Wednesday, September 22, 2010

Top 10 things you don't want to hear during an accreditation visit.

We talk about 7 Quality Partners (Standards Development Organizations, Accreditation Bodies, Proficiency Testing Providers, Education Bodies, Professional Organizations, Hardware and Reagents Suppliers, and the Public).  These are the groups that create the foundations and support for Laboratory Quality,.  All of them play a valuable and for all intents and purposes, equal rolls.   Except for the Public.  When the public, either in the form of the media, or the regulators, or the legislators or the litigators get in the mood to fix quality, then everything else fades in comparison.

In most laboratories, the proficiency testing provider is the one that you have the most frequent contact with.   The accreditation body is the one that you probably have the least contact with, but generates the most stress.

Many accreditation teams are comprised of well meaning volunteers, some of whom have had assessment training, and many of whom have not.  With respect to my colleagues, just because a person has done many site visits (oh I do these all the time) doesn't necessarily mean that they have ever done one correctly.

If, when your laboratory is undergoing an external assessment, you hear one of the following utterances, it probably is time to worry.

1: You should do it the way I do in my lab.
2: You don't do mass spec? We've been doing it for years.  I thought every lab did mass spec.
3:: Oh I don't bother with the standard, I just look around and get the big picture.
4: Oh we're not here to be the police.  We think of ourselves as educators first and friends second.
5:  I understand, but we have decided that we are going to interpret that requirement differently.
6: Well if you thought that was picayune, I have another one for you.
7: Actually I have another commitment, so if you don't mind I'm can get this done in about an hour.
8: What do you mean you didn't get a copy of the new requirements.
9:  Actually, I've never actually done microbiology, but our microbiology specialist couldn't make it.
10: Sorry but its our policy to not do a summary or exit report.  We will be in touch soon.

Others that you have experienced (or said yourself) are welcome.


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