Need help explaing the need for qualification to a coworker

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

I’ve tired everything I can to explain this, but I am working with someone who thinks that all new equipment needs to be qualified. Forget that their are any SOP’s or MVP that explain it.

I never have and never will qualify a conveyer. However, this person thinks since it is new it is needed.

Could someone help give me some other way besides the basics of validation life cycles and risk assessment to get this through to them???

Thanks!!!

2

Sounds like you’ve tried to point them in the right direction. Maybe it’s not possible to convince this person?

Only other thing I can think of is to ask them to answer questions like:

  • Will the equipment cause the product to not meet specifications?
  • What’s the worst case if the equipment fails?
  • Will the equipment contribute to any variability in the product or process?

Turn it back on them and make them rationalize it. Does your validation master plan allow for equipment used in a process to not be validated if there would be no added value? Maybe there’s a deeper “root cause” to the insistence. :slight_smile: Good luck!!

3

[quote=yodon]Sounds like you’ve tried to point them in the right direction. Maybe it’s not possible to convince this person?

Only other thing I can think of is to ask them to answer questions like:

  • Will the equipment cause the product to not meet specifications?
  • What’s the worst case if the equipment fails?
  • Will the equipment contribute to any variability in the product or process?

Turn it back on them and make them rationalize it. Does your validation master plan allow for equipment used in a process to not be validated if there would be no added value? Maybe there’s a deeper “root cause” to the insistence. :slight_smile: Good luck!![/quote]

That is great advice as always :slight_smile:

I am going to try and push it back and make them think about it if it happens again.

Also it seems he was holding back information on the type of equipment. He made it seem like something non critical now as I dig deeper and ask more questions it isn’t what he described and is critical to the process.

4

[quote=seal]That is great advice as always :slight_smile:

I am going to try and push it back and make them think about it if it happens again.

Also it seems he was holding back information on the type of equipment. He made it seem like something non critical now as I dig deeper and ask more questions it isn’t what he described and is critical to the process.[/quote]

The danger in this kind of thinking (that qualification is not needed) is that the regulations are broad and sweeping. 21CFR 820 Subpart G (5)(g) states for equipment “Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed.” Sounds like IOQ to me. The regulation is not specific and does not separate “critical” and “non-critical” equipment, but states “all equipment”. So in order to cover ourselves, my company takes the “all equipment” stand. There is no question of criticality or value-added effect on the process. Our interpretation of the regulation is literal. There are ways to do this without full-blown IOQ… we handle a lot of the process with our Equipment Program by using the Equipment Entry process to define intended use and requirements, then showing how the equipment meets those requirements. It’s a pretty painless process, but we do qualify everything.