As a part of inspection preparation, the laboratory should review retained documentation in all departments/specialties. The purpose of this process is to "clean house." While an electronic or hard copy document control and storage plan may be in place in the laboratory, there are times when documents are improperly filed/stored/retained. Ideally, the laboratory should include this type of organizational review as an ongoing process as a part of the Quality Management (QM) plan. Various workplace hinderances may provide random gaps in the documentation process.
Pre-inspection preparation is a time to verify that all documentation is easily accessible and complete. While it may not be possible to recreate missing documentation, it is likely that missing documents are misfiled, have not been filed, or awaiting review or signature.
Note: If documentation appears to be missing, the appropriate manager should be notified, and appropriate corrective action should be taken. The laboratory staff should not create any documentation during this process, but rather note issues and refer to management.
An additional point to organization and review of documentation is to familiarize the staff with location of all documents that are likely to be requested by the surveyors. For the laboratory to present with an organized process for the surveyors on the day of the survey provides a positive survey atmosphere.
Specific documents for review and organization may include but are not limited to the information summarized in the attached table.