Is DCR (Document Change Request) Needed for Initial QMS Procedures?

J

JodiB

#1
I've been writing all of the required procedures and forms for our QMS to be compliant with ISO/IEC 17025. Document Control is very much like ISO 9001 so this is a generic question..... We will be using Document Change Request (DCR) forms for requesting and tracking changes to existing documents. We will also use DCRs for new documents. If someone sees the need for a new procedure, etc. they would initiate a DCR.

So here's the query... It is obvious that I have to create these new procedures in order to establish our documented QMS. But the chicken and egg question is .. do I need to create a DCR for each of these? If you say yes, then would you respond differently if I were to put the effective date of our Document Control procedure (that outlines the DCR requirement) as AFTER the creation of the other procedures? yeah, pretty sneaky huh? But seriously, I will create all these DCRs if I have to, but would really rather save the time and trouble if they are not truly needed.

Opinions please?
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
It really depends upon how your document control system is set up. There is no requirement that I am aware of that says you have to.

Have you written a document control procedure yet?
 

Mikishots

Trusted Information Resource
#3
There's no requirement in the standard. It would be a requirement only if you had it in your internal process. I would reconsider the need to use these forms; as you can tell, they are creating unnecessary paperwork and creating odd situations right off the bat - this is a sign that their purpose has not been fully thought through.

I have seen these types of forms used before; Doc Control was flooded with forms from nearly every person on the floor asking for the creation of documentation for things that didn't require it. The system fell flat on its face within a month. In other companies, I have seen new procedures and revisions to procedures being drafted, and then forwarded for review; this is effective. Ownership makes it work, rather than just someone filling out a form saying "fix this" or "we need a procedure to say this".
 
Last edited:

Kales Veggie

People: The Vital Few
#4
I've been writing all of the required procedures and forms for our QMS to be compliant with ISO/IEC 17025. Document Control is very much like ISO 9001 so this is a generic question..... We will be using Document Change Request (DCR) forms for requesting and tracking changes to existing documents. We will also use DCRs for new documents. If someone sees the need for a new procedure, etc. they would initiate a DCR.

So here's the query... It is obvious that I have to create these new procedures in order to establish our documented QMS. But the chicken and egg question is .. do I need to create a DCR for each of these? If you say yes, then would you respond differently if I were to put the effective date of our Document Control procedure (that outlines the DCR requirement) as AFTER the creation of the other procedures? yeah, pretty sneaky huh? But seriously, I will create all these DCRs if I have to, but would really rather save the time and trouble if they are not truly needed.

Opinions please?
Do as you please. You decide who/what the chicken is.

Do not be afraid of an auditor.
 
J

JodiB

#5
Yes, I've written the procedure and we Approved it ( and placed on the network location) a few months ago.. and it is what contains the requirement for the DCR. I like using a form because it documents : that the annual review took place, if training is required due to the change, if there are other documents affected, if additional resources are required... etc. So I created the DCR without any real intention of using it for the initial manual of procedures... (what we're writing right now to create our QMS and pass the accreditation audit.) I had thought it would be a good system for AFTER we get all the required procedures written and we dreamed up some supplementary work instructions.

But it seems a bit silly to create a DCR for these initial QMS procedures. I was wondering about finding a loophole, like "our Doc Control procedure was the last procedure that was Approved so none of its requirements applied to the other procedures..." OK, not technically true but let's play the game....

Say a doc control procedure lays down a requirement that new procedures are initiated with a DCR. Do all procedures approved and distributed prior to the Doc Control procedure get grandfathered in? Do only the procedures approved / distributed after the Doc Control procedure require a DCR?
 

insect warfare

QA=Question Authority
Trusted Information Resource
#6
Say a doc control procedure lays down a requirement that new procedures are initiated with a DCR. Do all procedures approved and distributed prior to the Doc Control procedure get grandfathered in? Do only the procedures approved / distributed after the Doc Control procedure require a DCR?
I would say NO to the first question, and YES to the second question....

Since the procedures created before the DCR existed would be held to the controls applied before this was implemented, those prior procedures should be traceable to the prior methods used. Attempting to "rewrite history" (so to speak) will usually make things worse in the long run (ask Stalin) :mg:

Brian :rolleyes:
 
#8
Jodie: For what it's worth, I've used a DCR to initiate a document. That way you have - as a matter of record - the reasons why a document was found to be needed. It's often too easy to just wave a wand and say "write one", when, in fact it might not really be needed or maybe another form of document is the best fit. Anyways, I'd suggest you use it.
 
S

SmallBizDave

#9
In my opinion you are over thinking this. The requirement to use the DCR in a particular way comes only from your own requirements. Nothing in the standard says this specific form must be used. So keep it simple - add a sentence where the DCR requirement is defined that says "No DCR is needed for the initial release of the baseline QMS procedures."

The systems I've written do not require anything like a DCR but if you feel it adds value to your system then you should keep it. But define the rules so it doesn't get in the way.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#10
In my opinion you are over thinking this. The requirement to use the DCR in a particular way comes only from your own requirements. Nothing in the standard says this specific form must be used. So keep it simple - add a sentence where the DCR requirement is defined that says "No DCR is needed for the initial release of the baseline QMS procedures."

The systems I've written do not require anything like a DCR but if you feel it adds value to your system then you should keep it. But define the rules so it doesn't get in the way.
I agree with your statement, SmallBizDave, except for:

"No DCR is needed for the initial release of the baseline QMS procedures."
IMO, if you have to put such a sentence in the procedure to head off a perceived reaction from the AB auditor, you are already over-thinking this. There is no "loophole" to speak of.

To JodiB:

If using a DCR is your current practice today, then simply document that you do this, and move on. If a DCR was not used in the past, that's fine, but obviously some other control was used. And the previous version(s) of your document control procedures should have outlined those controls. That is what you would show an auditor, should they stumble upon this situation.

Brian :rolleyes:
 
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