Hardcopy or electronic CAR (Corrective Action Request) form (& others)?

Thirty years ago (to be safe) this topic would not exist. There would have only been one way of processing a Corrective Action Request: Using a copy of the CAR master form, the originator would have completed his/her section longhand, either hand-written or with a typewriter, and delivered the CAR form to the next person, and so on. Each person would have filled-out his/her section longhand until the CAR was done. Afterwards, the completed forms that were to be kept as records would have been stored in a file cabinet.

Not anymore. Now the master may be in MS-Word or MS-XL format, for example, and ‘could’ be filled-out (1) as before, or (2) ‘electronically’, or (3) a variation of both. How do you do it at your company?

(1) Using a copy of the form (even if the original is in Word or XL), fill it out longhand all the way, and when done, store it as a record in file cabinet?

(2) Using a ‘copy’ of the form in MS-Word (for example), have each person access the form using a PC, and ‘type/enter’ the pertinent information, and when done save the form in the appropriate records folder?

(3) Same as 2, above, but allow those who don’t have access to a PC to write the information longhand and then have ‘someone’ else enter the handwritten information onto the ‘electronic’ form?

Thanks –

Alex

Ingeniero1 said:

How do you do it at your company?

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Access Database.

E-mail notification from the originator to the recipient.

All backed up as part of the network.

Ingeniero1 said:

Thirty years ago (to be safe) this topic would not exist. There would have only been one way of processing a Corrective Action Request: Using a copy of the CAR master form, the originator would have completed his/her section longhand, either hand-written or with a typewriter, and delivered the CAR form to the next person, and so on. Each person would have filled-out his/her section longhand until the CAR was done. Afterwards, the completed forms that were to be kept as records would have been stored in a file cabinet.

Not anymore. Now the master may be in MS-Word or MS-XL format, for example, and ‘could’ be filled-out (1) as before, or (2) ‘electronically’, or (3) a variation of both. How do you do it at your company?

(1) Using a copy of the form (even if the original is in Word or XL), fill it out longhand all the way, and when done, store it as a record in file cabinet?

(2) Using a ‘copy’ of the form in MS-Word (for example), have each person access the form using a PC, and ‘type/enter’ the pertinent information, and when done save the form in the appropriate records folder?

(3) Same as 2, above, but allow those who don’t have access to a PC to write the information longhand and then have ‘someone’ else enter the handwritten information onto the ‘electronic’ form?

Thanks –

Alex

Click to expand...

The dreaded phrase "It all depends" comes to mind in situations like this.

Every system has to be geared to deal with the weakest link. Strengthening that weakest link is almost always a budget matter, not a technological one.

In transferring from a manual system (handwritten or typed) of document to an electronic system, it sometimes helps to re-examine the documents, themselves, and the organization's requirements regarding those documents.

Obviously, in the scope of an entire organization, CAR documents are (and should be) a very small proportion of ALL documents. If the organization is diligent in "mistake proofing" and FMEA (Failure Mode Effect Analysis) of its processes, there should be fewer and fewer occasions to generate a CAR.

Fate of a completed CAR?
The question arises immediately in my mind: "What do you intend to do with a completed CAR?" If the answer is: "Store it as a record." - the simplest solution in transferring to electronic record keeping is to simply scan the manually produced documents (from folks without access to PC entry) and store them as images. This is a simple and cheap resolution to a problem.

Many organizations go a step further and analyze CARs for myriad factors:

• is this recurring?
• does one department have more than other departments?
• did we overestimate our capability and capacity?
• do these forms fulfill our real need?
• do we have a statistical report of our CARs?
• how do these CARs affect our budget? our profit?

In such cases, then it makes sense to be able to extract the CAR data into a database so the organization can "crunch the numbers" to extract information vital to its ongoing viability. This means someone has to backstop the "weak links" by translating manual entries into electronic entries. The decision to do this is again budget-based:

• Is it more efficient and effective to hire an intermediary to translate the documents from "weak links" into electronic data
  or
• to retrain and re-equip all the weak links?

As I said in the beginning: "It all depends"

I second the motion!

To add to what Wes said above ...

Our form is an electronic template (Microsoft Word). As much as possible is completed in the computer, and then it is printed. The printed copy is completed by hand and then kept in a paper file until action is completed. Finally it is scanned back into a computer file and the paper is recycled.

I have recently become aware of a new tool. The curent version of Adobe Acrobat (6?) can make a PDF form that can be either printed out or completed on a computer. I don't know the technical details (I have an older version of Acrobat) but I have seen the resulting forms online at a few places - notably some online forms from the Georgia Department of Motor Vehicle Services.

Which method to use? It depends ... what works for you?

Ingeniero1 said:

Thirty years ago (to be safe) this topic would not exist. There would have only been one way of processing a Corrective Action Request: Using a copy of the CAR master form, the originator would have completed his/her section longhand, either hand-written or with a typewriter, and delivered the CAR form to the next person, and so on. Each person would have filled-out his/her section longhand until the CAR was done. Afterwards, the completed forms that were to be kept as records would have been stored in a file cabinet.

Click to expand...

Also 30-40+ years ago, the original form would probably have been a mimeograph copy (low budget), printed from a stencil (medium budget) or typeset in a printing shop. The smells of mimeograph fluid and stencil correction lacquer would have been fairly common. Copies would be made in real-time with the original using the transfer medium called "carbon paper". (Of course, a really big company might have one or two photocopy machines or those new machines with the funny name - Xerox. But that was for important correspondence and documents, not forms.)

Graeme said:

To add to what Wes said above ...

Which method to use? It depends ... what works for you?

Also 30-40+ years ago, the original form would probably have been a mimeograph copy (low budget), printed from a stencil (medium budget) or typeset in a printing shop. The smells of mimeograph fluid and stencil correction lacquer would have been fairly common. Copies would be made in real-time with the original using the transfer medium called "carbon paper". (Of course, a really big company might have one or two photocopy machines or those new machines with the funny name - Xerox. But that was for important correspondence and documents, not forms.)

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Back in 1968, I had one of the first Xerox machines - I threw my 3M machine out after I got the Xerox - the difference in being able to print on normal bond typing paper versus that awful tissue for the 3M process was a "miracle."

The cost worked out to about 25 cents a page and worth every penny. We still used carbon paper in our IBM electric typewriter (before the "ball" which allowed changing typeface), but we kept an old Royal manual typewriter around, "just in case." We had both a mimeograph machine and a spirit duplicator (purple print, similar fumes to a blueprint machine.) We had multiple part forms interleaved with carbon paper (long before NCR carbonless copies) and if you filled them out in the manual typewriter, you ended up with forearms like a heavyweight boxer from pounding the keys so hard to make an impression through all the carbons.

Only newspapers and similar organizations had "facsimile" machines with about 60 dots per square inch resolution for instant transmission. Mostly, we used a telex machine up through the late 70's. (Some wealthy organizations had twx machines.) I remember special systems to keep coils of punched paper streamers for repeat messages and "boilerplate" or to capture an incoming message we might have to reprint for some reason.

We got a postage meter in 1967 and people came from all over our office building (over 200 tenants in a giant Chicago skyscraper) to see it work. Same thing when we got the Xerox machine.

Everything was very expensive in terms of cost per page or per minute. An overseas phone call was planned in advance with a script. Often we would telex the other party to arrange the logistics for the phone call. I remember several times getting to the office at 3 am CST to make a phone call to London for 9:00 am GMT phone conference.

In exchange for instant low-cost communication anywhere in the world, we have given up privacy, because we are "always" available, 24/7, at work, home, vacation, etc.

I am an Access user. It makes my life a lot easier. We have 1 computer terminal in each production department and all of our access forms can be completed via the intranet. After the information is entered, the employees simply click the save button and the database is updated automatically. I can see everything from the comfort of my desk and I always know what stage of completion the documents are in.

mshell said:

I am an Access user. It makes my life a lot easier. We have 1 computer terminal in each production department and all of our access forms can be completed via the intranet. After the information is entered, the employees simply click the save button and the database is updated automatically. I can see everything from the comfort of my desk and I always know what stage of completion the documents are in.

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Just curious.

1. How many documents in your "universe?"
2. What is the approval process (from author to final release?)
3. If more than one person besides the author is required to approve a document, how does that person know a document is ready for approval?
4. If the approver decides against approving, what mechanism is used to recycle the document back to the author?
5. Do you control/manage ANY non-Access documents (blueprints? Work Instructions? Procedures? Correspondence?)
6. Are you the sole Administrator of the Document Control System?
7. What happens when you take a vacation or are sick or away at a seminar?
8. Are you the only one who "reminds" an approver that a document needs approval?
9. Are you the only one who prods an author if a document (like a CAR) is due?
10. What distinction do you make between "Record" documents (a record after an activity takes place - like a CAR) and "Plan" documents (a plan for a future activity - like a blueprint or Work Instruction?)
11. Is your Quality Manual in Access?
12. If you have documents which are not Access based, how are they managed and controlled?
13. If you have two different systems for controlling and managing documents - why?

1. How many documents in your "universe?"
325 (including manufacturing and receiving specifications)

2. What is the approval process (from author to final release?)
The document is submitted with handwritten changes (changes are initialed by the author). The electronic document is copied to an in-process folder, the version is changed, the date is removed and the changes are made.The document is then sent to the author, approver and any other involved parties via e-mail. The mail contains buttons that allow everyone on the mailing list to approve or reject the changes. If the changes are rejected by anyone, we resolve the issue prior to resending. Once everyone agrees and I have approvals, the date is revised, the overview is updated, the document is posted to the intranet, all involved parties are notified of the revision via e-mail and the training requests are generated.

3. If more than one person besides the author is required to approve a document, how does that person know a document is ready for approval?
see # 2

4. If the approver decides against approving, what mechanism is used to recycle the document back to the author?
see # 2

5. Do you control/manage ANY non-Access documents (blueprints? Work Instructions? Procedures? Correspondence?)
Yes I control all sorts of documents and I never stated that all documents were in access I simply stated that the majority of our interactive documents are in access and available via the intranet. All of our QMS documents are available via the intranet no matter what software is used (access, excel, word, powerpoint or adobe) In addition, there is limited access to read only drawings.

6. Are you the sole Administrator of the Document Control System?
I am the administrator with a back-up if I am unavailable

7. What happens when you take a vacation or are sick or away at a seminar?
see #7

8. Are you the only one who "reminds" an approver that a document needs approval?
A report is posted to the intranet with a list of documents needing approval. If it is a hot item, I will remind the involved parties of the need for approval.

9. Are you the only one who prods an author if a document (like a CAR) is due?
A report of open cars/pars and complaints is posted to the intranet for all to view. If a response is not received within 7 business days, I send a reminder to all involved parties.

10. What distinction do you make between "Record" documents (a record after an activity takes place - like a CAR) and "Plan" documents (a plan for a future activity - like a blueprint or Work Instruction?) Our record control procedure clearly identifies which QMS documents are to be retained as records, by whom and where. In addition, all of our documents have a section to which they are posted on the intranet. The sections are: Quality Manual, Procedures, Instructions, Forms and Specifications. Under those sections are subsections for each department.

11. Is your Quality Manual in Access?
No the QM is not interactive.

12. If you have documents which are not Access based, how are they managed and controlled?
see # 1

13. If you have two different systems for controlling and managing documents - why?
Only one system! I just use access as a tool to help track the performance of our QMS.

I hope that this clarifies your questions.

Graeme said:

Also 30-40+ years ago, the original form would probably have been a mimeograph copy (low budget), printed from a stencil (medium budget) or typeset in a printing shop. The smells of mimeograph fluid and stencil correction lacquer would have been fairly common. Copies would be made in real-time with the original using the transfer medium called "carbon paper". (Of course, a really big company might have one or two photocopy machines or those new machines with the funny name - Xerox. But that was for important correspondence and documents, not forms.)

Click to expand...

You're reminding me how old I am...

QMS in our company originally was created and stored in electronic format.
We use special templates forms for all our records and if necessary we print them, sign and keep in hardcopy.
As for CAR usually we fill the CAR form and print it out and give to relevant personnel for implementation as the first stage of corrective action, then I fill follow-up actions, sign it by hand and keep the records in file.