Confirms operators have the necessary training, skills, and authorization to perform their tasks.

Does the operator have documented training records?

Which training modules have been completed by the operator (check all that apply)?

Last Training Completion Date

Number of training hours received on this process

Describe any gaps in operator training identified.

Was competency assessment performed?

Upload copy of operator training certificate (if applicable)

Process Control & Monitoring

6 of 10

Evaluates the methods used to control and monitor the manufacturing process, including data collection and analysis.

Cycle Time Measurement Frequency

Statistical Process Control (SPC) Usage

Description of Key Process Parameters Monitored

Last Calibration Date of Monitoring Equipment (e.g., Gauges, Sensors)

Data Collection Methods Used

Frequency of Data Collection for Critical Parameters

Summary of Trending Data & Analysis (attach data if available)

Attach Example Monitoring Data Report

Non-Conforming Material Handling

7 of 10

Reviews the process for identifying, segregating, and correcting non-conforming materials or products.

Is there a defined procedure for handling non-conforming materials?

Briefly describe the procedure for identifying and segregating non-conforming materials.

Average number of non-conforming materials generated per shift.

What actions are taken with non-conforming materials (select all that apply)?

If 'Other' was selected above, please specify the action taken.

Is documentation readily available that tracks the disposition of non-conforming materials?

Date of last review/update of the non-conforming material handling procedure.

Upload sample documentation of non-conforming material disposition records (e.g., MRB logs).

Quality Control & Inspection

8 of 10

Focuses on the effectiveness of quality control measures and inspection processes throughout the manufacturing cycle.

Sample Size for Incoming Material Inspection

Inspection Method Used (e.g., Visual, Dimensional, Functional)

Record of Key Inspection Results (Summary)

Representative Inspection Record Example (PDF/Image)

Number of Rejected Units (Last Shift/Period)

Disposition of Rejected Units

Last Calibration Date of Measuring Equipment

Inspection Criteria Used (Select all that apply)

Environmental, Health & Safety (EHS)

9 of 10

Assesses adherence to EHS regulations and procedures within the manufacturing area.

Noise Level Measurement (dB)

SDS Availability for Hazardous Materials

PPE Usage - Check all that apply

Last Safety Training Date

Observations Regarding Housekeeping (Spills, Waste Disposal)

Fire Extinguisher Inspection Status

Location of Spill Kit

Photographic Evidence of EHS Issues (if applicable)

Continuous Improvement & Corrective Actions

10 of 10

Examines the system for identifying, implementing, and tracking corrective actions and improvement initiatives.

Describe the process for identifying potential areas for improvement within the manufacturing process.

Which tools or methodologies are used for continuous improvement (e.g., 8D, Kaizen, 5S)?

What is the average time taken to implement a corrective action?

Date of last formal review of improvement initiatives.

Describe how employee feedback is solicited and incorporated into improvement activities.

Attach documentation related to recent improvement projects (e.g., project plans, reports).

How are completed corrective actions verified for effectiveness?

Describe the process for tracking the effectiveness of corrective actions over time. How are they closed out?

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