Grandfathering certified operators of special processes

[tschones]

For the few processes that we have that fall under the "special process" category, they are operator intensive, and thus we are declaring operator recertification as our means of revalidation. Our training records show that someone has been certified, but doesn't contain the date of when certification was obtained.

Because of the new standard's requirement for process revalidation, my interpretation is that an external auditor is going to want to see that we have recertified those operators when they come to perform their 9000:2000 audit. Members of our Training group would like to know if there is any way we could grandfather these people in and perform the recertification after our upcoming audit in June.

At the risk of biasing the results, I don't believe an external will look favorably on "grandfathering". Please give me your thoughts on how you think an external auditor would assess this situation.

Tom

 

[Al Dyer]

tschones,

Although this statement may sound harsh, why grandfather??? It sounds like a cop-out. The men and women that do the job hopefully know it and can train it. They can train the new people and retrain current personnel with their experience.

If I was an external auditor I would seek out the people with experience and ask them their opinion. They are the real people that know the true system.


How do you re-certify your operators?? Is there a test and who is qualified to give it, the maintenance manager?

Any company that has a chance of certification, or re-certification should have already discussed this situation and have a plan in place.

What is the real question???

Al...

 

[Randy]

You guys are going off track with this! Think 'KISS'. Now look at the the word "competence".

Training, recertification and all that other mumbo jumbo aren't worth diddly if employees aren't competent in the performance of their duties. This was recognized early on by TC-207 when they developed ISO 14001 and recognized by TC-176 when ISO 9000 was revised.

The idea and desire is for an organization to develop a methodology of ensuring the "competence" of the worker regardless of task. This is done by combining training, education and experience and showing that employees can achieve desired results from the mix. Licensing, certification, credentialization and all those other things don't necessarily ensure competence, they just aid in the proof of it.

 

[Mike S.]

Sometimes the vocabulary gets in the way.

Validation: confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

The question is, can you grandfather operator certification.

I say why not? Does the past recent history show that the product has worked as expected, thus showing (as Randy said) competence of the operator? I call it demonstrated performance -- a real-life test.

If the re-certification is easy and in-house, you could re-certify folks now if that makes you more comfortable, but ask yourself which method YOU think gives you a better picture of whether the operator (and process) is truly performing adequately and go with it.

Am I missing something???

 

[wkl]

I'm new at this so maybe I'm wrong. But when we registered to the 94 standard we grandfathered in all our journeymen as qualified welders and train apprentices. This was ok with our external auditor.

As far as validation and revalidation goes the ultimate validation IMHO is meeting customer requirements. Therefore if you do not receive customer complaints concering that process your process is validated and revalidated in an ongoing fashion.

Just my opinion.

 

[CarolX]

my nickle's worth

Tom,

I would say go for it. Only you know best what works for your company. Just be prepared to discuss your position.

When we did our 94 thing, we "grandfathered" some areas. We also found some seriously weak areas. So it was greatly benificial for us to review the whole system.

wkl -

Welcome to the Cove!


CarolX

 

[Randy]

wkl said:

Therefore if you do not receive customer complaints concering that process your process is validated and revalidated in an ongoing fashion.

Just my opinion.

Have you validated the customer complaint process?
Do you have a customer complaint process?
Do customers know about the customer complaint process?
Do the customers know how to use the customer complaint process?
Have the complaints made by customers been proven to be valid?
How do you determine the validity of customer complaints?
How do you know the methods utilized to validate customer complaints is adequate?

Guess what? These aren't all the potential questions, they're just the ones that popped up in about a 1 minute time period.

 

[M Greenaway]

Think that what Roger is getting at is that relying on reported customer complaints as a measure of any process, let alone as validation of a process, is unreliable to say the least.

To my mind validation of a special process necessitates undertaking some kind of quantifiable measure of the output of the process.

For example electro-plating is often considered a special process if you have no means of measuring the output (plating thickness, adhesion, etc) of the process.

So what you should do is define the critical process parameters (including operator competence), run some product under these parameters, and then get the product checked - which in the above scenario may well require being sent away for laboratory analysis.

Also probably the greatest potential variable in the above scenario is the operator, hence regular re-validation (by sending product away for lab analysis) is probably a sound idea.

PS I dont like the concept of grandfathering, seems like a cop out - my grandad was useless at both welding and electroplating (ahem).

 

[wkl]

Randy

The answer to your questions would be yes.
All of our customers are either QS-9000 or TS 16949 so they are quite aware of the process.

On sending weld to a lab for validation- all our welds are unique to the specific job no production type welding. Therefore it would be impossible to send a sample to a lab and consider it a validation of our welding process.

 

[Randy]

wkl said:

On sending weld to a lab for validation- all our welds are unique to the specific job no production type welding. Therefore it would be impossible to send a sample to a lab and consider it a validation of our welding process.

Welding is a science. As a science welding has to follow basic principles and guidelines. The principles are the same whether your welding a race car, components on an aircraft, a submarine, off shore oil rig or the containment vessel of a nuclear reactor. Simplified "Control the heat and control the flow of the bond".

Can you show consistency in the product you put out?
Are your operations performed by established and recognized guidelines?
Is there some rhyme or reason to the way you perform certain "special" operations?
Can you develop your own validation criteria thru deductive reasoning?

The consistent usage of "we can't" by many folks is just another way of saying "we won't". Don't get caught in that trap. Use the phrase "Is there any reason why we .....?", or a similar phrase to work yourself thru situations like this.