What's your open door (mapping study) policy?
In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door).
I have a question regarding open-door mapping studies…
When evaluating data from this kind of study, is it typical to acquire data for informational purposes only, and then evaluate potential impact to contents in storage?
For example, if our stability guidance allows for “short term” excursions, it is difficult to develop a specification. In your opinion, would it be better to develop the protocol without specs and evaluate the impact of the data after the study? Thanks for your help!
Thank you for reaching out! Let me first say that I am not a fan of open door studies. They are often included in validation mapping, but don’t actually have acceptance criteria. If it doesn’t have acceptance criteria, it isn’t validation. If it isn’t validation, it doesn’t belong in a protocol. I have seen some folks publish a specification for the expected performance in an open door situation (and a power fail as well) so that they could evaluate the open door performance with a pass/fail answer.
What I always come back to with this question is this: If you have a problem with the door being left open (or, opened too much) then you have either:
1) A training issue (door left open)
2) A process issue (door opened a lot)
3) An equipment issue (door latch doesn’t work well).
You can’t make these issues go away with validation or a test. Find and apply the appropriate fixes:
1) Train your employees to close doors and check
2) Fix broken latches
3) Buy appropriate equipment for processes that require frequent access.
This is where a good monitoring system can help; it will tell you when there is a problem from a door being open. You can only evaluate your data from a “door open study” if you actually know how long the door has been open, and the only way I know how to do this is with a monitoring system with door contacts. If you have invested this much in you monitoring system, just use the system to monitor your temperatures, and forget about how long the door can be left open.
This is my experience: typically, people will do an open-door study and keep the information for future reference. Then in the case that the door is left open, they can go back to the data set and use it in a rationale to explain why the door having been left open for X minutes was, or wasn’t a problem. It is supposed to be the magic bullet in their OOS deviation investigation/resolution down the road.
Your stability guidance allows for “short term” excursions, which will be measured likely by your monitoring system. “Short term” should be “defined as out of spec for a maximum of X minutes”. Your open door study will show what value the building monitor probe reads at X-minutes open. How can we develop specifications for that? We can’t. The best you can do is just do the study without acceptance criteria, and note at which time the various sensors fall out of specifications, and more importantly, what the temperature is for your monitor probe when the first sensors goes out-of-spec.
Then this monitoring probe value (which is likely in-spec) is the minimum/maximum you are allowed to reach when the door is left open, or at the very least the time at which you officially start timing your excursion, as it would represent the last known time the first deviating location would have gone out of specification.
Please do email again if you want to discuss further!
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