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Do we have to document all corrections and corrective actions in ISO 9001 10.2.2 ?

#1
Hi everybody

I´d like to hear your opinion in this issue

If in an internal audit, serveral Nc´s were written down, some of them were minor in impact, other
with big impact.
in the first case, one example, the auditee didnt follow the steps described into the procedure,
passed some info to the wrong responsible, other, in the job description was an activity which was
not his responsibility.
In other NC with more impact, the auditee didnt perform the supplier evaluation (big importance)
Now doing a follow up of this audit report and considering
the next clause.

10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.


Do I have to document all the nc´s mentioned in the report (minor and major)
considering that some will be fixed with a simple correction, while others will need
a root cause analysis?

For nonconformities, I have a format, on it I include the description of the nc and
define if is a simple correction , if it is, just apply correction, I ensure correction is done and thats all,
report is closed down.
While if the nc deserves a full analysis, I use ishikawa, define action plans, after the action plans,
evaluate effectiveness of the CA, if it was effective, is closed down.
So requestioning,

all minor fixes from the audit report need to be documented?

Thanks for your help
 

optomist1

A Sea of Statistics
Trusted
#2
Hi Qualprod....in a very general non-industry specific, it would seem to be prudent to maintain a large spreadsheet/database of "Lessons Learned"...regardless of level of severity/importance of the NC....helps avoid reinventing the wheel, should you or one of your colleagues move on...
 

somashekar

Staff member
Super Moderator
#3
You are talking about internal audit.
As an output of your internal audit, you will record all the findings.
Some will be fixed with a correction. This will be recorded as a part of the action to address the finding. This will close out.
Some will get into your corrective actions process, and will be handled suitably and more details of root cause analysis, corrective action, follow up audit, verification and close out and will get recorded.
So I will say that the documentation will be proportionate to the extent of severity of the finding.
If you do a good internal audit and miss out on recording all your findings, the purpose of the internal audit is defeated.
Though the classification of the finding as Major or Minor is not necessary in an internal audit, it must be left to the audit result analysis to determine the nature of the finding. So the recording is essential. All the findings will later have to be suitably addressed.
 
#4
If it's not documented, how do you know it doesn't keep happening? How do you identify trends? How do you remember to verify the results for effectiveness down the road?
 
#5
You are talking about internal audit.
As an output of your internal audit, you will record all the findings.
Some will be fixed with a correction. This will be recorded as a part of the action to address the finding. This will close out.
Some will get into your corrective actions process, and will be handled suitably and more details of root cause analysis, corrective action, follow up audit, verification and close out and will get recorded.
So I will say that the documentation will be proportionate to the extent of severity of the finding.
If you do a good internal audit and miss out on recording all your findings, the purpose of the internal audit is defeated.
Though the classification of the finding as Major or Minor is not necessary in an internal audit, it must be left to the audit result analysis to determine the nature of the finding. So the recording is essential. All the findings will later have to be suitably addressed.
Thanks Soma
I will correct and document which really is deserved, as you said “extent”. E.g if finding was, “ into a procedure , a procedure was missing in a reference” really was not causing a problem, in this case I modify the procedure , create new revision and that’s all,I will not document anything, while in other finding, e.g. an audit in two processes were not performed , for this , I will do a root cause analysis, and will document it.
Documenting means to have a list of changes due to findings with date, responsibles, audit number,etc.
So If sometime I’m audited , I can prove have documented actions taken for the nonconformities.
Are you agree with this approach?
Thanks
 

Jim Wynne

Super Moderator
#6
Thanks Soma
I will correct and document which really is deserved, as you said “extent”. E.g if finding was, “ into a procedure , a procedure was missing in a reference” really was not causing a problem, in this case I modify the procedure , create new revision and that’s all,I will not document anything...
You need to document and retain evidence of the nature of the nonconformities and any subsequent actions taken. (My emphasis). This is separate from your risk analysis that informs the decisions as to how to react to nonconformities. In other words, it should go like this:
  1. Nonconformity is identified and documented;
  2. Nonconformity is reviewed in order to determine the extent of the correction/corrective action necessary;
  3. Actions taken are documented and retained.
All of this is exclusive of the followup and verification of effectiveness of the actions taken.
 
#7
You need to document and retain evidence of the nature of the nonconformities and any subsequent actions taken. (My emphasis). This is separate from your risk analysis that informs the decisions as to how to react to nonconformities. In other words, it should go like this:
  1. Nonconformity is identified and documented;
  2. Nonconformity is reviewed in order to determine the extent of the correction/corrective action necessary;
  3. Actions taken are documented and retained.
All of this is exclusive of the followup and verification of effectiveness of the actions taken.
Thanks Somashekar
In your answer
"Some will be fixed with a correction. This will be recorded as a part of the action to address the finding. This will close out. "
In this point .
In the case of simple correction, and this is a nonconformity with very low impact, ok, why to keep a record of the changes if is very very minor?
While a correction or corrective action with more impact, in this case, yes, to keep records, e.g. fishbone, action plans, effectiveness.
If someone ask you records about this ncs, you say there are only records of high impact nonconformities, whats your opinion?

Thanks Jim
According to your comments, my responses, after the yours,

  1. Nonconformity is identified and documented-- ok, they are in the audit report
  2. Nonconformity is reviewed in order to determine the extent of the correction/corrective action necessary; --- Ok, is reviewed in a meeting
  3. and is decided if apply correction or corrective actions, by using a spreadsheet to have an evidence of the revision, showing the ncs, and in an additional column to describe the action plan, also is used for the follow-up.
  4. Actions taken are documented and retained.-- in my case I have a special format to address correction and corrective actions, into it, I describe the problem what is the correction, date , responsible and closeout.
2 questions, in this last point, 1- Why to keep records of changes/modifications to whatever document if ncs are of very low importance?I think is enough to keep them in the audit report, and if someone asks you about records of changes , you may say, no records, only records of changes
are maintained for ncs with medium or high impact, dont you think like this?
and question 2- where you say "Actions taken" will also be a record, the spreadsheet I use for the follow-up, which is used to describe the actions taken to solve the ncs?
Thanks



,
 

John Broomfield

Staff member
Super Moderator
#8
qualprod,

If the system waits for an internal audit before correcting its processes then yes you do need to document the corrections and the actions taken to remove the root causes.

You also cite this as a nonconformity:

“auditee didnt follow the steps described into the procedure“

Which clause requires conformity to procedures?

More likely this is a failure to monitor and correct the process. Determining and removing the root causes of this nonconformity is worthy of record if only to determine the effectiveness of your corrective action.

John
 

Jim Wynne

Super Moderator
#9
2 questions, in this last point, 1- Why to keep records of changes/modifications to whatever document if ncs are of very low importance?I think is enough to keep them in the audit report, and if someone asks you about records of changes , you may say, no records, only records of changes
are maintained for ncs with medium or high impact, dont you think like this?
What if someone asks why you have decided you don't need to fulfill the requirement that says you need to document and retain evidence of the nature of the nonconformities and any subsequent actions taken? This requirement doesn't allow for exceptions. When a nonconformity is identified, you have the option of not doing a full-blown corrective action if the risks of not doing so are relatively small. This doesn't mean that you also have the option of not documenting what you have done.
and question 2- where you say "Actions taken" will also be a record, the spreadsheet I use for the follow-up, which is used to describe the actions taken to solve the ncs?
I don't understand the question. You seem to be saying that you do, in fact keep a record of actions taken.
 

Jim Wynne

Super Moderator
#10
If the system waits for an internal audit before correcting its processes then yes you do need to document the corrections and the actions taken to remove the root causes.
It doesn't matter how or when a nonconformity is identified insofar as subsequent actions taken are concerned.
 
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