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

[bsgoldschmidt]

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.

 

[indubioush]

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

 

[bsgoldschmidt]

@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?

 

[indubioush]

It is up to you (as the manufacturer) to determine what process variables must be included in your process specifications.

 

[SligoRover37]

Hi Everyone,

What is (or was) the difference between ISO 11607-2:2006(R)2015 and ISO 11607-2:2006 & AMD1:2014? Are they identical?
What is the "(R)2015" indicating? I'm unfamiliar with this notation. I understand that both the above standards have been withdrawn and replaced by ISO 11607-1:2019. (Is there a transition date before this standard becomes mandatory?)

A communication from a regulatory agency has recently been received recommending that for packaging sterilization of devices for use in a clinical trial that they should comply with both ISO 11607-1:2019 and ISO 11607-2:2006(R)2015. I'm surprised that although the regulatory agency have suggested the 2019 version for Part 1 that they are suggesting the withdrawn standard for Part 2, when there is a 2019 standard available. Any insights why the agency are suggesting this approach would be appreciated?

Regards,

Mack

 

[planB]

Mack,

standards have a life-cycle, and are eventually reviewed to decide whether they need to be revised or not. For ISO 11607-2:2006, the review came to the conclusion that the standard does not require a revision and remains published unchanged: it got (R)e-affirmed in 2015. However, it got amended (AMD) in 2014. Amendments typically comprises corrections of minor "annoying" issues (such as errors distorting the original meaning, inconsistencies, ambiguities) while the bulk of the standard remains in place. The advantage is that an AMD is a fast-track minor standard revision while full-fledged revisions (as happened in 2019) take longer and more formal / voting steps.

Both ISO 11607-1:2019 and ISO 11607-2:2019 are still relatively new revisions. Different regulators have different policies by when compliance to the latest revision is expected or whether a new revision is recognized/harmonised fully or at least partially.

Hope this helps,

 

[SligoRover37]

Thanks PlanB for this very complete and precise reply about the notation of the standards.

I'm still a little puzzled by the out-of-synch recommendation but maybe someone else who reads this thread can pass on any similar experiences.

Regards,

Mack