Training Records - assembly line staff

ThatSinc

Involved In Discussions
#1
Hi All,

I've got to solve a problem with training records not being maintained, that may be due to an overburdensome process for training, so I'm hoping I can either rule that out or find ways to simplify it.

The company has no software managing anything QMS related; nothing on document management, training, calibration, NCR, CAPA, nothing at all - all manual and paper based.
In addition, there is no software managing production; all batch records are raised manually and all stock issue is performed manually.

Devices are manufactured from machined components into sub assemblies, then into further assemblies, and onwards until the final device is assembled.
All assembly is in accordance with the controlled technical drawings that are issued with the batch card.

All assembly is by hand, and not all operators are able to manufacture all assemblies.
Currently there is a training sheet for each assembly, which is signed by the operator and supervisor as appropriate, to show that they are competent in manufacture of that assembly - there are hundreds of assemblies.

When assemblies are revised, a new training card is issued with the updated assembly drawing to the production supervisors for rolling out to staff.
Same as previous, signed off by operator and supervisor to show that they are clear on the updates between revisions - this isn't consistently happening.

Typically changes are made on a "completion of previous batch" basis, so the next batch card issued will be to the updated drawing.


I can't see a better way of managing this, within the current manual framework, to show that any operator at any time is trained on the assembly that they are manufacturing - Unless I'm really overcomplicating things and that level of detail isn't required? (but to me it seems it should be)

Does anyone have any guidance on, or examples of, manual training systems for assembly manufacture?

At the moment I'm having to tie this down to operators and supervisors not following the process as documented and the corrective action of "retraining" in the training process.

Cheers,

TS.
 
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Tagin

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#3
At the moment I'm having to tie this down to operators and supervisors not following the process as documented and the corrective action of "retraining" in the training process.
It seems as if the company has no consequences to not following this requirement.
 

ThatSinc

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#4
It seems as if the company has no consequences to not following this requirement.
How do you mean?

Operators have shown that they are able to build the updated assemblies correctly with no issues, so the investigation aspect with regards to ensuring that what has been made is correct has been done. Containment/correction with regards to getting existing training records up to date is underway.

I'm looking at how to avoid this happening again, preferably without a big stick.

This method of documenting competence was brought in as not all people can build all assemblies, so approval to build each one was determined as being necessary.

I don't know whether it's overkill to have to review competence every time an assembly is revised, or how to rationalize it another way.
 

Tagin

Trusted Information Resource
#5
How do you mean?

Operators have shown that they are able to build the updated assemblies correctly with no issues, so the investigation aspect with regards to ensuring that what has been made is correct has been done. Containment/correction with regards to getting existing training records up to date is underway.

I'm looking at how to avoid this happening again, preferably without a big stick.

This method of documenting competence was brought in as not all people can build all assemblies, so approval to build each one was determined as being necessary.

I don't know whether it's overkill to have to review competence every time an assembly is revised, or how to rationalize it another way.
It seems that there is no disciplinary consequence, but also that there is no process consequence - not having the required training on file did not stop the production process from being performed, and presumably, did not prevent product from being released. Which also makes me wonder if there is adequate controls on preventing unqualified people ("not all people can build all assemblies") from working on assemblies they shouldn't be working on.

I agree with your mindset that there probably should be a training record for every revision, and that the training record process should be as friction-free as possible. It doesn't sound like it could be more friction-free, so why are they not complying? What do they say?

Since you say the qualified workers are able to produce error-free product even without the training records, maybe you could address revision changes slightly differently per 7.5.1a: "documentation of procedures and methods for the control of production", where instead of requiring a training record, you instead focus on requiring a 'heads-up' supplemental instruction sheet to be provided for each applicable worker when there is a batch with a new revision, where the supplemental instruction sheet details the differences between the previous and current revision, and anything special that the workers should look out for. This would probably be a one-page list of a few bullet points (unless the revision is extensive) and can be tailored to be more relevant to the workers (and maybe even be broken down into per-station relevant changes) than just showing them an entire new drawing.
 
#6
This is posted in the ISO 13485 forum. Does that mean your organization is ISO 13485 certified? If so, your QMS should start with determining competencies for people affecting product quality (mainly) and then identify what actions are to be taken when there's a shortfall. Training is only one such action. People don't follow procedures because they are a PITA - and it sounds like your training procedure is one such PITA. If it doesn't mention competencies - as required by the standard - the your QMS isn't compliant, and someone at the company needs to fix that. Has anyone done an audit internally of this process? What was found, if they did?
 

ThatSinc

Involved In Discussions
#7
It seems that there is no disciplinary consequence,
I figured airing that dirty laundry wasn't necessary to discussing the corrective action in fixing the process so it doesn't happen again.
If the process was in a position where I didn't think it could be improved and it was just a case of negligent people not caring enough to actually do anything - then disciplinary consequence would be the corrective action.

Does that mean your organization is ISO 13485 certified?
Yes indeed.

and it sounds like your training procedure is one such PITA
In that respect, very much so.

If it doesn't mention competencies - as required by the standard - the your QMS isn't compliant,
The training procedure does indeed mention competencies, many times. But not in terms of detailing the competency requirements for individuals - but in that management will determine the level of competency through OJT and observation of performing assembly tasks.

The hiring process for personnel, which isn't part of any documented process, and is managed directly by the MD for the company, includes assessment of peoples skills and abilities to be able to understand technical drawings and follow instruction, and where relevant use different pieces of equipment - heavy duty folding/pressing machines etc.

Has anyone done an audit internally of this process? What was found, if they did?
Through internal audits and NB audits, it's been found that people know what they're doing, and have the relevant competencies but the documentation doesn't follow - hence this discussion :)
 
#8
have the relevant competencies but the documentation doesn't follow - hence this discussion
For clarification: The people are competent, however, the required competencies HAVE NOT been documented? Or the verification of the people compared to the required competencies hasn't been documented?
 

ThatSinc

Involved In Discussions
#9
For clarification: The people are competent, however, the required competencies HAVE NOT been documented? Or the verification of the people compared to the required competencies hasn't been documented?
I'm going to go with "a bit of column A and a bit of Column B"

But only because
A. "documenting required competencies" is something that I'm unclear on how broad or specific it needs to be, and
B. "verification of people compared to the required competencies" is what is currently missing, if you consider the operator and supervisor signature and competency rating (scored on a 1-5 level) on any specific assembly record training/competency sheet being the verification.
 
#10
I'm going to go with "a bit of column A and a bit of Column B"

But only because
A. "documenting required competencies" is something that I'm unclear on how broad or specific it needs to be, and
B. "verification of people compared to the required competencies" is what is currently missing, if you consider the operator and supervisor signature and competency rating (scored on a 1-5 level) on any specific assembly record training/competency sheet being the verification.
Aha! Until the required competencies are defined, then the rest is a bagatelle...

On the degree of specificity, is it required, for example, that operators know how to use basic measuring equipment such as micrometers, vernier calipers? If so, how would they demonstrate to someone who does know, how to use them? What does that demonstration looks like?
 
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