Quality Control Laboratory Audit Checklist

Customize this Laboratory Quality Control audit checklist to inspect documentation, equipment and processes to ensure high quality standards in the lab.

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Health & Safety
Quality Control Laboratory Audit Checklist

Documentation, Procedures & Personnel

Equipment, Materials & Environmental Control

Quality Control & System Performance

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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Quality Control Laboratory Audit Checklist

Customize this Laboratory Quality Control audit checklist to inspect documentation, equipment and processes to ensure high quality standards in the lab.

1. Are all required documents (manuals, procedures, work instructions) readily accessible and up-to-date?

2. Are the laboratory manual and procedure documents clear, comprehensive, and easy to understand for all staff?

3. Are the procedures confirmed to accurately reflect current practices and align with industry standards?

4. Are training records for all laboratory staff up-to-date and properly documented?

5. Are there any training gaps or discrepancies identified for staff roles and responsibilities?

6. Is there documented evidence of adherence to standard operating procedures (SOPs) for sample handling and testing?

7. Are reported incidents or accidents properly documented and investigated?

8. Is any noncompliance or irregularity found during the audit documented?

1. Is all laboratory equipment regularly calibrated and serviced to maintain accurate and reliable results?

2. Are calibration and maintenance records for each piece of equipment up-to-date and performed on schedule?

3. Are there sufficient material supplies (chemicals, consumables, reagents) available for all tests and procedures?

4. Are all stored materials and reagents properly labelled and within their expiration dates?

5. Are storage conditions appropriate to ensure materials and reagents are not exposed to environmental factors that compromise their quality?

6. Are proper waste disposal measures implemented for all waste types (chemical, biological, sharps, general) according to regulations?

7. Is the lab confirmed to be clean and well-maintained, including workstations and storage areas?

8. Are safety measures (fire extinguishers, emergency exits, safety signs) confirmed to be in place and functional?

1. Are quality control results regularly reviewed to identify and investigate reasons behind any pass or fail cases?

2. Are control charts and graphs used for monitoring performance up-to-date?

3. Are there any significant deviations, irregularities, or trends identified in the control charts and graphs?

4. Is the performance of the Laboratory Information System (LIS) optimal for data accuracy, system responsiveness, and report generation?

5. Are there documented recommendations for improvement or rectification (e.g., process enhancement, equipment upgrade)?

6. Is the final audit report prepared to clearly communicate the findings and highlight key areas requiring attention?