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.
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.