Equipment Change or Process Change? Validation protocol for a planar freezer

R

RV123

Guest
#1
I am reviewing a validation protocol for a planar freezer in which the rate in the procedure has to be changed in one of the temperature ramp up steps from +15C/min to +10C/min to avoid an overshoot.

Would you consider this strictly a process change or an equipment change or both?

Thanks!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Administrator
#2
Re: Equipment Change or Process Change?

Welcome to The Cove! :bigwave: This is a good first question.

An equipment change is needed when the equipment can't perform the desired function. If a temperature change can't be ramped at the right speed, whether from hot to cold or cold to hot, the equipment would need to be altered in some way. It's up to the organization to find the right solution for that. It isn't part of the process unless the process is set to include an equipment change every time, or even occasionally, to meet the need. This could mean changing out a piece of hardware or software, for example, as part of a tool setup or performing PM. Even these are usually separate processes that are linked, so as to make the manufacturing process least complicated for the operator. That decision is up to the organization, though.

The process change involves the impact this has on the product or material during production. There are some materials and applications of treatments in some industries that demand specific controls in order to achieve the right physical properties, chemical stability or some other relevant outcome. The process addresses finding out what those requirements are, how they will be performed (methods once the equipment is ready to perform) and how to verify the requirements are being met (thermostats, timers, calibration, databases, logsheets or whatever).

I hope this helps!
 
R

RV123

Guest
#3
Re: Equipment Change or Process Change?

Thanks Jennifer!

I think we are leaning towards process change because the equipment is capable, as is, to change the ramp up rates. As no modification is necessary (just a change in setting) I think we are outside the scope of equipment change. I realize that bit of detail would have been helpful in my original post :notme:. Your reply was helpful though, because it confirmed that an equipment change really means and alteration, and not just a change in operating perameters.

Thanks again,

Ray
 

MIREGMGR

Inactive Registered Visitor
#4
Re: Equipment Change or Process Change?

Agreeing with your "lean-direction", and in accord with Jennifer's first sentence/second paragraph, I would consider that to be a process change.
 
Top