Audit disclosure

[Cliff]

What are your policies toward inspectors / assessors and revealing the results of your internal audits?

I attended a Joint Commission conference many years ago where one of the surveyors indicated TJC would never ask for the results of internal audits, and it's likely FDA would not either; however, they cautioned against refusing to provide the results to FDA.

During a recent AABB assessment I "refused" to provide the results of the audits and AABB reluctantly accepted my decision.

My feeling is that if our internal audits are open for review there could be a perception of performing less than thorough audits for fear of getting "caught" and possibly cited The intent of an audit is to make an honest attempt at improving.

[Liz]

Our Internal audits are presented on a monthly basis to the BOT along with other info.

The CAP, JCI and MOPH inspectors want to know that we have audits in place but never have they asked to see the results. My Chair said to politely decline if asked.

Liz

[Malcolm Needs ☆]

We make our internal audits available to external auditors, but we do not make available the results of our National External Quality Assessment Scheme (NEQAS) to them, on the grounds that these are private to each laboratory (although we have nothing to hide - it is a matter of principle).

[David Saikin]

As an assessor, I like to see that you are doing internal assessments. Most places usually perform some sort of Quality review on a regular basis. I like to see these . . . theoretidally your audit sutff sould show up in that review in some form or another. Professionally, I don't care what you audit - it is your operation. What I do care about is that you are auditing something that is pertinent, i.e., allows you to provide better service (improves quality). Even if I thought your monitors were NOT pertinent, I would not cite, but only offer a recommendation.

[Lcsmrz]

During an assessment, I have to verify that internal audits are being performed as specified in their Quality Manual -- I usually ask to see summaries and any corrective actions, just to see if the facility can produce them. If I spy a repeated error, I check to see if a root cause was identified and how effectiveness of corrective action is being handled.

The intent is always to assess the capture of errors, the process of error handling, and effective follow-up to prevent recurrences.

I think the practice of refusing requests for internal audit documents stemmed from the past FDA practice of issuing a 483 for incidents discovered, investigated, corrected and (if necessary) reported by the facility before the investigator arrived.

[David Saikin]

Larry - I t hink the feds have stopped that practice . . . what do you think?