Corrective Action: "shall be appropriate to the effects of issues encountered"

M

mlthompson

#1
Good Day Everyone! Please help me understand this requirement. I know the ISO standard says action shall be taken to eliminate recurrence. But then this statement is made. I always thought that this meant my company has the choice on what action to take (i.e., don't spend $150,000 to fix a $100 problem) or maybe just tolerate certain nuisance issues using existing controls.

I am now being told that "appropriate actions to the effects" only refers to effect on customer or end user. I am also being told that corrective actions (those that eliminate recurrence) must be taken on all nonconformities despite the magnitude of the issue. To implement poke yoke methods for every known problem can be very expensive and probably not feasible in most company's capitol budget.

How to you understand this requirement and what does your auditor check for to show compliance?

Thanks Much!
 
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M

mlthompson

#3
This is what my registrar is telling me. I know CAs must be implemented to correct our issues, I'm concerned about needing to fix those nuisance issues that doesn't justify fixing.
 

Jim Wynne

Staff member
Admin
#4
mlthompson said:
This is what my registrar is telling me. I know CAs must be implemented to correct our issues, I'm concerned about needing to fix those nuisance issues that doesn't justify fixing.
The registrar or the auditor? I find it hard to believe that a registrar would have such a nonsensical policy. CAs should always be appropriate to the effects, or potential effects, regardless of who the effect happens to. That means that sometimes the reaction will be "it's not worth pursuing." As long as you have a record of review and can explain it in terms that make sense, you should be in the clear.
 
M

mlthompson

#5
I have recently received an advisory notice from my registrar regarding the "magnitude" comment. In regards to the "effects only on the customer/end user" comment, this was told to me by my Corp QA Director who says that this is the interpretation of the registrar.
 

Jim Wynne

Staff member
Admin
#6
mlthompson said:
I have recently received an advisory notice from my registrar regarding the "magnitude" comment. In regards to the "effects only on the customer/end user" comment, this was told to me by my Corp QA Director who says that this is the interpretation of the registrar.
I'd like to hear from some of our third-party folks on this one, as well as any other Covers who might have had similar experiences.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
We need the facts

Jim Wynne said:
I'd like to hear from some of our third-party folks on this one, as well as any other Covers who might have had similar experiences.
I agree with you, Jim. Since it is a formal advisory issued by the Registrar, according to Mike, it should be OK to post a copy here. Sometimes, when you read the advisory carefully, it might make sense. I would advise Mike to post a copy so we can evaluate it. Otherwise, we are limited to Mike's understanding of the advisory. I can not believe that a Registrar would make an all encompassing policy such as this, irrespective of the impact magnitude.
It would not be the first time, however, that a poor written advisory would have to be retracted.
 
A

Aaron Lupo

#8
I was wondering if his Corporate QA Director could be reading too much into the advisory notice or just not understanding what is being said. I have never heard such a thing either. Sometimes as they say "stuff happens" and as was already mentioned just make sure you document that you feel it is not worth pursing and the reasons why.
 

Helmut Jilling

Auditor / Consultant
#9
Advisory was mis-stated

I am aware of this Advisory, and with all due respect to the parties, it was misread or misunderstood.

The topic of the Adisory was about root causes. There is no statement that corrective action has to be done regardless of cost, regardless of magnitude.

The actual quote is:
"It is our view, ... that corrective actions are actions that are taken to specifically address the root cause of a problem regardless of the magnitude of that problem. First, proper corrective action cannot be taken until the actual root cause of the problem has been identified."

It went on to explain that the point is, unless you have analyzed and identified the systemic root causes, you are not in a position to understand whether the proposed actions will be effective.

It was not about doing corrective action regardless of cost or magnitude. It was about knowing the root cause, whether a big problem or small, will allow you to determine effective solutions.

Even the standard makes it clear that actions have to be approrpiate to the magnitude of the issue. A registrar cannot overturn the standard. There is no blank check required. It would not be feasible, in any case.

Hope that satisfies the concerns, folks...
 
Last edited:
#10
Root cause.............

is their opinion???
Surely, this will frighten organizations into thinking that they need some structured process to find a simply obvious reason for an issue? It's not necessary to formulate an '8D' or similar to find the root cause, but I could see that's what auditors and (some) management are going to interpret. From my experience (and from some articles published in the British IQA Journal many years ago) the diagnosis of some problems doesn't need much analysis. I'm thinking these auditors/Regstrars are making mountains (sorry Icy:lol: ) from (potential) molehills:bonk: If organizations are going to have effective actions, we must be careful not to over analyze issues.........:caution:

Do what you will and show you worked on an effective action, rather than worrying about what 'advice' you get from folks like this..........:rolleyes:
Andy
 
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