Who is responsible for writing the validation of a new process?

[ZaMoon]

Good morning,
I am looking for who is responsible for writing the validation of a new process (includes RFID and computer system)? We are a medical device company under the FDA and I am use to people providing necessary input and RA/QA writing the validation. Please provide any thoughts.
Thank you!

 

[yodon]

Responsibilities are not prescribed. Companies do things differently. The bottom line is that whomever is assigned needs to have the necessary background, experience, etc. to do the work.

 

[optomist1]

regardless of industry or product...ideally should be a collaborative effort...instinctively led by the SME, likely the process or production/mfg. engineer, with input from quality orgianization....not all firms have the same structure and nomenclature so i may a bit off here...but the poitn is is it must be a collaborative effort...

 

[kuyakut]

It is always the Subject Matter Expert, but some companies hire validation engineer.

 

[shrikantborkar]

Hi ,,
In my capacity as the Manufacturing system Manager (Manufacturing Engineering) , New Process Introduction, Its verification was my responsibility however Validation to be carried out with witness of the customer .
its correct Local Available expertise either from the company or to get hired but the responsibility lies with Manufacturing system Manager

 

[Deftlyhandled]

Good morning,
I am looking for who is responsible for writing the validation of a new process (includes RFID and computer system)? We are a medical device company under the FDA and I am use to people providing necessary input and RA/QA writing the validation. Please provide any thoughts.
Thank you!

Hi ZaMoon

I agree with Yodon and Optimist. Yet collaboration can be a hard thing to bring into a culture, but a collaborative approach to validation is necessary to having a solid validation process and report. I think of it like having the foundations of a structure capable to support weight.

Obviously you asked this a few months ago so this maybe a bit late, but the fact that your asking indicates your organisation doesn't have a clear approach on this? If I were in your position, I would advocate treating this like a project involving an external contractor - even if you don't have a third party.
Clearly define the roles and responsibilities, and the requirements for that role (lot's of people here said you need a subject matter expert (SME), but your RFID / computer systems SME will have a different scope of involvement to your SME for other product attributes, does your QA review from a processing perspective or RA/QA only?) and build a kind of project scope to help guide the process.
This approach is best used as a guidance and the scope should be revisited periodically - maybe this is not necessary for your organisation, but it sometimes helps to get all participants agreement at the beginning that this scope isn't a blunt instrument to pressure people with.

In the long term, I would include in your quality manual, or whatever your core quality document is called, a section on how to deal with validations like this, or go all out and work up a Validation Master Plan (not, as I understand it, a strict requirement under 21 CFR 820)

I hope this helps.