4.2.2c - Description of the interaction between the processes of the QMS



I am updating my Quality Manual to the new standard and do not understand section 4.2.2c - a description of the interaction between the processes of the QMS. Can anyone give this to me in simpler terms? Any help would be greatly appreciated. Thanks


What I'm doing is this:

Identifying the company's "key business processes," usually 10-12 major processes such as Order Management, Design & Development, Materials Management, etc. These high-level flows become the Level 2 (System Maps) for the Business System, and they are also used to identify the Level 3 (procedures/work instructions) needed.

I then create a system-level view of how these key processes tie together; I can't show you this in text, but think of the process model picture that's in the standard (figure 1), but using the company's key processes instead.

This is particularly useful if the company has an intranet-based system; you can make each of the "boxes" or areas in this chart have a hyperlink to the associated System Map, which in turn links to the Procedures/Work Instructions.

I would love to hear how others are addressing this.

Personally I love the new process approach to the Standard. I'm so sick of the 20 elements.
This is more creative and can be implemented in a way that is much more meaningful to individual companies. I think it's going to be harder for auditors, but that's another whole topic.


Greg Mack

What I have done is create a simple one-page flow chart that shows the relationship and interaction of our major processes within the business.

It isn't any easier than that.

Dan Larsen

I'm wondering if everyone is getting to wrapped up with the flow chart issue to respond to this aspect of the standard. Don't get me wrong...a flow chart of the system can be good, but I question if that's what the intent is.

I read the clause as simply telling the company to make sure the manual addresses how the individual elements interact. For example: make sure that the appropriate sections feed back to management review; does the nonconformance system feed appropriately to corrective action; if a calibration is found out of conformance, does the system properly interact with other aspects of the system to respond; etc.

Although a flow chart approach will work for this aspect of the standard, I think making sure all sections of your manual properly cross reference potentially applicable sections (either in text, cross reference matrices, or flow charts), you'll meet the intent.

The transition books I've been reading suggest that this is one of the "no change required" sections...permissible exclusions (4.2.2 (a)) is getting all the attention.

This is probably one of the sections where "auditor expectations" will probably end up being the driving force.

Jon Shaver

Recognizing that quality problems often occur as one process completes an action and another takes over, I believe 4.2.2a simply asks you to indicate the flow for this "handover" - i.e. how does output from one process become input for another. Perhaps replacing "interaction" with "interface", makes it clearer.
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