LPA (LAYERED PROCESS AUDIT) CHECKLIST

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--- PROCESS DEFINITION & DOCUMENTATION ---
[ ] Is the process flow diagram (PFD) current and accessible? (Yes, No, N/A)
[ ] Briefly describe the process being audited.
[ ] Are process inputs clearly defined and documented? (Yes, No, N/A)
[ ] 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? (Yes, No, N/A)

--- EQUIPMENT & TOOLING ---
[ ] Equipment ID/Asset Tag Number
[ ] Last Calibration Date
[ ] Next Calibration Due Date
[ ] Calibration Result (within tolerance?)
[ ] Equipment Condition (Visual Inspection) (Excellent, Good, Fair, Poor)
[ ] Any observed issues/deviations from expected operation?
[ ] Maintenance Schedule Followed? (Yes, No, N/A)
[ ] Upload Calibration Certificate (if applicable)

--- RAW MATERIALS & COMPONENTS ---
[ ] Incoming Material Rejection Rate (Last 3 Months)
[ ] Last Raw Material Supplier Audit Date
[ ] Raw Material Traceability System Used (Lot Number Tracking, Batch Number Tracking, Serial Number Tracking, No Traceability)
[ ] Storage Conditions Verified (Select all that apply) (Temperature Control, Humidity Control, Proper Ventilation, Protection from Sunlight, Pest Control)
[ ] Describe any discrepancies found during raw material inspection.
[ ] Attach recent Certificate of Analysis (CoA) for critical raw material.
[ ] Material Handling Equipment Inspection Frequency (Daily, Weekly, Monthly, Quarterly)

--- WORK INSTRUCTIONS & PROCEDURES ---
[ ] Are work instructions readily available at the point of use? (Yes, No, Partially)
[ ] Describe any instances where work instructions were unclear or inadequate. (If applicable)
[ ] Are work instructions reviewed and updated periodically? (Yes, annually, Yes, as needed, No)
[ ] How often are work instructions reviewed (in months)?
[ ] Which of the following methods are used to ensure adherence to work instructions? (Visual aids (e.g., posters, diagrams), Operator training, Supervisory oversight, Regular audits, Other: [Long Text Field])
[ ] Are changes to work instructions documented and communicated effectively? (Yes, No, Partially)
[ ] Upload an example of a recent work instruction revision (if applicable).

--- OPERATOR TRAINING & COMPETENCY ---
[ ] Does the operator have documented training records? (Yes, No, N/A)
[ ] Which training modules have been completed by the operator (check all that apply)? (Process Overview, Equipment Operation, Safety Procedures, Quality Control, Problem Solving)
[ ] Last Training Completion Date
[ ] Number of training hours received on this process
[ ] Describe any gaps in operator training identified.
[ ] Was competency assessment performed? (Yes, No, N/A)
[ ] Upload copy of operator training certificate (if applicable)

--- PROCESS CONTROL & MONITORING ---
[ ] Cycle Time Measurement Frequency
[ ] Statistical Process Control (SPC) Usage (Implemented & Effective, Implemented, Needs Improvement, Not Implemented)
[ ] Description of Key Process Parameters Monitored
[ ] Last Calibration Date of Monitoring Equipment (e.g., Gauges, Sensors)
[ ] Data Collection Methods Used (Manual Data Entry, Automated Data Logging, Statistical Process Control (SPC) Software, Operator Charts)
[ ] 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 ---
[ ] Is there a defined procedure for handling non-conforming materials? (Yes, No, Not Applicable)
[ ] 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)? (Rework, Scrap, Return to Supplier, Quarantine for further evaluation, Other (specify in long text))
[ ] If 'Other' was selected above, please specify the action taken.
[ ] Is documentation readily available that tracks the disposition of non-conforming materials? (Yes, No, Not Applicable)
[ ] 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 ---
[ ] Sample Size for Incoming Material Inspection
[ ] Inspection Method Used (e.g., Visual, Dimensional, Functional) (Visual Inspection, Dimensional Measurement, Functional Testing, Automated Optical Inspection (AOI))
[ ] Record of Key Inspection Results (Summary)
[ ] Representative Inspection Record Example (PDF/Image)
[ ] Number of Rejected Units (Last Shift/Period)
[ ] Disposition of Rejected Units (Rework, Scrap, Return to Supplier)
[ ] Last Calibration Date of Measuring Equipment
[ ] Inspection Criteria Used (Select all that apply) (Blueprint Specifications, Customer Requirements, Internal Standards, Industry Standards (e.g., ISO))

--- ENVIRONMENTAL, HEALTH & SAFETY (EHS) ---
[ ] Noise Level Measurement (dB)
[ ] SDS Availability for Hazardous Materials (SDS Present and Accessible, SDS Present but Not Easily Accessible, SDS Missing)
[ ] PPE Usage - Check all that apply (Safety Glasses, Hearing Protection, Gloves, Respirator, Safety Shoes, High Visibility Vest, None Observed)
[ ] Last Safety Training Date
[ ] Observations Regarding Housekeeping (Spills, Waste Disposal)
[ ] Fire Extinguisher Inspection Status (Up to Date, Expiring Soon, Expired)
[ ] Location of Spill Kit
[ ] Photographic Evidence of EHS Issues (if applicable)

--- CONTINUOUS IMPROVEMENT & CORRECTIVE ACTIONS ---
[ ] 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)? (8D Problem Solving, Kaizen Events, 5S Methodology, Value Stream Mapping, Root Cause Analysis, PDCA Cycle (Plan-Do-Check-Act))
[ ] 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? (Statistical Process Control (SPC), Process Audits, Customer Feedback, Visual Inspection, Functional Testing)
[ ] Describe the process for tracking the effectiveness of corrective actions over time. How are they closed out?

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