Excluding 7.5.2 - Validation of Processes for Production and Service Provision

[hiroyuki6]

Our company's scope is Marine Engineering works including precision machining and steel fabrication. Our consultant advise us that we could exclude 7.5.2 as we do not have any special processes.

However, during the audit, the auditor claimed that it could not be excluded.

Our consultant insist that we can exclude this.

May I know what 7.5.2 is and based on our company's scope, can we exclude the clause?

Thanks in advance

 

[keres]

Re: Excluding 7.5.2

Is there welding, painting, casting processes in your QMS?
And what is the full scope of the QMS?

 

[harry]

Re: Excluding 7.5.2

Our company's scope is Marine Engineering works including precision machining and steel fabrication. ......................

Welcome to the Cove.

What kind of steel fabrication works are you involved? Generally, only non-structural, architectural and decorative steel works like window/door grilles qualify for exemption as special process.

Don't you also need to qualify your process, equipment, personnel and methods?

 

[rob73]

Hiroyuki6
As Keres points out, if you have any welding process these will be "special processes". As a welding process cannot be normally verified except by destructive testing, most auditors will see this as a special process.
See also this thread Special Processes - Can someone help us with a definition of Special Processes?

Rob

 

[Howard Atkins]

I never understand why every one runs to exclude this clause.
All it requires is that:

7.5.2-The organization shall establish arrangements for these processes including, as applicable (NOT ALL INCLUSIVE-HA)
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

Despite this you are prepared to

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 equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of product release, delivery and post-delivery activities.

It is difficult to think of a situation where there the requirements of 7.5.2 do not exist

 

[somashekar]

Our company's scope is Marine Engineering works including precision machining and steel fabrication. Our consultant advise us that we could exclude 7.5.2 as we do not have any special processes.

However, during the audit, the auditor claimed that it could not be excluded.

Our consultant insist that we can exclude this.

May I know what 7.5.2 is and based on our company's scope, can we exclude the clause?

Thanks in advance

You registered in March 2009 and first posted now ... How I wish you could have consulted us here before ....
Tell us all your processes in your factory manufacturing flow., and we could help you if you have any such process requiring validation, and also help how this could be done in a simple way.

 

[manojdparab]

As far as my understanding, 7.5.2 is applicable for your company if you are having any special processes like welding, painting, normalising, etc. then this clause is applicable to you. Please see ISO 9000:2005 for the definition of special processes.

ISO 9000:2005 NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified
is frequently referred to as a “special process”.

Hope this will help.

Regards
Manoj

 

[Big Jim]

Not only can you not claim exclusion to 7.5.2 if you have any special processes (things like welding, brazing, soldering, plating, and painting), you also cannot claim exclusion if you outsource any of these things.

 

[wweng7]

Can we exclude only "Service Provision" portion if we do not service our products?

 

[Howard Atkins]

Why bother to exclude.
If you don't do it you don't do it.
You cannot be audited for what you don't do.