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Controlling documents in two different Applications

qualprod

Trusted Information Resource
#1
Hi everyone

I would like to have your thoughts regarding the control of documents

This is may case:
I have an application to manage the documents of the system management. Into this app, I control the changes, and the creation of documents. Also into this app, is defined the numbering of the documents. The documents of the management system are controlled into this app., e.g. Policy, quality objectives, procedures of the processes, work instructions, etc.

On the other side, I have an app called Inventor, which produces 3D drawings, but the numbering of drawings is defined into the inventor and is different to the one in the app of the management system, the drawings are produced in the process called "Engineering"

Questions:
1- Do the Inventor drawings, need control into my main management systems, or can be controlled into Inventor?​
2- The names of the drawings from Inventor, must follow my type of naming defined into the management systems or can have the native code of Inventor?​
3- The scope of the control into the Management System should be only for the documents which are part of the system? (policy, quality objectives, procedures of corrective actions, of complaints, procedures of the processes) or can go beyond that? although is not easy, for example in Engineering, e.g. specifications, comparative tables, calculations, data sheets, quotations, etc.​

Any Idea to manage this stuff?

Thanks
 
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Big Jim

Super Moderator
#2
1 & 2. There is nothing in the standard to prevent you from having two document control systems.

3, If they are documents needed by the quality management system including all the topics you mentioned need to be controlled.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
To follow upon @Big Jim 's post:

Over the years I have seen many types of document control systems in various companies. One of the problems many people have with understanding document control is that there are so many ways a company can set up document (and record) control.

I remember some years ago a large corporation established what they called "distributed" document control where each department controlled documents they owned. Corporate had a basic document that described a basic system each department in each location had to follow.

The other extreme is a centralized document control system in a company/corporation.

The essential aspect is that appropriate documents (and records) have to be controlled. How it is done doesn't matter as long as what documents (and records) must be controlled and that the basic document control aspects are defined and followed.

I originally wrote Flow Charts for 2000 (a .pdf file) around 1998. The date on the .pdf posted says 2002 or 2004, but the last actual revision was in 2000. See slides 15 through 22 for some thoughts on the basic requirements of a document control system.
 
Last edited:

qualprod

Trusted Information Resource
#4
1 & 2. There is nothing in the standard to prevent you from having two document control systems.

3, If they are documents needed by the quality management system including all the topics you mentioned need to be controlled.
Thanks Jim

But according to this:
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this International
Standard
shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

Do the documents produced in the Engineering process (transmittals, emails, revision sketches, memorandums, minute of meetings,calculation sheets) "are information required by the quality management"
I understand that the standard it refers to document needed to "drive" the system (policy, quality objectives, procedures into the processes, procedure of audits, of corrective actions, etc.).
If we consider to have a tight control of documents produced in Engineering (hundreds of documents) under the existing procedure of control of documents into the management system, would be a crazy decision in my opinion.
Maybe to mention in the management system that drawings are controlled into the Inventor software, but not to mention transmittals, emails, memorandums, minute of meetings, etc.

I think there must be a scope, for example to control only what is "driving" the management system and other way apart
,I mean a special control into the Engineering process (in fact in some way or other they have a control) , but not to include
this control into the management system.

What do you think guys?.

Thanks
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
FYI - “Documented information” is the term that replaces the terms “documents” and “records”.
 

Eredhel

Quality Manager
#6
Are you trying to control a drawing number and revision letter at the design, planning, and/or production stage? Just not sure if I know for sure what your goal is.
 

qualprod

Trusted Information Resource
#7
Are you trying to control a drawing number and revision letter at the design, planning, and/or production stage? Just not sure if I know for sure what your goal is.
In any step theyy have to be controlled, from sketching, revision, approval, what changes is the revision number, the code doesn´t change, In sketch is P0, P1... in revision R0, R1... approved for construction is 0,1,2,...
e.g. PS-M-00/rev. P0, R0, 1,etc.
But I think the main question is What kind of documents should be in control under ISO 9001, if only
those which drive the management system or any document produced in the processes (transmittals, memorandums, minute of meetings, invoices,etc)
Thanks
 

Al Rosen

Staff member
Super Moderator
#8
From the the standard

7.5 Documented information
7.5.1 General
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness
of the quality management system.


7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International
Standard shall be controlled to ensure:

a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

The organization determines the documents necessary for the QMS that are to be controlled in addition to the documents specifically required by the standard.
 

Big Jim

Super Moderator
#9
"Drive" isn't in the standard. That's in your mind in trying to limit the scope of what needs to be controlled. And you really don't need to. In earlier days of quality management systems there seemed to be a driving force to have lots of very detailed procedures, and it has never really been so.

You probably already have controls in place for much of it. Sort out what you already have and go from there. For example most companies now save all emails since memory is so cheap. Does it need much if anything more?

Also, the last version required written procedures for six topics (control of documents, control of records, internal audit, control of nonconforming products, corrective actions, and preventive actions). The latest version no longer has any requirement for written procedures unless you elect to have them. Don't get hung up on overly complex document and record controls from the past. Let that sink in and you should start feeling some weight off your shoulders.
 

Randy

Super Moderator
#10
The answer to your questions are simple...Do whatever you want, the way that works for you, in the way you need it to be done.

Just be consistent and make sure others that need to know, know.

Everything else is fluff, smoke & mirrors
 
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