7 replies to this topic

[hoalefst.vn]

I would like to request clarification regarding the training requirements for becoming a Food Defense Qualified Individual (FDQI) under the FSMA Intentional Adulteration (IA) Rule. According to FSPCA, there are four IA training courses, each aligned with specific regulatory responsibilities: (1) IA Food Defense Plan Preparation and Reanalysis – supports §121.126 and §121.157; (2) IA Conducting Vulnerability Assessments Using KAT – supports §121.130; (3) IA Conducting Vulnerability Assessments (full VA method) – supports §121.130; (4) IA Mitigation Strategies – supports §121.135. My question is: for one individual to be considered a fully qualified FDQI responsible for preparing the food defense plan, conducting the vulnerability assessment, identifying mitigation strategies, and performing reanalysis, does FDA expect that person to complete all four courses, or is there a minimum combination that satisfies the competency requirements in 21 CFR 121? Additionally, if training is taken from a non-FSPCA provider in Vietnam, but the curriculum fully matches the official FSPCA IA materials and covers all FDQI responsibilities in §121.126, §121.130, §121.135, and §121.157, would FDA consider this acceptable for FDQI qualification during inspection, especially in cases where English presents a significant language barrier?

 

[chrcia228]

Following 

[TimG]

Good morning. While I haven't confirmed this with research, I have been told by several auditors that the FDA's Food Defense 101 'course' (its really just like a half hour or an hour little training session) complies. It lets you print out a certificate of completion at the end.

 

If you want to get a pretty well-rounded more in-depth class for it, AIB at one time offered a food defense online course that was about a day or so in length. I recommend that for anyone who is writing the food defense plan, but I'm pretty sure the FDA 101 meets the requirements.

[kconf]

That is correct. I have taken the free Food Defense course myself.

[G M]

Having been through a long certified version of the training, it was made clear before hand that doing that version was not a requirement.  Practical industry experience can also qualify you.

[kingstudruler1]

if you are unfamilar with food defense, I believe taking those courses is a good idea.   In theory, you could pick between the KAT course and full VA method (just three courses).   The KAT method is much simplier than the full method.   For the most part I only use KAT.   Probably advantages to both.  

[jfrey123]

Having some training certificates is kind of nice, but all too often someone goes and gets a cert but lacks the ability to practice what they just learned in a real life scenario.  But some food for thought:

 

eCFR :: 21 CFR 117.3 -- Definitions.

"Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe 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."

 

Note FDA doesn't truly define a "Food Defense Qualified Individual" per se, they merely point out what they expect from a "qualified individual" to do any task involved in food safety.

 

Jumping forward to 21 CFR 121.126:

eCFR :: 21 CFR Part 121 -- Mitigation Strategies to Protect Food Against Intentional Adulteration

Qualifications of individuals for certain activities described in paragraph ©(3) of this section.

Each individual assigned to certain activities described in paragraph ©(3) of this section must:

(1) Be a qualified individual as that term is defined in § 121.3—i.e., have the appropriate education, training, or experience (or a combination thereof) necessary to properly perform the activities; and

(2) Have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.

(3) One or more qualified individuals must do or oversee:

(i) The preparation of the food defense plan as required in § 121.126;

(ii) The conduct of a vulnerability assessment as required in § 121.130;

(iii) The identification and explanation of the mitigation strategies as required in § 121.135; and

(iv) Reanalysis as required in § 121.157.

 

So long as a person can demonstrate they possess knowledge to complete the food defense plan, vulnerability assessment, and identify/explain their mitigation strategies to satisfy the CFR's in 121.126, 121.130, 121.135 and 121.157, they are qualified to hold the FDQI role.  If those plans are in place, really the only way to challenge the person's qualifications would be for the FDA to audit the plan and determine whether there are any flaws in what was implemented.

[TimG]

Be aware that customer auditors and GFSI will be looking for verification of qualification. FDA might not challenge your qualifications, but your customers auditor absolutely will. The food defense 101 course takes 15 minutes to do.

If you're going to spend 30-60 minutes each audit proving you are qualified to hold the FDQI role instead of 15 minutes once and 2 minutes each audit to pull up the cert...well.