Third Party Audit Nonconformance for Training effectiveness

[sagai]

That's identical to standard iso9001 than.
that's for me not for training, that's for "b., ... or take other actions to satisfy these needs" in this context.

My fall back position actually, is that as part of the training I actually dedicate a Q&A session where I also ask questions to make sure the audience got the important bits of the training. It is also common to ask a questionnaire to be filled out.

Again, it has nothing to do with the fact that actually yes, human can make mistakes.

I am just thinking what if the root cause is that actually the employee had a party before and he was tired that's all. Than I would limit them what and how much they can drink than?

Cheers!

 

[QC JEWEL]

Ok,
Then I think for now these will be the proposed actions:
1.-Review training class content to see if tis is appropiate.
2.-If it is ok, review with QE/PE if questions or doubts are about training class, ask them to review again the training material.
3.-Quality and product engineer to review and update control plans/pfmea according to aiag manuals.
4.-Quality Manager/Engineering Manager to review CP & PFMEA's on documents reviewed.
5.-If weakness on documents re-train to QE/PE.

As preventive or systematic correction:
Review training procedure to include to include in each training we have to identify the way that training effectiveness will be done: test, supervisor feedback, quality trends and rejections,
Please advise.

 

[TPMB4]

Might be irrelevant but are the QE/PE competent to produce those documents? If training has given them knowledge it does not guarantee competence. Knowledge and competence is not the same thing.

Is there someone in your organization that could act as a mentor for these people? They have had training which if you have checked and it appears suitable then perhaps they need a period of on the job mentoring before they are let loose on their own. It might only be a case that the mentor reviews some of their work and gives constructive criticism or advice for a short period of time.

Our company operates a kind of mentoring system for general production operatives. An experienced worker in the process works with the new operator showing them the process and reviewing/checking their work for a period of time (usually a week in the case of production operatives in a simple process). After a period of time, that is suitable for the process, the experienced operator recommends to someone senior whether or not the operator is competent to carry out that process unsupervised.

I know the QE/PE level is a lot higher but perhaps some of that could apply at more senior levels as well as shop floor. At the end of the day it is a case of ensuring that the QE and PE get these things right. Experience is worth a lot and you get it by doing it but by being mentored I think these people will get there quicker than if you just tested them.

OTOH could these incorrect PFMEA be one offs or a rare occurrence?

 

[QC JEWEL]

OTOH could these incorrect PFMEA be one offs or a rare occurrence?

Bassically there is only one CP and one PFME in our plant and both covered all of our products.

We are a small company so the Managers would be the mentors.

 

[Ninja]

Bassically there is only one CP and one PFME in our plant and both covered all of our products.

We are a small company so the Managers would be the mentors.

Do all of your products share all of the same characteristics and potential failure modes? No exceptions at all ?

All made by exactly the same process, and of exactly the same material?

How many products?

 

[QC JEWEL]

Do all of your products share all of the same characteristics and potential failure modes? No exceptions at all ?

All made by exactly the same process, and of exactly the same material?

How many products?

As far as I have been in the company only one CP/PFMEA applies for everything..

 

[TPMB4]

We produce a lot of parts which are basically the same so have similar documents in the PPAP such as the PFMEA and control plan. However the dimensions, weight or some other characteristic does change across the product family. We therefore have a kind of template for these which we modify to "personalise" it to each individual part. Not as laborious as it could be but I do think even if parts are similar there can always be differences that pose a potential risk to production so each part needs looking at.

Of course I don't know what your products are so they might genuinely able to be covered by one PFMEA and one CP.

 

[TWA - not the airline]

I just came to this company and I had External audit last week, we got a NC due training effectiveness: Requirement 6.2.2 the evaluation of the effectiveness of training is not effective, company did not provide effective evidence of the evaluation of the effectiveness for the following courses; FMEA and APQP for the following positions Quality Engineer and Product Engineer. Auditor found that PFMEA and control plan where not filled out properly, personnel took training class on march 2013.

Sounds to me like you had something to show the auditor as an effectiveness check, but then the auditor found some errors in the documents and concluded that this effectiveness check is not effective. So you need to find out what exactly was wrong with the PFMEA and the control plan: Did the engineers violate GDP or did they fill in correct information but in the wrong places or were important information missing or even wrong. Depending on the results you can then conclude whether to further train on GDP, on the forms that are used, on the overall procedure, underlying standards and other requirements, GMP or other general quality principles or the product/process for which the PFMEA and control plan were to be developped. If the issue was indeed part of the initial training then your RCA should go in the "effectiveness check" direction, if not then it is probably more of a "training needs/training matrix" thing...

 

[sagai]

another bit is to commensurate your effort with the finding itself.
If it is a one time error, I would simple talk to the guys were involved to see what went wrong actually, fix it and that's all.
Cheers!

 

[AndyN]

Auditor found that PFMEA and control plan where not filled out properly, personnel took training class on march 2013.

As Sagai posted earlier - and before we run off on a wild goose chase - what does this mean? Is it a badly designed form with lots of useless boxes which add zero value to the actual PFMEA or Control Plan?

Is it a simple case of some "awareness" issue that some parts of the form should be completed?

Are the basics of the PFMEA and Control plan in place, but some supporting info is missing and could simply be corrected?

It seems that to suggest the training system is "ineffective" is a huge leap of assumption on behalf of the auditor - without knowing more - like the answers to the above.