Corrective Action - CAPA - Root Cause - Not following the training procedure!

Q

QE

Dear all,

I am working on a CAPA file. This is one of the weird one, what do u do if your root cause analysis boil down to....a service technician is not following his training procedure.

Thoughts appreciated !:confused:
 
J

Jeff Frost

Re: CAPA - For not following the training !

Dear all,

I am working on a CAPA file. This is one of the weird one, what do u do if your root cause analysis boil down to....a service technician is not following his training procedure.

Thoughts appreciated !:confused:

You need to keep working on the CAPA because you have not defined why this individual is not following the training procedure. Keep asking why until you reach the true root cause and then implement corrective action.

The next question should be why is the service technician is not following your organizations training procedure?
 
Q

QE

Re: CAPA - For not following the training !

Dear Jeff Frost

I did a 5 why on this and "negliance" is the only thing I can think off & I can come up with !

I don't think management is going to be happy about it, neither FDA ?

any thoughts !

You need to keep working on the CAPA because you have not defined why this individual is not following the training procedure. Keep asking why until you reach the true root cause and then implement corrective action.

The next question should be why is the service technician is not following your organizations training procedure?
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: CAPA - For not following the training !

a service technician is not following his training procedure.

Thoughts appreciated !:confused:
Try asking the technician why didn't he follow the procedure, after being trained on it. Share with us what he says.
 
Q

QE

Re: CAPA - For not following the training !

The technician had 2 piece of equipments. and he used the one where he should have used the second one. he is no more with the company.

I read the procedures and they are written explicit. does this indite the validation of those procedures ?



Try asking the technician why didn't he follow the procedure, after being trained on it. Share with us what he says.
 
B

Boscoeee

Re: CAPA - For not following the training !

The technician had 2 piece of equipments. and he used the one where he should have used the second one. he is no more with the company.

I read the procedures and they are written explicit. does this indite the validation of those procedures ?

:caution:The question that you have to ask is "Do I know why the Technician selected the wrong piece of equipment? If you do, then you have the answer on how to proceed! :2cents:If you do not, I recommend that you discuss with other professional technicians on your staff for plausible reasons why the Technician selected the wrong piece of equipment and provide corrective actions for those reasons! This strategy allows you the opportunity to really test your process and procedures for Technicians and your problem solving skills.

Always remember that training is about proving competence in the training that an employee receives! It appears that in this case the technician's competency remains in question!
 

rnsvasan

Involved In Discussions
I would recommend analyzing in two ways
1. If your service technician had done intentionally then better to Pl involve HR person so that to find out what policy made him to do so and what will be in other cases
2. If competency or absence minded – As said by Mr.Boscoeee, Import proper training or analyze why the system helping him to do wrong work - poka yoke
 

Bev D

Heretical Statistician
Leader
Super Moderator
There are really 2 possible causal paths for your "why-why" here: either he unintentionally used the wrong piece of equipment (oops, lack of attention, whatever) or he unintentionally used the wrong piece.

either way, you are most likely looking at mistake proofing the process to prevent re occurence. When human actions are at the root of a nonconformance/noncompliance we need to focus on corrective actions that go beyond disciplinary and retraining actions because these are not usually very effective at preventing re-occurence whcih is the POINT of corrective actions.

For unintentional actions simple mistake proofing will usually suffice. do both pieces of equipment have to be available at the same time? why are they different and why does that difference matter? if no real difference - get rid of one. if there is a difference can you use concepts of flow to segragate the work so that the portion that requires equipment A is done in a physically different area than teh part that requires equipment B? etc.

For intentional actions, soemtimes training on why there is a difference - the consequences of using the wrong equipment - can be helpful. However, we still must take some action to prevent re-occurence. these are typically lock down and/or buddy systems in addition to the above actions.

ASK the other techs: hwo could they make the same mistake? why do they think it happened, what might prevent it from happening again?
 
D

David Posival

Thank you Bev D. I am working on a similar problem and will follow your advice in prevention rather than just identifying the reason and replacing the person, as recommended by management.
:thanx:
 
J

Jim Shelor

Re: CAPA - For not following the training !

Dear Jeff Frost

I did a 5 why on this and "negliance" is the only thing I can think off & I can come up with !

I don't think management is going to be happy about it, neither FDA ?

any thoughts !

Nirlep

At the risk of sounding uneducated, what is a “training procedure”?

Is it a procedure that only technicians in training are required to use?

If so, was this technician in training supposed to be under the direct supervision of a trained technician?

If this is only a “training procedure”, what do the trained technicians use when they perform this action?

I would like to know more about the use of “training procedures”, the supervision required for technicians in training, and what procedures trained technicians use.

It seems to me, depending on the answers to my questions, that this issue can go much farther and be much more serious than a technician in training failing to complete a training procedure correctly.

By the way, why is the technician no longer with the company, fired?

Respects,

Jim Shelor
 
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