Validation of Processes for Production and Service Provision Procedure

V

v.dam15

hi
Where There Is A Factory Or Facility That Some Of Its Processes Can Not Be Verified Except After The Prouct Or Service Is In Use So At The Time Procedure Is Written Shall The Procedure Mention All These Processe In Details In The Procedure Or Shall Name It Only Or Do What
 
Marc

Marc

Fully vaccinated are you?
Leader
Re: Validation of Processes for Production and Service Provision

Details. You want to put in the details.
 
V

v.dam15

If Many Processes Shall I Put Them In One Procedure Or What This Is Too Much For One Procdure Or To Make A Record Of Each Process (filled).....
 
Marc

Marc

Fully vaccinated are you?
Leader
Can you be more specific? What product and processes are you trying to document procedures for?
 
Y

Yew Jin

If I am understanding correctly for the question, it will be
"Can we use a general validation and verification procedure to cover difference process in the plant?"

The answer is "yes", the important thing is we need to include the matrix for the acceptance criteria for each process such as no special cause in spc plot, process capability study....
 
C

cuadra - 2010

Dear v.dam15:

The ISO 9001:2000 standard provides the requirements for conformance in the Clause 7.5.2 Validation of processes for production and services provision.

This clause describes what some people may call “special processes”, in other words processes where the resulting output cannot be verify by the subsequent monitoring or measurement system. If you do nothing, then your customer becomes your “beta tester”.

Please read the clause, the standard requires that you validate this kind of processes.

Examples of stuff that you cannot test are “airbags”, etc.

In this cases you need to implement some kind of validation process such as but not limited to “destructive testing”, “lot testing”, etc.

I hope this helps,

Cuadra
 
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