Approval of Documents - Is Verbal Approval good enough?

[Ka Pilo]

You also cannot write up as a non-conformance, something you cannot observe.
If procedures are accurate, being followed and the output is good...
If everyone you talk to seems to have a good grasp of the system and how it works....If rejections, returns, rework etc is under control....If you are told by multiple people that "We request a change - Joe makes the change - we check it - and Joe issues it....
It can hardly matter that you can't "Audit past approvals". What you have discovered, and have evidence of, is that the "system" is in place, understood, functioning properly and effective...

If on the other hand you discover the opposite of the above, if you discover outdated documents, poor understanding, conflicting answers etc, then you have evidence to question the process....Whether you can see documented "past approvals" or not.

I think that the bottom line is that, and effective system can and does work well without a lot of "sign-offs" while a poor and/or ineffective system will still be ineffective with a whole "drawer full" of sign-offs.

Peace
James

I've got your point, enjoyed this discussion, learned quite a bit, and have modified my stark views (to a degree), but will examine further.

 

[ScottK]

Perhaps many of you have taken auditing classes more recently than me...
Are they no longer drilling "objective evidence" into auditors heads anymore?
Now, I haven't taken a training class in a long while but that phrase has stuck with me for many years...

Basically if there is a "shall" then there shall also be objective evidence of compliance.

The section reads that "a documented procedure shall be established to define the controls needed to approve documents for adequacy prior to use"....
so as long as your procedure defines the approval process sans sign off then you are OK if the system is effective.

However - To contrast what db said earlier "Remember we don't develop controls to apease auditors" is not necessarily true for all of us.
Each of my plants gets audited 2 or more times a month by customers and the path of least resistance to satisfy these customers (drug and device) is to have signed approvals for our SOPs.
When business hinges on audit results, some appeasment is warranted if multiple auditors are writing findings on the same issues.
That's customer focus - also required by the standard - since part of the customer requirements is an effective (in their eyes) QMS.

 

[db]

Perhaps many of you have taken auditing classes more recently than me...
Are they no longer drilling "objective evidence" into auditors heads anymore?
Now, I haven't taken a training class in a long while but that phrase has stuck with me for many years...

Basically if there is a "shall" then there shall also be objective evidence of compliance.

The section reads that "a documented procedure shall be established to define the controls needed to approve documents for adequacy prior to use"....
so as long as your procedure defines the approval process sans sign off then you are OK if the system is effective.

However - To contrast what db said earlier "Remember we don't develop controls to apease auditors" is not necessarily true for all of us.
Each of my plants gets audited 2 or more times a month by customers and the path of least resistance to satisfy these customers (drug and device) is to have signed approvals for our SOPs.
When business hinges on audit results, some appeasment is warranted if multiple auditors are writing findings on the same issues.
That's customer focus - also required by the standard - since part of the customer requirements is an effective (in their eyes) QMS.

First of all, Scott... yes you are correct about appeasing auditors. There is this thing out there call the real world, and when the auditors are your customers, or when your parent corp, or the customer rules means you are stuck with a certain registrar, then the rules of behavior changes.... you are quite correct on that.

Once again (and I am not disagreeing with you) ISO 19011 clearly states that interviewing is an acceptable way to obtain audit evidence, which allows for verbal evidence. It also allows for observation, which also does not require documentation on the part of the auditee.

 

[ScottK]

Once again (and I am not disagreeing with you) ISO 19011 clearly states that interviewing is an acceptable way to obtain audit evidence, which allows for verbal evidence. It also allows for observation, which also does not require documentation on the part of the auditee.

Fortunately my current company will pay for decent training so I'm signing up for RAB QSA certified auditor/lead auditor course.

That will get me into the new millenium since I got the bulk of my classroom training in 1995/96.

 

[Big Jim]

Fortunately my current company will pay for decent training so I'm signing up for RAB QSA certified auditor/lead auditor course.

That will get me into the new millenium since I got the bulk of my classroom training in 1995/96.

You should find current training very useful.

The old mantra of "say what you do, do what you say, and document everything" is dead, except in the minds of those that had it seared into their brain from overzealous practitioners.