1 reply to this topic

[sunil malethia]

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 

 

 

 

 

 

 

 

[kingstudruler1]

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.