4.2.3d What kind of media are you using for your controlled documents? Procedures?

[Claes Gefvenberg]

4.2.3d

... to ensure that relevant versions of applicable documents are available at points of use,

Let's talk a bit about how we handle this. I think it's a good idea considering the fact that the number of computer based systems is increasing steadily. The question came up in the thread Notes on equipment

Those of you with paper based systems: How do you keep track of the documents you send out? Do you use reciepts?

Those of you with computer based systems: How do you handle it?

/Claes

 

[D.Scott]

We follow Jim's post exactly and also print on the bottom of each page "verification of current revision required after: (date of printing)".

Seems to work well so far.

The big problem for us is documenting that changes are communicated to the employees.

We have a document controller in each plant who reviews each change and is responsible for training/documentation but with so many employees it sometimes becomes a nightmare.

Employees are supposed to read their Job Spec (work instructions) every day to be sure there are no changes etc. We even color code changes for easier detection, but as it is everywhere, getting employees to actually read them is like pulling teath.

Dave

 

[Claes Gefvenberg]

D.Scott said:
---X---
The big problem for us is documenting that changes are communicated to the employees.
---X---

I'll say it is... and that's what I'm on about. As long as the system is strictly computer based I see no problem in keeping the correct information available where it is needed (Assuming there is a terminal there of course).

A paper based system on the other hand, is indeed a nightmare. The usual old metod of enclosing a return reciept with each send-out creates a considerable amount of work for very little in return: Getting that slip of paper back does in no way guarantee that the document can be found in its proper place, and every now and then you don't get it back... Then you have to chase people down and get it, or they will come to the conclusion that the QMS is unimportant.

It's like shaving a pig: A lot of noice for a very small amount of wool...

/Claes

 

[Bob_M]

Is the paperless working?

I've seen and started similar threads here before and asked about the disclaimers at the bottom.

We currently have a mixed system. Mainly because we only have 1 computer in the production area and one in the shipping area. The Foreman gives production any paperwork they need for a specific job. Additional paperwork in kept in limited binders (hard copies) within the department. So keeping track of THEIR copies is not to hard. BUT... (Currently very small quantity of employees )

We have a plan to start printing the needed documents with all JOB PACKETS and collecting them and trashing them. I still have a bit of work before this is ready system wide.

What are you people with paperless systems doing with the printed and uncontrolled copies? Simply teaching the production employees to throw them away? Other than training how do you keep them from KEEPING their copies and force them to check for upgrades?

 

[Mike S.]

We're "mixed". It has worked for us over the years (from 25 to 250 employees). The master is on the computer network, but not everyone has access to computers, so there is a controlled hardcopy with "real" approval signatures in the Q office and controlled copies wherever needed on the floor. All copies list who has a controlled copy, so in the event of a change, I look to see who has a controlled copy and go get it, destroy it, and replace it. No "receipts" -- I just make sure the employees who use the hardcopy know the new one is there.

 

[D.Scott]

Similar to us Mike, but what do you do for your off shifts? We work 24/7 and can't always get to everybody on changes. You have to pass the baton to someone else sometime and therein lies our biggest problem.

Bob - training and retraining is about all we have. You always have one who keeps the hard copy "just in case".

Dave

 

[Mike S.]

When we were working 3 shifts, there was always some overlap shift-to-shift. If I gave a new or revised procedure to the shop on first shift, the supervisor was responsible for passing the word (baton) and doing or ensuring any trainting or re-training necessary. If a person could not relay the message, detailed written or recorded (voice) memo's were left with instructions to call me or another relevant person at home with any immediate questions. A small handheld tape recorder was sometimes used for lengthy explanations and it worked well. It worked as well as could be expected -- not perfect, but nothing is.

 

[Randy Stewart]

Mixed Up

Our SOPs and manuals are on the intranet. Since we are mainly engineering it has not been difficult. In the manufacturing area, the Managers and Supervisors are responsible for developing work instructions (prototype changes on the fly) based on customer input and known issues. The work instructions are posted in the work area each day. You may end up with a drawing on a piece of paper/napkin showing to move weld locations 3 mm and it's signed by the product engineer. Some auditors have really questioned it but it has worked. No mater what system you put in place it is only as good as the people using it.

 

[Aaron Lupo]

We have a paper system. Why the **** FDA because of them we have paper all over the darn place. We used to have some systems that were eletronic until the FDA came in and said we don't care if you are a small company that can't afford to spend the thousands of dollars needed to be compliant with 21 CFR Part 11. it doesn't matter that you have a plan in place for becoming compliant and you can show you are making progress, nope go back to paper.

Am I coming across as bitter?

 

[Claes Gefvenberg]

Re: Is the paperless working?

Bob_M said:
---X---
What are you people with paperless systems doing with the printed and uncontrolled copies? Simply teaching the production employees to throw them away? Other than training how do you keep them from KEEPING their copies and force them to check for upgrades?

Now, there's a good question. We check it in the internal audits of course, but apart from that, nothing much. We have used this system for a number of years now, and so far we're not aware of any major problem.

I think the trick is to make the electronic access to the system as simple and straightforward as possible. It m u s t be easier to get the information from the intranet than keeping your own "stash".

/Claes