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Wednesday, February 9, 2011
Ranting on a Rant.
A recent article in Quality Digest Daily (www.qualitydigest.com) posed the question “Internal Quality Audits – Valuable or False Security?” The question was written within The QA Pharm, an anonymous blog focused mainly on issues in the Pharma industry.
An interesting question, with an even more interesting answer. QA Pharm contends that internal audits are not helpful because they tend to be done by auditors who have been working too long and who are too politically aware and avoid sensitive concerns, and senior management doesn’t support them anyways. And they never get to the root cause because company culture gets in the way.
In a way I am not too surprised by the rant. My experience with folks who have transitioned from pharma to health care is that the pharma culture is hyper reactive to the point of absolute risk aversion, which tends to either paralyze or drive folks in the opposite direction. People who care for pharma quality tend to get extremely passionate. The rest get bashed to indifference.
Pharma does have certain problems. Most drug release decisions are made through a series of graduated studies, on pharmaceutical effect, and then controlled safety studies, and then “larger” population studies, and then after-the-fact post-market analysis. In their world even 6 sigma (3 defects per million) can be enough to sink the ship. But they are not unique. It only takes one airplane to fall out of the sky or one bridge to fall down to create industry chaos.
In contrast the health care may be a little more tolerant, maybe too tolerant.
My biggest problem with QA Pharm is not on his opinions with respect to the frustrations of practicing qualitology in the pharmaceutical industry. It is more with the folks who read the rant, and interpret the opinion as generalizable.
Health care laboratories are just at the beginning part of the quality process and the introduction of internal quality audits is just being introduced in a significant way. That is not only true in Vancouver, but it is my personal experience that this is the case across Canada, across the United States, and in many countries worldwide. This is not the time for health care laboratorians to be thinking that internal quality audits are a waste of time, or too political.
Internal quality audits can and should be an important component of technologist training, quality manager training, pathologist training. They can and must (shall) be a component of quality monitoring infrastructure, and the foundation of quality research and outreach.
So QA Pharm can have his(?) point of view, and that is fine, if it is intended to apply only to the pharma industry. That internal audits are a WOT, is not my point of view and it has no place in health care laboratories.
PS: Some of you may be in the receiving group for a POLQM Weekend Workshop blast out. next week.
PPS: Some of you might consider sending the link to to friends and colleagues who might be interested. All a part of being within an interest network. Twitter works well as well.