Frequently missed Questions Quiz 2 Flashcards
A recall plan is only required by the FDA for food processors whose hazard analysis identified hazard(s) requiring the use of Preventive Control(s).
TRUE - answer straight out of chapter 15, and is the statement right on the Module 2 Introduction page, beneath where my video of “additional notes” is attached.
Your FDA-compliant recall plan requires that a different named person holds each of the following listed positions of responsibility: Recall Coordinator, Operations Manager, Public Relations Representative, Marketing Specialist, Logistics Coordinator, QA technician, Administrative Support Personnel and Regulatory Compliance Attorney
FALSE - You are asked to name who holds each of those positions, but there is no requirement that they all be held by different people. This was clearly stated in my video of “additional notes” for Ch 15.
In the situation where your company was involved in a Class 1 recall of product that was mis-branded (failed to have a contained allergen listed on the label) and your recall notification includes details of how you plan to have product sent back to your processing location for re-labeling, the FDA cannot require you to land-fill that product.
FALSE - I told you in the beginning of the video for Ch 15 that you can REQUEST that product be re-worked, but the FDA can over-rule your wishes and demand that the product be sent to land-fill.
Notification of the public is only appropriate or required by the FDA if a food has been found to contain a microbial pathogen such as Salmonella that was confirmed by FDA testing and the product has already left your control.
FALSE! - Class 1 recall requiring notification of the public could be caused by a microbial pathogen OR a hard/sharp pieces of foreign material such as broken glass or metal shavings OR presence of a toxin or mis-labeled allergen. I discussed examples from all 3 types of hazards with the slide for recall classifications near beginning of the video of “additional notes” for Ch 15.
Pre-FSMA food processors were only required to be able to track and recall food or ingredients for one step forward or one step backwards but now the FDA requires that food processors must be able to trace their food ingredients all the way back to the original grower of the plants or the person who raised the animal.
TRUE - how else would you determine if you needed Supply Chain Preventive Controls?
Training materials for the FSMA rules were released after a committee of people from academia, regulatory and food-processing backgrounds worked together on the Food Safety Preventive Controls Alliance, and the only other country with a member on the FSPCA was Canada, because they already had similar rules in-place for their residents.
TRUE - I talked about this in my personal “Introduction” video.
An “Educate as you Regulate” policy allowed FDA Inspectors to enter food processing establishments prior to their compliance deadlines, and offer them ‘advice’ on situations that would become violations at a later date, without actually citing them with a Form 483a, but the time for that has now passed.
TRUE - again, was mentioned in my Intro video.
FSMA regulations were broken-up into a number of separate rules that each had their own compliance deadlines and training materials, but several of them, including the “Preventive Controls for Human Food” and the “Preventive Controls for Animal Feed” require that “Qualified Individuals” oversee the Plan and records review.
TRUE - was noted in Ch 1 in the definitions section for “Qualified Individual” and in the chapter on “Regulations” and in my “additional notes” video
Q19 Each FSMA rule is only applicable to that specific industry segment (i.e. human food processors need PCHF, pet food companies need PCAF, Farmers need the Produce Rule, Truck drivers need the Sanitary Transportation Rule, Audit companies need the Qualified Auditor Rule, etc.) so that companies only ever need to worry about one set of rules at a time.
FALSE - I mentioned in my “additional notes” video that depending on what type of product you make, your company could be subject to multiple or all of the FSMA rules.
Q20 Because U.S. food processing companies had all of the FSMA Rules fully in-place before March of 2020, the recent COVID-19 pandemic has had no noticeable impact on the way U.S. food processors conduct their business, unlike the business disruption and widespread famine-taking place in other parts of the world.
FALSE - Did you WATCH the video titled “Food Processing in the time of COVID-19 - 2021”??? There are MANY changes that food processors had to make, in order to achieve “social distancing” and lessen the likelihood of employees spreading illness to their co-workers, and also the last part of that statement is also “false” because the rest of the world has not yet experienced “wide spread famine”.
