The problem, of course, is that it varies greatly depending on things like
# of products
product risk classification(s)
somewhat related to the above, #s of reportable events for the products
# of geographies in which products are sold (and expectations of how quickly new products are submitted in each)
# of R&D projects (or manufacturing change projects) to support etc
# of manufacturing facilities
It is less dependent on # of employees or revenue, except to the extent the impact the above (including post market burdens on the RA/QA team)
So, in one instance, a company with one product, 2 geographies, moderate to high risk product, double digit reportable events annually and 2-3 R&D projects had 1 RA and 1 QA person and did fine. As they added manufacturing capability, 2-3 QC folks were added. As they add geographies (particularly EU and Japan) the plan would be to add more.
Another company with only 2 products, but 10+ geographies and PMA/Class 3 has 4 RA people and 3 (I think) QA people. Bigger companies may have more, but it is hard to use their ratios, as specifically what work is done tends to vary from smaller companies.
Software in particular, is challenging to assess, but I would tend to map out the work/timing and then estimate how many are needed, rather than trying to use a ratio, which (experience says) will vary all over the map.
Ginger
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 28-Nov-2022 03:58
From: Franky Dubois
Subject: QARA resource percentage ?
Hello,
I just have a quite open question.
Is there somewhere an industry average percentage available of QARA staff versus the total company size.
We are a software company with 42 people and have 1.4 QARA --> about 3% This feels as insufficient, especially with all additional local legislations and registrations
Greetings,
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Franky Dubois
QA/RA Manager
Gent
Belgium
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