Regulatory Open Forum

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  • 1.  QARA resource percentage ?

    Posted 28-Nov-2022 03:59
    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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  • 2.  RE: QARA resource percentage ?

    Posted 29-Nov-2022 09:47
    My previous company was 5% (2 people for 40 total). That was for a mature medical device company that outsourced all manufacturing. I felt like that was sufficient given the maturity of the product. With newer companies hoping to expand into different markets the percentage should be higher to have more RA folks. And, if your company is newer and has not established good supplier relations, you'll likely need more QA folks. 

    Interested to see what others have for percentages...

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    Joseph De Croos PhD
    Director, Quality Assurance & Regulatory Affairs
    Kitchener ON
    Canada
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  • 3.  RE: QARA resource percentage ?

    Posted 29-Nov-2022 10:55
    I lead a 3-person team in a 30-person start-up for med devices. 10%

    #1 I lead the direction of the team, communicate with regulatory bodies, and stay informed of changes to guide resources. I present at board meetings and investor meetings. 

    #2 is the engine member actually documenting most of the QMS - This is the "QMS Expert" and can answer details about label symbols, where info is at, how many CAPA are open/closed, Drives Change notice to closure, etc.

    #3 is a catch-all employee focused on DHRs, training, production issues, etc.​​​

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 4.  RE: QARA resource percentage ?

    Posted 29-Nov-2022 11:15
    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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  • 5.  RE: QARA resource percentage ?

    Posted 29-Nov-2022 12:06

    Franky,

    It really depends on what all you are performing work wise. i typically see anywhere from 10-20% which can include the RA team. I currently have around 7% but not all of our organization is involved in the QMS today. From a CM environment I've seen it on the higher side because we had a lot of inspectors. 

    From your info that seems low, you need to justify what is needed and if supported you will get it. 

    Hope that helps,

    Brooks



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    Brooks Sease
    Mr.
    Lansing MI
    United States
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  • 6.  RE: QARA resource percentage ?

    Posted 30-Nov-2022 00:44
    Hello Franky,

    This was an interesting discussion I had over the years managing regulatory and quality departments.  As you can imagine the number of people or percentage of overall company in the roles did not stay the same or even go up, but always went down.  I had discussions with people about a "magic number" of QC inspectors, QA persons, RA persons in a company based on size.  What I found is there were about 1 QA person per 20 - 26 employees, 1 QC person per 10 - 20 production personnel, and 1 RA person per 30 - 45 employees.  This of course highly depended on the product complexity and classification of the product.  I have seen with the EU MDR the number of RA and post market personnel needing to increase (although this does not always happen).  I think with software products you are looking at a lower number of employees per QA person, but more importantly, needing a dedicated QA Software person especially if you are doing design and development (software development) internally.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 7.  RE: QARA resource percentage ?

    Posted 03-Dec-2022 10:04

    You are looking for a staffing model. Percentage of total employees is a common approach, but there are other methods as well. One good one looks at the activities you need to perform over time, say during one year, and estimate their number and time to complete (mean and standard deviation).

    As a starting point consider  some common activities such as internal quality audits. How many do you perform in a year and how long does each one take. Along the same line, you could how many customer audits you host each year as well as how many audits (or inspections( from regulators. The common activities probably include design changes, management review, incoming inspection, etc.

    Less common activities may include filing an MDR with FDA, an EU Vigilance Report, and populating the various UDI databases.

    As part of the Paperwork Reduction Act, FDA must make these estimates for its regulations and update them on a regular basis. Consider 21 CFR Part 820 as an example. In the early days, FDA estimated the time by section. In the most recent case, they estimate by Subpart. https://www.federalregister.gov/documents/2022/08/22/2022-18072/agency-information-collection-activities-proposed-collection-comment-request-current-good

    For Purchasing Controls-Subpart E, they estimate there are 29,424 companies that keep records in this area and that, on average, each company will spend 28 hours per year on these records. As an other example, the same 29,424 companies spend an average of 6 hours per year for Acceptance Activities-Subpart H. (Unfortunately, FDA doesn't provide any measure of variability with the estimates.)

    FDA has estimates for all the Parts of device regulations such as 803, 806, 807, and 830.

    In my experience, the FDA estimates are low, so you should double or triple them. You should  also add additional time for corresponding activities in ISO 13485:2016 that are not in FDA QSR. If you have implemented EN ISO 13485:2016/A11:2021 add even more time.

    Start with the FDA approach, develop the model for your company, make the estimates over one year, and add them up. Convert the times to full-time equivalents for QARA, and you will have a staffing model.

    At Management Review, discuss any changes in regulations and, as part of resources, include changes in the staffing model.

    For example, FDA will issue the final rule for QMSR. In the draft rule they estimate that for companies that already have ISO 13485:2016 will need 2.6 hours to learn the new regulation. For companies that don't have ISO 13485:2016 (FDA estimates there are 4,445 such companies) the one time burden is 64 hours.

    The annual record keeping estimate for Quality Management System (proposed §820.10 and ISO 13485) is 348 hours. The annual record keeping estimate for Control of records (proposed §820.35) is 2 hours. Note that the proposed §820.35 includes all complaint records.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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