CCP failure
Dear experts
i would like to know about concept of CCP failure, CCP deviation & CCP breakdown & documented guideline and examples on CCP concepts
During discussion with a external expert , expert gives below examples for differentiate:
CCP failure: when defined SOP/ procedure not followed in case of control measure breakdown / failure defined as CCP ( metal detector)
i.e. get market complaint of metal contaminate ( more than defined size of hazard ) and Correction and corrective action not followed
CCP deviation: when CCP not checked or verified at defined frequency of schedule . for example : QA office verified CCP at 2. 30 Hours in place of defined frequency : every 2 hours
CCP breakdown : when control measure not working as per intended use of machine , for example metal detection not functioning & do not detect the test probes or sieve of shifter got damaged during intended use.
As per my understanding, CCP failure shall be when your CCP not working as per intended purpose , for example metal detector not sense the test probes during verification of metal detector function at defined frequency .
Hence please suggest and if any guideline / documented for same , please share
It might just be semantics. All three of these are not good, but im not sure why the "classification" is important.
My defintion and the USA FDAs definition of a deviation is: Failure to meet a critical limit.
I dont like the metal detector example. What they called a "failure" could be within the limitations of the technology. Depending on size, shape, metal, orientation, it is possible for a piece of metal larger than the test piece to not be detected by a functioning metal detector. Im not sure I would call that a CCP failure.
What they are calling a "break down" I would call a deviation or failure. As most likely the critial limit has not been met.
It might just be semantics. All three of these are not good, but im not sure why the "classification" is important.
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The only difference I see is which root cause analysis methodology you might need to use. Even that is kind of a picky differentiation -- they could all make one necessary and you could probably use the same form and method if you wanted to.
The only difference I see is which root cause analysis methodology you might need to use. Even that is kind of a picky differentiation -- they could all make one necessary and you could probably use the same form and method if you wanted to.
I didnt not notice this was posted in FSSC 22000. Ive never worked with it. maybe they differenciate between the three?