The first on-site audit was from a very southern state known for political corruption, which should have been a clue. The single auditor, which based on education/experience would have been the support person in the other audits, had not looked at the documentation provided, so the first day was spent going over the QA manual and SOPs. The second half day ... almost ... was spent trying to get him to leave my office and look at the lab before he left. He only got one foot in the door before turning around to leave.
Every audit has to have something found to make it a true audit. Usually the "dings" are unimportant and are easily changed if everything is in good shape. The major "dings" from the audit were that we did not have a "mission statement" in our QA manual and a series of other paperwork additions, which were equally unimportant. If there had been anything amiss there would have been no way to catch it.
The next on-site audit cost was going to increase by over 2000% because they were contracting audits for anything out of their state to a private firm, so we moved to the current primary accrediting state from the northeast. It is still a better run program than the southern one from my experiences.Statistics: Posted by Wayne Stollings — Thu Jul 14, 2011 9:09 am
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