Rubber Initial & Inspection Stamps - Valid or a violation of FDA quality guidelines?

RCW

Quite Involved in Discussions
#1
We currently use an inspection stamp system. For example QC3 is assigned to Bob Kranch. Recently a number of people have purchased rubber stamps with their initials and have begun to use them on the travel sheets that go around with the in-process material. A number of questions have arisen from this....

1) Are these considered valid stamps if they are logged into the current stamp control system? (example: BK is assigned to Bob Kranch)

2) Is this a violation of FDA quality guidelines if these intial stamps are used? Or for that matter, if any stamps are used?

Any input on this matter would be appreciated since there is a lot of fussing going on here.
 
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Wes Bucey

Quite Involved in Discussions
#2
I'm a little confused, RCW. In the past, you have written about FAA requirements. Now you are writing about FDA. Has your company changed focus or have you changed jobs?

To the point of the question:
there is no requirement in either FAA or FDA that inspectors sign off an inspection in a particular mode, as long as the method they use is documented within the organization's QMS.

This means they can use stamps with numbers, initials, or symbols. They can even, wonder of wonders, sign their names in ink. The only no nos I am aware of are using erasable ink or graphite (pencils) and no "Wite Out" is allowed on the document.

They can also use electronic signatures on computer based documents.

*Acronyms
FAA - Federal Aviation Administration
FDA - Food & Drug Administration
QMS - Quality Management System

:topic: Frankly, it doesn't make any difference if you buy the stamps or the employee buys the stamps, the main issue is controlling the use of the stamp so no person uses the stamp belonging to another. That would be as much forgery as signing the guy's name. Back in the 70's, in my bank, all my employees were also notary publics and had their own seals. Our obligation as the employer was to assure ONLY the person to whom the seal belonged used it on any document in our bank. We paid each employee a minimum fee to cover the cost of a standard seal and seal holder. Some employees paid extra out of their own pocket for fancier seals and seal holder/embossers. Today, the State of Illinois only approves black ink stamps, not embossers, for notaries.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Frankly, it doesn't make any difference if you buy the stamps or the employee buys the stamps, the main issue is controlling the use of the stamp so no person uses the stamp belonging to another.
I think Wes hit the nail on the head with this statement and I do't think it's far off topic....

Personally - I would never allow stamps in my QMS because that means another control system to implement, train, enforce. And you bet an FDA auditor will ask you to prove the system if he/she spots this.
 
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