Now, opinions differ on this, but my obviously correct one is that QC should be a separate process from QA.

That is to say, that someone (e.g. part of the study or operations, or in a separate QC capacity) should be checking over the correctness of any datasets. For example, doing a comparison of any copied or transcribed data against the original source. Checking all values in report tables against sources. Checking values in report text. Checking units, formats, spelling, grammar, etc. etc.

This should be done before any audit, inspection, quality assurance review.

You see, QC are the processes that ensure a quality product: things like daily form reviews, tests, monitoring, metrology, audit trail reviews, etc. No one person or team is responsible for these, rather they are processes that exist throughout.

QA is a role that ensures these and other quality-related processes are in place and operating correctly. An independent, top level view if possible. They may do this through testing, record reviews, regular inspections and audits, document and procedure reviews, analyzing metrics.

Yes, they will do some QC here and there to make sure everything is in order. Critically they should not be the QC process itself: rather they should be making sure the QC process is doing its job.

QA's value is not in catching every mistake (though they might), but in long term quality, stability, and consistency.

So if I'm looking at a data set or a report, and I start to find multiple errors - I'm not going to go take that as a signal to go through with a fine toothed comb and try to find and correct every single error.

Instead stop! It's already clear that a QC process was inadequate, and the data set / document was sent for review prematurely.

Send it back for a proper QC.

Until next time, thanks for reading!

– Brendan

p.s. Enjoy this message? Read more at the Hyland Quality Systems website.