ISO 9001 Clause 6.3 Facilities and 6.4 Work Environment - Discussion

Marc

Fully vaccinated are you?
Leader
From: ISO Standards Discussion
Date: Thu, 30 Mar 2000 21:07:32 -0600
Subject: Re: Q: Facilities & Environment /Udo/Kozenko

> From: Rob Udo
>
> Does anyone have suggestions on implementing section 6.3 Facilities
> and 6.4 Work environment of ISODIS9001:2000? How do you make
> this auditable?

The "quick and dirty" answer is in the word "identify" which appears in both sections and is very easy to audit (simply say, "Show me..." as in: The side of the car that I can see is painted blue...). That's the first half.

The other half would be part of what I refer to as the "background noise" of an audit as a whole. The "background noise" answers some systemic questions such as "Is the Quality Policy implemented effectively?" and "Is this really a quality system or just a bunch of managers who want that free trip to Vegas if they pull this off with me?" <g> (If you have no "gut level feelings" then you shouldn't be an auditor, simple as that.)

Finally and as an aside, if you lump 6.3 and 6.4 together with the old 4.1 as you review complaints, corrective actions, preventive actions and management review documentation, you'd probably "cross t's and dot i's" about as well as could be done by an outsider.

David M. Kozenko
 

Marc

Fully vaccinated are you?
Leader
From: ISO Standards Discussion
Date: Thu, 30 Mar 2000 21:09:38 -0600
Subject: Re: Facilities & Environment /Udo/Hankwitz

From: "Hankwitz, John"

Rob,

Section 6.3 states, "The organization shall identify, provide and maintain the facilities it needs to achieve
the conformity of product, including:

a) Workplace and associated facilities;
b) equipment, hardware and software;
c) supporting services

To audit this requirement, I would start by looking at nonconforming product history. If their quality records indicate they are producing very little of it, I would not spend lot of time investigating it. If they have a significant amount of nonconforming product, I would then look for objective evidence that they have taken an effort to maintain the three listed areas.

Section 6.4 states, "The organization shall identify and manage the human and physical factors of the work environment needed to achieve conformity of product."

Once again, I'd start by checking nonconforming product history. Corrective actions taken to eliminate existing, and prevent future nonconformity should be addressing the "workplace, equipment, support and environment" in their corrective action reports. If they aren't, I'd have a case for issuing another finding based on these clauses.

John Hankwitz
 
P

Poonam_QA

Thanks for guidance. Actually I want to know how to make a procedure to cover clause 6.3 & 6.4.


From: ISO Standards Discussion
Date: Thu, 30 Mar 2000 21:09:38 -0600
Subject: Re: Facilities & Environment /Udo/Hankwitz

From: "Hankwitz, John"

Rob,

Section 6.3 states, "The organization shall identify, provide and maintain the facilities it needs to achieve
the conformity of product, including:

a) Workplace and associated facilities;
b) equipment, hardware and software;
c) supporting services

To audit this requirement, I would start by looking at nonconforming product history. If their quality records indicate they are producing very little of it, I would not spend lot of time investigating it. If they have a significant amount of nonconforming product, I would then look for objective evidence that they have taken an effort to maintain the three listed areas.

Section 6.4 states, "The organization shall identify and manage the human and physical factors of the work environment needed to achieve conformity of product."

Once again, I'd start by checking nonconforming product history. Corrective actions taken to eliminate existing, and prevent future nonconformity should be addressing the "workplace, equipment, support and environment" in their corrective action reports. If they aren't, I'd have a case for issuing another finding based on these clauses.

John Hankwitz
 

Stijloor

Leader
Super Moderator
Thanks for guidance. Actually I want to know how to make a procedure to cover clause 6.3 & 6.4.

Welcome to The Cove Forums. :bigwave: :bigwave:

There is no need/requirement to develop a procedure for this.
You must meet the requirement; that's all.

Stijloor.
 
P

Poonam_QA

Actually our Management wants me to make a procedure for "Facilities and Maintenance" that would cover Clause 6.3 & 6.4. This would be further implemented in the organisation. Can I have some guidance on it? It would really be helpful to me.
 
P

Poonam_QA

I have already made the six mandatory procedures. On the same way I have to make this for the Organisation
 

Chennaiite

Never-say-die
Trusted Information Resource
Actually our Management wants me to make a procedure for "Facilities and Maintenance" that would cover Clause 6.3 & 6.4. This would be further implemented in the organisation. Can I have some guidance on it? It would really be helpful to me.

Why cant you understand from your Management, the Purpose, Scope and Responsible finction for the Procedure they are seeking and then go back to the responsible function to understand the flow of activities, output document existing/required, timeline/frequency for activities, as required, etc. There you have the procedure.
 
P

Poonam_QA

I know very well about responsible departments for it. but I need one sample for this procedure like how to justify for adequate workplace, good work environment etc.:)

Why cant you understand from your Management, the Purpose, Scope and Responsible finction for the Procedure they are seeking and then go back to the responsible function to understand the flow of activities, output document existing/required, timeline/frequency for activities, as required, etc. There you have the procedure.
 
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