Documentation - When a procedure or document is changed (updated, obsoleted etc)

C

chaosweary

#1
Is there a requirement in the ISO 9001 or TS 16949 that requires that affected personnel be contacted or communicated to, when a procedure or document is changed (updated, obsoleted etc)? Just can find the reference off the top of my head even though it is common sense.

:thanx:
 
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D

ddunn

#2
ISO 9001 4.2.3.2d "relevant versions of applicable documents are available at points of use" and 4.2.3.2g "prevent the unintended use of obsolete documents"

These paragraphs would imply that affected personnel be contacted or communicated to, when a procedure or document is changed.
 

Jim Wynne

Staff member
Admin
#3
ddunn said:
ISO 9001 4.2.3.2d "relevant versions of applicable documents are available at points of use" and 4.2.3.2g "prevent the unintended use of obsolete documents"

These paragraphs would imply that affected personnel be contacted or communicated to, when a procedure or document is changed.
There is no notification requirement. Employees need to be aware that they are responsible for insuring the currency of documents they use. 4.2.3.2(d) and (g) can both be accomplished without notification.
 

RoxaneB

Super Moderator
Super Moderator
#4
chaosweary said:
Is there a requirement in the ISO 9001 or TS 16949 that requires that affected personnel be contacted or communicated to, when a procedure or document is changed (updated, obsoleted etc)? Just can find the reference off the top of my head even though it is common sense.

:thanx:
Define "contacted or communicated to", please. I ask only because if this is in regards to training, while there is no requirement which clearly states "The organization shall contact or communicate changes to documentation to affected personnel", the intent is definitely in ISO 9001...albeit in a rather circular way.

6.2.2 - Folks will be competent and the organization determines what competent means (i.e., I would think that this would include being up to speed on existing documentation)

7.1 - Establishing documentation necessary to ensure product meets requirements. Logically, personnel impacted by this documentation would be trained on current document and future modifications.

7.5.1 - Availability of work instructions...and people trained on them and how to find them and understand them.

8.5.2 - Have you determined a lack of knowledge on the current documentation to be root cause? If so, you may wish to communicate future changes to affected personnel to reduce the likelihood of the problem occurring again.
 
C

chaosweary

#5
Intent

I understand the intent. The trouble is selling it after you have written an area up and cited 4.2.3 and 8.5.2 and they want to "discuss the point". I may have to lessen it to an opportunity for improvement than a finding since I can find no instances where the absence of notification has caused a non-conformity. I was hoping :cfingers: for the manual to just jump out and state it.
Many thoughtful insights, :thanx:
 

RoxaneB

Super Moderator
Super Moderator
#6
Without understanding the full situation, I will admit to being confused to citing 4.2.3 and 8.5.2 in conjunction with "notifying" personnel on changes. Granted, if the whole issue is notifying, there is a possible Opportunity for Improvement here. If the issue is a lack of training for affected personnel, then I don't think the properly clauses were linked into the nonconformance. Just my two cents.
 

Miner

Forum Moderator
Staff member
Admin
#7
The closest thing to a requirement is 4.2.3.c to ensure that changes...are identified., and the requirement for training of the users of the documents in question.

While it does not specifically require that you notify other interested parties, it implies a requirement to notify users in order to train.
 

Caster

An Early Cover
Trusted Information Resource
#8
De ISO fy it

chaosweary said:
Is there a requirement in the ISO 9001 or TS 16949 that requires that affected personnel be contacted or communicated to, when a procedure or document is changed (updated, obsoleted etc)? Just can find the reference off the top of my head even though it is common sense.
Ah un common sense. I have never won a battle quoting the requirements.

I suggest you fall back and start again from business world. Forget ISO.

I had just such a case. I asked the author to give me a copy of their changed document. I tore it up and threw it in the trash.

When they asked why, I said no one needs this document.

They insisted it was needed. I asked how anyone knew about the latest change.

They said cause I told them.

I said, then I'll change our procedures to state that you communicate all work methods and subsequent changes verbally. And my job is done because it meets ISO requirements. But your job is going to get really interesting, really soon.

They are like kids in a temper tantrum, they know they are being bad but the want and need someone to stop them, because they can no longer help themselves.

Good luck, let us know what happens
 
S

Scoobz

#9
There is a requirement within ISO9001:2000 relating to Human Resources that should be considered:

"6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience."

How then can you justify that a person is 'suitably trained' to perform a task if they are not aware of the current procedures? You can't. Therefore, if it essential that dissemination of information is transparent and complete. Procedural controls shall be provided for the use of all personnel who require them and those people shall be adequately trained in the content of the procedure to assure the quality of the product.

Quoting any reference to a Regulatory Inspector does NOT justify something but it helps as a background. You must then apply justified rationale to your actions. I find it doubtful that an Inspector/Auditor would be satisfied by being told documents are published but not provided or trained to staff. Therefore, some sort of communication must take place.

Personally, it is logical that each process (procedure) has an 'owner' and it is they who shall be notified when a document is published. It is then their responsibility to cascade that information to the relevant personnel and to assure they are competent.
 
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