Recently our notified body auditor wrote a minor obsveration regarding ongoing training or maintaining familiarity with regulations and QS standards. It was triggered in part because our system for keeping current to external standards had severed due to a change in ownership of the company. That link and the ability to become of aware of external standards has been restored. However the harder part is showing that everyone who needs to know about changes to external standards has been "trained" or made aware of the change.

The exact finding is as follows:
"The process for identifying who must be familiar with regulations and QS standards and the process on how the familiarity is updated when standards and regulations change, is not clearly defined."

We have a very robust training system that keeps track of all the internal procedures we need to train to and upon completion records most of these "training" records via an Intranet electronic system. We can even show that each person who needs to be aware of changes is sent an email from Document Control that a change has occured.

However where we have extenal standards that we need to be aware that system doesn't allow auto-tracking of the training. An individual would have to read the changed standard and create a paper record and forward that to the training department.

Has anyone else had a Notified Body auditor require evidence of training to extenal standards or changes to external standards. In most cases it is not the initial "training" but the ongoing documenting the training for changed standards and regulatons that is difficult to maintain. Most exempt staff are hired because they are already trained and familiar with the standards that affect their job area.

Recently our notified body auditor wrote a minor obsveration regarding ongoing training or maintaining familiarity with regulations and QS standards. It was triggered in part because our system for keeping current to external standards had severed due to a change in ownership of the company. That link and the ability to become of aware of external standards has been restored. However the harder part is showing that everyone who needs to know about changes to external standards has been "trained" or made aware of the change.

The exact finding is as follows:
"The process for identifying who must be familiar with regulations and QS standards and the process on how the familiarity is updated when standards and regulations change, is not clearly defined."

We have a very robust training system that keeps track of all the internal procedures we need to train to and upon completion records most of these "training" records via an Intranet electronic system. We can even show that each person who needs to be aware of changes is sent an email from Document Control that a change has occured.

However where we have extenal standards that we need to be aware that system doesn't allow auto-tracking of the training. An individual would have to read the changed standard and create a paper record and forward that to the training department.

Has anyone else had a Notified Body auditor require evidence of training to extenal standards or changes to external standards. In most cases it is not the initial "training" but the ongoing documenting the training for changed standards and regulatons that is difficult to maintain. Most exempt staff are hired because they are already trained and familiar with the standards that affect their job area.

As an auditor, it is difficult to comment on another auditor's ruling, without having access to everything he saw at the time. You run the risk of not seeing the whole picture.

However, as an auditor, I don't see this was necessarily an approrpiate finding. Perhaps, if the lack of an appropriate system is clear enough. But, to presume inadequate understanding because you could not demonstrate a formal training process for external standards appears to be a stretch. I think I would write an NC only if I see a lack of knowing the requirements in the external standard, not based on an assumption of not knowing them.

I'm in agreement and it sounds like HS :horse: to me too.

As long as you keep folks up to speed with relevant information IAW your requirments or the way you say you will, and it's effective then who really gives a rip? Not me.

Without all the details this just tastes a bit bogus and fells like a personal "whim".

What kind of external Standards? I have a hunch the issue is regulations from a government body directly affecting product or usage. Seems to me simple enough to write a procedure which shows what job title has responsibility and authority to "use personal discretion to ensure organization receives all necessary updates to Standards and Regulations which directly affect our product or business."

Further, "to coordinate with top management to ensure all applicable personnel receive notice and training as required to implement any changes required to comply."

MAJOR RULE OF PROCEDURES: Don't paint yourself into a corner!

The exact finding is as follows:
"The process for identifying who must be familiar with regulations and QS standards and the process on how the familiarity is updated when standards and regulations change, is not clearly defined."

What does "familiarity" mean in this context? Does it mean identifying who needs to know that standards exist, or that those people need to be able to recite the requirements without looking at the standard? If the standards in question are necessary to producing conforming product or services, and people need to be aware of changes in order for there to be a continous stream of conforming product, then you need to define your method for disseminating the information. IMO, it's perfectly legitimate in such instances for an auditor to ask people who need the standards how they verify that they're working to the current requirements.

It seems that the finding could have been worded better, perhaps changing "familiar with" to "aware of" and "familiarity" to "awareness."

I agree with most of what has been offered. However, from a risk management perspective, and since we are talking about the feedback from a Notified Body auditor, what implies, regulatory compliance with European Directives and Harmonized Standards, the auditor might have assessed a process not robust enough, which could lead to products being either designed or manufactured against invalid versions of directives or standards. It seems a valid risk, which should be managed, in my opinion. This is one of the situations, as I see it, that the auditor might be adding value by identifying a risk to the organization.

Just my 1.1 oz of oil, roughly :2cents:

This particular auditor had a particular concern about keeping current with CMDCAS rules and regulations, since he was a CMDCAS certified auditor. I also formerly worked for 2 1/2 years as a notified body auditor and understand that there is a constant change to the directions Health Canada meters out. This is through audits of the Notified Body organization as well as other changes that take place periodically.

Except for these concerns, I think we have a system that stays current on external standards. We are notifed by a service about changes. Our document control group sends an email to each affected group, individual within the group and the manager of that group. It is then up to each individual to read and understand the changed standard or regulation and then fill out a individual training form that is sent to the manager of the department to be filled in the individuals department folder.

This is not quite the same as training for floor personnel. This is primarily for salaried Exempt personnel responsible for understanding external standards and implementing appropriate changes to the company Quality System to deal with the content of those standards. Therefore it is there job to maintain current knowledge of externals standards that affect their job in some way.

Our document control group sends an email to each affected group, individual within the group and the manager of that group.

In view of the finding, which made reference to "The process for identifying who must be familiar with regulations..."

I guess the question might be, "How does the doc control group know who to notify?"

I'm still not certain what the auditor meant by "familiarity." I think if he's looking for training, retraining and records thereof, he's barking up the wrong tree. It sounds to me like you have the bases covered, except perhaps for formally identifying who gets notified when new versions are available.

Jim

Thanks for your reply. We have who should be notified as well. Each group/department that needs to be kept appraised of a specific standard lets document control know that they need to be notified. Doc Control has a list of all the external standards needed within the company. Along side of the standard is a list of departments, individuals, etc. that need to be notified. When Doc Control is notified by the service that a standard has changed an email is sent to everyone affected that the standard/regulation is changed. It is then up to each individual to seek out a copy of the changed document and read it. The service provides us with a copy of those electronically so we can easily get them as we need them.

The only concern I have again is that changes made by Health Canada may not be so easy to keep up with.

You need to get with the auditor and have him explain the finding vis a vis what you're actually doing, and have him show you the "shall" that's been (allegedly) violated.

Recently our notified body auditor wrote a minor obsveration regarding ongoing training or maintaining familiarity with regulations and QS standards.

Hi, Gary -

I always ask this - but here goes anyway.:D

Can you give us the exact words of the finding and what clause the auditor cited, please?

As stated in the first post.

The exact finding is as follows:
"The process for identifying who must be familiar with regulations and QS standards and the process on how the familiarity is updated when standards and regulations change, is not clearly defined."

Clause 6.2.2

Gary, another thought:

I've had auditors question how we determined the effect on our products when an external standard is revised. We had one Engineer who was fluent in standards reading go through the revisions and write a memo to file that said, "No effect" or else he introduced the changes to the rest of the manufacturing staff through training.

Perhaps this was the root of the auditor's finding? If so, that would be a valid issue, I think. But I would expect that to be cited under 7.3.2, Input requirements...

I've been asked what our practice is for training for ISO 9001/quality system. I just show the records that everyone has gone through our orientation and part of that is an ISO 9001 overview (among a myriad of other topics). We also have a quality system refresher each year. And then I can show them exactly who has or has not reviewed their new/revised area documents. Our system is set up so when you review a new or revised document you click a button that shows you have read, understand, (or have gone to your supervisor, manager, MR to have the changes explained) and agree to follow the instructions. Supervisors assess people constantly, but record an awareness/competency review yearly. In some ways I feel that the awareness and competency requirements in the standard are kind of silly. After all, if you run your business the right way, you are going to be sure that your people are competent anyway. oh well.