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FSMA
HACCP 101
Hazards
Prerequisite Programs
Miscellaneous
100
What is a "small business", as defined by FDA?
A business employing fewer than 500 full-time equivalent employees.
100
What does HACCP stand for?
Hazard Analysis Critical Control Point
100
What kind of hazards are E. coli and norovirus?
Biological hazards
100
What does cGMPs stand for? And what is the name of the regulation (must include the subpart)
current Good Manufacturing Practices. 21 CFR 117 Subpart B
100
This activity takes place prior to implementation of the HACCP plan to ensure its effectiveness
Validation
200
When is the compliance deadline small businesses must comply with the Preventive Controls for Human Food rule? (month and year)
September 18, 2017.
200
What is a critical control point?
A critical control point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
200
Shrimp is categorized as what type of hazard? Biological, chemical or physical?
Chemical (because shelfish, it is a major food allergen)
200
What 4 things sum up the cGMPs?
1. Clean 2. Cleanable 3. Functional 4. Good condition
200
This step takes place annually or when changes occur and can be performed by the HACCP team or a outside consultant.
Verification
300
According to the Preventive Controls for Human Food rule, all employees must be trained (and the training documented) on these two topics
Food safety and food hygiene
300
Once a company has established the HACCP team, the next step is to...
Describe the product and its distribution
300
Cross-contamination with wild yeast leads to quality defects in beer, but no adverse health consequences. Is wild yeast a hazard?
No
300
What is the difference between an SOP and a policy?
A policy is a brief explanation of a company's expectations. It doesn’t fully explain to employees how the company expects them to fulfill that expectation. An SOP tells employees exactly what the company wants them to do.
300
When is a corrective action taken?
Corrective actions are performed when a deviation occurs.
400
How does one become a Preventive Controls Qualified Individual?
Training (FSPCA PCQI training) or equivalent experience
400
The following two things should be considered when determining the significance of a hazard
Likelihood and severity
400
True or false: a parasite is a biological hazard
True
400
Name 2 examples of "additional Prerequisite Programs" (hint: they are not cGMPs)
- Document control - Product recall & traceability - Allergen control - Food defense
400
What is the difference between a Class 1, 2 and 3 recall?
- Class 1 = reasonable probability of serious adverse health consequences or death - Class 2 = May cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. - Class 3 = Not likely to cause adverse health consequences.
500
True or false: Breweries are exempt entirely from FSMA's Preventive Controls for Human Food rule
False: breweries must still comply with Subparts A (General provisions), B (cGMPs) and F (records)
500
What is the next step after you conduct a hazard analysis and determine a hazard requires a CCP?
Establish a critical limit.
500
Name the 3 ways a hazard can be dealt with
Prevented, eliminated or controlled
500
Where and how should toxic chemicals be stored?
Secured in a locked cabinet away from food processing and storage areas
500
What does GFSI stand for? Can you name a GFSI benchmark scheme?
Global Food Safety Initiative. SQF BRC Global Standards Food Safety System Certification 22000 Global G.A.P. Primus GFS