New equipment qualification

Dear Friends,

In the case of new equipments(additional Reactor) installation who will arise the CCF?? From production or from Engineering???

Two CCFs are required or not???
One is for IQ&OQ user dept. Engineering
Second is for PQ user dept. production.

and same as above in the case of older equipment replaced by new equipment…


May I ask you what is CCF?

Change control form

This will be raised by Engineering person . The reasons must be:
-Design Improvement
-Change of vendor
-Minor modification
-Change in a particular component attached other than mentioned in the previous approved design.

This should be certified both by QA and Production.

Note: I request you folks not to write abbreviations. If you write you must mention the readers here what those abbreviation mean. We have here seniors and juniors. Its a learning curve for us all. Kindly take positivity of this Note



In my opinion,

In any existing facility if any new equipment is to be installed, Change Control shouldbe initiated by the user department [Production-In above mentioned case]. The logic behind this is the Justification i.e. why the new reactor is required … might be increased productivity…

And Definitely once change control is initiated, it must be circulated to all stackholders…for information & necessary actions.
In above mentioned case " Engg- DQ /Installation / Fabrication / Updation of drawings etc. Electrical / Instrumentation / Civil Engg. for respective updates., QC with respect to additional sample loads during OQ / PQ.

In addition to above Don’t forget to add QA also.

Happy Reading !