Does anyone have Document Control Procedure that I can look at for some ideas?

Thanks,

Dennis:):truce:

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

Dennis,
Here is our procedure we are updating

Here is our ISO:1994 doc procedure.

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

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?

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.

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 b@llocks again !!

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.

An update to the previous document submitted for thought.

Maybe this is what you are looking for.

Maybe this is what you are looking for. The concept we talk about in threads like QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do? (http://elsmar.com/Forums/showthread.php?t=4866)
is making the document readable and usable so the intended audience (the workers) can understand and follow the intent.

Wes,

My document was even worse, even the update. But it is only a paper talking about quality system documentation and data. I decided to cut it down for a basic overview to the management of my new employer (see attached). [If I remember correctly, I don't think Jim is fond of the Pyramid concept anyway!] I kinda have a mess going where a system was developed to the 20 elements and when they changed from QS to TS they only added process sheets resembling that of the registrar in the Quality Manual along with a schematic similar to the one ISO created. So their level threes are really heavy and in some cases wag the level twos (like the tail wagging the dog). I even subdivided the level threes into three dictinct documentation groups due to how they developed their documentation software systems.

Jeff,

I was only updating a paper that I keep revising to reflect changes to my understanding of developing Quality Management Systems. Thanks Anyway!


Doug

Guys guys! come up with a user friendly procedure. Instead of a narrative form of procedure use flow charting.

Guys guys! come up with a user friendly procedure. Instead of a narrative form of procedure use flow charting.

You have no argument from me. Do you have a flow chart to share that covers all documents and how they are controlled? That would be interesting to see!

Thanks,
Doug

Sorry Douglas I must of misunderstood your problem.

I agree the procedure we use at my employer could use some work. Show me one thats perfect for a automotive, appliance and recreational vehicle metal stamper and I'll use it instead.

Doug,

No hard feelings. I don't have a problem with criticism. I treat the mistakes I make and criticism by others as an opportunity to learn from them.

Jeff

Sorry Douglas I must of misunderstood your problem.

I agree the procedure we use at my employer could use some work. Show me one thats perfect for a automotive, appliance and recreational vehicle metal stamper and I'll use it instead.

I do not believe that I was critiquing your procedure. I was only explaining why I updated a post. I also believe that it was off that update that you submitted your procedure for use.

Thanks,
Doug

Jeff,

Your procedure is in a right direction but use flowchart in the procedure 5.0

Thanks.

Jcl

:thanx: :thanks:

My idea was that from one side the TS requires the procedure to clarify all the a) to g) requirements of the chapter <4.2.3 Control of documents>; from other side somebody may have the Quality System Documentation (e.g. the QM, QP, WI, forms, drawings, etc. - all'em somewhere determined as components of the QS Documentation); then you have a table <a to g> vs. <QM to forms>; then do make it a table and tell inside how the stuff is done.
The attached procedure is awful and I am thinking about updating it at the very first opportunity; however I still see the "table idea" as the most simple and effective.

I like that table idea!

Our current flowchart procedure is attached. It probably makes no sense to an outsider, but our staff can run through it blindfolded.

Do you have a flow chart that covers all documents and how they are controlled? This is the significant issue here. There is a 'standard' flow for document control, but even within a company the requirements in different departments, not to mention inter-department systems procedure requirements, and thus flows, can (and almost always do) vary significantly.

To everyone,
Does anybody here use a special instruction to document temporary work instruction in there production area?
Thanks in advance.
Best regards,
Raffy

To everyone,
Does anybody here use a special instruction to document temporary work instruction in there production area?
Thanks in advance.
Best regards,
Raffy


Yes, we allow processes/procedure changes on a "temporary basis" provided the change is submitted via our Continual Improvement Process. Temporary basis is typically 30 days, however if they need 90 days to evaluate the effectiveness of the change that is not a problem. Longer than 90 days could indicate you have other issues adn will alert an Auditor to potential issues with other procedures in your QMS (Quality Management System).

The "change" is tracked via the Continual Improvement Process and reviewed during the ISO meetings for effectiveness. We hold ISO meeting bi-weekly and the Management Review meeting quarterly.

IF it is determined that the change should be perminant, than all documents will be changed to reflect the improvement. IF the change is not effective, close the Continual Improvement and make no document or process/procedure changes. Inform your employees that you are going back to SOP (standard operating procedure). Retrain your employees if needed, keep records of the training. This leaves you with records. Records of attempted continual improvement, and a record of the failed attempt. Edison didn't create the light bulb on the first try. Tracking your failures is highly effective to finding solutions.

By allowing a trial period on a trial project, we can test to see if the requested change is effective or not without disrupting the entire production process. This way we control and limit our exposure to errors and failures. If we have errors we can track them and make adjustments to all affected products.

In some cases you will need metrics to determine if the proposed change is effective or not. If you determine that metrics are needed, you can include them in that departments "Quality Objectives" and make sure it is reported during your ISO meetings.

I hope that answers your question. Please ask if you have questions.

We are currently developing our Quality Management Sytem, can anyone give me an example of Control of Records, Corrective Action and Preventive Action SOP?

Brothers,

Thanks for all the info, i'm working as osh secretary in Malaysia and now cracking my head to prepare osh manual for hospitality industry, documentation procedure, erp...etc. glad that i found this forum...vry helpful...tks:agree1:

Maybe this is what you are looking for.

This is a great procedure. Very straight-forward and to the point.

Hope this helps !

We are currently developing our Quality Management Sytem, can anyone give me an example of Control of Records, Corrective Action and Preventive Action SOP?

Try these :2cents:

Maybe this is what you are looking for.

hey everyone! there is one thing i do not see in any of these examples and its one of the things giving me fits. do any of your procedures speak to who should create training associated with changes to the procedures and the level of training that is appropriate? we are currently experiencing the "hot potato" effect with who should take responsibility for creating, executing, and recording the training.

we have 3 levels of training - read and understood, electronic presentation (create a ppt and put it in an email), and live presentation (sit face to face with people and train)
i am having a hard time creating a "user friendly" definition of when each type of training would be required.

i may also be guilty of spoon-feeding my users a little...:rolleyes:

hey everyone! there is one thing i do not see in any of these examples and its one of the things giving me fits. do any of your procedures speak to who should create training associated with changes to the procedures and the level of training that is appropriate? we are currently experiencing the "hot potato" effect with who should take responsibility for creating, executing, and recording the training.

we have 3 levels of training - read and understood, electronic presentation (create a ppt and put it in an email), and live presentation (sit face to face with people and train)
i am having a hard time creating a "user friendly" definition of when each type of training would be required.

i may also be guilty of spoon-feeding my users a little...:rolleyes: It was suggested that this is off topic and that an appropriate thread should be created, so I have copied this post to Who should create training associated with changes to the procedures? (http://elsmar.com/Forums/showthread.php?t=35746). Please respond in that thread.

Thanks!