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Informational Please help this newbie understand ISO 9001 Work Instructions

Ninja

Looking for Reality
Staff member
Super Moderator
#41
Seconding Andy (though I was never a machine operator)...

Functional: Any person competent to train can be a trainer.
For the QMS documentation...you have a choice: keep a running list of who is formally determined as "competent trainer" and use them to train or...formally allow anyone who is trained to the document to act as trainer.
You also get to determine if formal, specific training record is needed at all or if you meet the requirement some other way (blanket "machinists know how to machine stuff, that's why we hired them").

We did the latter...anyone trained to a document could act as trainer for the document, as long as the training date for the trainer preceded them signing off on training someone else.
That worked for the auditor...but didn't work perfectly in real life (poor training as a result, not everyone is a great teacher).
We ended up leaving the "if you are trained, you may be trainer", but then had a separate, informal list of "preferred trainers".

If I had it to do over again, I would likely do the same thing.
Establishing a list of "competent trainers" also establishes a list of "incompetent to train" by omission...and we ended up with disgruntled employees and angst. It was far easier to manage when it was 'known but undocumented'.

When I gave a new employee a list of processes/tests/WI to be trained to, I also wrote next to each one the initials of who I would allow to be the trainer. It worked well without causing significant angst...and met the requirement both functionally and to the letter.

HTH
 
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Big Jim

Super Moderator
#42
What matters is that those doing the work are competent. Other than they may gain competency from education, training, and experience the standard is silent on how they gain competency. It is up to you to determine how and to keep a record of how the competency was gained.

In other words, do what works for you.

Don't forget though that the organization needs to determine what competencies are needed. That is often shown on a job description but could also be from a job posting, skill list, or some other means.

It isn't rocket science.
 

tony s

Information Seeker
Trusted Information Resource
#43
Who is responsible (required) to train machine operators on the WI’s? QM, QT or can a floor supervisor or the operator who has a Technician/Leader Role?
IMHO, employees should not be trained on the WIs. What they need is knowledge specific to their job. WIs are just part of the materials to support the training of employees.
 

Big Jim

Super Moderator
#44
Keep in mind that in the 2008 version work instructions were not required, but if you had them they needed to be readily available at the point of use. The wording changed in the 2015 version but the intent seems to be the same.

8.5.1a1-2 The organization shall implement production and service provision under controlled conditions . . . controlled conditions shall include, as applicable . . . the availability of documented information that defines . . . the characteristics of the products to be produced, the services to be provided, or the activities to be performed . . . the results to be achieved . . .
 
#45
And...don't forget that section 4 has to do with determining a number of things about your QMS which might drive the need for documentation. If you consider needs and expectations of interested parties, for example. Or internal issues...
 
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