Re: How do you audit past verbal approvals against ISO 4.2.3a?
I disagree that this is often the reason for such constructs.
What happens if the guy who gave verbal approval for operating documents leaves for another company, taking the document management guy with him and now there's only "folklore" to determine what system was in place for "management approved" instructions?
If this occurs than there was and is a major problem with the way the QMS system was set up and if an auditor never caught it then HE wasn't doing his job. As someone else already pointed out, there needs to be a document that describes how documents are approved....With this in place your scenerio above should not occur.
Isn't it just easier to sign the bloody thing?
By the time you fit all the controls around a "verbal approval" scenario you've more often than not doubled your effort, or halved your confidence in the process.
It might be. But much depends on the individual comapny.
I don't think that anyone here is saying NOT to have written approvals, only that, by the way the standard is written, it is not required.
Admittedly though, certain pedantic members of the "QA Community" have indeed lost sight of what matters about approval.
Well - there are all types in every field

Approval should be meaningful - the approvers should have some ownership of the process and some authority over it.
If someone is just signing because the Quality Manual says a Grade X person must approve the document and the signer actually knows nothing about the process being described by the document, then the signature is next to worthless.
Good point. If a document is written as you suggest above, it is indeed a poorly conceived procedure.
l issue with poorly contrived signature systems is not the signature requirement itself but the parameters used to judge the applicability of the signature.
For example: I would not have the Marketing Director approve a work instruction for manufacturing - I would have the Manufacturing Director approve it and if the Manufacturing Director felt they were too far from the details of the process to be able to add value in the form of their review and approval of the process then they should delegate that to their supervisors/managers who DO have the familiarity to make such review and approval meaningful.
If the QMS does not allow for this kind of meaningful, intelligent use of the approval signature construct, then the issue lies with the QMS, not with the act of signing things.
Well I suppose there might be companies out there that have such poorly designed systems with unqualified people approving documents, but I suspect they are few.
Of course the flip side of your "poorly designed" system
with signatures is that, if the review process is "well designed" and consistantly executed,
without signatures the system will still be robust and well functioning.
So - The signatures make no difference in whether the system is good or bad.
Further, as a company gets larger the case for written signatures only gets stronger. It is in the migration from small time operators to more significant market share players that a lot of companies find that their "culture" of "fast and loose" bites them and makes their transition harder.
Agrred. I worked for such a small company and saw this to an extent where it was difficult to get them to let go of some of their "seat of the pants" operating methods. However I can tell you, from that same experience, that trying to impose too much too early will get you resistance that can kill a program, or at least seriously delay it's maturing into a good sound and widely accepted operating system.
The Quality Professional needs to be aware of potential needs that come from such growth and be prepared to suggest and implement appropriate changes as needed. Such changes
can be increased controls, but such changes might also be a streamlining of controls and eliminating unnecessary paperwork. It all depends on business needs and on the maturity of the QMS.
So the bottom line still is - verbal approvals are acceptable under the standard provided teh method is documented, consistantly applied and effective.
You can require written approvals if that is best for your situation.
You can allow verbal approvals if that is best for your situation.
Peace
James