ISO 11607-2 "Critical Parameter" vs. "Process Parameter"

#1
I'm new to Quality Engineering as a field in general, but I've been asked to look into a GAP assessment for the ISO 11607-2 document. I went through the document and noted the changes from the prior versions to see what has changed, and for the most part it seems the same except that there seems to be a significant difference between the change from critical parameters to process parameters. My understanding is that critical parameters are those that are defined as critical to the final important aspects of the part (i.e. its functionality, etc.) whereas process parameters seems to be more like parameters that affect any of the final aspects of a part even if they aren't critical per se. Am I understanding that correctly?

I would really appreciate an in depth discussion about this because I don't think I really understand since it seems like this change could be rather burdensome/significant compared to what it was before. Additionally, as I am new to Quality in general, any tips/tricks that you use to find out this type of information quickly would be much appreciated so that I can be more efficient in the future.
 
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#2
In the forward, it states the following:
the terminology of “critical” process parameters has been discontinued and the concept of a process specification has been introduced to include all elements required to manufacture a product that consistently meets specifications.

You previously were only required to define, control, monitor, the "critical" process parameters. Now there is no such "critical" distinction; there are only process variables and process parameters.

process variable
chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process, changes in which can alter its effectiveness

process parameter
specified value for a process variable
 
#3
@indubioush, so it means every process variable then assuming that said process variable alters the effectiveness of the cleaning, disinfection, packaging or sterilization process? So if it doesn't affect those things (let's say speed of a device is a particular process variable) then it doesn't require control/monitoring then yes?
 
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