How can I differentiate between OOS, change control and deviation



How can I differentiate between OOS, change control and deviation..

Answer / kartik renalson

OOS stands for out of spcification , it means when product/intermidiate/raw material is manufactured and tested for the defined specification and result obtained for any of the specification does not complies, it is reffereed as OOS.

change control is the document raised it require to change in existing parameter. Change in process or process modification, change of equipment/eqyipment position, change of oganogram etc. change can be anything including man, method, methodology, machine.

deviation referes to the non compliance of any of the activity/operation as per predefned process/ SOP.

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