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ISO 9001 Containment Requirements

LUV-d-4UM

Quite Involved in Discussions
#11
The auditors usually require "Containment" when we respond to findings even if the findings are normal such as non-conformance to a work instruction. Do we have to do "Containment" in response to a finding in ISO9001 external audit?
 
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R

randomname

#12
Correction includes both containment and remedial action. And yes, it also applies to audit NCS. Can't write a proper problem definition until correction has been done, since full magnitude is not likely to be known (e.g. Was it an outlier or did it represent a larger, more systemic problem?). If the former perhaps CA isn't necessary (depending on risk), but if systemic CA likely makes sense.
 

Big Jim

Super Moderator
#13
It seems as though different CBs have slightly different rules and definitions. I would check with your CB to understand what they actually want.

In my perspective, correction includes containment and something related called extent of the issue. Even if your CB doesn't require it, I would recommend you do. You will have a healthier QMS if you do.
 

LUV-d-4UM

Quite Involved in Discussions
#14
It seems as though different CBs have slightly different rules and definitions. I would check with your CB to understand what they actually want.

In my perspective, correction includes containment and something related called extent of the issue. Even if your CB doesn't require it, I would recommend you do. You will have a healthier QMS if you do.
Thank you Big Jim. We are addressing "Containment" for external audit corrective actions. I think the auditor is in compliance with the ISO standard for auditing. I appreciate everybody'd feedback.:applause::agree:
 

howste

Thaumaturge
Super Moderator
#15
Here's the ISO definition of correction:

ISO 9000:2015 said:
correction
action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action.

Note 2 to entry: A correction can be, for example, rework or regrade.
I'm not sure where people are coming up with the idea that correction includes containment. If anything, I would say that containment of a nonconformity is more likely include correction. Unfortunately containment is not defined in any ISO document that I'm aware of.

Generally all of these terms are used in the context of corrective action for a nonconformity. Correction eliminates the nonconformity, while corrective action eliminates the cause of the nonconformity and prevents recurrence. Containment is something that we do to keep the effects of the nonconformity that already exists from causing further problems internally and with our customers.

Any way you look at it, containment is a good idea and should be considered along with each nonconformity encountered.
 

Big Jim

Super Moderator
#16
Here's the ISO definition of correction:



I'm not sure where people are coming up with the idea that correction includes containment. If anything, I would say that containment of a nonconformity is more likely include correction. Unfortunately containment is not defined in any ISO document that I'm aware of.

Generally all of these terms are used in the context of corrective action for a nonconformity. Correction eliminates the nonconformity, while corrective action eliminates the cause of the nonconformity and prevents recurrence. Containment is something that we do to keep the effects of the nonconformity that already exists from causing further problems internally and with our customers.

Any way you look at it, containment is a good idea and should be considered along with each nonconformity encountered.
I have seen containment as part of the correction portion of nonconformances from CB auditors using the CB's form.

ANAB Heads Up 137 provides a bit more detail and may help to see where it came from. This ANAB publication is directed to CBs and how they answer nonconformances written against them by ANAB, but the principles are much the same, and it was passed on to auditors as an example by many CBs. Here is the pertinent portion:

Correction – in order to be fully accepted, the response must include the following components:

1. The extent of the nonconformity has been determined and contained
a. The nonconformity has been corrected and the response is written in the past tense. (E.g.
the missing record was found (not will be found)).
b. The CB has examined the system to see if there are other examples that need corrected
(extent of the issue) and have also addressed the extent in their response.
c. Including the evidence ANAB found and any other evidence the CB may have found.
 

howste

Thaumaturge
Super Moderator
#17
ANAB Heads Up 137 provides a bit more detail and may help to see where it came from.
In that Heads Up ANAB only uses the terms correction (not containment) and corrective action, but requires the CB to look for other instances of nonconformity that must also be corrected. You could imply that looking for other NCs is part of containment. ISO 17021 also only uses the terms correction and corrective action.
 

LUV-d-4UM

Quite Involved in Discussions
#18
Thank you. As Big Jim said containment is good for my quality system. I am given enough chance to better my system and I give credit to my CB auditors.
 

Big Jim

Super Moderator
#19
In that Heads Up ANAB only uses the terms correction (not containment) and corrective action, but requires the CB to look for other instances of nonconformity that must also be corrected. You could imply that looking for other NCs is part of containment. ISO 17021 also only uses the terms correction and corrective action.
Heads up 137 comes very close to saying containment. As noted in the prior post:

" The extent of the nonconformity has been determined and contained"

The word containment has been bantered about within some CB for at least ten years. It is also used in some of the CB nonconformance forms.

I'm explaining what I have seen. If it of value, take advantage of it. If you see no value to using the concept, then don't use it unless it is on your CB's form.
 
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