Training Records - assembly line staff

Tidge

Trusted Information Resource
It sounds to me as if there are a number of common tasks that are applicable across a wide variety of assemblies. I recommend defining the common processes as ones that assemblers can be trained to, as opposed to treating each individual assembly print as a unique "cuckoo clock" that assemblers train to. As an example of simplified process:

1) Cut the piece(s)
2) Deburr the piece(s)
3) Assemble to print
4) Inspect

Implementing four general processes (general cutting, general deburring, general assembly, general inspection) should be able to cover a multitude of assemblies. Obviously the design team responsible for any new designs has to make sure/attest that any existing processes are suitable for use with new designs. The individual design will all have their unique specifications, but the general training should apply across the varieties.
 

ThatSinc

Quite Involved in Discussions
It sounds to me as if there are a number of common tasks that are applicable across a wide variety of assemblies.

I would say that yes, the same common tasks would be applicable across *most* of the assemblies.

The difficulty comes where you can have the same competency requirements for two different assemblies, but an operator makes one of them every day but has never made the other in their entire time being employed.
I would say that they are still competent in making the second assembly, and could be asked to make it and have no problems making it - correct?
The reality is that they would not be allowed to make it unless they've been observed and signed off.

It is that reality that led to the cuckoo clock approach

There are competency requirements set for all equipment used, e.g. for things such as a the ferrule crimper, and anyone that has shown competency and been signed off to use that can make any assembly that goes through that process.

The process for evaluating competency in all cases is simple observation and evaluation by the area supervisor, who has been determined as competent by the MD through experience, and observation.


Obviously the design team responsible for any new designs has to make sure/attest that any existing processes are suitable for use with new designs.

When implementing each design, would it simply be a case of reviewing existing processes and a mental check that they all apply - or would it be expected to have the process requirements for each assembly to be documented?
Currently there aren't documented step-by-step assembly instructions, the operators have a technical assembly drawing and work directly from that with the relevant notes on the drawing.
 

simone

Registered
If I understand correctly, the problem is mainly in regards to changes. So maybe add an additional control to change process?
As part of the change approval process, determine if re-training is necessary for the particular change and if so, on what specifically or who (whatever resolution fits your organization).
If training is required, the change cannot be considered implemented/complete before the training records are completed. The person responsible for change management cannot "complete" the change with seeing the training evidence. This would give you immediate followup on whether re-training is been done as required (and documented which seems to be the main problem) and also the option to determine if re-training is at all necessary for a particular change.
Also you would probably need some way to determine which operators can work on which assembly. Given there are hundreds of assemblies maybe a matrix is not feasible but maybe you could have one permanent record for each assembly with list of operators that are trained on it (regardless of the revision, because training per revisions is managed via the changed process)?
 

Tagin

Trusted Information Resource
I would say that yes, the same common tasks would be applicable across *most* of the assemblies.

The difficulty comes where you can have the same competency requirements for two different assemblies, but an operator makes one of them every day but has never made the other in their entire time being employed.
I would say that they are still competent in making the second assembly, and could be asked to make it and have no problems making it - correct?
The reality is that they would not be allowed to make it unless they've been observed and signed off.

It is that reality that led to the cuckoo clock approach

There are competency requirements set for all equipment used, e.g. for things such as a the ferrule crimper, and anyone that has shown competency and been signed off to use that can make any assembly that goes through that process.

The process for evaluating competency in all cases is simple observation and evaluation by the area supervisor, who has been determined as competent by the MD through experience, and observation.

9000:2015 doesn't help much with its definition of 'competence', but TS9002:2016 says this:
7.2 Competence
The intent of this subclause is to determine the required competence for the jobs or activities in the organization that can affect conformity of products and services or customer satisfaction, and to ensure that the persons holding those jobs or carrying out those activities (e.g. managers, existing employees, temporary employees, sub-contractors, outsourced persons) are competent to perform them. The competence of persons can be based on their education, training, and experience. Those who are able to demonstrate their competence are sometimes referred to as being qualified.

The organization should determine competence requirements by either an activity or job position/role.

So, to me, demonstrating competence by job role (proficiency of use of equipment, reading and translating drawings into actual steps, etc.) should be sufficient to define a particular level of competency. Also, where you noted in your initial post that there are hundreds of assemblies, it is implausible to think that a worker trained 4 years ago on assembly #279 revision C and never built it since will have retained that information; instead, they will likely have to read the drawing as if it was the first time they saw it.

When implementing each design said:
13485:7.3.9 Control of design and development changes
...The review of design and development changes shall include evaluation of the effect of the changes on...product realization processes.

Records of changes, their review and any necessary actions shall be maintained
 

ThatSinc

Quite Involved in Discussions
So maybe add an additional control to change process?

I thought about this, but adding more gatekeepers to the process just adds another layer of being a PITA.
Changes would still get implemented without training and then you'd end up with two non-conformities.


Also you would probably need some way to determine which operators can work on which assembly.

This is the part I'm now contemplating how to implement.

Clearly the most streamlined approach would be the general competencies, operators can show that they are able to use equipment/tools and that they can read and understand technical drawings and translate them into step by step assembly operations.

However, would it need to be documented which general competency is required for each assembly somewhere, or would that be implicit in the assembly detail?
e.g. crimping ferrules onto a fluid pipeline assembly. The assembly drawing has the ferrules included and a note regarding the use of the crimper.

Do I need to list the competencies required (general assembly, use of crimper, use of heat shrink gun) to be able to make the pipeline assembly somewhere?


Also, where you noted in your initial post that there are hundreds of assemblies, it is implausible to think that a worker trained 4 years ago on assembly #279 revision C and never built it since will have retained that information; instead, they will likely have to read the drawing as if it was the first time they saw it.

Agreed, and route cards are always issued with the relevant revision of the drawing.
And this adds to the weight of the competencies; operators know how to read drawings and assemble things.
The training per drawing is essentially a way of explicitly showing that they have made that item before and can make it successfully.
 

Tagin

Trusted Information Resource
However, would it need to be documented which general competency is required for each assembly somewhere, or would that be implicit in the assembly detail?
e.g. crimping ferrules onto a fluid pipeline assembly. The assembly drawing has the ferrules included and a note regarding the use of the crimper.

Do I need to list the competencies required (general assembly, use of crimper, use of heat shrink gun) to be able to make the pipeline assembly somewhere?

If the competencies are not listed, then how would it be determined which workers are allowed to build that assembly? Can you tell an auditor something like "The production mgr allocates work by examining the drawing, determining required competencies, and then matching those required competencies with qualified workers."?

It might all be much easier if you just have a sheet for each assembly stating what competencies are required. If that list of competencies is fixed, you could even make it a checklist form, so it lists all the competencies, and for that assembly just check which ones are needed.

It sounds like the granularity of the competencies is part of the issue. It might be worth it to train up workers so there are only 2 or 3 'tiers' of competence. Then, this assembly only requires Tier1 workers, another assembly requires Tier2 workers, etc., yet another assembly requires Tier1 for the first 3 steps and a Tier3 for the final steps.
 

ThatSinc

Quite Involved in Discussions
If the competencies are not listed, then how would it be determined which workers are allowed to build that assembly? Can you tell an auditor something like "The production mgr allocates work by examining the drawing, determining required competencies, and then matching those required competencies with qualified workers."?

That's exactly how it currently happens.

It might all be much easier if you just have a sheet for each assembly stating what competencies are required. If that list of competencies is fixed, you could even make it a checklist form, so it lists all the competencies, and for that assembly just check which ones are needed.

If the above response to an auditor wouldn't be considered acceptable, then this is definitely a possible solution - but it'll be one hell of a long check list.

It sounds like the granularity of the competencies is part of the issue. It might be worth it to train up workers so there are only 2 or 3 'tiers' of competence. Then, this assembly only requires Tier1 workers, another assembly requires Tier2 workers, etc., yet another assembly requires Tier1 for the first 3 steps and a Tier3 for the final steps.

Another possible solution, in line with the one above.

It's sorted for the machine-shop where machinists are competent at a level of loading, setting, or programming each type of machine, and then following that they can make any part that's relevant to that machine at their desired level.
 

Tidge

Trusted Information Resource
Obviously the design team responsible for any new designs has to make sure/attest that any existing processes are suitable for use with new designs. The individual design will all have their unique specifications, but the general training should apply across the varieties.

When implementing each design, would it simply be a case of reviewing existing processes and a mental check that they all apply - or would it be expected to have the process requirements for each assembly to be documented?
Currently there aren't documented step-by-step assembly instructions, the operators have a technical assembly drawing and work directly from that with the relevant notes on the drawing.

As part of design transfer (into the manufacturing phase) the design team is accountable for determining that the complete DMR (the recipe that includes both ingredients, instructions, and equipment) is appropriate to be transferred.

For the examples we are discussing here (familiar machine shop/assembly operations that are spelled out in procedures) it is typical that a pre-production build is done to verify that the existing equipment/people can do what the DMR requires. Often, a 'simple change' doesn't do this... but that doesn't mean that the design team can ignore speaking to the reason for not doing such a thing. I can offer some examples of when I've seen this 'break down':
  • existing shop procedures didn't allow for enough tumble time for deburring a new component
  • rivet machines didn't have the fixturing to support a new assembly
  • pre-fluxer didn't have a large enough field of coverage for a new PCB Assembly, requiring additional 'hand fluxing'
  • CNC machine couldn't 'finish' a part; the part needed some hand-finishing, requiring extra, non-documented work.
One of the more embarrassing elements of design transfer are those first NCRs where the machinists/assemblers respond with "if someone had asked us..."
 
When assemblies are revised, a new training card is issued with the updated assembly drawing to the production supervisors for rolling out to staff.
Typically changes are made on a "completion of previous batch" basis, so the next batch card issued will be to the updated drawing.

Seems to me that the combination of the above creates the lack of incentive to get training done.

Here are some possible solutions:
  • Set up some kind of training matrix (typically in Excel) that is managed by the QA department. Each time a document revises, the matrix will get updated to show who is required to train to the document. The matrix will also get updated to show whose training has been completed. (Similar to what you have, but QA should have a hand in this.) This matrix is posted where all employees can view it.
  • Require that the change originator provide training to the appropriate individuals rather than simply providing training cards to the line supervisors. Additionally, you could require that the originator perform this training prior to the release of the document.
  • Rather than doing a "completion of previous batch" for your disposition, try to always "work to new" and require training to be completed prior to continuing the build. History record may have two revisions listed in those cases, which is fine. The default you have now results in an attitude of "a change happened, but we don't need to do anything about it."
  • As part of line clearance activities, ensure assemblers check their training. You can have an "I assert I am trained" checkbox. Or, you can have a line clearance verification by a second individual where the prior-to-build checks are confirmed.
  • Assign builds to a lead assembler, and confirm that they are trained prior to issuing the build to that assembler.
In addition, there should be a quality review process where training is reviewed for all completed history records, and a nonconforming product report is issued when an untrained individual assembled a clinical level item.
 

ThatSinc

Quite Involved in Discussions
Seems to me that the combination of the above creates the lack of incentive to get training done.

I think there are a lot of historical issues that are contributing to the lack of incentive, and without wanting to air dirty laundry about a company I'm working with, I'd say that most of the difficulties in training are for the reason that "re-training"/"Signing to show competence on the revised assembly" on the changes that are being made genuinely isn't necessary.
Many of the changes are fixing historical errors, things that have just "been worked around" in production.


Set up some kind of training matrix (typically in Excel) that is managed by the QA department. Each time a document revises, the matrix will get updated to show who is required to train to the document. The matrix will also get updated to show whose training has been completed. (Similar to what you have, but QA should have a hand in this.) This matrix is posted where all employees can view it.

This would essentially be what exists now, as the competency/training folder for each assembly is on the production floor - and is split by product specific and generic/common assemblies - it is within 10M of any of the assembly operators when they are working at their stations.
The QA Department consists of half of 1 person, this is a very small company that is finding this implemented solution over-burdensome, so maintaining essentially the same system but adding additional checks would just not work.

Rather than doing a "completion of previous batch" for your disposition, try to always "work to new" and require training to be completed prior to continuing the build. History record may have two revisions listed in those cases, which is fine. The default you have now results in an attitude of "a change happened, but we don't need to do anything about it."

I've never worked anywhere that a change could be made half way through a batch, with one half being to an old revision and the other to the new. or are you suggesting closing off the original batch and starting the new at that time? Essentially an "implement immediately" disposition.

I have a side question on what constitutes a "batch" along those lines, when considering configured devices, but that's for another discussion thread.

As part of line clearance activities, ensure assemblers check their training. You can have an "I assert I am trained" checkbox. Or, you can have a line clearance verification by a second individual where the prior-to-build checks are confirmed.
This is what the production supervisor tried, without the checkbox activity on the paperwork. Spoiler alert: didn't work.
Adding the checkbox activity would likely just lead to an additional NC.



I think the competency matrix solution, whilst it will take some time to implement, may be the most streamlined way forward and I will need to work with management to determine how best to record competency requirements for the various assemblies - likely in some form of grouped matrix.
And an update to the change control procedure for whether any changes to assemblies have affected the competencies required for it.
 
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