Applicability and CGMPs
Hazards
Preventive Controls
Qualified
Not Elsewhere Classified
100
The GMP requirements are primarily located in these two subparts
What are Subparts A and B?
100
Part 117 requires facilities to consider these three categories of hazards
What are biological, chemical including radiological, and physical hazards?
100
What is the goal of a preventive control?
What is to provide assurance that a hazard requiring a preventive control will be significantly minimized or prevented and that the food will not be adulterated or misbranded?
100
All employees engaged in manufacturing, processing, packing, and holding of human food must be these individuals
What are qualified individuals?
100
This section of the Hazards and Controls guidance contains tables of commodity/hazard associations
What is Appendix 1?
200

This Part of Title 21 of the Code of Federal Regulations will be removed in September 2018


What is Part 110?
200
What is the goal of the hazard analysis?
What is to identify known or reasonably foreseeable hazards and determine if any require a preventive control
200
These are the five types of preventive controls specified in Part 117 (not including the category "other")
What are process, food allergen, sanitation, supply-chain preventive controls and recall plan?
200
This organization provides the standardized curriculum recognized as adequate by FDA for the PCQI.
What is the Food Safety Preventive Controls Alliance?
200
Q. If you are trying to determine if a firm has a preventive control program that may not be traditional CFR nomenclature, which systems thinking-based skill would you use?
A. What is open-ended questions.
300
This section of the GMPs was newly established in Part 117
What is 21 CFR 117.95 Holding and Distribution of human food by-products for use as animal food?
300
If a facility concludes there are no hazards requiring a preventive control, must this conclusion be documented?
The hazard analysis must be written regardless of the outcome.
300
Facilities must manage their preventive controls by conducting as appropriate these three types of activities, collectively known as preventive control management components
What are monitoring, corrections and corrective actions, and verification?
300
True or False: The PCQI must be an employee of the facility
False: A PCQI may be, but is not required to be, an employee of the facility.
300
Which Systems Thinking habits should be used when performing an inspection using a systems approach?
What are: looking at the big picture, recognizing interdependencies, assessing from many perspectives?
400
An alcoholic beverage facility is subject to these subparts of Part 117
What are Subparts A, B, and F?
400
Name three entities in the supply-chain who can control hazards
Who are the facility, the ingredient supplier, or a customer?
400
Name three components of a facility's written corrective action procedures.
What are: 1) Appropriate action is taken to identify and correct a problem that has occurred with the implementation of a preventive control; 2) Appropriate action is taken to reduce the likelihood of recurrence; 3) All affected food is evaluated for safety; 4) All affected food is prevented from entering commerce if safety cannot be assured
400
Per 117.4, the training in these two subject areas must be documented.
What are food safety and food hygiene?
400

If a facility does not identify a hazard requiring a preventive control that it should have identified, and the facility is not implementing controls for that hazard, what is the FDA investigator’s best course of action?

What is: Cite the firm for not identifying a hazard requiring a preventive control and support the cite with observations of the lack of appropriate controls

500
A facility that manufactures low-acid canned foods is subject to these subparts of Part 117.
What are: Subparts A, B, and F for microbiological hazards controlled under the LACF regs; A, B, C, and G for chemical and physical hazards
500
Name three reasons why hazards may be in foods
What are because the hazard occurs naturally, is unintentionally introduced, or is intentionally introduced for the purposes of economic gain (where there is a food safety impact)
500
What are three components of the supply-chain program?
What are using approved suppliers, following written procedures for receiving raw materials and other ingredients, and conducting supplier verification activities?
500
Name three responsibilities of the PCQI.
What are: Preparation of the food safety plan, validation of the preventive controls, written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production, determination that validation is not required, review of records, written justification for review of records of monitoring and corrective actions in a time frame that exceeds 7 working days, reanalysis of the food safety plan, and determination that reanalysis can be completed in a timeframe that exceeds the first 90 calendar days of production?
500
This is the expected supplier verification activity when the hazard requiring a supply-chain-applied control is one that has the potential to cause serious adverse health consequences or death to humans
What is an onsite audit?
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