“It is strongly recommended that a laboratory conduct its own internal quality audit with sufficient frequency to assure that test analyses provide continuously reliable results.” Donald C. Singer and Ronald P. Upton

A laboratory quality audit ensures that a laboratory's systems meet rigorous quality standards, follow Good Laboratory Practices (GLP), and produce reliable, high-integrity data. These audits are critical for ensuring that decisions based on laboratory data—whether for compliance, investigation, or other purposes—are founded on trustworthy results.

According to Guidelines for Laboratory Quality Auditing by Donald C. Singer and Ronald P. Upton, internal audits conducted with appropriate frequency allow labs to maintain reliable results, identify gaps in their quality programs, and prepare for external client audits.

This article outlines nine essential steps to prepare for and perform a successful laboratory quality audit.

Why Conduct a Laboratory Quality Audit?

Laboratory data directly impacts strategic decision-making across projects like remediation, compliance, and product development. Poor-quality data can lead to costly resampling, project delays, and budget overruns. An audit is a proactive measure that verifies quality systems, compliance, and consistency, ultimately safeguarding the credibility of laboratory results.

The success of a laboratory audit depends on four core principles:

• Adequate Preparation
• Precise Execution
• Insightful Documentation
• Productive Follow-Up

Step-by-Step Guide to Performing a Laboratory Quality Audit

1. Define the Purpose of the Audit

Clearly articulate the objective of the audit. Determine whether the audit is aimed at assessing compliance with internal quality standards, addressing client-specific requirements, or ensuring adherence to regulatory guidelines. This step involves identifying key drivers behind the audit, such as improving operational efficiency, preparing for external inspections, or aligning laboratory practices with industry benchmarks. A well-defined purpose ensures the audit remains targeted and relevant to organizational goals.

2. Define the Scope of the Audit

The audit scope determines its boundaries and focus. Clearly outline what the audit will and will not cover:

• Will the audit evaluate only a single laboratory or encompass multiple sites within the organization?
• Are specific analytical methodologies, equipment types, or processes under review, or will the audit include all laboratory operations?
• How will the audit impact daily laboratory activities and staff involvement?
  By establishing these parameters, you can minimize operational disruptions and allocate resources effectively, ensuring that the audit process is streamlined and impactful.

3. Determine the Audit Team Resources

Audit success relies on assembling a team with the right expertise and sufficient capacity to handle the scope of the audit. Consider the following factors:

• Does the team possess specialized knowledge of the analytical methods, equipment, or regulations relevant to the audit? For example, if the audit involves specific instrumentation, ensure team members are well-versed in its operation and standards.
• Are there enough team members to thoroughly examine all aspects of the defined audit scope, including documentation, processes, and personnel interviews?
• Is the team balanced in terms of technical and interpersonal skills to conduct the audit effectively and maintain good communication with laboratory personnel?
  By addressing these questions, you can ensure the team is prepared to deliver a comprehensive and insightful audit.

4. Identify the Authority for the Audit

The authorization for the audit defines its legitimacy and scope. It may originate from:

• The company’s quality assurance policies or manuals, specifying internal protocols for routine audits.
• Contractual obligations with clients, requiring the laboratory to demonstrate compliance with agreed-upon standards.
• Requests for third-party evaluations, particularly when external validation of quality systems is necessary for certification or accreditation.
  Clearly documenting the source of authority establishes the framework for the audit’s scope and purpose, reinforcing its credibility and ensuring all parties understand the audit’s objectives.

5. Identify Performance Standards

Laboratory quality systems vary widely among organizations, making it essential for the audit team to benchmark the laboratory’s processes against established standards. Common frameworks include ISO/IEC 17025, GLP (Good Laboratory Practice) regulations, or other relevant industry-specific guidelines. The audit team should:

• Review the laboratory’s Quality Manual and standard operating procedures (SOPs) to ensure alignment with these standards.
• Verify that all critical functions, such as sample handling, data integrity, and quality control, are fully addressed within the laboratory’s systems.
• Adapt the evaluation to accommodate unique aspects of the laboratory’s quality framework while ensuring no key areas are overlooked.
  This approach allows the audit to provide meaningful insights into how the laboratory’s quality systems compare with industry best practices.

Preparing for On-Site Activities

6. Develop a Technical Understanding of Laboratory Processes

Before arriving on-site, audit team members should conduct an in-depth review of:

• The laboratory's quality manual ensures familiarity with its content and alignment with relevant standards.
• Relevant procedures, such as standard operating procedures (SOPs) and quality control protocols, to identify potential focus areas.
• Historical audit reports, including past findings, corrective actions taken, and trends that may require attention.
  This foundational work enables the team to prioritize "mission-critical" areas, anticipate potential challenges, and design a targeted approach for on-site evaluation. Additionally, it helps in refining audit checklists to address the specific nuances of the laboratory’s operations.

7. Contact the Laboratory Being Audited

Early and effective communication with the laboratory (auditee) is essential for a successful audit. This step involves:

• Establishing rapport with key personnel to ensure a collaborative and transparent process.
• Clarifying the logistics of the audit, such as timing, locations, and the availability of resources.
• Requesting and reviewing preliminary documentation, such as policies and training records, to aid in pre-audit preparation.
  Sharing the formal audit plan in advance not only demonstrates professionalism but also sets expectations for both parties, paving the way for smooth execution.

8. Perform Initial Document Evaluation

A thorough review of lower-tier documents (e.g., procedures, SOPs) against higher-level requirements, such as the organization's quality policy or industry standards, is crucial. This process involves:

• Identifying discrepancies between procedural documents and overarching quality guidelines.
• Pinpointing areas where documentation may lack clarity or completeness.
• Establishing a preliminary focus for on-site investigations, ensuring efficient data-gathering efforts.
  This step not only enhances the audit team's understanding of the laboratory’s processes but also helps in creating a structured roadmap for subsequent phases of the audit.

Conducting the Audit

9. Develop Written Checklists

Comprehensive and well-organized checklists are critical for a systematic audit. These should:

• Address specific data needs, detailing the exact information required for evaluation.
• Link each question directly to relevant standards (e.g., ISO 17025 or GLP requirements) to ensure consistency and accountability.
• Differentiate between general and lab-specific requirements, ensuring tailored assessments.
  Avoid creating a generic “wish list.” Instead, focus on checklists that are practical and targeted, allowing for a thorough yet efficient evaluation across multiple laboratories. Regular updates and reviews of these checklists can further enhance their effectiveness.

Best Practices for a Successful Laboratory Audit

1. Maintain Objectivity: Ensure the audit focuses on improving processes rather than assigning blame. Approach every finding as an opportunity to strengthen the laboratory’s systems and practices, and avoid focusing on individual errors or assigning responsibility without examining systemic causes.
2. Document Findings Thoroughly: Prepare detailed and organized reports that clearly outline audit observations, non-conformances, and areas for improvement. Include specific examples, references to relevant standards, and actionable recommendations to provide a robust basis for corrective actions.
3. Communicate Clearly: Foster open and transparent dialogue with laboratory personnel to ensure they understand the audit findings and their implications. Use clear, non-technical language when discussing complex issues and encourage feedback or questions to promote a collaborative environment.
4. Follow Up: Develop a structured follow-up process to verify that corrective actions have been implemented effectively. This may involve scheduling subsequent reviews, tracking progress through status updates, or conducting mini-audits to assess improvements.

Final Thoughts

Conducting a laboratory quality audit is an essential step in maintaining high standards of data integrity and reliability. By following these nine steps, laboratories can identify areas of improvement, prepare for external audits, and ensure compliance with internal and regulatory standards. The process not only enhances operational efficiency but also builds trust with clients and stakeholders.

Investing in regular audits demonstrates a commitment to quality and continuous improvement—a hallmark of any successful laboratory.

This content includes text that has been generated with the assistance of AI. Lab Manager’s AI policy can be found here.