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.

 

[robertjone336]

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

Is this same in every company, We are Dubai based freight forwarding company, and I need to create the JDS for Manufacturing system Manager

 

[ZaMoon]

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.

Never too late to help Thank you for your advice, I am actually getting ready to write another large validation and I am incorporating your approach into my project plan.