API Q1 and R&D department (?)

[jennin77]

Hi,

I see many companies having a R&D department in the organization chart but no real procedure for that and no inclusion in the quality manual, no management in the Q1.

Do you think it is acceptable from a QMS point of view? Are you aware of any interpretation of the API Q1 related to R&D?

 

[SPDL310]

Q1 does not mandate any defined organizational structure. Where R&D is placed in the org would depend on the duties it performs, but in most cases I would assume it falls underneath the umbrella of the engineering department.

If R&D is tasked with the development of of new products and procedures. As long as they follow design and documentation control procedures listed in Q1 and other applicable specifications I don't see an issue with that. I know that there are some tax write off for R&D personnel, and designating a specific department for those personnel makes it easier to account for those tax breaks.

Another scenario is that The R&D department is dedicated solely to research application that doesn't include product design. The group would then be outside the scope of the quality plan and Q1.

Regardless of the function of these R&D departments they obviously square with these companies QMS, if they are API license holders, as they are passing annual audits.

 

[jennin77]

Hi SPDL310, thanks a lot, great feedback