Internal Quality System Audit Checklist Microbiology

This internal quality system audit checklist microbiology covers topics related to laboratory management systems. This checklist can assist auditors in verifying that their lab complies with all applicable health and safety standards.

Examine whether quality documents comply with ISO 9001 requirements; including reviews of records, quality manuals and procedures.

Analytical Methods
An audit checklist for microbiology laboratories covers all key areas of its analytical processes. These include sample receipt, analytical methods and controls, recording/reporting results as well as creating documented procedures to log samples in/out of the lab.

Accuracy and reliability in laboratory tests is of utmost importance, and regulatory bodies, customers, and accreditation agencies all expect labs they work with to produce consistent and accurate results. To demonstrate this commitment to accuracy and consistency, labs are mandated to conduct internal audits annually conducted by individuals independent from the process under scrutiny.

An audit questionnaire must be tailored specifically to the process to be audited in a laboratory, so as to be applicable and relevant to their responsibilities and functions rather than generic audit questions. An auditor should ideally develop this audit questionnaire by interviewing senior personnel of the laboratory.

Analytical Controls
Clinical microbiology laboratories utilize analytical controls such as quality control (QC) for testing methods, analyzing results of QC samples and reporting them timely. Other aspects of their quality assurance program may include training, equipment calibration/maintenance and specimen collection/transport procedures.

Assigning an audit checklist depends on the technical processes at play in a laboratory’s operation and the scope of audit being undertaken. To be effective, an audit team needs to understand these processes so they can focus on and address key issues identified during their investigation.

Management Reviews are an integral component of laboratory quality systems and should be carried out regularly throughout the year. As shown in Figure 2, these reports provide visual displays of key quality indicators like performance over time and between lab sections as well as any complaints being tracked for follow up action. Making these available to laboratory staff allows them to monitor trends and implement improvements with greater ease.

Recording and Reporting of Results
An ISO quality system audit is conducted to measure how processes comply with ISO 9001 standards, with particular attention paid to any processes which lack defined documentation. If there are gaps, such as those without traceability of raw materials or components used in batches; testing records for every product type and stage; as well as warehouse storage and distribution records will all be noted in the audit report.

Audits will focus on whether there is an established process for recording and reporting test results as well as whether there is a documented procedure for tracking samples that are removed from laboratories – something the QA department should strive to do effectively.

Internal audit is a systematic process by which staff of a company inspect its various departments, sections and areas. To avoid conflicts of interest and ensure impartiality during this review process, those conducting it should remain independent from those being audited. Once completed, any results should be reported back immediately to top management as soon as possible.

Training
Microbiology laboratories must offer their staff training that aligns with institutional standards. This may include instruction in compliance with Good Manufacturing Practice regulations, quality assurance, and the laboratory’s quality management system. Training may be provided via written materials, training schedules or via laboratory-specific checklists.

Laboratory advice should also be communicated effectively to clinical colleagues. This may take the form of written communications, such as antibiograms or specimen collection instructions; or verbal messages delivered directly to physicians with critical test results or alerts about antibiotic resistance.

Laboratory must establish and implement procedures for tracking samples leaving their facilities and checking sample integrity, which may involve verification of analyst qualifications, analytical methods, control procedures, reporting results to medical and scientific personnel as well as tracking outgoing samples for quality assurance purposes. Logging outgoing check samples must also be recorded. Logging professional development activities and competencies is required of medical and scientific staff and thus often falls upon human resources personnel or institutional administrators for this task.