In this task, you will evaluate previous audit reports to gain insights into the laboratory's previous performance. This will help you identify areas of improvement and track progress over time. What were the key findings of the previous audits? Were any critical issues identified? What actions were taken to address them? Use this information to guide your assessment and ensure continuous improvement.
Meet with laboratory supervisor for process understanding
Meeting with the laboratory supervisor is crucial to gain a comprehensive understanding of the laboratory's processes and procedures. This task will provide an opportunity to discuss the workflow, challenges faced, and any recent changes or improvements. It will also help establish a collaborative relationship with the supervisor to ensure a smooth audit process. What are the main processes undertaken in the laboratory? Are there any unique requirements or challenges? How can the audit process be streamlined to minimize disruption?
Review laboratory quality system manual
The laboratory quality system manual serves as a guiding document outlining the laboratory's quality management system. This task involves reviewing the manual to understand the laboratory's documented processes, procedures, quality objectives, and key performance indicators. It will help you assess whether the laboratory is compliant with the defined quality system and identify any gaps or areas for improvement. What are the key components of the laboratory quality system? How is it structured? Are there any recent updates or revisions to the manual?
Verify equipment calibration and maintenance records
Equipment calibration and maintenance are fundamental to ensure accurate and reliable test results. In this task, you will verify the laboratory's equipment calibration and maintenance records to ensure compliance with established protocols and regulatory requirements. It will help identify any overdue calibrations, maintenance issues, or deviations from standard practices. How often are the equipment calibration and maintenance activities performed? Are there any specific calibration intervals or requirements for different equipment? How are deviations or non-compliance addressed?
Inspect laboratory environment and safety measures
A safe and controlled laboratory environment is essential for accurate testing and ensuring the well-being of laboratory personnel. This task involves inspecting the laboratory environment and safety measures in place to identify any potential hazards, non-compliance with safety protocols, or areas for improvement. It will also give you insights into the laboratory's commitment to maintaining a safe working environment. Are there any specific safety measures or protocols in place? Are there adequate fire safety measures, emergency exits, and first aid facilities? How are safety incidents or hazards reported and addressed?
Check compliance to standard operating procedures
Standard operating procedures (SOPs) provide instructions for consistent and reliable testing practices. In this task, you will assess the laboratory's compliance with SOPs by reviewing records, interviewing staff, and observing processes. It will help identify any deviations from established procedures, inconsistent practices, or areas requiring additional training or clarification. Are the SOPs easily accessible to all staff members? Are there any documented deviations from SOPs? How are deviations or non-compliance addressed?
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Deviation 1
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Deviation 2
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Deviation 3
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Deviation 4
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Deviation 5
Review sample test records and data integrity
Reviewing sample test records and ensuring data integrity is critical for maintaining the laboratory's credibility and ensuring the accuracy of results. This task involves analyzing sample test records, checking for completeness, accuracy, proper documentation, and adherence to data integrity principles. It will help identify any data inconsistencies, missing information, or potential issues with data integrity. How are sample test records documented? Are there any specific data integrity measures in place? How are data discrepancies or anomalies investigated?
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Inconsistent sample IDs
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Missing signatures
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Data alteration
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Incomplete documentation
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Lack of timestamp
Verify staff training and competency records
Ensuring that laboratory personnel are adequately trained and competent is crucial for reliable and accurate testing. In this task, you will verify staff training and competency records to assess compliance with training requirements, certifications, and qualifications. It will help identify any gaps in training, areas requiring further development, or opportunities for continuous education. How often are training records updated? Are there any specific competency assessment procedures? How are staff members' skill gaps addressed?
Ensure containment of control samples and data
Proper containment of control samples and data is essential to maintain the integrity and traceability of testing processes. This task involves assessing the laboratory's practices for containing control samples and data, ensuring appropriate storage, labeling, and retrieval procedures. It will also help identify any potential risks of cross-contamination or unauthorized access to control samples and data. How are control samples stored and labeled? Are there any specific security measures in place? How is sample chain of custody maintained?
Review non-conformance and incident reports
Non-conformance and incident reports provide valuable insights into the laboratory's ability to identify and address quality issues. This task involves reviewing non-conformance and incident reports to assess trends, root causes, and effectiveness of corrective actions. It will help identify any recurring issues, systemic problems, or areas requiring enhanced monitoring. What are the common types of non-conformance or incidents reported? How are root cause analyses conducted? How are corrective actions tracked and verified?
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Issue 1
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Issue 2
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Issue 3
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Issue 4
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Issue 5
Check corrective and preventive actions records
Corrective and preventive actions (CAPAs) are essential for addressing identified issues and preventing their recurrence. In this task, you will review CAPA records to evaluate their effectiveness in resolving non-conformances, incidents, or other quality-related problems. It will help assess the thoroughness of investigations, adequacy of actions taken, and tracking of implementation. How are CAPAs documented and tracked? Are there any specific timelines or escalation procedures? How are the effectiveness of CAPAs assessed?
Perform in-process audit by witnessing ongoing lab testing
Witnessing ongoing lab testing provides real-time insights into the laboratory's testing practices and adherence to protocols. This task involves observing and documenting ongoing lab testing activities to assess compliance with established procedures, equipment use, and personnel competency. It will help identify any deviations, training needs, or opportunities for process improvement. How often are in-process audits conducted? Are there any specific areas or tests to focus on during the observation? How are observations documented and communicated?
Meet with laboratory supervisor for process understanding
Will be submitted
Review laboratory quality system manual
Will be submitted
Verify equipment calibration and maintenance records
Will be submitted
Inspect laboratory environment and safety measures
Will be submitted
Check compliance to standard operating procedures
Will be submitted
Review sample test records and data integrity
Will be submitted
Verify staff training and competency records
Will be submitted
Ensure containment of control samples and data
Will be submitted
Review non-conformance and incident reports
Will be submitted
Check corrective and preventive actions records
Will be submitted
Perform in-process audit by witnessing ongoing lab testing
Will be submitted
Prepare preliminary audit report
Preparing a preliminary audit report is a key step in documenting the audit findings, observations, and preliminary recommendations. This task involves compiling the assessment results, analyzing the data, and preparing an initial report. It will help summarize the audit findings, highlight areas for improvement, and facilitate alignment with the laboratory management. What are the key sections to include in the preliminary audit report? How should the findings and recommendations be categorized and prioritized?
Hold closing meeting with laboratory management
A closing meeting with laboratory management provides an opportunity to discuss the audit findings, answer questions, and clarify any concerns. This task involves scheduling and conducting a closing meeting to present the audit findings, discuss recommendations, and obtain management's commitment for corrective actions. It will help ensure mutual understanding, agreement on improvement actions, and set expectations for the final audit report. What are the key points to cover in the closing meeting? How should the findings and recommendations be presented?
Approval: Audit Supervisor (Preliminary Report)
Will be submitted for approval:
Prepare preliminary audit report
Will be submitted
Hold closing meeting with laboratory management
Will be submitted
Prepare final audit report
Preparing a final audit report is a critical step to document the audit findings, recommendations, and management responses. This task involves compiling all the audit information, processing the feedback from the closing meeting, and producing a comprehensive final report. It will serve as a record of the assessment, a reference for future audits, and a communication tool for relevant stakeholders. What are the key sections to include in the final audit report? How should the findings and recommendations be organized and presented?
Submit final audit report to management
Submitting the final audit report is essential to communicate the audit findings, recommendations, and management's commitment to corrective actions to the relevant stakeholders. This task involves preparing the final report for distribution, obtaining required approvals, and submitting it to the designated personnel or department. It will signify the completion of the audit process and initiate the implementation of improvement actions. What is the distribution list for the final audit report? Are there any specific approval requirements? How should the report be submitted (e.g., email, hard copy)?
Approval: Laboratory Management (Final Report)
Will be submitted for approval:
Prepare final audit report
Will be submitted
Submit final audit report to management
Will be submitted
Plan for follow-up audit
Planning for a follow-up audit is essential to ensure the effectiveness of corrective actions, assess progress, and drive continuous improvement. This task involves scheduling a follow-up audit, discussing the scope and objectives, and identifying the key focus areas. It will help establish a structured approach for monitoring compliance, addressing any pending corrective actions, and fostering a culture of ongoing quality improvement. How frequently should follow-up audits be conducted? What are the criteria to assess the completion of corrective actions? How should the scope be defined for the follow-up audit?
