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Quality control laboratory audit checklist

Quality control laboratory audit checklist

This audit checklist guides you in reviewing key aspects of your lab for compliance, including staff training, equipment, and record management.

Use this template
or download pdf
Quality control laboratory audit checklist

This audit checklist guides you in reviewing key aspects of your lab for compliance, including staff training, equipment, and record management.

Use this template
or download pdf

About the Quality control laboratory audit checklist

Maintaining smooth laboratory operations involves more than just daily tasks—it requires a reliable system for monitoring and improving quality standards. This quality control laboratory audit checklist is an invaluable tool for systematically assessing compliance across personnel, equipment, and procedures. With this checklist, you’ll streamline the entire audit process, providing clear documentation that supports quality assurance efforts. Whether you’re managing audits across multiple sites or within a single laboratory, this tool enhances efficiency, accountability, and consistency in your operations.

Key elements of a quality control laboratory audit checklist

This quality control laboratory audit checklist covers vital aspects of your lab’s performance. Here are the key components:
  1. Organizational structure and personnel – A clear organizational structure is critical for efficient operations. In this section, you’ll assess if your team is adequately trained, with roles clearly defined and sufficient staffing to meet the lab’s needs.
  2. Facilities and equipment – Properly maintained and calibrated equipment is the backbone of accurate testing. You’ll verify that your lab facilities are suitable for the tests conducted and that all instruments are properly maintained.
  3. Documentation – Keeping detailed and secure records is essential for compliance. This section checks that all procedures and testing records are documented and stored securely.
  4. Sample handling – Effective sample management is necessary for accurate testing and reliable results. You’ll assess here if samples are properly labeled, stored, and tracked.
  5. Quality assurance – Consistent quality checks, such as internal audits and corrective actions, are crucial for maintaining lab standards. This section focuses on whether quality control is continuously monitored and documented.
  6. Reporting and data integrity – Finally, you’ll verify if test reports are clear, comprehensive, and reviewed before submission. It’s also critical to protect data integrity through secure access and backup systems.

Best practices for using the quality control laboratory audit checklist

To make the most out of your quality control laboratory audit checklist, follow these best practices. First, every lab operates differently, so customize the checklist to your lab’s specific needs. Feel free to edit it to address the unique processes, equipment, or regulations relevant to your work. Involve multiple team members in the audit process. Auditing from a single perspective might miss key insights, but when different staff members, from lab technicians to management, contribute to the audit, it becomes more well-rounded. You can also use the checklist to standardize procedures across multiple locations. If your organization operates several labs or facilities, consistency is key. Implementing the same customized checklist across all locations helps ensure uniform quality standards, while allowing for adjustments based on site-specific needs.

Start using Lumiform’s quality control laboratory audit checklist today

Improve your data management process with our specialized template. Built to maintain accurate and complete data, this form streamlines your audits, ensuring no important detail is missed. Capture key metrics with ease and identify inconsi

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Preview of the template
Page 1
General Information
Laboratory Name
geolocation!!!
Responsible Person
Date of Audit
Organization and Personnel
Is there an organizational chart defining reporting relationships?
Are responsibilities of key personnel clearly defined and documented?
Is there adequate staff to perform required laboratory activities?
Is the laboratory staff appropriately trained and qualified for their responsibilities?
Is there a documented training program for new and existing staff?
Are training records maintained for all laboratory personnel?
Facilities and Equipment
Are laboratory facilities suitable for the tests/analyses conducted?
Is the laboratory environment (e.g. temperature, humidity, lighting) controlled and monitored?
Is access to the laboratory restricted to authorized personnel only?
Are all equipment and instruments properly identified, calibrated and maintained?
Are calibration and maintenance records available for all equipment?
Are there procedures for handling, transporting, storing and using equipment?
Documentation and Records
Are all SOPs, testing methods and protocols documented and approved?
Are all laboratory records (e.g. testing, calibration, maintenance) complete and properly maintained?
Is there a document control system to ensure the use of correct/current documents?
Are records stored securely and accessible only to authorized personnel?
Are there procedures for record retention, archiving and disposal?
Are all deviations, non-conformances and corrective actions documented?
Sample Handling
Are there documented procedures for sample receipt, identification, handling, storage and disposal?
Are samples stored under appropriate conditions to preserve integrity?
Is sample traceability maintained throughout the testing process?
Are there procedures to handle and investigate sample discrepancies or issues?
Quality Assurance
Is there a comprehensive quality assurance program in place?
Are quality control procedures (e.g. blanks, spikes, duplicates) routinely performed?
Are proficiency testing or inter-laboratory comparisons conducted periodically?
Are audit findings and corrective actions documented and followed up?
Is there a process for handling customer complaints and feedback?
Reporting and Data Integrity
Are test reports clear, unambiguous and in compliance with requirements?
Is there a process to review and approve test results before reporting?
Are there procedures to identify and address data errors, omissions or anomalies?
Is there restricted access and control over raw data, calculations and records?
Are electronic records and data maintained with appropriate security and backup?
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.