Wayne Stollings wrote:
The focus seems to be less about what we do, but what we say we do and how we document it.
Sounds as if he didn't like you using PT samples for both audits and troubleshooting. If that's correct, spell out in your SOP, in advance, which PT samples are to be used for audits and which are to be used for troubleshooting. Don't just segregate the products though. Publish two distinct (but similar) procedures, each with their own product.
Pretty thin, huh?
I tried that, but since there are no true PT audits anything we analyzed with a known concentration was potentially a PT audit in his eyes. It did not seem to matter that we did them in a pattern, for a specific reason, and had separated the procedure for how we would do an internal PT sample. We have four systems so each one would get an audit and a blank every month, either when we had a concern, maintenance, or just normal rotation at the end of the month. In order to know if there was contamination not detected by the procedures defined in the methods we used both a blank and a known because some contamintation seemed to show up in blanks and others in samples with organics in them. This process had already shown us where we should check for contamination in areas with which the methods were unaware could be contaminated. We may be able to restart the program once the new accredited audits are available, but we may not have time then either. The old program had two audits with wach set of samples which were collected in the field. The new program may include two additional audits for the lab to collect and recover. We may not have the time for our internal checks with all of the new audits coming in. The scary part is the cost of the four audits will exceed the analytical costs of the samples by a significant amount.