Work Environment - Different thoughts on quality manual verbiage

[tomjess]

6.4 Work Environment

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

 

[energy]

try these and come back

tomjess,

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

https://elsmar.com/elsmarqualityforum/threads/2504/

https://elsmar.com/elsmarqualityforum/threads/2649/

 

[Randy]

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

 

[Claes Gefvenberg]

Social interaction

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

 

[gpainter]

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.

 

[energy]

Re: Social interaction

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.

 

[Randy]

"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

 

[KenS]

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.

 

[db]

Read the standard

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)

 

[energy]

Re: Read the standard

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?