What are the steps to conduct a biosafety and biosecurity audit of your laboratory?

Biosafety and biosecurity are essential aspects of laboratory management that aim to prevent the accidental or intentional exposure, release, or theft of biological agents that can cause harm to humans, animals, plants, or the environment. A biosafety and biosecurity audit is a systematic and objective evaluation of the policies, procedures, practices, and equipment related to biosafety and biosecurity in your laboratory. It helps you identify and address any gaps, risks, or areas for improvement. In this article, you will learn the steps to conduct a biosafety and biosecurity audit of your laboratory.

1 Plan the audit

The first step is to plan the audit by defining its scope, objectives, criteria, and methodology. You should also establish a team of qualified and independent auditors who have the relevant expertise and experience in biosafety and biosecurity. You should communicate the purpose and expectations of the audit to the laboratory staff and stakeholders, and schedule the audit at a convenient time. You should also prepare a checklist of the items to be audited, based on the applicable standards, guidelines, and regulations.

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Dennis Odoi

Biomedical Scientist || Health Writer || Public Health Enthusiast || Reproductive Health Advocate || Entrepreneur || Certified Google Digital Marketer
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Planning the audit is a foundational step in conducting a biosafety and biosecurity audit of a laboratory. This process involves defining the scope, objectives, and criteria for the audit, as well as assembling a qualified audit team. Establishing a thorough plan enables the identification of specific areas to be assessed, ensuring comprehensive coverage of biosafety and biosecurity protocols. This step also includes developing audit protocols and checklists, determining the timeline, and coordinating with relevant stakeholders. Effective planning sets the stage for a systematic and rigorous assessment, promoting the enhancement of safety measures and compliance with biosecurity standards in the laboratory environment.

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Arslan Arshad

Medical Laboratory Professional | Global Health Security | Quality Assurance | Biorisk Management | Bioethics | One Health | Planetary Health
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The purpose, scope and criteria of the audit. The team should have relevant experience preferably IFBA certified professional. Take into loop all the stakeholders. Make checklists for all the items required.

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Arslan Arshad

Medical Laboratory Professional | Global Health Security | Quality Assurance | Biorisk Management | Bioethics | One Health | Planetary Health
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Start the audit by defining the parameters, objectives, metrics and methodology. Biosecurity Is a qualified, independent team with biosecurity expertise. Communicate audit objectives and expectations, plan in a timely manner, and develop audit plans based on applicable standards and procedures.

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2 Conduct the audit

The second step is to conduct the audit by visiting the laboratory and collecting evidence through observation, interviews, document review, and testing. You should follow the audit checklist and verify the compliance and effectiveness of the biosafety and biosecurity measures in place. You should also identify any nonconformities, deviations, or best practices, and document them with supporting data and photos. You should be respectful, professional, and objective during the audit, and seek clarification or feedback from the laboratory staff as needed.

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Arslan Arshad

Medical Laboratory Professional | Global Health Security | Quality Assurance | Biorisk Management | Bioethics | One Health | Planetary Health
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Visit the laboratory and gather and analyze evidence through observation, interviews, document review, and testing. Follow the audit checklist and ensure biosecurity and biosecurity programs are compliant and effective. Identify inconsistencies, deviations, and best practices, and document them with supporting data and images. Maintain a respectful, professional, and objective approach to seeking clarification or feedback from laboratory personnel as needed.

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3 Report the audit

The third step is to report the audit by compiling and analyzing the audit findings and recommendations. You should prepare a clear and concise audit report that summarizes the scope, objectives, criteria, methodology, and results of the audit. You should also highlight the strengths and weaknesses of the biosafety and biosecurity system, and provide suggestions for corrective and preventive actions. You should ensure that the audit report is accurate, complete, and consistent, and that it follows the agreed format and style.

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Arslan Arshad

Medical Laboratory Professional | Global Health Security | Quality Assurance | Biorisk Management | Bioethics | One Health | Planetary Health
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Collect and analyze the results and report statistical findings. Create clear and concise reports that summarize scope, goals, values, process, and results. Highlight the strengths and weaknesses of biosecurity and biosecurity programs, and make recommendations for corrections and prevention. Ensure that the report is accurate, complete and consistent by following the agreed method and format.

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4 Communicate the audit

The fourth step is to communicate the audit by presenting and discussing the audit report with the laboratory management and staff. You should explain the audit process, findings, and recommendations, and answer any questions or concerns. You should also acknowledge the cooperation and contribution of the laboratory staff, and appreciate their efforts and achievements. You should seek their feedback and input on the audit report, and agree on the actions and timelines for implementing the recommendations.

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Arslan Arshad

Medical Laboratory Professional | Global Health Security | Quality Assurance | Biorisk Management | Bioethics | One Health | Planetary Health
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Communicate statistical findings through reporting to laboratory technicians and staff. Explain the process, findings, and recommendations while addressing questions and concerns. Recognize and appreciate employee performance and contributions. Ask questions, participate in the reporting, and collaborate on actions and timelines to implement recommendations.

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5 Follow up the audit

The fifth step is to follow up the audit by monitoring and verifying the implementation of the recommendations. You should establish a mechanism for tracking and reporting the progress and outcomes of the corrective and preventive actions. You should also provide support and guidance to the laboratory staff as needed, and address any challenges or issues that may arise. You should evaluate the effectiveness and impact of the recommendations, and document any changes or improvements in the biosafety and biosecurity system.

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6 Review the audit

The sixth step is to review the audit by assessing the quality and value of the audit process and report. You should solicit feedback from the auditors, the laboratory staff, and the stakeholders on the audit performance, results, and benefits. You should also identify any lessons learned, best practices, or areas for improvement, and incorporate them into the future audits. You should also update and revise the audit plan, checklist, and report as necessary, and maintain a record of the audit activities and outcomes.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the steps to conduct a biosafety and biosecurity audit of your laboratory?

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1 Plan the audit

2 Conduct the audit

3 Report the audit

4 Communicate the audit

5 Follow up the audit

6 Review the audit

7 Here’s what else to consider

Laboratory Management

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