Hi

Can anyone help me on this procedure? we are at logger heads at my company about what we actually need to say in it. We have different thoughts of what needs to go in it.

Any examples would be great.

Thanks in advance

tomjess,

here are a couple of threads. Maybe they'll help. If not, come on back!;)

http://Elsmar.com/Forums/showthread.php?s=&threadid=2504&highlight=6.4+Work+Environment

http://Elsmar.com/Forums/showthread.php?s=&threadid=2649&highlight=6.4+Work+Environment

:ko: :smokin:

What 6.4 boils down to is this ...you have to take into consideration "Human Factors Engineering" principles. You also have to absolutely include your EHS dudes in your QMS.

The problem is, most Quality types have no inkling what "Human Factors Engineering" is. Many Safety gurus don't either.

9004 6.4 does give a good basic list, but unless you are really adept at the tasks described, you may miss the boat. Then again most auditors don't know squat about safety, ergonomics, hygeine and all that stuff either.

Not meaning to ring my own bell, but I've been doing 6.4 stuff for years as an EHS professional. A lot of people need to get real smart, real fast...or get outside help;)

I have a feeling that social interaction (Jim mentioned 9004/6.4) is one thing that may be overlooked...

Some of old Demings points are very relevant here: Particularly this one:

8. Drive out fear, so that everyone may work effectively for the company.

Finally: Jim also asked a crucial question: Do you really need a procedure for this?

/Claes

Remember 6.4 is related to product conformity, so chances are your customer will call out this in their print and of course as an expert in your industry you should know the requirements for the product you produce.

Claes Gefvenberg said:

Finally: Jim also asked a crucial question: Do you really need a procedure for this?

/Claes

From one of your previous posts:

Hi,

The FDIS says: "The organisation shall determine and manage the work environment needed to acieve conformity to product requirements"

Besides, did anyone ever read the last line of 4.9b in the current standard?

"and a suitable working environment."

It's already there. And yes, it would mean that both human and physical factors should be adressed.

An addition to Jims examples: How often do you see a noncom for a dirty or untidy workplace?

/Claes

Claes,

If you ask the question, "why do you need a procedure?", how would tomjess and myself address this section of the standard?
Just asking. All suggestions are welcome. :bonk: :ko: :smokin:

"Human Factors Engineering" encompases the full spectrum of human and physical factors in any type (not only work) environment.

An addition to Jims examples: How often do you see a noncom for a dirty or untidy workplace?

You'll probaly start seeing N/C's. Here in the states an untidy workplace is citable by OSHA. Work environment (6.4) is pointing at workplace safety and specifically in 9004 states "hygiene, cleanliness, noise, vibration and pollution" as things to take into consideration.

This 9000 stuff is going to start getting real fun:rolleyes:

Our manufacturing processes must be performed in a Class 100 clean room. This has led to a wide range of auditable procedures, work instructions etc. Additionally, the use of chlorine, hydrogen and methane has produced safety requirements, calibration requirements, training ....as well as work environment development. And yes, a dirty floor would be considered a non-conformance.:eek:

6.4 says:
"The organization shall determine and manage the work environment needed to achive conformity to product requirements."

Although most of the stuff mentioned so far might be valuable, the bottom line is you need to make sure your environment does not cause nonconforming product. An example would be a painting process performed outside. If wind-blown grass, dirt and empty chewing gum wrappers sticking to the paint will cause a reject, then you must prevent those things from sticking to the paint!

We must be careful not to read too much into the standard. Whether the painting process is environmentally friendly, or complies with health code is not an issue here. Do we have to concern ourselves with the environmental and safety stuff…you bet! But it is not addressed here. Show me the “shall” which says the organization has to comply with safety or environmental rules. You will not find it in Clause 6. Remember, that the auditable standard is 9001, not 9004. (I can feel you burning with anger)

db said:

Do we have to concern ourselves with the environmental and safety stuff…you bet! But it is not addressed here. Show me the “shall” which says the organization has to comply with safety or environmental rules. You will not find it in Clause 6. Remember, that the auditable standard is 9001, not 9004. (I can feel you burning with anger)

db,

Would a simple statement in the QPM be sufficient to "address" this requirement? Nothing specific, just a one liner saying we do consider the working environment. Or, do you just ignore it until asked about it by the Registrar, or Internal Auditor? I'm still looking for a specific answer on how to address it. We all know what it is. Did I miss something? :bonk: :ko: :smokin:

Good reply energy, I think the things we have been discussing are important, and I would probably address them in the QMS. We can place any additional requirements on our QMS that we desire. If we want our system to work well for us, then we truly need to consider the things addressed in 9004. But we are doing that for effectiveness and to meet our needs, not because they are “required”. There is where I lay the distinction.

There is no requirement for management review meetings, but meetings are probably the most effective way to conduct management review. There is no requirement for mapping our processes, but that may be the most effective way to meet the requirement to define, analyze and show interrelationship of them. There is no requirement to add safety, health and environmental issues to 6.4, but it makes sense to include them there, or in 7.5 (7.5 gets my vote).

I purchased a few of the Pocket Guides from Quality Pursuit for ISO 9001:2000. This guidebook provides (in their experience/opinion) what the possible actions by auditors will be. For 6.4 the following is stated "Management's Role - Auditors will be expecting that requirements for work environment have been clarified and that practice reflects everyone's compliance with the statements of clarification." "Each Employee's Role - In the case of clutter and cleanliness, most auditors will document the problems only when the abuse clearly jeopardizes the quality of product or services."

There is more information provided (in laymen's terms) for each clause (and subclause) of the standard. In the past we use the ISO 9002:1994 Pocket Guide and were very happy with them, so we will trust this version as well until proven unreliable (which I doubt seriously will happen). If anyone is interested I think the copies are only US $7.50 each, less if you buy bulk. Their site is Quality Pursuit, Inc. (http://www.qualitypursuit.com)

From our registrar the following guidance was provided:
The Standard requires that an organization identify and manage the conditions of the work environment needed to achieve conformity of product/service. These conditions could include the physical, social, psychological and environmental factors.

It is necessary to consider physical factors and abilities to adequatly perform a task. Such things as an individual's ability to lift a certain weight, vision acuity, ability to distinguish colors, etc., may be relevant for certain tasks. Additionally, the work environment itself may need to be suitable for the activities performed. Proper lighting, ergonomics and cleanliness of the work area may be essential to the ability to produce conforming product. Ambient temperature, humidity and vibration may be conditions requiring control and monitoring when performing tasks such as calibration of sensitive equipment.

No guidance was directed to the social or psychological factors, and I am presuming they won't be focusing on them per-se, but will note any flagrant occurrences that they witness. I would be curious to know what examples they could provide as violations for these factors, but have not asked.

For what it is worth - I would also suggest the factors relating to product preservation and protection be considered along with equipment/human indications.

db said:
There is no requirement to add safety, health and environmental issues to 6.4, but it makes sense to include them there, or in 7.5 (7.5 gets my vote).

6.4 Work Environment

"The organization shall determine and manage the work environment needed to achieve conformity to product requirements."

Is the product what is made / produced or the delivery of the contract vehicle requiring something to be made or produced?

At times I think the product isn't the gizmo that comes off the production line but the actual contract itself requiring it. The gizmos and duhickey's are just elements of the product that need to be fulfilled.

So if is stipulated the all applicable health, safety and environmental laws are to be complied with and that is not the case, I guess there would be an N/C even if the gizmo's quality is not effected.

Isn't this going to be a fun thread?:biglaugh:

First of all Randy, yes...this is a fun thread!

Secondly you stated:

So if is stipulated the all applicable health, safety and environmental laws are to be complied with and that is not the case, I guess there would be an N/C even if the gizmo's quality is not effected.

Adding the stipulation changes everything. Now, you have to comply with the stipulations as required by 7.1 a), even if it has no bearing on 6.4.

Now:

At times I think the product isn't the gizmo that comes off the production line

You sir, have challenged my entire paradigm! Without a doubt, I was clearly thinking product being the item being produced. But by definition a product is an output of a process and a process is a series of activities. And if we think about it. The 'gizmo' is just one product of the activity. Let's chew on that (rather than the nightcrawlers being discussed in a different thread :eek: ).

Consider a machining operation. The "product" is the part being machined. What we call by-products (in this case - chips) are, by definition, also products. 6.4 would apply to ensure our by-products also conform to requirements. Based on this thinking, where would the 'requirement' be for the chips? If there is no expressed requirement for the chips, could a NC be written for 6.4?

Man am I getting confused! :confused:

Help me Randy!

Your correct (IMHO) in your confusion, as am I. :bonk:

I think if we were to consider the gizmo's and widgets as part of the overall product and not the whole we could then put everything in proper perspective (good Lord now I'm doing the Aristotle and Plato thing).

Chips would have to be managed I/A/W requirments specified in the contract vehicle itself "comply with all applicable environmental and safety regulations" (pretty standard language here in the states). They could be either recycled, handled as hazardous waste, regular waste or whatever, but at least the process of their handling be stipulated somewhere.

What has to happen now is a more intense integration of all sectors within an organization and less territoriality. A QMS cannot be the sole domain of the quality guys. Each and every business process is a stakeholder in the overall system and its functioning and bears an equal burden.

You're right about the outputs...
Here are some examples I put into simple words for the folks here:

Product/Subassembly/component production - at each phase you actually have a finished product even if it is a sub-part of a collective unit. Are conditions (at each phase) suitable for production/development/etc... of such part.

Reports/data/etc...are also product (or by-product) of service/product. Is there enough light to fill out the form? Dry place to use to write on? Storage location available (or where ever it is turned in) provide conditions to keep it legible and prevent damage or ruining?

This could go on and on, basically - identify your product and then identify the 'musts' to be provided as a work environment.

Again, these are just a few examples but I thought some might find them helpful.

Wow... This thread is growing fast.... It ran away from me, while I was going home from work..

energy said:

From one of your previous posts:

Hi,

The FDIS says: "The organisation shall determine and manage the work environment needed to acieve conformity to product requirements"

Besides, did anyone ever read the last line of 4.9b in the current standard?

"and a suitable working environment."

It's already there. And yes, it would mean that both human and physical factors should be adressed.

An addition to Jims examples: How often do you see a noncom for a dirty or untidy workplace?

/Claes

Claes,

If you ask the question, "why do you need a procedure?", how would tomjess and myself address this section of the standard?
Just asking. All suggestions are welcome. :bonk: :ko: :smokin:

Hi Energy,

I actually had that post in mind. I don't claim to hold any definite answer. When I said "Do you really need a procedure for this?" I meant just that: We need to discuss it.

Anyway, if we single out social interaction, I can't really visualize a procedure for that (and may very well be completely wrong :bonk: ). Perhaps a Human relations policy would be more suitable there? If employees feel terrible for some reason, they will produce terrible results... That much we know...

As for the physical factors, I have issued several NC's for untidy workplaces against 9002:1994 4.9b, and would do the same thing now. Those NC's usually led to cleaning instructions. If you work in a terrible mess, terrible results can be expected.

Then we have the equipment and buildings... ...but that seems to have been covered by others while I was on my way home?

/Claes

Claes,

Infrastructure is just a re-constituted version of the old 4.9 Preventive Maintenance. That also has to be addressed. Yes, we have a Preventive Maintenance Procedure in place. It's just another one of those things that we are being led to believe, needs no procedure. This stuff is confusing enough without seeing that it may not have to be documented. That's what philosophy does vs. practical. Ut Oh, here I go again. Time to cool my jets, take a time out and come back with something constructive or find something else to do. Sheeze! :bonk:
:smokin:

energy said:

Anybody,

If you ask the question, "why do you need a procedure?", how would tomjess and myself address this section of the standard?
Just asking. All suggestions are welcome. :bonk: :ko: :smokin:

Let's try it again:frust: If it is determined that no procedure is needed, or undesirable, how would YOU address it? In fact, for any section of the standard where we may not want to have a procedure, how do we "address" it to satisfy a Registrar without some mention of the applicable section of the standard somewhere? Or is it just a matter of when asked, "Have you considered the employee's work environment and its effect on Product conformance?" to just say "Yea, we have. Next?"
The question is simple. Maybe too simple for a simple answer.
If it is, go ahead, humor me.:ko: :smokin:

Energy, I'll put my auditor hat on.

Yes it is just about that simple. The next questions would probably be "How did you consider it?" "What did you do?" "What did you determine?" "Who participated in this consideration?"


I'd document the answers, verify by asking somebody else, and move on to other things.

Energy

I dont think a good auditor would ask the closed question 'Have you considered the work environment.......'

He would probably look at the environment, the process and the resultant product and make his judgement of your ability to satisfy this requirement based on what he actually sees.

i.e. if you are making silicon chips in a dusty old shed it may be concluded that you have not met the requirement. If you demonstrate that you have an environmentally controlled area that is dust free, and everyone wears special overalls, etc, then you have met the requirement.

In the absence of a general Procedure. I would satisify this in training by saying the work environment is acceptable for the products produced and if the customer requires more then this is noted on the control plan. Auditors are going have to interview more and traingis going have to be up to snuff

Once again the the question was answered before I even got the time to read it :D Great... I have nothing to add...

/Claes

Jim Wade said:

Hi energy

From a recent post: here's just one way (not THE way and it's not for everybody):

Recent example from one of our clients (this won't apply to other situations, obviously): no procedures, just a one-off statement to the registrar in an Interpretation document: "We operate a normal office environment with no special aspects critical to providing our services. The bi-monthly directors meeting discusses from time to time improvements to the environment and makes and records appropriate decisions on actions (see directors' meeting agenda checklist)". That's all.

The Interpretation document, which we wrote especially for the registrars as part of their interview process, addressed each clauselet by repeating the 'standard's' words and then telling them how we interpreted it into our language. Gave them the chance to object before we hired them. If they did, we didn't! :)

rgds Jim
_____________________
Jim,

Does your "interpretation document" consist of a section/subsection/subheading in the Quality Manual itself or is it a separate "level 2-type" document similar to the "curious 6" procedures?

O.K. That does it for me. I now have an idea of what options there are. Randy, your Auditor hat fits well. I was concerned about just that sort of thing. There has to be evidence that it was given due consideration. Jim, I like the "Interpretation" thing. As our QPM is the standard verbatim, we can do this at the end of each section that will not have a Process/Procedure referenced. And to everyone else, gpainter, M.(want to be my auditor?:) ), Claes, your inputs were also valuable and greatly appreciated.:ko: :smokin: