ISO 9000 Clause 6.2.2 - Competence - Compiling a list of required competencies

[Mike S.]

Re: Re: Competence 6.2.2

prove it[/B].

Yeah, but not just for competence! Don't you have to prove that your instruments are calibrated, or that you have doc. control, or that you test or verify that shipped product is good? So why pick on competence?

 

[SteelMaiden]

Re: Re: Competence 6.2.2

I spent a few days in the hospital a couple of years ago (they were trying to find any sign of intellegent life). I noticed that my blood pressure reading were all over the board. I also noticed that one nurse's aide had rather constant readings. I asked to see a gage R&R, but no one knew what I was talking about.

It's pretty tough to do a GR&R on blood pressures, cuz it's not recommended to to take consecutive BPs on the same arm and most of us only have two arms. (at least the standard R&R with 10 samples and three operators)lol

I know what you mean, some people can get mine right off, and others will try and try until they have me so nervous the pressure spikes, then they are ready to send me to ICU. I usually run at about 118 to 124 over 72 to 76. Not bad for an old broad....but I've had em tell me I'm at 180 over 110. for crying out loud, what's up with that?

 

[Mike S.]

Re: Re: Competence 6.2.2

Stew said "Would you expect to see a hospital have to throw the ISO flag just to get competent doctors?"

I spent a few days in the hospital a couple of years ago (they were trying to find any sign of intellegent life). I noticed that my blood pressure reading were all over the board. I also noticed that one nurse's aide had rather constant readings. I asked to see a gage R&R, but no one knew what I was talking about.

The risks are higher, and the oversight greater, for hospitals/doctors than mfg. in general. But I'll bet some of those hospital regulations are "common sense" for most of those they apply to, but they have to state it anyway and the auditees have to prove it to the auditors. How much different is it than ISO 9001?

A medical story that made me a bit uneasy: My daughter had to have an x-ray. We went to the satellite medical center run by the hospital -- one of the top 100 hospitals in the US by the rating board. Above the x-ray machine controls was a posterboard like your kids would use for a school project with various x-ray settings handwritten on it. Like set it to this setting for a chest x-ray, this setting for a femur, etc. There were scratched-out settings replaced by new settings written in sideways to squeeze it in the space -- no doc. approval, revision number, initials by the changes, nothing. An opportunity for improvement IMO.

 

[Randy Stewart]

So why pick on competence?

Because it's so subjective! I can give you objective evidence that my gages are calibrated or that doc is under control. But an auditor does not need to be weighing how I consider someone competent.

 

[db]

Re: Re: Competence 6.2.2

That's what I'm getting at. You are being told to prove it.

Just what do you have to prove?

A) That you identified your competency needs
B) That you took action to satisfy theses needs
C) That you evaluate the effectiveness of the action taken.

A) You can easily identify your competency needs during your process development. You can identify your competency needs through your 7.1 and 7.2 stuff. By the way, nowhere does it say that the records have to be all in one place. For example, on your product specific stuff, the "proof" of competency needs are in the product specs.

B) The action taken could be as simple as assigning someone you know is proficient on a particular machine. The record is the record that shows that person was proficient. If the auditor wants to know how you know the person is proficient, then show past production records indicating satisfactory performance. No additional records are needed!

C) Evaluate the effectiveness. Look at rejects, rework and inspection records. If the operator on the machine is competent, then the product produced will be acceptable.

We don't have to create an entire industry in our organizations to meet these requirements.

 

[htanaka]

Re: Re: Competence 6.2.2

... and then check how competent we are. And then do it again and again for ever - PDCA applies.

where does ISO say this?

Here, for "check how competent we are"

<I>6.2.2 Competence, awareness and training
The organization shall c) evaluate the effectiveness of the actions taken</I>

For the rest (<I>And then do it again and again for ever - PDCA applies</I>) isn't that what continual improvement is all about?

Don't take "for ever" literally - we might reach a situation of stability when we have all the competence we will ever need forever. Then we can stop

 

[db]

Re: Re: Re: Competence 6.2.2

For the rest (<I>And then do it again and again for ever - PDCA applies</I>) isn't that what continual improvement is all about?

Don't take "for ever" literally - we might reach a situation of stability when we have all the competence we will ever need forever. Then we can stop

Ah, but the standard does not require it. Look at my previous post. If we determine the competence required from our "Contract Review" (old language) and our "Product Planning" (old language), then we assign employees that have demonstrated the ability to achieve that level of competence (putting our "best people" on it), then we evaluate the effectiveness through inspection, or other means, we have met all of the requirements. The job file contains all of the documented "proof" that we met the standard. No job descriptions, no stupid yearly reviews, no performance testing. We meet the standard by doing our jobs and getting the product out.

 

[energy]

Re: Re: Re: Competence 6.2.2

Yeah, but not just for competence! Don't you have to prove that your instruments are calibrated, or that you have doc. control, or that you test or verify that shipped product is good? So why pick on competence?

Because ISO makes a big deal about it? What does instruments have to do with it? Good product? These are good business practices. Was Competence on the 94 version? Just another hoop and I'm sticking with it?

 

[htanaka]

Re: Re: Competence 6.2.2

That's what I'm getting at. You are being told to prove it.

If by "you are being told to prove it" you mean "ISO 9001 says you must prove competence", I disagree.

We are asked to CHECK <B>how</B> competent we are. Period.

At any one point we may find out we are less competent in some area than we wish to be. Presumably, we then do something about it and check again (PDCA, continual improvement.)

<B>This is not about competent versus incompetent.</b>

It's about HOW competent we are versus HOW competent we want to be, which is - in many cases - a shifting target. For example: productivity needs to increase, technology or methods change, benchmarking shows us that "they" can do it better, and so on.

 

[htanaka]

Re: Re: Re: Re: Competence 6.2.2

Ah, but the standard does not require it.

I suspect we are in agreement, Dave.

But - to be sure - what is IT? What exactly are you saying the standard does not require?