Technical Laboratory Audits
Most laboratory staff will be familiar with the concept of audits – many will have completed ISO or NATA accreditation or reviews. In the case of ISO accreditation, the aspects of the laboratory that are reviewed are mostly administrative – procedures, policies and the like. Are these up to date? Do staff know where to find them? Do they follow the procedure or policy correctly? NATA accreditation looks at types of analysis in depth, but audits will focus only on the accredited analytical methods, not on the entire laboratory. Companies may also conduct their own internal (or inter-group) audits, but often these will also focus on administrative details, not the technical aspects of the laboratory.
Technical laboratory audits require auditors who are familiar with the laboratory environment and with the instruments used and analyses carried out. It is, however, not appropriate for the auditors to be employed at the laboratory being audited. The auditors need sufficient understanding of the work carried out in the laboratory in order to ask appropriate questions and to determine how well the laboratory staff are adhering to the written laboratory methods.
A technical audit will require the auditor (or auditors) to spend much of the audit in the laboratory. Depending on the type of laboratory, this may involve observing sample preparation and instrument set-up, reviewing control charts and calibrations with the operator or technician, looking at instrument logs or historical charts or considering reporting requirements or how results are presented. All technical audits will require talking directly to technical staff to determine if procedures are followed and how well the staff understand the analytical technique itself.
Like all audits, a technical audit should not feel like an examination of their skill or a test of their knowledge to the technical staff. The audit is examining the laboratory processes in place to ensure appropriate and accurate laboratory analyses. If these processes are adequate and training is carried out properly, this will be demonstrated in the audit. When the processes are inadequate or training is incomplete or inappropriate, the audit will identify this and allow the laboratory manager(s) to improve these aspects.
Outcomes from an audit should be presented at the end of the audit. In general, a powerpoint presentation will be an appropriate way to report findings to the laboratory management and staff. While a written report may be issued later, a presentation at the laboratory allows all participants immediate access to the outcomes of the audit. Outcomes can include such things as identified best practices and areas for improvement. Best practices can be shared with other laboratories from the same business area or group to improve the overall quality of all laboratories’ performances. Areas for improvement can be the basis for a plan to improve aspects of the laboratory into the future.