Training non conformance

[tulip222]

Hi

I’ve started in a company where it appears some training forms for staff have not been completed.

They are clearly competent in their roles (manufacturing) however there are gaps when reviewing against the training matrix.

I want to make sure I correct this. Obviously starting with getting the forms signs and a recap of sops etc however how is it best to tackle a non conformance on this one? Will a risk assessment be appropriate?

 

[SeanN]

It's good that "hey are clearly competent in their roles" but the NC is clearly with gaps in training matrix. From this observation, you can open an CAPA, investigate the root cause(s) and a plan to prevent it from recurrence. It could be, for instance, lack of a QA trainer etc.

 

[Golfman25]

The first question you need to ask is how did they become competent? Were they trained and it wasn’t documented? Were they included in the training matrix even though they were already competent? Why are they on the training matrix? How do you determine competency? Was there really a non-conformance or an overzealous predecessor?

 

[DanMann]

If it is for manufacturing-based roles, could the staff not being trained impact on product quality? Do you have verification (QC testing) records of the batches these staff worked on to prove it?Competence of staff is defined by your training plan, so if they have missed training, then your company had declared them not competent. If the training wasn't necessary, then you should remove the requirement for others as well.

 

[Bev D]

The nonconformance is to your own procedures…as you have explained it. There is no lack of competence; there is a lack of signatures.
A simple correction will remediate the lack of signature. You (or the person who determined competence) can simply sign the form with a note as to what happened and the clear demonstration of competitive and todays’ date. If you wish you could investigate why the form wasn’t signed (as Golfman stated). Better yet if you think this. A critical process perhaps a re-engineering of the process is needed? The critical thing here is competence, not filled out forms. Or you could simply move on. And you may have bigger fish to fry. It’s up to your judgment.