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When do you make your new or changed documents effective?

Statistical Steven

Statistician
Staff member
Super Moderator
#11
Yeah - 6 months would never work in my world. Sometimes I've needed it done and closed in 6 hours. But that's been on a local scale.

Even when I've managed the QMS in multiple facilities I've shot for under two weeks unless I had to personally travel to do the training.
How do you deal with multiple countries and translation requirements?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#13
How do you deal with multiple countries and translation requirements?
Haven't had to cross borders except to England so translation wasn't necessary.

I'd imagine if I worked for a company that large and I was in charge of the QMS I'd have a translation service I'd work with and bi-lingual English-local trainers in each region that I could train.
With communication resources available today there's no reason a procedure can't be disseminated to 90% or more of the affected people within a month.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#14
Haven't had to cross borders except to England so translation wasn't necessary.

I'd imagine if I worked for a company that large and I was in charge of the QMS I'd have a translation service I'd work with and bi-lingual English-local trainers in each region that I could train.
With communication resources available today there's no reason a procedure can't be disseminated to 90% or more of the affected people within a month.
We have a 13 week lead time from the translation service. Besides that, training is centralized.
 

Pancho

wikineer
Super Moderator
#16
I'm with Jennifer. Folks are responsible for consulting their documents at the time of use, thus changes are effective immediately upon publication. I think that a lengthy delay would do away with the continuous part of improvement.
 
M

Mauri

#17
Effective immediately once the approval ink has dried. :)
It' hard enough to keep track of what is up to date without having documents in limbo before going into effectiveness.
Document changes are done for all facilities from the head office, so a change could be done for a day or two before the site manual gets updated.
 

jkuil

Quite Involved in Discussions
#18
I have seen a few examples from immediate implementation to a 30 day waiting period (never beyond).

A nice method was to add a training activity to the implementation activities in a change request. The owner of the change request determines the training requirements:
  • none - if it is only textual. Applicable employees are informed through e-mail of the next revision
  • read only - for minor changes. Read and understand is signed off within the learning management system
  • classical training - if changes need to be explained. Training attendance is recorded.
  • Re-qualification - if previous qualifications are deemed inadequate after the change

The training plan is approved with the change request. The best thing is that the change owner can manage the timeliness of the training activity. If he want immediate implementation he needs to organize that everyone is trained immediately upon release of the document. The plan also must state how many emplyees at least need to have completed the training (generaly 80%, where the remainder must be submitter to training before restarting the activity). The revised document is implemented as soon as the training activity is completed according to plan. This again requires an approval by a change manager. Generally this was achieved within 2 weeks. The procedure required completion within 30 days. The system provided a notification of overdue implementation activities. In addition timeliness of training was reported into the Management Review.

This methodoly was supported by a document management system and a learning management system that interface with each other. That did facilitate this process. However, I suppose it can be managed without these systems.
 

Helmut Jilling

Auditor / Consultant
#19
I'm with Jennifer. Folks are responsible for consulting their documents at the time of use, thus changes are effective immediately upon publication. I think that a lengthy delay would do away with the continuous part of improvement.
Oh, c'mon...

"Folks are responsible for consulting their documents at the time of use..."

Does that really work? And if it does work, it would consume a lot of time if everyone consults all their docs, everytime they want to do something. That is not a very effective approach.

But, don't get irritated with me, I think I agree with your premise, just not the method.

We make approvals and the whole doc control thing too complicated. First, most changes are pretty small, non-substantive changes. There is no need to hold things up and do formal "training" just because a form number changes. For simple changes, let the doc owner approve the change and someone post it wherever appropriate. Put a post-it note on it to identify the change, or highlight it.

For more significant changes, evaluate what is needed. Sometimes, training or new tooling is needed. In thoses cases, you want to hold up the doc until everythiing is in place. TS-16949 actually requires you to make a record of the implementation date. In other cases, the impact on the operator is the same, and just informing them is enough. Limit the sign-off approvals needed to those who are impacted. Other managers can simply be informed of the change. Reduces costs and time of the change process.

Basic points:
Don't overcomplicate the process.
Don't make 10 people sign off every basic change if it is not an issue.
Do decide what is appropriate and needed for more substantive changes - is training needed, what approvals are needed, etc.
 

Helmut Jilling

Auditor / Consultant
#20
Very large company! Public Company!

Not sure how this related to the Six Sigma Scale...but they espouse Lean and Six Sigma.
ummm...yeah...why am I not surprised? Six months would certainly not be "Lean." And the only relation to Six Sigma, is they both use "Six" in the sentence. This is why I argue that support processes should also be measured and reviewed, because that is where much of the waste, bloat and ineffectiveness currently hides. Support processes may not produce revenue, but they certainly can chew up the bottom line.
 
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