Ideally, clinical and pharmaceutical laboratories should be inspection-ready all the time. Maintaining operational checklists that keep up to date with changes in international standards and regulatory requirements is the first step. Laboratories should think about how to prepare for a laboratory inspection well before a regularly scheduled regulatory visit.
Check Standards Routinely
Regulatory requirements and international standards for compliance in the measurement, operations, and management of samples and materials undergo frequent updates and revisions. Lab managers should subscribe to relevant newsletters and interest groups that provide notice of upcoming changes.
Synchronize Documentation with Practice
Sloppy or inconsistent paperwork is a red flag for inspectors. Ensure that documentation is in synch with practice. When inspectors arrive to conduct their observations, one of the things that will certainly get their attention is if operational practices don’t match documentation. Operational inconsistencies between shifts in a department, or between different laboratory departments, create areas of concern for inspectors.
Conduct Regular Internal Audits
Select a single process and follow it from start to finish over several days or shifts where workers performing the steps of the process trade-off. Note inconsistencies in the sequence of steps in the process, or in the handling of samples or materials. Consistency is critical to reliable results, and reliability is in everyone’s best interest. A laboratory’s reputation may ride on the consistency in the results it produces.
Don’t Ignore the Obvious
Routine breeds inattention. It can be all too easy to assume that everyone takes cleanliness, fire safety, appropriate handling of hazardous materials and waste, and proper storage of samples and materials seriously. Workers may assume that they’ve got the routine down, but a new set of eyes on what they are actually doing as opposed to what they think they are doing may turn up issues that will leap out to an inspector immediately. Ensure that staff members cover the basics consistently, across all lab operations.
Professional organizations and expert trainers and educators will know the best practices and the latest information on regulations and standards applicable to specific types of laboratories. Implementing updated standards may require changes in longstanding operating procedures or refreshers for laboratory staff. Researchers and technicians may not have time to independently research and react to regulatory changes that affect aspects of lab operations. One of the best ways to prepare for laboratory inspections is to invite outside experts to present training or conduct impartial audits that can alert lab managers to areas in need of operational improvement.