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  ISO 9001/4:2000
  Please Explain 'As Applicable'

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Author Topic:   Please Explain 'As Applicable'
meserret
Lurker (<10 Posts)

Posts: 9
From:Istanbul, Turkey
Registered: Jan 2001

posted 23 January 2001 09:41 AM     Click Here to See the Profile for meserret   Click Here to Email meserret     Edit/Delete Message   Reply w/Quote
Nowadays we are trying to make comments on ISO 9001:2000. Everything seems clear but, i dont understand; there are lots of "applicable"s in the standard. Does this mean that there is an absolute necessity or does it mean it is up to the company? Does it give a freedom to the user? Can you please help me? Thanks a lot...

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Meserret

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Marc Smith
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posted 23 January 2001 11:17 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I suggest you take a quick read through Elsmar.com/obsolete/tuv.html

You will see the first part is a number of questions and there are accompanying answers. When the auditor comes questions such as these will be asked. You will have to answer.

Where ever you see "...where applicable..." it is no different than in the past. To some degree it is the same with how you deal with exclusions. If there is a stated requirement which you do not do you have to be ready to explain why it is not applicable to your business / company.

This is typical where there is a 'laundry list'. QS has a lot of laundry lists. Where ever you see "...where applicable..." or "...as applicable...", you have to look at the 'requirement' and ask yourself why you do not do it. Let's look at:
-------------------
7.5.1 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. Controlled
conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities.
--------------
Do you use and need work instructions? Maybe not - some companies are quite simple and train employees (lione item b). I have clients with no measuring devices (line item d) - they're a service industry.

It is up to you to be ready to explain why each line item and its contents are, or are not, applicable to your company.

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Bryan
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From:San Jose, CA USA
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posted 23 January 2001 04:36 PM     Click Here to See the Profile for Bryan   Click Here to Email Bryan     Edit/Delete Message   Reply w/Quote
Marc you say:

Do you use and need work instructions? Maybe not - some companies are quite simple and train employees (lione item b). I have clients with no measuring devices (line item d) - they're a service industry.

I was under the impression that all activities, (quality related) were to be documented. Did I miss something somewhere where WI are not needed if a person is trained to do a job ?

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Marc Smith
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posted 23 January 2001 04:52 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Yup - you can train many things. You only document what it makes sense to document. QS is a bit more anal than ISO about documentation required, though.

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Marc Smith
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posted 23 January 2001 05:00 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
However, before you take that and run with it -- let's take a person who solders connections. You train them to solder - no need for a work instruction telling them to warm and adjust the pencil. Maybe you also teach (train) that person how to read certain markings on a circuit card and they they *may* not need an instruction for that.

You just have to look at your processes and ask yourself - what do I *really* need to document for people to do their jobs and what can I *train* them to do. And remember - what one company trains employees to do another company might have a work instruction. Many factors do come into play for consideration. Including turnover rate of personnel in that position, job requirements (High school grad? Prior experience within or outside of the company? Related college degree? Degree of complexity of the job? -- To name a few).

Many of my clients have appreciated how, with my help, they have significantly reduced their documentation in favour of training and/or common sense.

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Bryan
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posted 24 January 2001 05:53 PM     Click Here to See the Profile for Bryan   Click Here to Email Bryan     Edit/Delete Message   Reply w/Quote
Thanks Marc,
Makes sense to me now. We were always lead here that if somebody did something, it had to be documented. I can see where WI may not be needed now and think we can reduce some of ours. Thanks again
Bryan

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gutieg
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From:Laredo, Texas
Registered: Jan 2001

posted 25 January 2001 10:51 AM     Click Here to See the Profile for gutieg   Click Here to Email gutieg     Edit/Delete Message   Reply w/Quote
Suppose that we have a situation in which we decide not to write any WI and instead "train" the people. Then, one day:

- Somebody got sick
- The "trained" people leave the company
- Our trainer got another job
- It 's the 3rd shift and something happened
in the process that nobody remembers or
knows how to deal with
- A supervisor from other area is assigned to
the line and need to understand the
operation

I agree that maybe not "everything" should be documented but at least a one page WI with a diagram and the CTQ characteristics is a very helpful thing to have.

Gus Gutierrez

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Marc Smith
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posted 25 January 2001 11:15 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I don't see this as an issue -- Again, you have to look at each instance. Typically where, for example, you only have one person in a position you typically want to consider the need for work instruction(s).

On the other hand, you can take any 'What If....' scenario too far. What If... is a problem in this way when you document disaster plans. Do you plan for earthquakes if your plant is in Tennessee? What If.... 50 key employees are killed in a bus crash on the way to a golf outing? How will you recover and who will be able to do those jobs?

It's all about taking a common sense look at what you are documenting and why. A team evaluation /. discussion helps.

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energy
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From:New Britain, CT
Registered: Nov 2000

posted 25 January 2001 02:43 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Marc,

We will be running three (3) different business units under our company name.
1. Distribution-off the shelf items with little or no light assembly required prior to shipment. (Licensed to provide other company products)
2. Service De-Ionization of resin for re-usable service bottles for Industry. (Basically, out with the old resin, in with the new.)
3. Fabrication of Industrial Equipment, using processes such as welding, electrical panel assembly, painting, coating and assembling light to heavy units.
My question to you, an obviously seasoned auditor, how do I use the phrase „as applicableš or „as necessaryš in my written procedures? My intention is to write a full blown Contract Review or 7.2.1 Identification of Customer requirements for the 3rd Business unit, as it includes Design Control and requires a contract with Customer approval. The procedure would be permeated with these phrases as they do not apply (I think) for Business units 1. and 2. These orders are phoned or faxed in.
Would it suffice to tell the auditor that the reason „as applicableš or „as necessaryš or „as neededš are used is because the other business units do not require the planning and attention as Unit 3? Or, do I have to state up front in the procedure that certain sections do not apply Business Units 1. and 2.?

It appears from your post that verbal explanation would be required if those terms are used. Yes? Any ideas on an easier way?

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Marc Smith
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posted 26 January 2001 01:06 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
What I have said is in response to '...as applicable...' in the standard. I would not write "as applicable' in a procedure. If you do I suggest you put your qualifiers in the procedure as well.

> Or, do I have to state up front in the procedure that certain sections do not
> apply Business Units 1. and 2.?

Yes.

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meserret
Lurker (<10 Posts)

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From:Istanbul, Turkey
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posted 29 January 2001 07:15 AM     Click Here to See the Profile for meserret   Click Here to Email meserret     Edit/Delete Message   Reply w/Quote
Thank you for your answer Marc. I read the documents and it helped me a lot.
Now I have two questions:
1-What about "applicable legal and statutory requirements" mean as stated in 7.3.2?
2-In 7.4.2 what does "Where appropriate, Requirements for qualification of personnel" mean? I cant think of a purchasing action that needed to give the requirements of personnel.

Thanks a lot.

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