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

I suggest you take a quick read through Elsmar.com/obsolete/tuv.html (http://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:
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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.
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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.

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 ?

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.

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.

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

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

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.

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 applicable” or “as necessary” 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 applicable” or “as necessary” or “as needed” 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?

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.

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.

Any takers on meserret's questions?

Yes - I know it has been a while - it got lost', but as I read through this I recognized some of the interpretations have stabilized and wondered what others would say now.

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.

Meserret,

1 - "Applicable legal and statutory requirements" would be any federal, state, or local requirements that your business must be in compliance with, such as: requirements for controls over environmental waste, Equal Opportunity Employment requirements, OSHA requirements, etc.

2 - "Where appropriate, requirements for qualification of personnel" - an example that I can provide here would be: At a former employer we were working on a NASA contract that required personnel involved in soldering be certified to a specific federal spec, and personnel involved in welding to be certified to a different federal spec.

Hope this helps to clarify. :bigwave:

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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I can address question 1 regarding "applicable legal and statutory requirements"... My company has to comply with Federal, State, County and Local environmental regulations. One of these requirements involves Title V compliance, which includes the monitoring and reporting of our Air Emissions. Other regulations relate to the generation of solid & liquid waste.

As for our Title V compliance, we maintain procedures, external documents (our Title V Permit, and county permits to operate an air emission point, etc.), internal monitoring forms, required reports, and have even included Title V Requirements in our Audit schedule.

As for your second question related to Purchasing Information, requirements for qualification of personnel - we picked up on this one as a result of one of our continuous assessments a few years ago... Our calibrations are primarilly performed by three different contracted services. When we originally contracted these calibration services, we never thought to verify the qualifications of the personnel performing the calibrations. As a result of this AR from our registrar, we now include a requirement (in our purchasing of these calibration services) that they provide us with evidence that the personnel actually performing the calibration service are qualified to do so...
PS: I think we could have argued our way out of that AR, but it made sense that we should take action to clarify our contracts, so we took a minor hit there.

I'm sure there are many other examples out there for both of these requirements... Hope this helps? E