Document Control Procedure - Ideas - Examples Attached

Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
i will do it like this

Dennis,

Here is my old Doc & data control from my manual.


1.0 All documents affecting quality shall be controlled and maintained. Each department manager is authorized to approve documents, or to assign a designate.

2.0 Documents shall be released and controlled by the department having the responsibility for that document.

3.0 Detailed procedures are available for each department. Procedures shall include instructions for assuring the correct issue is in use, removal of invalid or obsolete documents, and identification of any obsolete documents that must be retained for legal and/or knowledge-preservation purposes.

4.0 Forms used for documenting activities related to this system shall contain an identification number except for any form developed and purchased prior to the release of this document and forms generated by the job system computer.

5.0 Quality Department

5.1 The Quality Department shall have control over the following documents:
Quality Manual
Quality Procedures
Inspection Instructions

6.0 Engineering Department

6.1 The Engineering Department shall have control over the following documents:
Engineering Procedures
Manufacturing Procedures
Purchasing Procedures
Drawings
Job Packet Documents
Work Instructions



7.0 Purchasing Department

7.1 The Purchasing Department shall have control over the following documents:
Purchase Orders
Approved Vendors List

8.0 Human Resource Department

8.1 The Human Resources Department shall have control over the following documents:
New Employee Orientation
Employee Handbook
Training Manuals


9.0 Document And Data Changes

9.1 Changes to documents can be requested by the following methods:

9.1.1 Verbally

9.1.2 Submitting a marked-up copy to the Department Manager

9.1.3 Product Change Request form.

9.2 Only the issuing department has the ability and authority to make changes. Changes may require a revision level change. Changes require the same review and approval as the original. Procedures are released as they are issued or revised.


Covers the basics.
Lift away!!!!

CarolX
 

CarolX

Super Moderator
Super Moderator
#5
Re: Re: i will do it like this

Jim Wade said:

Not getting at CarolX in particular (her post just triggered the thought) I have a general question....

Why is it so common for procedures to use the shall word?

It seems so stiff and formal and is a word rarely used in normal business - why not use people's everyday language?

For example: "we control and maintain our documents"; "departments release and control their own documents"

Just a thought...

rgds Jim
Jim,

That is kinda a carry over from my old days as a QM for Dept of Defense contractors. Semantics was everything with them. If you used anything less, you were not in compliance with their standard. Perhaps that is why you see it so often, especially since the 1994 version of ISO9000 was almost a duplicate of MIL-Q-9858. Many of us are using a revamped version of our old Quality Manuals.

Hope that clears it a bit.

Regards,
CarolX
 

apestate

Quite Involved in Discussions
#6
I have a question on the subject. Something has been bothering me for a while about 4.2.3 in ISO 9001:2000

(c) to ensure that changes and the current revision status of documents are identified,

What is this subclause talking about, exactly? I see drawings with changes identified by a letter, and that letter corresponds with a log indicating changes...

I also see procedural documents listing the changes made to each revision in a document history sort of section..

ensuring the current revision status is simple enough. dash one at the end of the document number does it for me. am I reading too much into this? If I were to interpret this one way, it would stipulate a list of document revisions on every form.

I have the details of document revisions elsewhere.

what does it mean to ensure that changes and the current revision status of documents are identified, and where will these changes be recorded?
 
#7
atetsade, first of all it does not say that these two items must be met by the same act. For example, you might identify the current revision status on the document itself. However, you might identify changes (on this document) are identified through training (this could be the best way for changes in the steps of a work instruction).

Different documents can use different means. As you stated, perhaps on drawings you use a letter to designate the rev level (common practice). On procedures you use a dash followed by the rev number.

The key point here is that anyone using the document knows what revision level they need and if there is a change, they must know what the change was. They should not have to disect the document, and compare it to the old document, to find out what changed.

So the two questions are:
Is the document current?
How do I know what changed?

Hope that helps.
 
M

M Greenaway

#8
Jim

I think the 'shall' statements are there to make the statements auditable (in a compliance sense of course), and also I think it has certain legal importance. Also maybe it is grammatically more correct to say 'departments shall control their own documents' in a sentence.

Of course I might be talking [email protected] again !!
 

Douglas E. Purdy

Quite Involved in Discussions
#9
Fundamental Thoughts - Not Procedure

DWPOZE,

I can provide a sample procedure as you requested (just let me know) to the fundamental paper on Quality System Documentation & Data that I have created during my work with various systems I have helped create. I know that this will probably raise some critique by the other experts, but I do think that there are some good basic concepts documented in the paper.
 

Attachments

Thread starter Similar threads Forum Replies Date
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
M I Attached My first Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Gman2 My Attached Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
L Document Control Procedure - Revision Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Document Control Procedure - Please Critique Document Control Systems, Procedures, Forms and Templates 5
J Document Control Procedure for the Construction Industry - Help Document Control Systems, Procedures, Forms and Templates 4
B Document Control Procedure - Critique Wanted Document Control Systems, Procedures, Forms and Templates 5
D Converting to Electronic Document Control - Procedure Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
A Document Control Procedure Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Please review and critique our new Document Control Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
J Document Control Procedure - Review and Feedback Needed Document Control Systems, Procedures, Forms and Templates 9
J Are these things really required in a document control procedure? Document Control Systems, Procedures, Forms and Templates 17
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
T Document Control System and Procedure Advice wanted Document Control Systems, Procedures, Forms and Templates 3
S Outdated Document Control Procedure & Upcoming Audit Document Control Systems, Procedures, Forms and Templates 7
J Feedback on Document Control Procedure Document Control Systems, Procedures, Forms and Templates 20
P Feedback on Document Control procedure please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Document Control Procedure Please Review Document Control Systems, Procedures, Forms and Templates 37
H External Document Control Procedure advice wanted ISO 13485:2016 - Medical Device Quality Management Systems 9
L Sample of Control of Document Procedure and Control of External Documents Document Control Systems, Procedures, Forms and Templates 2
T Changes to document control procedure - need review Document Control Systems, Procedures, Forms and Templates 4
J Document and Record Control - One Procedure or Two? TS 16949 Document Control Systems, Procedures, Forms and Templates 9
A Document Control Procedure needed Document Control Systems, Procedures, Forms and Templates 1
J Document Control Procedure Examples Document Control Systems, Procedures, Forms and Templates 11
J Corporate Procedures and document management/control procedure IATF 16949 - Automotive Quality Systems Standard 6
T Please Comment on my Document Control Procedure Document Control Systems, Procedures, Forms and Templates 8
W Why is a Document Control Procedure necessary? Small 2 Person Business Document Control Systems, Procedures, Forms and Templates 14
G ISO 9000:2000 Document Control Procedure P423 Document Control Systems, Procedures, Forms and Templates 7
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 50
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9

Similar threads

Top Bottom