Paperless Corrective Actions - Sign Offs for Responsibilities such as Verification

K

Ken B.

#1
After one year of being ISO 9001:2000 certified I am considering going to a paperless system for my Corrective and Preventive Actions. I am a little confused however about not being able to sign these documents. Is it acceptable for names to be typed in under the Root Cause areas and the verifactions? I want to make sure I am doing this properly. Any thoughts on going to this type of system would be greatly appricated.
 
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N

noboxwine

#2
Kenny---Go paperless across the board !!

Paperless is good ! No where in the standard does it tell me what media I use to manage my system. It is perfectly acceptable for you to sign your C/A anyway you'd like ! Here's what I do:

Any handwritten documentation for the C/A is scanned into a .pdf document. I type all the info into the C/A itself in a .wrd document and insert the scanned files into it. I also insert any e-mails as well. So, at the end of the day, all the information is network available and accessible from one eletronic document in seconds. Groovy, huh ?
 

SteelMaiden

Super Moderator
Super Moderator
#3
Re: Paperless Corrective Actions

Originally posted by Ken B.
I am a little confused however about not being able to sign these documents. Is it acceptable for names to be typed in under the Root Cause areas and the verifactions? I want to make sure I am doing this properly. Any thoughts on going to this type of system would be greatly appricated.
If you say in your procedures/policies that documents need a signature, then you have to have signatures (electronic signatures count) but, why limit yourself? If your workforce is responsible and accountable, why not just say that you will document within the CA/PA who is responsible for investigations, actions, etc? I have never seen a legal document stating that corrective actions must contain a signature.

If you create a database for your system, there are electronic means of capturing who has done what within the document. But, even that is not a requirement. We used word for awhile before we completed our database, we just made sure that everyone understood that if their name was in the assignment, they were accountable for whatever actions they were responsible for. As long as the auditor asks a question and your employee doesn't say something like "I don't have any idea what you are talking about, I've never seen a corrective action in my life" you should be good to go.
 
A

Aaron Lupo

#4
I agree with Steel and Nobox, however, I must add that you need to consider all the REGULATORY Requirements for the industry you are in. For example I work in the Medical Device industry which is controlled by the FDA, and the FDA wants you to either have Electronic Signatures or they want hand signed. I am not sure what your Company does Ken, but I would suggest checking the regulatory requirments for your industry. JMHO.
 
J

Jimmy Olson

#5
We us a paperless system for our CA and PA system here and have done so for quite some time. We haven't had any problems and the auditor has never seen a problem with it.

As long as you can show that it's being effective you could probably get away with doing the whole thing on sticky notes :vfunny: (okay, that might be pushing it)
 
K

Ken B.

#7
I do have one more question. When I print these documents the approval section is not signed. I do keep a master copy of all documents. if the master document is signed is that good enough? will this pass an audit? This is my last stumbling block ( I hope) Thanks.
 

SteelMaiden

Super Moderator
Super Moderator
#8
Originally posted by Ken B.
I do have one more question. When I print these documents the approval section is not signed. I do keep a master copy of all documents. if the master document is signed is that good enough? will this pass an audit? This is my last stumbling block ( I hope) Thanks.
Ken, I think that this depends a lot on what your procedure says (or will say after revision;) ) and as our astute colleague pointed out, if there are regulatory requirements for a signature; and maybe also what program you are using as your electronic file.

If you are using a word processer you can 1) revise your form to read "closed by" instead of "signature" and state that the name of the person responsible for closing out the CAR will be entered to show who was responsible, 2) get rid of that "box" on your form all together, 3) print your final copy and have it signed as you stated.

If you are using a database, why not just make sure that your field titles do not lead anyone to believe there should be a "signature" and make sure that your procedure doesn't say that there are copies that are signed off? (depending upon your industry and the regs)

To make a long story short, whatever works best for you will work for the auditors as long as everyone using the system knows how the process works (and nobody ever says "I didn't do that!);)
 
K

Ken B.

#9
Thank you Maiden,
Sometimes us new guys need to have things explained in laymens terms. I am in the corrugated Packaging industry so the Regulatory requirements are not really an issue. Our Quaility Manual will be revised and this should take care of this issue. Your help is truly appreciated. Ken.
 
Last edited by a moderator:
C

Cathy

#10
I have seen an very good little database that you can buy. It looks after CA/PA. Doc Control and Internal Audits.

There is the web site. I have a demo CD but I don't know if I can Upload it to the site (don't think so but if there is a way I will) http://www.mirams-waterhouse.co.uk/

you can buy the basic package and set it up your self or they will do it for you.
 
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