How to deal with resistance to GDP Document Control Discipline


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I'm struggling a bit on a very practical thing regarding good documentation practice towards ISO 9001.

The situation is as follow:
I started working for a company of 600 people. The basic proces is:

Cust custom product request -> custom design phase -> construction drawing phase -> work orders to production -> 8 production assembly and final test processes -> product delivery

Each product has a value of +/- 4-5milj euro and we do around 100-150 pr/j. So in my opinion, first time right is of high priority.

I'm responsible for the management of the CAPA system and the DMS system and high level analysis of data.

The status of the DMS is as follow:
The only formal (in written procedure) structured control is on work instructions and procedures(process description).
The synchronisation of the original control and publication tool can be better.

The tracking info (a number only system) works for some departments and only for office people who have the coding explanation at hand, not for the people at the shop floor, however we are bound to it on group level.

Due to the above editable copies of original instructions are stored all over the place on local and network folders outside the DMS original control structure. The same is for registers, records etc. all that is not an instruction or procedure. The departments are creating there own systems outside of the DMS. For records ok but not ok if not described how.

The problem I'm facing is:

I would like to make the system work for everyone and be able to fullfill the needs of ISO.
So my suggestion is to make an alternative coding that works locally for each department, next to the group doc coding.
Review the process descriptions with the department heads and clean up the processes and underlying documentation and make it fullfill the DMS needs and the needs of the other departments related to those processes.
Inventarize all the non controlled copies on the network and graduately clean that up.

The problem is, when communicating this with the department owners, the feedback is that "it works for my department, so why should we?", "are we controlling just for the controlling, what does this bring for me?" etc.
In my experience classic defence that I have experienced in the past before. However I never worked for a 600+ company only for 10 times smaller and there it was much easier to talk with a GM and departments heads and was also the benefit much more clearer.

So has anyone the same experience within a large company? How did you deal with this? How can I get clear the benefit for a department when, due to unclear info, I have not much insight in the department processes myself etc etc Good suggestions are very welcome!



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Re: How to deal with resistance to GDP Document Control Discipline?

Department heads with systems that work for them have no reason to change things. Whatever size company, and whatever solution you implement, you will need buy-in from top management and a directive from the CEO supporting your efforts.

As for the tool, it seems to me that you need a web-based QMS. We have one on a wiki, and it has worked great.


Re: How to deal with resistance to GDP Document Control Discipline?

01mercy - The culture you hint at sounds familiar! *Folks protecting their silos, optimizing locally, *departments creating their own systems to survive - I've worked in Mom& Pops to Global 100 size manufacturers.

Suggestions are:
the following beg quantification to the degree you can with the information systems available, and in $$ language for higher ups, in other forms of waste measurements for Operations.
"first time right is of high priority."
"synchronisation of the original control and publication tool can be better"
"The tracking info (a number only system) works for some departments and only for office people who have the coding explanation at hand, not for the people at the shop floor."

The key is building relationships with formal and informal leaders, and it takes work to identify who those folks are. Sharing the quantified loss(es) will eventually strike a nerve with leadership and then it becomes a matter of attacking one (if you have the luxury of time to focus on just one or maybe the significant two!) problem and improving it and then broadcasting the victory - for starters.


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Re: How to deal with resistance to GDP Document Control Discipline?

Thanks for your input.
Currently I'm making an inventory on all the drives of copies and files that need to be QMS controlled (at least written down how we manage them).

Already getting the feedback:
Nice, but if you have insight in that all, the response you will get is "do we have a problem than?"

My logic would say: If you have original copies all over the place that can be altered, if you have your QMS template used for all kinds of documentation to look like if it's under control and use coding that is not written down on how and where and trained.... yes you have a problem because you do not comply to what the standard means with "control".

But than I fully relate to the standard requirement and not to the beneficial part of doing that.
I rather fall back to the last instead on solely what the standard says.

I find it rather difficult to each time make people understand and explain what's the benefit of following the standard. And on top of that.... if I can explain than it's like "because our customers want that" etc etc.

We have an upcoming ISO 9001:2015 audit, anyone any experience in difference of auditing toward the DMS and QMS in general? I've heard it will focus much on leadership and risk management but I just wonder how they are going to audit for the first one.


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I checked with my manager what best to do to create understanding of the ISO standard regarding documentation practice requirements.

We will, based on the what the ISO requires and the state of the current document control practice, make a presentation what will be the benefits for the departments when working according to ISO 9001.

I figured that this is important before improving because only if we have mutual consensus on the why&how only then there will be coop.

So if anyone has some good suggestions on readings how to clearify the benefits for different types of departmens in a company when using a certain level of control of documentation...
Please share with me, it's more than welcome! :yes::agree1:


There is a Document Control "Basics" powerpoint deck here in the Cove.
YOu may want to use some or all of it.
40 slides.


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Can anyone tell me where this document is?
If I search the attachments for "document control" I can't find a file with 40 slides.
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