Minimal R&D Quality Requirements

[Mandy]

Although I have years of quality experience, I've always working in companies that manufacture products, and that have a solid quality management system.

I've recently started a new job where I need to build up the quality system in a very small company which is focused on research and development for a LDT product.

Since I've never really worked with R&D I'm unsure how much quality to "force upon them". For example, sometimes they wear lab coats, but sometimes not. Where can I find out the minimum quality requirements for R&D.

Thanks very much.

 

[bluepagen]

Although I have years of quality experience, I've always working in companies that manufacture products, and that have a solid quality management system.

I've recently started a new job where I need to build up the quality system in a very small company which is focused on research and development for a LDT product.

Since I've never really worked with R&D I'm unsure how much quality to "force upon them". For example, sometimes they wear lab coats, but sometimes not. Where can I find out the minimum quality requirements for R&D.

Thanks very much.

Minimal requirements? Start with the required quality procedures for the standard or spec you are trying to follow. Do they have department procedures? Is there a chain of custody that is required? Do they confirm an operation is completed prior to handing it off to the next step? Some sort of method to control the work steps? Do they have work instructions? Is it a lab situation or are the lab coats for safety precautions?
It might be beneficial to go to the attachments and start looking there for examples of procedures or examples forms.
Good luck.

 

[Ronen E]

Although I have years of quality experience, I've always working in companies that manufacture products, and that have a solid quality management system.

I've recently started a new job where I need to build up the quality system in a very small company which is focused on research and development for a LDT product.

Since I've never really worked with R&D I'm unsure how much quality to "force upon them". For example, sometimes they wear lab coats, but sometimes not. Where can I find out the minimum quality requirements for R&D.

Thanks very much.

Hi,

Would it be accurate to say that at some point in the future the designs emerging from this company are likely to be implemented on the European and/or the USA market? If so, then I'd recommend applying Design Controls from this stage onward - either by ISO 13485 (s. 7.3) or by 21 CFR 820.30. Some of the more general provisions of either of those systems (e.g. Document Control, Internal Auditing etc.) are likely to be beneficial as well.

Regarding the lab coats example, I wouldn't refer to it as "QA". It's either a H&S issue or a GMP issue. If there's a solid reason behind it, then it should be standardized and enforced. Not everything has to be "managed" on small start-up companies, though.

Cheers,
Ronen.

 

[Mandy]

Very good points Ronen. Thanks