Closing Actions

What's this. Garry? BTW - welcome!

 

Exactly.

Who knows? Auditors do things for bizarre reasons.

However, it may well be that some need to remain open for what appears to be a long time - for example a design process corrective action may be open until the next iteration of the process - could be a year or more. If you can expalin why and that it's assigned, time limited etc then no auditor should be arbitrarily writing ncs for Corrective Action.

 

All processes are expected to have performance indicators. It is a common practice to track "aging" of audit nonconformances, especially due to the (9.2.2e) subclause "take appropriate correction and corrective actions without undue delay;"

This subclause does not mean there is a need for "hard stop" because actions should not be closed until effectiveness is verified. As an internal auditor I had a nonconformance open for over a year. Our CB auditor started talking about "without undue delay" until I showed him the embedded comment in the date cell of my Excel-based log - an extensive string of descriptions about what happened with whom and on what day, and what was to come next. That shut him up; he moved on.

 

"Expected" by whom? Expectations are not requirements. Why would anyone put performance indicators on document control, for example?

 

I asked that same question, pushing back with the rationale that process performance indicators were for production only. I was met with "Clause 6.2.1, 'The organization shall establish quality objectives at relevant levels and functions of the organization.'"

Is control of documentation relevant? Is corrective action relevant?

 

That's not the processes. Levels usually refers to the hierarchy and functions to roles/departments. Why would anyone (unless in the documentation business) set objectives for document controls? Look at the dashboard of a car. Not a lot of measurements going on relating to the objective of travel...

 

OK, cool. Time-bound corrective actions are very normal to ensure stuff "gets done". Actions - described in action-oriented verbs - plus assignments to people (not departments) and time limited ensures this.

 

Tony, my apologies for misquoting, you are right! "...relevant functions, levels and processes..."

Is document control a process? Is corrective action a process? Our colleague Craig Cochran said it in his book ISO 9001:2015 In Plain English: "Everyone who's irrelevant raise your hand."

I noticed it says "and" and not "or" and I also noticed you said "...we can infer..." but 9001:2015 says straight out "The organization shall establish quality objectives at relevant functions, levels and processes..." I don't have a copy of 9002 in front of me so I can't go farther on that here.

Of course performance indicators should be related to monitoring and measurement; I agree. I also agree with the "or" statement. I do not know why these support processes would be excluded from objectives, given their importance to the QMS.

Andy, It is not easy to measure success in transactional processes like document control and corrective action. But if an inspector is not provided with an up-to-date version of a specification or an inspection form that contains acceptance parameters, is that acceptable? If a supplier is not provided with an up-to-date version of a drawing, do we tolerate it?

If failure is not an option or is unacceptably wasteful, we would want to know if and how often it's occurring, and where in the process(es); we can avoid waste by reducing that.

 

Let's put it this way. Do you need to know the exact amount of gas in your tank? It's a process. You put gas in, it's stored and then becomes an output. All you care about it when the light comes on to tell you you need to fill up or you know you don't have enough to do your journey without a stop. The ONLY time you might want to look at it is when there's an issue with overall gas consumption, like when it suddenly got really bad and the tank might be leaking...

 

It's all about risk, isn't it? When you can't afford to get it wrong, keeping close attention to gas levels is worthwhile. I do, to ensure I don't run out on those long stretches of country road that make up my commute.

 

It's about risk, isn't it? The more critical the process and the more documents a place has (some of my clients had several hundreds or even over a thousand) the more important it could be to ensure documents are kept current and pay attention to that. It can be pretty simple to make an objective to ensure no out-of-revision documents are in use in processes.

I reiterate that I once voiced the same types of arguments you ad Wes keep presenting. The registrar I audited for stated in no uncertain terms that at least one objective/target for each QMS process. Te reports got that built into them. So we were not making that up.

 

It's about risk, isn't it? The more critical the process and the more documents a place has (some of my clients had several hundreds or even over a thousand) the more important it could be to ensure documents are kept current and pay attention to that. It can be pretty simple to make an objective to ensure no out-of-revision documents are in use in processes.

I reiterate that I once voiced the same types of arguments you ad Wes keep presenting. The registrar I audited for stated in no uncertain terms that at least one objective/target for each QMS process. Te reports got that built into them. So we were not making that up.

For management review, it also makes sense to make an objective that serves the organization. I have seen some that really struggle to hold these reviews. Others struggle to get actions on output decisions. The target/objective could be about that.

It might help to recognize that a target/objective can change as the organization's needs change. They aren't arbitrary and they aren't etched in stone.

 

However, for most, this isn't a requirement, hence making it so for all is futile. It's true that some organizations who process documents might need objectives etc for such a process, but they are not the majority. I'm reminded of the saying, just because you can, doesn't mean you should...

 

I just explained that it (having a target/objective for each QMS process) was enforced as a requirement in my CB. There's nothing I can do about that. What that target/objective will be is based on the organization's needs.