ISO 9001:2015 Clause 7.5.2 - Is Review and Approval applicable to Records?

[howste]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Dear Howste

Your last paragraph

"Review and approval for suitability and adequacy" should be done for every record (in my opinion) at a minimum by the creator so that we know the record is readable and has the correct information in it. Other approvers may also be added if the organization believes it would add value.

I think it is what we used to do in 2008 version, where we defined a timeframe
to revise documents for adequacy, because sometime they remain the same for a long time, which means are not part of the system improvements.

BTW, at doing this activity , the idea is that document owners revise their documents at time defined (say 2 years from the last change), the evidence in my opinion, could be to change number of revision, even if it was not changed.

I could think in having an email from the owner saying " I have revised the documents xxxx,xxxx,xx ,etc.) and not change the revision on the documents, but is not a good idea.

What do you think in both topics?
Thanks

The text you are quoting is about records, but it sounds like you're talking about documents such as work instructions or procedures because you wouldn't need to update records periodically.

To answer your question about periodic review: In my opinion it doesn't really matter if you change the revision number/letter at the time you review or if you keep a record that the review took place. Actually ISO 9001 doesn't even require a record that the review took place. If you do choose to do it though, it's probably more important that whichever method you choose that it's useful and effective for the people your company. I believe either one would be acceptable in an audit.

 

[charanjit singh]

In my opinion, certain Records do require review and updating, while others do not (they only have to be preserved properly). Here are examples of what I am saying:

Example 1): Records of Training of personnel: Need to be reviewed and updated as and when due, since there may be refresher training,acquisition of additional skills by those who are in the company, induction training of new-comers and deletion of those who would have left the organisation.
Example 2): Updating of calibration records of measuring equipment and gauges.

Example 3) Records that do not require to to be reviewed for changes are those of the products that have been already manufactured and delivered to the customer.

These are just a few examples from a manufacturing organisation.

 

[howste]

In my opinion, certain Records do require review and updating, while others do not (they only have to be preserved properly).

I understand what you're saying, and it makes sense. But I don't agree that you are updating the records. Per ISO 9000:2015 a record is a "document stating results achieved or providing evidence of activities performed." As this evidence doesn't change, we don't update the records. The cases that that you are talking about you I would say that you are either adding new records or replacing old records with new records.

 

[QAMTY]

Re: ISO 9001:2015 Clause 7.5 7.5 - Is Review and Approval applicable to Records?

Dear Howste

The idea of changing the revision in the procedure/WI, it is because
if I request an email for revisions, ok, that´s my evidence, but the procedures will keep the same revision (no change).

But if the evidence is lost, how can I know when the procedure was revised?

Because the "key data" to know the last time the procedures were revised, is the revision number and the date.

I hope I ´ve explained clearly
Thanks

 

[mogobadip]

I see many horses running around the stables . What is to review? Can an organization document a procedure for review of records and still not follow that procedure?Training records review differs from pillar to post, in my organization I would set up a criteria for a validating training and competency certificate/record and no review shall be necessary, when training and competency is due when the records are near expiry they shall be carried out as required by the scope of the work being carried out to ensure quality. This will be continuous.

Let us define review, records are permanent


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[mogobadip]

Another element that I will entertain is the knowledge of the auditor relevant to the scope of work being audited.

Quality is not subjective. If I get audited and I am lazy to think I will resort to "quality is subjective"


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[mogobadip]

I understand what you're saying, and it makes sense. But I don't agree that you are updating the records. Per ISO 9000:2015 a record is a "document stating results achieved or providing evidence of activities performed." As this evidence doesn't change, we don't update the records. The cases that that you are talking about you I would say that you are either adding new records or replacing old records with new records.

You are more than just correct, i see new and replace. From academic perspective quality is used to monitor trends associated with technology and customer requirements. If technology changes and customer requirements change, previous training and competency including customer demands of the product specification change. This is because technology can either make the product easy to use, or it can make it quicker for the client to obtain. These changes are going to affect procedures, costs, etc


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[howste]

Dear Howste

The idea of changing the revision in the procedure/WI, it is because
if I request an email for revisions, ok, that´s my evidence, but the procedures will keep the same revision (no change).

But if the evidence is lost, how can I know when the procedure was revised?

Because the "key data" to know the last time the procedures were revised, is the revision number and the date.

I hope I ´ve explained clearly
Thanks

Here's what I said:

Actually ISO 9001 doesn't even require a record that the review took place.

I meant that if you review the procedure/WI but don't make any changes then there is no record required. If you make changes at the time of the review then (of course) you would need to update the revision.

This thread's topic is about clause 7.5.2, but what we're discussing now is in 7.5.3.

 

[QAMTY]

Thanks Howste

Ok, I can understand that ISO doesn't require the evidence, but internally in a business, how the Director, manager, any worker could know that procedures were revised?
Can you image a huge amount of procedures and also formats (used for records) that were not revised/changed in two or three years, and we ask the owner of the process
to revise them for adequacy, and he sends me an email or by phone, and say, everything is ok, Should I trust in this without keeping at least the email?

This would be an evidence to ensure people are complying with that.
In the daily work, how do you think is practical to do for this issue?.

Thanks

PD

Hey, an Idea came to my mind from an elsmar member
He says that other practice to comply with 7.5.2 could it be covered
when performing internal auditings, does it sounds ok for you?

 

[howste]

Thanks Howste

Ok, I can understand that ISO doesn't require the evidence, but internally in a business, how the Director, manager, any worker could know that procedures were revised reviewed?
Can you image a huge amount of procedures and also formats (used for records) that were not revised/changed in two or three years, and we ask the owner of the process to revise review them for adequacy, and he sends me an email or by phone, and say, everything is ok, Should I trust in this without keeping at least the email?

This would be an evidence to ensure people are complying with that.
In the daily work, how do you think is practical to do for this issue?.

Thanks

PD

NOTE: I edited the quote of your post because "revise" and "review" don't mean the same thing and I want to answer what I think you're really asking.

7.5.1b says we shall have "documented information determined by the organization as being necessary for the effectiveness of the quality management system." If you believe that having evidence of periodic document reviews is important for your system to be effective, then you should maintain records. There are lots of ways to do that. An email from the document owner stating they did it would be one way. Adding a note in the revision history of the document is another way. I don't think this is a huge issue to worry about unless you have problems with outdated documents that don't agree with the actual processes being performed. If your internal and external audits are finding discrepancies related to this then it should become a high priority.

Hey, an Idea came to my mind from an elsmar member
He says that other practice to comply with 7.5.2 could it be covered
when performing internal auditings, does it sounds ok for you?

I'm not sure what this means. Is this the same thing I mentioned above, or something different?