Document Control Under The New TS16949 Regime - What do you control, and why?

T

TownDawg

#1
Good morning. I wish I would have typed this last night, when it was fresh on my mind -- but hey.. better late than never maybe.

I've been thinking conceptually through document control again, working the actual reasons WHY we do it in my mind -- and trying to nail down what should be controlled.. what should not.

Under the QS9 system -- that question was easy. If it's important enough to write it down, control it. Under a TS system though, I'm not sure sure it is as clear cut -- and I don't mean that in a bad way, just being philosophical here. This might be the wrong sub-forum, but let me ask this anyway.

** What do you control, and why? **​

I've got a little different attitude lately about it, but I'm not sure I can capture it accurately with words, without enough coffee. (I was more clear-headed last night. ain't THAT a switch??)

Your comments are welcome. ;) It might get me back in that groove again.
 
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T

TownDawg

#2
Well, this one is pretty quiet, so let me post again.

What do you control, and why.

I have a read-only directory (RW to me of course). It is on a shared drive. My plan is to upload the approved documents.. (at least the ones generally agreed upon) to the Lotus Notes server, take advantage of the QSI/ibs software that supports the ISO/TS-16949 effort, and utilize the built-in email addressing capabilities to route the documents, and make them official.

On the subject of document numbering, that's another thread. Control is at issue here. Preservation.

Old section 4.15 (Material Handling, preservation etc.. in a new 21st century sort of way.) content, wrapped up in a section 4.4 (was it 4 or 5?.. oh.. document control was 5 -- sorry, memory lapse).. section 4.5 doc ctrl.. that insisted.. "hey, it is is important enough to perserve/maintain -- guess what, done deal."

Now it's 16949. Process. Efficiency. Effectivity of the process through process measurement, etc.. etc.. (again, another thread.) As we describe the QMS, we essentially describe the documentation of the process as it is, and to a lesser degree of how we want (the QMS to be) it, and finally -- to keep everyone honest.. audits.. three different kinds no less.

Now, we got paperwork. At least e-Files. --> and I am back at the subject of -- "what do you control, and why:"

enough said for now. Thank you. I admire the verocity, and diversity.. and certainly plain talk where needed. Feedback?
 
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K

Karen R

#3
What do we control and why?

Glad to hear people asking the right questions!! I try to keep it simple - if more than one person needs the information to perform their job, then it should be controlled.

So, if I have a list of reports I run daily, for my own reference, does it need to be controlled? I would ask the following questions - will I consistently run the reports as required without the list (because of training, experience or some other prompt)? Does someone need to cover for me in my absence? If so, will they be able to run the proper reports without the list? If I (or my designee) misses a report, how significant will the impact be?

If the need for the document is limited (I and my back-up have enough experience to run the reports and if we miss one, the person we send it to will simply ask) - then there is no need for "the system" to control the document.

If I (or my back-up) would be at a loss without it, if there is not another means to trigger a reminder (in this example, my daily, weekly and monthly reports show up as tasks on my electronic calendar which is shared with my back-up, so no need for list), if it would be difficult to train a new employee consistently, then the process should be documented. If it should be documented, it should be controlled.

We have a very simple system - creating our documents in Word or Excel and using a shared folder with read-only access as an icon on every desktop. So "controlling" documents is very easy. In fact, our people have become so used to (dependent on) the convenience of finding everything in the shared folder that they now PREFER the documents to be controlled. Amazing, eh?? :magic:
 
V

vanputten

#4
Hello All:

I think we have jumped a step. Before we can determine what documents need to be "controlled", we have to define the term.

So what does "controlled" mean and why do you do it? The answer to this will help you answer your own question.

Regards, Dirk
 
K

Karen R

#6
I think that Section 4.2.3 of the TS standard does a pretty good job of summarizing what "control" is (managing change, making available, etc.). The "how" is a simple matter of answering each of the "questions" posed by the section...

a) how do you approve documents prior to issuance? Do you need formal reviews and sign-offs or is verbal approval ok? Who does it, what do they do, when do they do it, how do they do it...

Simple... not necessarily "easy" :)
 
V

vanputten

#7
Hello TownDawg:

Maybe I am mis-understanding your question. Maybe you and I are driving at the same thing and I am confused but I do nothtink the thread is back to where is started. Often, when someone asks what needs to be "controlled", the answer is a list of typical documents.

We do not know what "controlled" means at your organization. You asked "what do you control and why?" That is not the same question as what is "controlled."

My question, what does controlled mean in your organization? And I do not want you to think about the mechanics such as "controlled means we sign an ECN." I ask the question from a principle stand point. Explain the concept of controlling documents from a principle standpoint and not a functional stand point. What is the business reason for controlling documents in your organization? The answer to this will allow you to answer your own question. There is no magic list of what should be "controlled." You have to think about the principle of "control", the methodolgy, etc. What one organization "controls" may not be what a different organiztion controls becasue of different business needs.

Regards, Dirk
 
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S

SteelWoman

#8
We determine that a document in the Quality system needs to be "controlled" based on only two criteria/litmus test questions:

1) Is it necessary to the Quality System?
2) Can it's alteration or misuse create a PROBLEM for the Quality System.

It has to meet BOTH criteria, not either/or. It's the responsibility of the Management Rep to make this determination. We've "uncontrolled" quite a few documents when we figured out, for instance, that while it may be important to the Quality System there was NO WAY it could create "quality evil" if it was altered or if someone didn't have the most current "version" for whatever reason. Example: Obviously a master document that outlines all the annealing cycles necessary to arrive at certain mechancial properties needs to be controlled - it is a necessary part of the Quality system AND if someone alters it or is using an outdated copy we create bad steel. But a log sheet someone uses to help them keep straight in their head what ppaps they sent out already probably doesn't need to be a "controlled document" - it ISN'T "necessary to the Quality system" (it is a redundancy to that information contained in individual files) and the form itself doesn't "do" anything for the Quality System that can cause "quality evil" - it's just a quick reference tool the way it is used. It's an incredibily simple system for determining controlled or uncontrolled that has withstood 7+ years of audits and use without problem.

Zat make sense? It IS Friday... I can't be held responsible for being coherent.
 
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T

TownDawg

#9
Steelwoman/Vanputten: Hey there. Yes, more of the answer I was looking for. I want to control what needs to be controlled, I don't want to control just to define the existence for a job. I am fairl well convinced that control is better when diversified as well. I've done the central document control QMS model, and although it works well, I'm not completely convinced it is the BEST model.

Again, thanks for your input. Much clearer. :)
 
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