Process Validation of 'Special Processes' - How do I?

  • Thread starter florin pirvulescu
  • Start date
F

florin pirvulescu

#1
We all agree what special processes are. But what is the approach in those cases it is not very clear to me. I have to options: 1. we can demonstrate compliance with 7.5.2 just establishing preliminary measures as appropriate according to a) to e) or
2. implementing all I've sad to 1. AND appointing a commitee wich has to gather to analyse the conditions and to complete a kind af a minute bla, bla...
What actualy an external auditor should be expecting to find?
:thanx:
Florin
 
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D

D.Scott

#2
I have seen this discussed by using an internal weld as an example. This must be validated at the time of welding because you won't be able to get to the weld once the process proceeds. I think you have defined what is necessary in your option #1. The use of a commitee stated in option #2 seems to be overkill.

As an auditor, I would expect to find evidence of how you are going to ensure you address the items a - e. Procedures/work instructions stating how you will review and approve, documentation of accepted equipment (example - calibration or specific type) and proof of qualification of the employee, work instructions, records and periodic revalidation.

I am sorry there is no specific information I can offer other than don't over-complicate it. Keep it as simple as possible.

Dave
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#5
About “special processes” I have a friend that says one important thing we all must think about:
All QMS processes should be considered “special processes” and treated the same way we normally do to those classic special processes. In other words all the identified QMS processes should be qualified (or validated).
Considering ISO 9001:2000 4.1 c), d) and e), if an organization wants to implement an “audit non conformance proof system”, the idea of treating all their processes as “special processes” is not so bad.
I agree that this could be a good idea. The only problem is that we also must consider the financial costs of this idea.
Any comments? :rolleyes:
 
F

florin pirvulescu

#6
António Vieira said:
About “special processes” I have a friend that says one important thing we all must think about:
All QMS processes should be considered “special processes” and treated the same way we normally do to those classic special processes.
OK, it could be an idea, as long as 16949 already has this requirement. The problem is (at least here in my country) that most of small and medium size companies use to have a QMR having other responsibilities. In most cases "other responsibilities" take all the time. So, the more complicated become the sistem, the more people get bore or stressed, all with appropirate results in sistem effectiveness. People are like water which flows on the easiest way.
You were right: "The only problem is that we also must consider the financial costs of this idea." We don't have strong labor unions to represent the employees, so supplementary tasks are noy reflected always in salary. Besides, IMO the standard has aleady to much philosophy, let's not overcomplicate our life.
 
V

vasudev

#7
what is validition of special process (man,m/c or production operation)& which processes are called special processes & why not all the processes are under scope of validation
 

Stijloor

Staff member
Super Moderator
#8
what is validition of special process (man,m/c or production operation)& which processes are called special processes & why not all the processes are under scope of validation
"Special Processes" is a term that was used in older standards. However, the term still exist.

If you are an automotive supplier, all manufacturing processes are considered "special" and must all be validated.

Colin answered your question in this post.

You may want to scroll down this page and explore the links that are provided there.

Hope this helps.

Stijloor.
 
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