This quote is also from my addendum (supplement) to my first report.
Anyway, you’ll see by the Exhibit AC Audit Schedules, that our side of the QA house, production inspection and MRSA, had only certain QOIs from the QA Manual to audit. Those were "our QOIs," even though some "other side of the house" (Completed Records, QA Planning, CAU) responsibilities were on them. The remainder of the QOIs in the manual were audited by "the other side of the house’s" auditor, who still works for them, (name), I believe (at least the last name is correct). He told me, when I started to make the System Audit book up, that the System Audit QOI, (I.D. number), was production QA’s QOI, and that he didn’t work to it, only we, production QA, had to. He was canceling all of the QOIs that his side of the house had to work to and he was instead going to work to the new (Process Instruction Procedure (PI)) instead. As you investigate this, you might be told that (he) does all of the auditing for PSD QA, both sides of the house, to make it look like we comply with the QOI. If so, have him show you his audit schedule and verify that "our QOIs" listed on my Audit Schedules are on his schedules. If we do not comply with the System Audit QOI, as I know we don’t because of my firsthand experience with what I’ve told you so far and the fact that no one has ever audited me to see if I was complying with any PSD QOIs, then please write us up.
The Last Inspector