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

[Jen Kirley]

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

Does your document control procedure include maintaining some type of history of changes to documents? If so, this practice should continue when the changes are made as part of corrective action.

10.2.2 is clear in its statement that documented information is to be retained as evidence of
a) nature of the nonconformities and and subsequent actions taken, and
b) the results of any corrective action

This requirement does not allow for no records retained, but also does not prescribe the type of record to be retained. A spreadsheet can work. I would not use this NC spreadsheet as a record of document change, however; I would do document changes according to existing process.

 

[qualprod]

It doesn't matter how or when a nonconformity is identified insofar as subsequent actions taken are concerned.

Jim

Thanks for your patience, I think I´m not explaining very well my case, hope you have the time
to help me how to address this issue.
Maybe I´m wasting time in the management of nonconformities according to what you are feeding me back.
I´ll explain.
Lets say in an internal audit, several nonconformities were found, we have an audit report.
some ncs were great problems, e.g. NC 1, (the responsible didn´t perform the supplier evaluation), other nc,
not a big deal, NC 2 (a number of a document into a document was wrong, just need to be corrected).

From here, the next: I use a format called Corrective action request (CAR) , into it I describe each NC, the source, the responsible
, if I´m going to apply just a correction or a corrective action.
If it is a correction , case 2, Into the report I define the task of modifying the document, also include the responsible and due date, once the document with the nonconformity is corrected, I complete the nonconformity report, the responsibles sign off the CAR and is closed out.

if it needs a corrective action, I also use the CAR , I use ishikawa, do the analysis, define action plans with responsibles and due dates, once
action plans were finished, we ensure corrective action was effective.
If was effective, we close out the CAR, signing it off , we keep the CARs in a special folder in the internal network in pdf format.

Now talking about the term "documenting" whichis to have records of actions taken.

In the case 2 , I find useful to use the CAR, because into it is shown the corrective action number, contains the full analysis,
the responsibles, also the report is used for the follow-up of the corrective action, additionally the corrective action number is included in the Master list of Corrective Actions, in addition to the nonconformity report, into it will define action plans to create a document, to create a special report, etc. , so , they are also records.
So, in this case of CARs are the records of the nc,s found in the audit report additionally the tasks into the corrective action are records.

But in the case of just corrections, I think is a waste of time filling out the CAR, if I decide that for that nc, what I have to do is a
simple correction of a document , then, my record could be the evidences of revision and approval of that document, If I´m requested records about that nc, I can show the evidences of the approval of the document. or some other correction....BUT no to show the CAR
because was not needed, the NC didn´t deserve to fill out the CAR.
If I fill out the CAR for the nc´s type case 2 (not critical) I may be wasting time and efforts, the only benefit I see
maybe it is that I may have data of ncs. for analysis in an easy way, because If at some time I need to know how many corrections
and corrective actions have been performed, with my master list I can determine it quickly.

Hope I explained well, please feed me back.

 

[skb76]

all

as you mentioned , (and some answering earlier form this post ...)
Internal Audit (x need to fix minor or major)

p/s refer to the attached file (my guess your NC/CAR record will be professional rather than this attach file!)

my opinion;

if you want keep simplify, y wont keep it a single document/form) ...

based on the attached file ... in case like your nc2 (just 'fill few words') to 'close' the nc/car

(any feedback form others...)

thanks in advance!

 

[qualprod]

all

as you mentioned , (and some answering earlier form this post ...)
Internal Audit (x need to fix minor or major)

p/s refer to the attached file (my guess your NC/CAR record will be professional rather than this attach file!)

my opinion;

if you want keep simplify, y wont keep it a single document/form) ...

based on the attached file ... in case like your nc2 (just 'fill few words') to 'close' the nc/car

(any feedback form others...)

thanks in advance!

Thanks skb76
The form you shared is similar to the one I use, and us used for correction bc and corrective actions
My point is , for ncs (non critical, just corrections)don't want to fill out the form, just do the correction, thus , Saving time.
What is your opinion?
Thanks

 

[Jim Wynne]

But in the case of just corrections, I think is a waste of time filling out the CAR, if I decide that for that nc, what I have to do is a
simple correction of a document , then, my record could be the evidences of revision and approval of that document, If I´m requested records about that nc, I can show the evidences of the approval of the document. or some other correction....BUT no to show the CAR
because was not needed, the NC didn´t deserve to fill out the CAR.

How would you associate the correction with a particular NC report?

 

[Kronos147]

some ncs were great problems, e.g. NC 1, (the responsible didn´t perform the supplier evaluation), other nc,
not a big deal, NC 2 (a number of a document into a document was wrong, just need to be corrected).

My point is , for ncs (non critical, just corrections)don't want to fill out the form, just do the correction, thus , Saving time.
What is your opinion?
Thanks

It's a slippery slope, IMO.

What are critical vs. non-critical?

If they are not logged, how do you recognize patters or recurrence?

 

[John Broomfield]

Recording every error/process nonconformity strikes me as overkill...

...but it may reduce the detail in documented procedures to an absolute minimum.

 

[Crusader]

I agree. every error does not require a CAR. My auditor recently did not agree totally. It blew his mind when we said that we determine when it's necessary and when it is not.

 

[Jen Kirley]

I agree. every error does not require a CAR. My auditor recently did not agree totally. It blew his mind when we said that we determine when it's necessary and when it is not.

I would be very interested in how you do that. Based on risk? The standard wants corrective actions for nonconforming outputs. When is an error not a nonconforming output?

 

[Sidney Vianna]

The standard wants corrective actions for nonconforming outputs.

The standard clearly allows for errors/nonconforming outputs NOT to be treated via a corrective action. ISO 9001:2015 10.2.1 b). evaluate the need for action....

There will be non-critical, non-repetitive issues where correction only is adequate.