Examples for Clause 7.5.2 - Validation of processes for production and service

M

MichaelWah

#1
Clause 7.5.2 Validation of processes for production and service provision

The first paragraph states that "The organization shall validate any processes for production and service provision where resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered."

Can someone provide examples of such processes/services ?

Thank you.
 
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Q

qualeety

#2
Process - Measuring Speed (excluded from 7.5.2)

We measure car speeds at various intersections. Once we get a speed reading, there is no way of "verifying" the speed.
 
R

Rob Nix

#3
Here's the example at the ISO website
iso.org said:
Example 8
Validation of processes

Situation:
A small garment manufacturer carries out cutting work on textiles that are delivered to an internal sewing department for the next phase of the process. The quality of the output of the cutting work can be checked after finalization of the work. It has implemented a QMS and claims conformity to ISO 9001:2000, with the exclusion of sub-clause 7.5.2 Validation of processes for production and service provision.

Issue(s):
Can the small garment manufacturer exclude sub-clause 7.5.2 Validation processes for production and service provision from its QMS and claim conformity to ISO 9001:2000?

Analysis and conclusion:
The organization is justified in the exclusion of the requirements of sub-clause 7.5.2 Validation of processes for production and service provision since it can inspect the result of the cutting process to determine conformance or nonconformance to specification.
 

kbg1000

Registered Visitor
#4
The referenced clause in the original question talks about processes that cannot be verified after production (except by a destructive test).

These used to be called "special processes" and had to be controlled using good process controls; control the process well, and you can expect the results (product) to be conforming. Examples are welding, bonding, and even baking a cookie!
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
What is your product or service? this could help us to determine if you have any processes that fall under the section...
 
M

MichaelWah

#6
I'm in the flexible packaging industry. We have gravure printing process, lamination process, slitting process and pouch making process.

I don't think this clause apply to us. But I'm curious about this clause. I will be holding a in-house class to brief new auditor (my colleagues) on the interpretation of clauses in ISO 9001:2000. Just to make sure when I arrive in this clause, I can tell them something :)
 
D

Denis

#7
I'm a Validation Manager in our business, this is how I would approach the issue.

Draw up a process map and identify all the key stages of the process with any deviations included, and how they are dealt with.

From this map identify the controlling inputs on the machines - heat, pressure etc.
If you control the inputs of the process you will ensure that the resultant output will be validated - there's alot more to it than that simple statement.

But, I would look at controlling the vital input variables. This however is a full time task.
 
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