To raise a NC beyond the audit scope? Two signatures were missing

[qualprod]

Hello to everybody

At auditing one process (sales) that is the scope, against 9001 and internal procedures.
In a document a signature was missing , clearly it is a NC, the procedures states one document have to be signed by the sales manager, after
a work order is sent to production.

But into the document, there is another requirement of signature of the Production manager (production process)
it is another nonconformity.

Can I write down the nc because the missing signature of the production manager as well? , even if the scope is to audit only sales process?
Please explain.
Thanks

 

[Randy]

You observed something that's required and wasn't done, happens to me all the time, so YEP, knock yourself out.

 

[John Broomfield]

Was this unsigned procedure in use or under review?

If in use what controls do production have to prevent use of a potentially invalid document?

 

[qualprod]

Was this unsigned procedure in use or under review?

If in use what controls do production have to prevent use of a potentially invalid document?

Thanks Randy and John
Yes is in use, in order for the next processcan continue, the responsible first checks if signatures appear , he ignored that, continued
with missing signatures, apparently, it was an urgency to deliver a product of the main customer.

 

[Jim Wynne]

Was this unsigned procedure in use or under review?

The unsigned document wasn't a procedure; it's a document that must be signed when (or after) a work order is sent to production.

 

[Jim Wynne]

Thanks Randy and John
Yes is in use, in order for the next processcan continue, the responsible first checks if signatures appear , he ignored that, continued
with missing signatures, apparently, it was an urgency to deliver a product of the main customer.

As Randy said, if there's a requirement and it wasn't met, you have a nonconformity, regardless of the scope of the audit. Perhaps your company has painted itself into a corner by not specifying acceptable exceptions to the rule.

 

[qualprod]

As Randy said, if there's a requirement and it wasn't met, you have a nonconformity, regardless of the scope of the audit. Perhaps your company has painted itself into a corner by not specifying acceptable exceptions to the rule.

So, at what extent or what cases the scope applies in an audit. ( I think the scope sets the limits)
What are the frontiers? or what criteria to follow to decide if a nc has to be writen down outside of the
audited process?
Thanks

 

[Jim Wynne]

So, at what extent or what cases the scope applies in an audit. ( I think the scope sets the limits)
What are the frontiers? or what criteria to follow to decide if a nc has to be writen down outside of the
audited process?
Thanks

Let's say that one fine day you're sitting at home and realize that you don't have your wallet. You surmise that you might have left it in a restaurant where you ate lunch earlier and decide to go there and see if anyone found it. While on the way there--a short walk--you see some papers lying on the ground that you recognize as yours. Although the papers are important to you, you decide not to pick them up because they're not within the scope of the present mission.

The audit scope basically defines the process(es) to be audited. As Randy suggested earlier, it's not unusual at all to find things that relate to other processes while you're auditing the scoped process. Are you suggesting that the potential (or actual) NC discovered while auditing Sales should just be ignored?

 

[Jean_B]

Look at scope as if focusing effort. You didn't go sampling to look for Good Documentation Practice errors, but this is right there, in your scope of the sales process. You didn't waste effort to find this while still conducting your audit to meet its objective.
It's the criteria set and auditor competence which should form the base of deciding whether something is to be a finding of non-conformity.
Example:
You are auditing from the quality perspective but find a non- conformity against a labour requirement you've heard of (perhaps you're subject to the same requirement, perhaps it's clear within a set of documents as the two kinds are compiled).
If you're not certain what to write against, you can't do much of anything expect look it up later. You need evidence.
If you're certain, but the audit programme/ scheme you're auditing under doesn't include it you don't have the specific or general criteria, so you can't make it an audit finding. But you can (have it) process through the applicable system's non-conformity process. Not a finding, still duly noted as it should be.
If you're certain the company should meet it, but hasn't made provisions for it in any system, make a note of the risk (not an NC, more similar to ye olde observations/recommendation), likely using reference to which kind of audit/inspection would take offence to it (and at what level).
If I'm doing an ISO audit and I find something that the FDA takes offense against but isn't strictly forbidden by the standard, I would include a caution within the report.
Luckily our system is designed to allow NC's against all regulations and standards we claim compliance to (long live the quality manual and declaration of conformity) in any of our audits. Regardless of the specific criteria we're looking at. That only leaves auditor competence.

 

[Kirby]

Look at scope as if focusing effort. You didn't go sampling to look for Good Documentation Practice errors, but this is right there, in your scope of the sales process. You didn't waste effort to find this while still conducting your audit to meet its objective.
It's the criteria set and auditor competence which should form the base of deciding whether something is to be a finding of non-conformity.
Example:
You are auditing from the quality perspective but find a non- conformity against a labour requirement you've heard of (perhaps you're subject to the same requirement, perhaps it's clear within a set of documents as the two kinds are compiled).
If you're not certain what to write against, you can't do much of anything expect look it up later. You need evidence.
If you're certain, but the audit programme/ scheme you're auditing under doesn't include it you don't have the specific or general criteria, so you can't make it an audit finding. But you can (have it) process through the applicable system's non-conformity process. Not a finding, still duly noted as it should be.
If you're certain the company should meet it, but hasn't made provisions for it in any system, make a note of the risk (not an NC, more similar to ye olde observations/recommendation), likely using reference to which kind of audit/inspection would take offence to it (and at what level).
If I'm doing an ISO audit and I find something that the FDA takes offense against but isn't strictly forbidden by the standard, I would include a caution within the report.
Luckily our system is designed to allow NC's against all regulations and standards we claim compliance to (long live the quality manual and declaration of conformity) in any of our audits. Regardless of the specific criteria we're looking at. That only leaves auditor competence.

Just a thought regarding your example - doesn't AS prescribe that the organization should comply with and statutory and regulatory requirements (4.2, 4.4.1, 5.1.2, etc.)?