4.2.3a Approve Documents - Is listing the verbage 'Engineering Manager' sufficent?

  • Thread starter Thread starter George Trybulski
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George Trybulski

4.2.3a Approve Documents

I have a master List File that shows the following (example)

Document Name Product Launch Checklist
Document Number ENGDOC-004
Rev. Level A
ISO 7.2.1
Issue Date 8/16/02
Approval Authority Engineering Manager

My question would be is listing the verbage "Engineering Manager" sufficent to meet the standard 4.2.3a (to approve documents for adequacy prior to issue) or should a specific persons name apply there. In the past I have had a person "sign a master copy" and keep it on file, however in this day and age of electronic documentation I find that to be outdated. Any comments or help would be appreciated.

Attached File included for those who like to "rob" ideas from other people as I do !!!!!!!!

George Trybulski
:ca:
 

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I HAVE ALWAYS USED TITLES INSTEAD OF PERSON'S NAMES. USUALLY THE CAPACITY WITHIN THE ORGANIZATION IS STABLE, BUT THE PEOPLE WITHIN THEM ARE TRANSIENT. SO SAVE YOURSELF TIME BY NOT HAVING TO UPDATE YOUR DOCS EVERYTIME SOMEONE GETS FIRED, PROMOTED OR RESIGNS. GOOD LUCK AND HAVE A DAY----------:bigwave:
 
George,

Great document. It's pretty similar to what we use (guess someone here had robbed it from you before :) )

We've always just listed a title rather than a specific person for our responsibilities and authorities and have never had a problem with it. The argument that we would make if questioned is that people change, but the position doesn't. I hope this helps.
 
I agree that a job title as the approving authority (i.e. Engineering Manager instead of John Smith) is the way to go. However, I still believe it is best to have the personalized signature of the current approving function on the document. That can be having someone actually sign their name in ink on a hardcopy document as you have done in the past Geroge, or it can be via an electronic signature. I'm not sure what the best way to do electronic signatures is, perhaps someone can shed some light on that.
 
Electronic signatures

We are currently considering this for our Corrective Action Form that just went on-line. I can tell you what my MIS guy says the plan is.

He is trying to purchase a business card scanner (100.00). If this gets approved we will send blank signature cards out and have the managers sign them. Scan them. Somehow MIS is assigning "PIN" numbers for each signature. You just enter your personalized pin# and your signature prints out.
 
Electronic!!!

I have gone a little easier on approvals. For the higher level documents it is left at the "original approval level" and instead of having signatures it is in the email tracking that follows the procedure. Personnel know that it is approved for use by the document being posted to our Control Doc Web Page by the Quality Systems Manager. For Departmental procedures, they need to be routed from the manager through the Qual Sys Mgr but changes may be done on the floor by the mgr. if they sign & date the change. It has worked for years now in our ever changing prototype environment. We control the few prints (CAD is master) in the same manner, with the addition of the customer being allow to change a print on the floor with signature and date.
 
Signing The Master Copy

George: This reply is a little late, but I wanted to weigh in on the subject of master copies and signatures. :)

The following may seem archaic and outdated to you, but it helps me explain where I'm coming from.

I write, store and maintain electronic and hard copies of all work instructions (WI) for the Manufacturing area in our plant. As such, I have to be able to access them at any time, regardless of whether or not the network server is behaving itself. I also have to archive obsolete WI's for quite a while (mainly because the Engineers want to have a historical record for R&D purposes). We also do not have a records retention policy- but that is a subject better left for another time.....frust

After receiving the signed-off WI back from the last of the approvers, I sign it and then make a copy for the respective dept. Then I red-stamp the docs with the date of issue. I place the original signed-off hard copy of each WI in its respective binder. The binders are classified by dept (Assembly, Punch Press, etc.).

Each one of these documents contains a set of sign-off boxes on the last page. They are labeled as:

AUTHOR SUPERVISOR QA ENGINEER ENGINEERING

I agree with one of the other posters who stated that it's better to list a title than a specific name. Turnover plays "revision ****" with docs that have specific approvers' names listed on them. Also, you may have more than one approved signer for any particular box. In my case, I am the only "Author", and there is only one "QA Engineer". Depending on the department, though, there six different supervisors, and at least that many engineers who are authorized to sign-off in their respective boxes. Flexibility is important here.

If you have a doc control program/application that has electronic signature capability, it can work well (as long as you are vigilant in updating the signatures on file). We don't have it here yet, but I have seen another company that does, and it does save them some time. Even then, they still keep a master copy of each WI in a binder. I look on it as a documentation "security blanket".
They do this even though they use Harrington Group's "Document Control System" for doc maintenance, report generation, and ISO compliance.

The computer may be my friend, but it is a fair-weather one .....

I hope this helps. Your results may vary.

Dan Hiland :) :bigwave:
 
Not with MY signature!

C Emmons said:
... I can tell you what my MIS guy says the plan is.

He is trying to purchase a business card scanner (100.00). If this gets approved we will send blank signature cards out and have the managers sign them. Scan them. Somehow MIS is assigning "PIN" numbers for each signature. You just enter your personalized pin# and your signature prints out.

What you are describing here is actually storing a picture of a person's actual signature in a computer.

[Caution! Strong personal opinions ahead!]
In my opinion, a system such as you describe has a major potential for abuse that can damage the cormpany and the people whose signatures are stored. Personally, I will not knowingly do anything that will result in my signature being captured in a computer system. There are many companies that do this, but none has ever been able to tell me (a) why they need it, (b) what they do with it, or (c) how they make it any more secure than any other of their records that are regularly stolen electronically. To me, allowing someone else to have my signature is as dangerous -- possibly more dangerous -- as letting them have my socialist insecurity number. (For one thing, there are a number of biometric identity verification systems that use the person's signature as the authenticator - it's that personal!)
[End of strong personal opinions.]

There are a number of secure digital signature or digital ID products on the market, all based on the public-key encryption algorithm. They all provide a signature or identification that (1) cannot be forged, (2) provides authentication of who made the signature and when, and (3) authenticates the document by verifying that it has not been changed since that signature was applied. Note that none of those three things can be provided by a picture of someone's signature, or even by the actual ink on paper.

This technology is not new, and it is available in many products. Every time you use a secure web page you are using a weak form of public-key encryption, because it is built into your web browser software. That is the part which encrypts your passwords and credit card numbers. If you have Microsoft Outlook then you also have digital signature capability for e-mail. (Select Options from the Tools menu, choose the Security tab, and see the "Secure e-mail" and "Digital IDs (Certificates)" sections.) There are also shareware and commercial programs specifically for this functionality, and the capability is built into many other products - Adobe Acrobat and Lotus Notes come to mind instantly.

As for documents in the QMS, using encrypted digital signatures should not be a problem. Our auditor was unfamiliar with it, but after a quick demonstration he accepted it with no problem.

Yet another system, also in the $100 price range, is one that creates an encrypted digital signature or ID based on a person's fingerprint. The user "signs" a document by just placing the correct finger on a small reader, and it verifies the identity and applies the digital signature to the document.

With all of the available alternatives - especially ones that are more secure and provide authentication of both the signer and the signed document - I would suggest seriously resisting using an actual picture of a signature. (Especially if it means memorizing yet another !@#$%^&* four-digit PIN!)
 
Secure feeling

We include name and title on documents. If someone leaves his job, so what? The procedure is still there and good to go until you want to make a revision. You simply approach the new "Authorizer" and get his signature on it. No biggee. I keep originals with actual signatures in a Master File in the office. It's easy, and maybe archaic, but I know that I can produce the original document as it was when signed and not have to be concerned with electronic hanky panky. If so, nothing like a hard copy original to :ca: JMHO :ko: :smokin:
 
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