James_Ball wrote:
The other thing is our QA guy is wanting the analysts to put the info together, which will be a pain to do as we always have enough other work to get finished on time.
Our QA got his "wonderful idea" that our results - even though methods were validated by cGMP or GLP - should pass gauge R&R test requirements, a test devised to measure variability in automotive crankshaft diameters.
Even results from oven solids and pH could not pass gauge R&R requirements, so chromatography procedures utilizing multiple sample preparation steps and then chromatographic assay had zero chance !!! Only after wasting multiple hours by multiple analysts with repeated "failures" did QA back off such requirements.
Funny, the QA Director had worked in QC lab at a large detergent company early in his career, but had zero feel for real R&D Analytical Chemistry.