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Topic : Construction Project Management
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Industry : Industrial Products/Heavy Machinery
Functional Area : Product Development
Activity: Question posted: 08 31 2009 17:00:16 +0000, 2 answers, 229 views, last activity 07 06 2010 20:18:08 +0000
 
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validation term is mostly used to checks process steps so that it must give practically feasible results with in specified limits and conditions.

 
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Clause 7.5.2 of ISO 9001:2000 & 2008 talks about this aspect. It states that the processes which can not be verified by inspection & testing must be validated. The standard also describes as to what needs to be done to validate the processes. In manufacturing most commonly known processes which need validation are welding & soldering. Such processes must be carried out by competent personnel using approved material & specific procedure. If all these steps are implemented in true letter & spirit then the processes will deliver desired results



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by   Major Bajirao Naik, Senior Consultant, Self employed  | 11 22 2009 09:49:47 +0000
  Answered by     Pragya Kothari, Construction-Heavy, DLF  | 09 15 2009 06:27:27 +0000
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Process validation can be classified as the validation of controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. Process validation is one of the most critical elements in the pharmaceutical industry today. The concept of process validation recognizes that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.

 
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