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.

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 ?

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.

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.

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)

Thank you for your help. I can go into this a little more at ease now.

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.

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!);)

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.

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.

Hey, I agree that paperless is best. I have created a database to manage my 8D system in MS Access. It is easy, uses current software, requires no upgrades,maint. fees, training, etc.

I have attached it for anyone who wants to check it out. It is zipped.

Its free and you can't beat that. ;)

If you want you can give me your feedback.

If you want you can give me your feedback.

You know something? You really are a clever fox. That looks good, and above all easy to manage. :agree: Nice...

/Claes

Hi cleverfox,

I downloaded the file but I wasn't able to open the file. Probably
it was been saved to the new edition of access. We're still using
the Access 97.

Would it be possible to re-attached the file again using Access97? Please...
Thanks in advance.

Best regards,
Raffy

Would it be possible to re-attached the file again using Access97? Please...

Raffy,

I'm not quite sure this works, but it's worth a try: Open a new (empty) database in Access97. Go to edit, import and chose CF's database. If you get in, import everything you find there, and it should run in the 97 version.

/Claes

Hi Claes,

I already try this option, but I still I wasn't able to open the file.
An error appears on the screen: "Unrecognized database format"

Best regards,
Raffy

Ok, try this one. (You may still have to import the contents).

/Claes

Raffy,

After you download the file, right click on the zipped folder that contains the database (you should have an option to extract the files). Select this option the files will be extracted into a new folder. Double click the icon and access will prompt you to open as is or convert to your version of access.

Claes,

Very good database.

mshell

Yes, it's pretty nice isn't it? I didn't make it, though. That honor belongs to cleverfox. I just converted it back to Access97 format. (At least I think I did, we'll have to wait for Raffy to validate it)

/Claes

I love databases and interactive forms. The databases make reporting much easier and the interactive forms speed up the process. I have been with my current company for only 8 months and I have converted as many forms as possible to interactive media and created databases for everything. Training and changing the culture is the hardest part when you convert a paper driven system to a paperless system.

mshell

I have converted as many forms as possible to interactive media and created databases for everything.

mshell
We are two of a kind, then... :agree:

/Claes

Yes, it's pretty nice isn't it? I didn't make it, though. That honor belongs to cleverfox. I just converted it back to Access97 format. (At least I think I did, we'll have to wait for Raffy to validate it)

/Claes
Claes,

I am running Access97 and I got it to open.

CX

Thank's Carol,

One never knows with Access...

/Claes

Hi Claes,

Thank you very much. I was able to open the file using Access97.
Thanks so much.

Best regards,
Raffy

Thank you Raffy,

Thank's to you I learned how to do reverse conversions of Access databases. Hadn't done that before. :agree:

/Claes

Here we seem to have clarified that your procedure states that master copies of documents are signed off, and you wish to move to a paperless system, then I can make a suggestion and vouch that the following is used quite succesfully in a large steelmaking facility, who by the way, is a tier 1 supplier to the auto manufacturers. In other words, this works and is simple and acceptable.

First revise your procedures after you decide on what your new methodology will be. Part of this methodology should be that you get a database to control document, record, calibrated tool and and statistical information management. In there you will assign responsibilities for reviewers and approvers and your procedure will identify the extent to which they must be involved (e.g. revisions that do not affect policy, i.e. spelling mistakes, minor clarifications) are handled by the next lowest approver called a "document coordinator". Send a copy of a document in email to the approver as an attachment when required. Save the response approval in either a public email folder, or print it out and save it as an approval record. OR include his approval comments on the appropriate comments tab of the database revision comments section. As long as legal regulations do not require your document to have a hand written signature, this will work for everything, including stats and tools. For those few that require hand-written approval, keep them as approval records. To the best of my knowledge, no where does the ISO standard dictate manual signatures for approvals are required unless regulated.

This database I spoke of is based on Access and is called ENVISOTRAK. Before you get your shorts in a knot about that, let me assure you that it was professinally developed, is packed with features and designed to not run on macros so that is is stable and protected from meddling fingers. I could go on and on about it, but I suggest you read up on it at wwww.veraccess.com. If you are interested in how you could integrate this into a SIMPLE QS or EMS system, I strongly suggest you begin by checking out the website, view the PowerPoint presentation right on line and ask questions. You may also elect to download a fully functional trial version using your own real or dummy data. I'd be more than happy to anwer questions from you or any other forum member on this approach. BTW, this product was shown to the MMTC, and they thought enough of it to say they were very impressed. I can't say more than that at this time because negotiations are under way concerning this and other projects.

Best Regards,
Dave
Veraccess

Hey, I agree that paperless is best. I have created a database to manage my 8D system in MS Access. It is easy, uses current software, requires no upgrades,maint. fees, training, etc.

I have attached it for anyone who wants to check it out. It is zipped.

Its free and you can't beat that. ;)

If you want you can give me your feedback.


Hi, CF, I am unable to open the database...probably due to it being read only. Any suggestions?

Did you notice that the thread is nearly six years old? I'm sure the link and probably the source is long since dead.

Did you notice that the thread is nearly six years old? I'm sure the link and probably the source is long since dead.


Yes, I did notice the date. I was able to find the file in another thread (in a zip file), but the file is read only and does not seem to have any content. I consider myself a begineer in Access, but that is what it seems to me - that the file is read only.

I'm just looking for some help in this area, If anyone has a readily-available database that can be used for NCMRs, customer complaints, internal audits, CAPA, etc. then I would like to try it. No sense in re-inventing the wheel.

Thanks,
Traffic

Hi Traffic,
Have you try downloading the access 97 file that was shared by Claes.
I just try to download it again and it can be open.
Thanks again Claes. :thanx:
Best regards,
raffy :cool:

Hi Traffic,
I just uploaded the same file I downloaded from this thread.
I hope this will work for you too, it works for me.
Thank you very much CF & Claes for sharing the database.:thanx:
best regards,
raffy :cool: