Additional Inspection Tips

  • During the inspection, you have several tools at your disposal. First impressions on entering a facility can indicate the level of organization and management throughout the program. Check for appropriate signage, storage conditions, tidiness, and use of protective equipment. Retrieval times for requested information can also be indicative of overall organization.

  • Follow the progress of a product from donor screening to infusion. When questioning staff about procedures, be flexible. Allow the discussion to move into related areas, to ensure you understand the whole process and the personnel’s role in that process. It is not necessary to follow the exact order of the checklist. Determine if you hear the same information from different staff members. 

  • Ask to see a procedure if one is ongoing, or ask personnel to mock up a procedure. This is a routine component of the inspection process. If a real procedure is being observed, allow the personnel to work without multiple interruptions. Write notes and ask questions later. If a patient is involved, be certain personnel have obtained the patient’s consent to have an observer present. Always follow institutional practices of gowning, limitation on the number of persons allowed in a clean room or other area, or other issues during observation. Do not compromise patient care or product handling by your inspection tasks.

  • Double check you have not overlooked something because you have searched in the wrong place. Ask personnel to provide you with the missing documentation – they may have filed it in a different location or system.

  • Remember that an additional SOP is not the answer to every deficiency. The Standards do require specific SOPs to be available for certain procedures, e.g., cryopreservation. In other cases, it may be possible to satisfy the intent of the standard by mechanisms other than an SOP.

  • An indication of problem areas may be obtained by reviewing variances. Are there repeated occurrences of the same problem, has corrective action been taken, and has it been effective? Remember,  variances and audit results are not in of themselves a reason to cite an applicant, but useful to assess whether or not the applicant complies with requirements to detect and correct problems and conduct follow-up.

  • If you see a clear deficiency that could be easily and rapidly remedied during your visit, offer the staff the opportunity to make the correction and provide you with evidence the correction has been made. It is not necessary to cite the applicant for that deviation, but you should include the evidence of correction in your report. However, this approach cannot be followed for deficiencies that are serious and require sustained evidence of correction and implementation.

  • FACT makes every effort to write Standards that do not conflict with regulatory requirements. However, if national regulations appear to be in conflict with FACT Standards, do not enter into a debate. Simply write a note on the checklist and in your report.