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What makes someone a "Qualified Individual"?

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OG Bean

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Posted 06 February 2019 - 05:21 PM

What makes somone a "Qualified Individual"?  Is it training only or does experience play a role?  How would you define it?


This is often a source of discussion during my audits.  I feel it's hard to define a qualified individual because a single item doesn't define it.  In some cases training defines it, but in other cases experience is the defininfg factor.


I have been known to overcomplicate things on the occasion, would that be the case here?



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Posted 06 February 2019 - 05:37 PM

This I believe will always be a topic of discussion. Each (education/training vs experience) come with their strengths and weakness.


I know there are more but here are a few threads. On the Food Safety Friday PowerPoint - it gives the definition of what the FDA considers a Qualified Individual.


https://www.ifsqn.co...s and HACCP.pdf



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Posted 06 February 2019 - 05:42 PM

According to the FSMA regulations for animal feed, 21 CFR Section 507.3, the definition is as follows:


Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.


I would say that you both are correct based on the definition at least if you look at the animal food regulations!



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Posted 06 February 2019 - 05:45 PM

Agree with KfromIA, I think the bottom line is whichever "qualifications" you have (training, experience, etc.), you need to be able to demonstrate that you are competent in the subject matter (likely as a result of the training/experience) and are therefore qualified to be the primary person overseeing food safety programs, policies, etc. 



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Posted 06 February 2019 - 07:37 PM

An example of a qualified individual would be that I am considered a qualified individual for the purpose of FSMA strictly based on experience and not on taking courses and gettting a certificate.


Likewise one could say that a person having been involved in food factory environment and conducting Internal Audits for years would also be a QI and be able to train others.


QI can also come from a combination of experience and training and while I have seen greenies take a PCQI course and get a certificate of training it is difficult to accept them as a QI as they lack practical experience.

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Glenn Oster.









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