Quiz 9 Flashcards
OSHA regulations require that all food-processing locations have a written Hazard Analysis explaining all of the potential food safety hazards with that processing environment, with lists of potential hazards that must be monitored on a daily basis that must be physically present at each location, or accessible via computer.
False
After identifying known or reasonably foreseeable potential food safety hazards, your hazard analysis evaluates severity of the hazards and likelihood of the hazards occurring in your situation and facility, to determine if each potential hazard needs a Preventive Control or if it can be handled by a prerequisite program or SOP.
True
The FDA has published a worksheet showing their preferred format for a Hazard Analysis in the textbook for this course, and that is the only format acceptable to the FDA inspectors when they audit food-processing facilities.
False
The exact same “thing” might or might not need to be a PC (Preventive Control), depending on what you do during your “process” and depending on who is your customer and whether the product leaves you as ready-to-eat or ready-to-cook.
True
“Intended or reasonably foreseeable use” and the “actual use by consumers” can change over time, but is of no concern to you, because the company cannot control what a consumer might do with a food after it is purchased.
False
“Severity” of a food safety hazard is determined by researching number of people who died from that hazard in the past, and dividing by the number of years researched, to determine if it is a statistically significant number
False
Likelihood of occurrence” of a food safety hazard might be determined by researching the history of occurrence in your facility, for your competitors, from published past foodborne outbreaks, and from the scientific literature.
True
Historical information from your own facility that should be taken into account during the hazard analysis would include laboratory test results from your ingredients, your finished products and your environmental testing.
True
Factors affecting likely occurrence of a foodborne hazard that must be considered in your hazard analysis would include the ingredients used, your processing operations, and your storage and transportation conditions.
True
The FDA definition for “Preventive Controls” includes the phrase ”consistent with current scientific understanding” so that food processors can define their own “new” controls for hazards in order to maintain profitable prices.
False
The four basic types of Preventive Controls (PCs) that the FDA expects to see included in food safety plans are: Supply Chain PCs, Food Allergen PCs, Sanitation PCs, and Consumer Preference PCs.
False
Different from traditional HACCP CCPs that are the “last best place to control a significant hazard”, Preventive Controls might not by themselves actually “control” a hazard, but might need to have multiple PC “hurdles” working together to achieve “control”.
True
If a food processor does not have a “cook step” or some other type “kill step” in their process, the FDA considers their finished product to be unsafe and subject to be recalled any time an FDA Inspector comes to the facility.
False
Filters, sieves, bone separators, metal detectors and X-ray machines could all be examples of Process Preventive Controls for removing physical hazards from food materials during your processing operations.
False
When conducting a Hazard Analysis for a food processing operation, products can safely be grouped together into the same Plan as long as all the same equipment is used for all of the formulations that are grouped together, regardless of their ingredients.
False
FDA regulations require that you have at least one written Preventive Controls Food Safety Plan available for inspection at your processing location; if that one plan is found to be accurate, the FDA will certify that all of your products are safe by issuing you a Form 483 for the facility.
False
Your company is not legally responsible for serious food safety hazards that occurred while ingredients or finished food product was still at a supplier’s location and not yet in your control inside of your processing facility.
False
The “Preventive Controls Qualified Individual” listed in your Food Safety Plan must show the FDA inspector their FSPCA-issued Preventive Controls for Human Food (PCQI) training certificate upon request or within 24 hours, in order for your company to keep it’s FDA grant of Inspection.
False: certificate from this class is only one way you can be a PCQI individual and this certificate is not required to be shown to the FDA.
As a required part of your FDA-mandated Food Safety Plan, a written Hazard Analysis (over all ingredients and food contact packaging materials) and copies of all processing forms and documentation must to be filed with the FDA and written approval issued by the FDA to the production facility prior to the start of producing the food for sale to the public.
False: USDA requires prior plan approval, and package labels but FDA does not require prior approval.
