Any Assessors out there? What regulations tell us what format to use? For years we have used Month Year format on review of SOPs. Our past inspection for AABB did not like that. CAP was fine with our format. Thanks Chris

we always use month/day/year format. I think they want to us to document the actual date we are reviewing them.

I would look to see what the quality manual say about date formats and whether it was consistently applied inthe documents. In the absence of written guidance, I would not want everyone to choose their own method and would expect to see some unwritten standard in use by everyone.

The short answer is that the date format you use must be defined within your facility.

JudiK hit the nail on the head. If your internal policy defines your standard format and the documentation demonstrates that you are adhering to that format, it should be a non-issue and nothing but an opinion from another facility. Step one on any regulation with abiguity is to define your terms.

We have had go-arounds with CAP and AABB folks in the past regarding annual review dates. The standards require "annual review" - so we defined annual review to mean review completion by the end of the month, one year from the last review. So if you last reviewed the document Jan 5, 2008 it is next due for completion of review by Jan 31, 2009. Anytime in January 2009 meets the definition. Some folks feel it has to be one year to the date and by clearly defining what "annual" means in our institution it became a dead issue.

While I agree with the "however you define it in your policy" concept, I think that you also need to strive for good laboratory practices, even if they are not specific standards or regulations. So in this case, the practice of documenting the date that something was done as "month/year" may not violate a particular standard and may even be what's defined in your policies, it doesnt strike me as a particularly good laboratory practice.

The short answer is that the date format you use must be defined within your facility.

We talked with AABB and they said basically the same thing.