Stamps vs Signatures - Stamps as inspection/approval sign-off vs. Initials

[Mike S.]

I think golfman's question is a valid one. Why? If "why" is because there is some kind of problem that has made this a priority for you, which system has the problem? That might be the one to avoid.

In aerospace, virtually every company I know of, small to large, uses stamps.

 

[Mike S.]

Golfman,
Like I said, I wasn't trying to be rude. There are no serious issues with the stamps... That I know of. I'm responsible for 9 worldwide locations and no one in the 8 satellite divisions that work directly for the quality department. So control is my major concern. And the fact that I want one system fro everyone. One QMS is difficult enough... imagine dealing with 9 QMS's.

One location using stamps and one using initials is not the same as 2 different QMS's. It is a minor detail difference. I doubt every procedure or work instruction is the same in every company, nor should it be, probably.

If there wasn't a problem in this area, I would leave this alone and pick a problem to solve -- help someone. JMHO.

 

[Pollyethelleen]

We use stamps because a stamp is easier to spot on a document or label.

 

[Mark Meer]

I just don't see how a stamp could be proof of acceptance. Anyone can grab a stamp off a desk. ...

... In aerospace, virtually every company I know of, small to large, uses stamps.

Two interesting takes. It appears from this thread that stamps are pretty common, even in highly regulated industries such as aerospace. But I can relate to the control concerns Candi1024, and the original poster expresses.

Again, I'm curious, to use the US FDA as an example (because they seem to be very particular as to what qualifies as a signature) - is there anywhere where they approve the use of stamps in lieu of a hand-written signature?

 

[Eredhel]

The shop where I worked when I first got into aerospace quality required both stamps and initials. Here we use just initials. It's my preference here because for us the initial is for quick glance documentation on the traveler for guys on the shop floor, there is digital sign off via bar codes for other tracking. Forgery could be a concern but I like being able to see at a glance someone's unique initial.

Really though for us a stamp or initial is extra, not the meat and potatoes, since our traveler system is ERP software with hand held scanners for the bar codes on each OP.

 

[Mike S.]

As far as control concerns with stamp usage, I think they are overblown, especially relative to signatures. Either stamps or signatures, like locks, may help control the actions of people who are not highly motivated to do bad things, but none of the above will stop the highly motivated.

If someone really wants to purposefully commit fraud such as getting "bad" product through the system and to the customer, they can usually do it via many possible routes. Signatures or initials can be forged; stamps can be duplicated, copied/pasted, or "borrowed" without permission. Superiors can force underlings to sign/stamp off bad stuff. Underlings may want to approve bad stuff on their own for their own reasons. Bad stuff can be mixed in with good after inspection. The list goes on.

We might like to pretend otherwise, but most of our systems designed to protect us will not protect against the highly motivated (this applies to stuff outside product quality, too). So, IMO, if a stamp does not give you protection, neither will a signature, or stamp + signature, or most any other practical protection you can put in place.

Additional "layers" of protection can be had in the form of your culture, hiring practices, training, etc.

 

[Mark Meer]

...We might like to pretend otherwise, but most of our systems designed to protect us will not protect against the highly motivated (this applies to stuff outside product quality, too). So, IMO, if a stamp does not give you protection, neither will a signature, or stamp + signature, or most any other practical protection you can put in place. ...

I agree 100% - which is why the emphasis on the importance of signatures has always been frustrating to me.

That being said, what I want to know is what regulators have to say on the subject.

Everything you said also applies to electronic signatures (arguably even easier to forge given scanning and photo-editing technology), and yet the US FDA has several pages of regulations and requirements that must be observed for such forms of signature to be considered valid.

So again, I'm curious: is there any documentation/regulation from regulatory authorities (US FDA, or otherwise), that indicates that a stamp is acceptable in lieu of handwritten signatures?

 

[pkost]

I agree Mark that for a determined person a wet signature provides little more of a barrier against fraud than a stamp; unfortunately regulators in the medical device world don't take the same stance and for some reason they a blind to the argument that if someone wants to they will fake a signature they can quite easily and even if it is obviously a fake, people will still generally accept it until it is too late and the damage is done



With regards to electronic signatures, this is slightly different. A scanned document including a wet signature is no better than the original paper copy, however this is not an electronic signature.

True electronic signatures are cryptographic in nature and cannot (when properly implemented) be copied/faked without significant time investment and cost. The FDA regulations (21CFR11) focus around this and require that a system for electronic records and signatures is validated and controlled such that you can trust the signatures you see.

Once the cryptographic aspect is sorted, the security of an electronic signature will boil down to the usual IT problems:
1. Passwords must be secure
2. Hardware/software must not be compromised e.g. keyloggers, virus'

 

[rogerpenna]

Old thread, but my input.

True electronic signatures cost money. Including annual or montly fees. So a company will register few of them. High level management only, CEOs, directors, etc.

You won´t have all of your employees registering true electronic signatures to sign electronic training forms, for example.


The decision of where you need signatures I think will pass through a good analysis of each form.


For example... work safety trainings should be signed. If an employee suffers an accident and says he did NOT receive training, the company will be even MORE complicated in the lawsuit...

Talking with some people at my company, they think ALL training must have signatures by the participants. Reason?

If an employee does something wrong but you can´t prove you trained him, the likelyhood is that you can´t fire him for "just cause", and thus the company will have to pay several fines and compensation for firing him. (local brazilian legislation, you can read more about these problems here:
Employer, beware - Brazil's labour laws - The Economist
Employer, beware


All that said, we did have signatures on forms like Management Review. To whom serves signatures from managers, directors, etc, at the QMS Management Review Meeting Form? To no-one but some auditors.