Controlling Level 4 Documents

J

JParrish

#1
We have yet to gain control of all the forms that are used in our facility. I beleive this is something that needs to be done, but not sure how to get started. Our facility is around 600 - 700 people, and the amount of forms used could be very extensive. I am also not sure how to determine if that form directly affects quality. Where do you draw the line? Any ideas on how to control these forms and when to control them!
 
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D

David Guffey

#2
In my experience, you definitely need to control the revision level of the FORM itself. If it's a form to be completed into a quality record, the quality record then needs to be controlled per 4.16.

The problem with controlling the blank form is that there may be so many copies out in the world available for use. If a form is revised, all those copies need to be rounded up, destroyed, and replaced. Using this method, we usually miss a few that are stashed away in somebody's desk.

To get around that most of the time, try to change forms so that previous editions could be used if necessary. Then, make sure your release documentation clearly states "previous revision may be used until depleted" or something similar. If the change is such that the world will fall apart if the old form is used, an extra effort must be undertaken to search for and find the newly obsoleted forms. You have to figure out how to do that within your own system.

One thing I doubt you want to do is get to the point of "issuing" forms. Avoid that at all costs if you can.
 
L

Laura M

#3
This is a tough one. A couple of thoughts come to mind.

Don't get too analytical about which ones affect quality and which ones don't. Personnel or accounting forms may not affect product quality, but there is valid reasons to control them. It's easier to control "all" forms than make a decision. Once people know "all" forms are controlled, then they get used to whatever system you put in place.

The previous suggested about "valid until depleted" only brings to mind how many revisions back? If you pull one out of you desk that is "valid until depleted" it can be a couple versions old, not just one, so be careful.

As a possible suggestion - we established "document control areas" -(file cabinets) that were out in manufacturing areas as well as office areas. Each dept. was given the flexability of determining how to manage them - how many to have etc. Copies of blank forms were kept in these files and it was the resp. of the person who updated the form (authorized personnel who reviewed and approved) to purge the folder. Users of the forms were trained NOT to make their own copies - we used a RED "QS9000" in the corner of controlled copies - and no color copiers were available.
Some departments actually kept only 30 days worth of forms and knew on the 1st of the month the file should be empty - and they replenished it (daily use forms). In most cases the files are closer than the nearest copier, so eventually the system took hold and worked. Another method of control was to only revise on the 1st of the month if possible, and copy the 1st month's worth in a differenct color as a visual indicator. FYI -if your're thinking - were too big, too dirty etc - this was implemented in a 3200 person facility with Die cast, machining, plastic injection molding, heat treating etc.
Not sure if this helps or not...
All manual systems take training and time. People invent their own systems when the system in place doesn't work for them. Get the users of the forms involved - make sure they understand the requirements, and let them come up with what will work. Make the forms easily accessible and controlled, and they will have less reason to work around it.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#4
JP,

You may find this useful.

You are setting out to purge the system of useless documents. While a huge task, once clean, keeping it clean may even be larger. Either way, it is nice to clear the slate.

What level 3 documents need to be controlled? As stated earlier, any form that becomes a Quality Record needs to be controlled. So what other documents?

Well, any document referenced in the QM or in Level 2 documents, these should be controlled. For other documents you collect, they need to be put to the test you mentioned; what effect do they have on the system? You may want to use a Risk Analysis tool (maybe create your own), such as an FMEA, to determine the level of risk involved. Low risk, low chance that it needs to be controlled. However, this is not a fast rule. Developing an RPN uses three criteria, Severity, Occurrence, and Detection. For Risk Analysis on Forms, I believe you need to pay particular attention to the Severity and Occurrence factors. Severity deals with direct impact of the failure. The higher, the more consideration should be given. The same is true of Occurrence. Many small failures add up to a big failure in the eyes of auditors. For this reason, even if the Severity rates low, a large Occurrence would drive me towards controlling the document.

I think you will find that many forms in your system are more in tune with working documents. This should make your document control more simplified. However, it is a good idea to make sure your internal auditors routinely challenge the form classification, in either direction.

I hope this helps. Any other ideas out there?

Regards,

Kevin
 

barb butrym

Quite Involved in Discussions
#5
watch yourself...don't make a mountain out of a mole hill...is the form just used to collect data for electronic entry? don't control it..... Is it used to track efficiency just within the area? don't control it..... Local control by a supervisor can be controlled easily within the area, and not bog down the doc system..keep it simple guys....some people get carried away
 
S
#6
I have experimented with control of forms and documents, on a small scale, at the point of use,i.e., manager,supervisor,team (cell). Each person/team would have a master list of their forms/documents, also a copy is given to the document control clerk. When changes are made the DCC reviews the master list and distributes copies as required.
This process was surprisingly effective, however I haven't implemented plant wide as of yet.
 
L

Laura M

#7
It was amazing to me the extent people went through to keep there own "stash" of forms before we implemented the above system. Once they knew they can get their hands on what they needed, they spent the time doing their job instead of at the copier. Work benches, desks got cleaner in line with our work-place organization efforts that coincided.
While I agree with "don't make a mountain out of a mole hill" build system that can be recognized from one dept to the next. At least where I was, when employees moved from dept to dept - they knew what to look for. The majority of the forms were tied to a PCP reference. Rather than have a "master list" we had a document matrix (by department) that listed the forms and where the master was kept. The master was then the reference "or equivlent" to the master list, and you didn't have to update the list when you update the master. Level 1,2 & 3 documents used the master list.
 
L

Laura M

#8
re Barb ..."is it used to track efficiency in the area... don't control it"

Not sure I agree here. Is that because efficiency isn't a "quality goal"? QS requires a business plan. Most business plans have efficiency goals. Could efficiency be an indicator for a quality goal....100% on-time delivery for example. It would seem that that's where you get involved in the "is it or isn't it" conversation in the original question.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
From my perspective, I see that data or information collected as part of an efficiency is not a controllable document. This is what I would classify as a working document. The need for the document is to compile information, but otherwise, is not subject to the document life cycle.

From the perspective of the Business Plan, and how it is stated in the governing SOP, controlling the form used to gather information as part of a Quality Record, then you might want to control the document. Here I would think that the only thing that would be controllable would be the format of the document, where data entry might be critical. This would be consistent I think with 4.5.2.a.

Back to the group...
 

barb butrym

Quite Involved in Discussions
#10
doc and data refers to the procedures and form masters.

Records are filled in forms with the appropriate information/evidence that the procedure was followed.
 
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