Fulfilling Training Requirements - We have NO Training Records on anything

T

Tarrah

Hello all-

I was brought into a company to help them pass their ISO 9001:2008, 13485 registrations (in 3 months). I am completely overwhelmed!

Last week we had our Stage 1 audit and it was a nightmare (16 NC, I didnt even count the OI's).

Right now I am struggling with section 6.2.2. We have NO training records on anything. I have a month for our Stage II audit. Does anyone have any wonderful words of wisdom?
 

AndyN

Moved On
Re: Fulfilling Training Requirement

Hello all-

I was brought into a company to help them pass their ISO 9001:2008, 13485 registrations (in 3 months). I am completely overwhelmed!

Last week we had our Stage 1 audit and it was a nightmare (16 NC, I didnt even count the OI's).

Right now I am struggling with section 6.2.2. We have NO training records on anything. I have a month for our Stage II audit. Does anyone have any wonderful words of wisdom?

Firstly it sounds like you should postpone your stage 2. This many NCs and Observations sounds like more work is needed and to conjure up training records is more than just that. Your CB auditor should have advised you of the need to postpone the stage 2, that's partly what a stage 1 is for, after all. Apart from not having any training records, what did you internal audits find in this regard? Why didn't they find this? They should have! DId you decide at Management Review that you were ready for the CB audit? If so, that needs fixing.....

You've got bigger issues to concern yourself with, obviously!

Secondly, if you are this far in and not that ready, you need some external help. So be prepared to find someone locally - there are some I can refer to you.

Keep coming here for help, you are in good hands....
 

Stijloor

Leader
Super Moderator
Hello all-

I was brought into a company to help them pass their ISO 9001:2008, 13485 registrations (in 3 months). I am completely overwhelmed!

Last week we had our Stage 1 audit and it was a nightmare (16 NC, I didnt even count the OI's).

Right now I am struggling with section 6.2.2. We have NO training records on anything. I have a month for our Stage II audit. Does anyone have any wonderful words of wisdom?

What has been Top Management's response?
It is their responsibility to provide adequate resources.

BTW, is your resume up to date? ;)

Stijloor.
 

howste

Thaumaturge
Trusted Information Resource
Re: Fulfilling Training Requirement

Wow, I agree with Andy. It sounds like the auditor shouldn't have recommended to proceed with the stage 2 audit.

Since you asked about 6.2.2, have you identified education, training, skills and experience requirements for all of the job positions in the company? You'll need to have records to demonstrate that all of these have been met.
 

DannyK

Trusted Information Resource
You can use the 16 NC as training material.
Select the personnel that are implicated in the specific findings and provide them with training in the areas where deficiencies were found. Record the training.
Also another idea is to provide introductory training to ISO 9001 & 13485. You may be able to find some training material if you do a search on the post attachments list of this site
 

Stijloor

Leader
Super Moderator
You can use the 16 NC as training material.
Select the personnel that are implicated in the specific findings and provide them with training in the areas where deficiencies were found. Record the training.
Also another idea is to provide introductory training to ISO 9001 & 13485. You may be able to find some training material if you do a search on the post attachments list of this site

Training is not a requirement; competency is. Training is one of a number of ways to acquire competency. When training is provided relative to the job, records are maintained. The effectiveness of training or other actions to help folks to become competent must be verified.

Just providing training to get out of that 6.2.2 hole, will only make the hole bigger and deeper. :mg::mg:

Stijloor.
 

AndyN

Moved On
You can use the 16 NC as training material.
Select the personnel that are implicated in the specific findings and provide them with training in the areas where deficiencies were found. Record the training.
Also another idea is to provide introductory training to ISO 9001 & 13485. You may be able to find some training material if you do a search on the post attachments list of this site

Danny - this is likely to lead the client to getting an NC for lack of effective corrective action, root cause etc.......
 

Randy

Super Moderator
I'll echo that there should not have been a date set for the Stage 2 'cause that dog ain't gonna hunt based on what you've said. You guys weren't even ready for a Stage 1 and the decison to go ahead was flawed.

I'd say thanks, but no thanks and totally reset the entire registration process and if the management doesn't understand then maybe you might need to say no thanks.

Oh yeah, I'd bet Andy's paycheck that many of those OI's are actually NC's that were softened up.
 

Howard Atkins

Forum Administrator
Leader
Admin
After reading this IMO it makes the TS method of no NC's at stage 1 but ready or not ready a more sensible method.:agree1:
 
P

Peter West

Reading between the lines that you have been brought in with just 3 months to go - does this mean there was someone there before, or is it that the company just expect a system up and running in that timeframe?

Serious concerns echo that which the Cove Elites have already mentioned. What is the top management's opinion, involvement and intention???

It may be better off to review the entire QMS, breaking it down to the parts that work and building up a proper system from there. It'll take longer but then at least it serves the company and would not just be a plaster to get by the external audit (which leads to multiple problems from that point on).

IMO cancel stage 2, consider realistically if you can develop and implement a QMS that will be integrated into the your Company's operations within the time limit following the stage 1, and consider possibly having to repeat the stage 1 if it means the system you implement works and provides benefit to the company.

Of course I suppose you will have to go by the words of your management. Good luck with it.
 
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