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For (a) then: yes, I could write up a procedure which documents requirements for the behavior of our personnel to ensure that they do not adversely affect ... the work environment (including any equipment within). But that's not what this paragraph says! It says the personnel should not adversely affect the product! And although in a generic sense, outside of ISO, our 'product' does happen to be a piece of equipment that's in this particular environment ... for the purposes of this standard, our 'product' is our servicing efforts. And here is where I fail to see how the behavior of our personnel could adversely affect that.
As for (b), no matter how you shake it, I can't see how this could apply: our servicing efforts do not require specific environmental conditions (fine, we don't do well in hail ...), nor, for that matter, does our equipment, even if as I said above, that's not the 'product' to which we're referring in this standard.
So on to (c): again, I can mostly ignore the specifics of the way this paragraph is written and blithely write up something about how our personnel are to behave working, say, on the 'clean side' of a hospital central sterilization department. We cover this anyways in general training -- gown, booties, etc. Still, these departments are our work environment and in performing equipment service, we always work in these 'special environmental conditions' -- whereas the standard asks us to ensure that we train if personnel are required to work temporarily in these conditions within the work environment. Is this hair-splitting, or is this simply not applicable?
And finally (d): here I completely buy the common sense in your example. Problem is, that example doesn't apply to how we work. 98% of our equipment, for instance, is fixed in place within these departments. The 'post-servicing re-validation' of the -- for us -- operating room, not only isn't our responsibility, but is actually instead a rigorously standard 'pre-surgery' disinfection procedure, done before each and every operation irrespective of whether there have been equipment servicing activities in the room or not.
It goes without saying that we do not, of course, engage in service activities while the room is being used for a sterile procedure.
It goes without saying that we do not, of course, engage in service activities while the room is being used for a sterile procedure.
You come a bit closer when you talk about the sterilizer, however. Do we follow 'procedures to avoid contamination that would defeat the sterilizer's purpose'? May I ask you to think closely about that for a second? The 'sterilizer's purpose' is to eradicate contamination. The very nature of a sterilizer is that it regularly deals with contaminated items.
The entire [central sterilization] department is all about processing of soiled, contaminated items.
Again: if it's "obvious" or something that of course your people know to do, write it up. Then make sure that your people in fact do all know to do everything. Then you're done.
but thanks again one and all!