How to write change control to replace new hygrometer.
Write the location and instrument ID number of existing hygrometer in existing procedure.
Give the detail of new hygrometer in proposed change
Write the justification why you want to replace.
Take new id number for new hygrometer.revise the instrument ID list;sop.maintain the calibration record for new hygrometer before installation.
If you are changing and existing hygrometer for a similar one you don’t need a change control because you are using a “like to like” substitution. You just need to document that you’re using a new instrument, to check calibration validity and to start a new report with measurements where you must to include the ID of the new instrument
What should be prefer temperature sensor with data logger or wire less data logger for mapping of cold storage ,walk-in chamber,freezer,B.O.D incubator
Selection of data adquisition systems depends on the operational range of the equipment. We use temperature dataloggers to mapping stuudies because the simplicity of data management but it’s possible to use any other system
Tania Mam…if we are using wireless data logger system for mapping of temperature distribution of walk in chamber , incubator like any system , we can not monitoring the data of real time whats going inside the system and suitable aspect to observing temperature on screen …in that it’s better to use display type temperature probe with data logger with wire system for temperature mapping …
write the short descriptions of the project exactly, like what you want to replace/introduce/relocate, where you want replace/introduce/relocate,
Replacement of new hygrometer (Make/Model: XXXXX, Range/Capacity: XXXX and Eq. ID.: XXXXXX) in the room or no. XXXXXXXXXXX of area name XXXXX for monitoring/recording of temp. / RH in the area.
Description of change:
Define the scope of replacement…
Define the purpose of replacement…
Define the objective of replacement…
Justification for Change
Why is this change required…
why this change is acceptable from a cGMP Perspective…
I hope this will help you!
If existing hygrometer found failed during calibration ,then what will be procedure followed to change for the same , this hygrometer used in operation area for daily routine monitoring & recording for temperature and %rh in logbook…plz respond fast
Fill the temporary chng control and use spare hygrometr for monitoring
What is temporary change control ?
There are many organization where they adopted a system in which they insist to raise planned deviation through temporary change control to avoid repetitive planned deviation which will help lot to implement quality culture in documentary.
Other many beneficial w.r.t. QMS representation during internal as well as external audit(s).
@ Meenakshi , In your organization is plan deviation allowed or not?
Is planned deviation is there but no temporary change control.
Planned deviation & temporary change control…Both are same.
Planned deviation means if u want 2 perform an activity on temporary base.,Proceed through change control and mentioned change category as temporary.
Thanks dear jaya