QMS changes before Annual External Audit

R

Rabab

#1
Hi All,

I would like to know what will be the case in the audit , if there were a major changes done on existing procedures before the annual external audit by few months.

Will the auditor refer to the old procedures in the audit or the new ones?
1- if the audit will be on the the old used procedures , then all gab points covered in the new issue will be reported despite they are mitigated in the new issued procedure and
2- if the audit will be on the new procedures , then there are no records for it as they are new.

I'm really confused and any feedback would be highly appreciated!
:thanx:
 
Elsmar Forum Sponsor
#2
Re: QMS changes before external annual audit

Why not ask your auditor? We can try to guess what one individual will do, but that may leave you more confused!

There are some mandatory requirements they'll cover. They may ask about changes. After that, who knows?

Call your auditor, ask them.
 

Randy

Super Moderator
#3
Common practice and actually a requirement the CB auditor has to meet..."Hey, have you made any changes?"

Reference ISO 17021:2011, 9.3.2.1 ....g) review of any changes,
 

somashekar

Staff member
Super Moderator
#4
Hi All,

I would like to know what will be the case in the audit , if there were a major changes done on existing procedures before the annual external audit by few months.

Will the auditor refer to the old procedures in the audit or the new ones?
1- if the audit will be on the the old used procedures , then all gab points covered in the new issue will be reported despite they are mitigated in the new issued procedure and
2- if the audit will be on the new procedures , then there are no records for it as they are new.

I'm really confused and any feedback would be highly appreciated!
:thanx:
It is your QMS, and at any instant if you feel the need to make a change based on sound reasoning, you must do it. Your change to procedures must be in no way linked to audits, external or internal.
Your procedure aids your business. Audits comes along now and then. Your business must dictate procedural changes, and nothing must be stopped or started looking around for audits times.
 
#5
It is your QMS, and at any instant if you feel the need to make a change based on sound reasoning, you must do it. Your change to procedures must be in no way linked to audits, external or internal.
This is not correct IMHO! You should have internal audits linked to changes in procedure. I don't think this is what you mean. However, for the sake of clarity for readers, we must be sure that internal audits should be performed during or after changes to the QMS are made - to give feedback on the effective implementation. It is, after all, what "Status and Importance" mean in the standard...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Hi All,

I would like to know what will be the case in the audit , if there were a major changes done on existing procedures before the annual external audit by few months.

Will the auditor refer to the old procedures in the audit or the new ones?
1- if the audit will be on the the old used procedures , then all gab points covered in the new issue will be reported despite they are mitigated in the new issued procedure and
2- if the audit will be on the new procedures , then there are no records for it as they are new.

I'm really confused and any feedback would be highly appreciated!
:thanx:
Rabab, any professional and competent lead auditor will pay attention to the effectivity dates of the procedures supporting the processes to be audited and seek audit evidence accordingly. It behooves you to emphasize the situation to the external auditor during the opening meeting, so s/he is aware of the issue.

In principle, the audit should be performed seeking evidence that your business processes are deployed according to plan, so there is limited value for auditors to seek for evidence of work against obsolete procedures and, most likely will refrain from auditing you against older versions of your command media and will focus on the current versions of the documents.

When auditing records generated by some of the processes, keep the auditor aware of the effectivity dates for your documents. If some of the new procedures support revised processes and records have not been generated yet, there are other types of audit evidence that the auditor can seek to determine if the processes and the system are implemented and effective.
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
In addition to the other great advice I would like to add that it depends on what the changes are about. If you are making major additions or subtractions that would change the audit scope, I would recommend you ask your registrar's customer service representative to see if any changes are needed for the arrangements.

As for records: looking at records previous to the changes might be okay if they support the standard's requirements and would help show the process had been in place and effective. Training would be an example, also inspection. But I would not expect to see months worth of records generated using a form that was implemented for only weeks.
 

Pancho

wikineer
Super Moderator
#8
Hi All,

I would like to know what will be the case in the audit , if there were a major changes done on existing procedures before the annual external audit by few months.

Will the auditor refer to the old procedures in the audit or the new ones?
1- if the audit will be on the the old used procedures , then all gab points covered in the new issue will be reported despite they are mitigated in the new issued procedure and
2- if the audit will be on the new procedures , then there are no records for it as they are new.

I'm really confused and any feedback would be highly appreciated!
:thanx:
Your QMS is a tool for improvement. Improvement is change. As Imai says, "not a day should go by without some kind of improvement made somewhere in the company".

When audits happen right after a change, recent records may indeed be on obsolete forms. While the "gab points" may be "reported", they have been addressed by your improvement process already. You can probably show that to the auditor's satisfaction. But even if you had an auditor that would naively issue a non-conformity, you'd already have the required corrective action done.

So never be afraid to improve your system. Do fear it never changing.
 
R

Rabab

#9
Thanks all for your valuable replies , I will start implementing those changes right now while keeping the record of the internal audit which led to those changes , I will also check whether these changes will lead to a change in the external audit scope or not.
Thanks again and wish me luck :)
 
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