What is the best way to conduct a laboratory quality audit?

1 Define the audit scope and objectives

The first step in conducting a laboratory quality audit is to define the audit scope and objectives. The audit scope defines what aspects of the laboratory's activities, processes, and results will be audited, such as equipment, methods, personnel, records, or samples. The audit objectives define the purpose and expected outcomes of the audit, such as verifying compliance, assessing performance, or evaluating improvement. The audit scope and objectives should be aligned with the laboratory's quality policy, goals, and customer needs. They should also be specific, measurable, achievable, relevant, and time-bound.

2 Select the audit team and criteria

The next step in conducting a laboratory quality audit is to select the audit team and criteria. The audit team consists of one or more auditors who have the knowledge, skills, and experience to conduct the audit effectively and impartially. The audit team should be independent from the laboratory being audited and should avoid any conflicts of interest or bias. The audit criteria are the standards, regulations, guidelines, or best practices that the audit team will use to evaluate the laboratory's compliance and performance. The audit criteria should be relevant, reliable, and consistent with the audit scope and objectives.

3 Plan and prepare the audit

The third step in conducting a laboratory quality audit is to plan and prepare the audit. The audit team should develop an audit plan that outlines the audit schedule, activities, resources, roles, and responsibilities. The audit plan should also include the audit checklist, which is a list of questions or items that the audit team will use to collect and verify evidence during the audit. The audit team should communicate the audit plan to the laboratory being audited and obtain their agreement and cooperation. The audit team should also review any relevant documents, records, or data from the laboratory before the audit.

4 Conduct the audit

The fourth step in conducting a laboratory quality audit is to conduct the audit. The audit team should visit the laboratory and perform the audit activities according to the audit plan and checklist. The audit activities may include interviewing staff, observing processes, inspecting equipment, testing samples, or reviewing records. The audit team should collect and document sufficient and appropriate evidence to support their findings and conclusions. The audit team should also identify any nonconformities, which are deviations from the audit criteria or expectations. The audit team should communicate their findings and nonconformities to the laboratory staff and management throughout the audit.

5 Report the audit results

The fifth step in conducting a laboratory quality audit is to report the audit results. The audit team should prepare an audit report that summarizes the audit scope, objectives, criteria, activities, findings, nonconformities, and recommendations. The audit report should be clear, concise, accurate, and objective. The audit report should also include the audit evidence, such as documents, records, or photos, to support the audit findings and nonconformities. The audit team should present and discuss the audit report with the laboratory staff and management and obtain their feedback and acknowledgement.

6 Follow up on the audit actions

The sixth and final step in conducting a laboratory quality audit is to follow up on the audit actions. The audit actions are the corrective and preventive measures that the laboratory should take to address the nonconformities and improve their quality and performance. The laboratory should develop and implement an action plan that specifies the actions, responsibilities, resources, and deadlines. The laboratory should also monitor and measure the effectiveness of the actions and report their progress and results to the audit team. The audit team should verify and close the nonconformities once the actions are completed and satisfactory.

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?