On-site inspections are understandably stressful experiences. Organizations essentially invite others to come to their sites, look through their documents, watch their work practices, and record observations. Organizations that voluntarily pursue FACT accreditation want to do well, and it is natural to feel nervous about what inspectors may find while assessing their programs.
When preparing documentation for inspector review, it may be instinctively enticing to avoid showing inspectors everything. Limiting what inspectors see limits the amount of deficiencies they find, right? Wrong. Although it seems counterintuitive, more citations result from inspectors not able to find evidence of compliance.
Do not think of an inspection as a day to avoid doing anything wrong. Think of it as a day to proudly show all that your program has accomplished! The easier it is for inspectors to find and review documents, the easier it is for them to check “Compliant” on that ubiquitous inspection checklist. Showing documentation upfront on the day of inspection will avoid extra time and effort to describe the documentation when responding to deficiencies afterward.
Therefore, be ready to show inspectors audits, adverse event investigations, and urgent medical need documentation for ineligible donors. The purpose is not to show the inspectors any shortcomings; the purpose is to show inspectors your approach to quality management and continuous improvement. Organizations that act like they have something to hide will appear to have something to hide. Confidently showing inspectors your quality documents, procedures, and investigations demonstrates a commitment to quality.
FACT and its inspectors want organizations to do well, and that does not end with an accreditation certificate. The ultimate goal of FACT accreditation is to continuously improve. The more you show us, the more we will be able to help you and the better value you gain from the accreditation process.