HACCP/ HARPC
This is a systematic, science-based approach to identifying, evaluating, and controlling food safety hazards.
What is a HACCP plan?
21 CFR 117, 21 CFR 111
What is the CFR reference for Good Manufacturing Practice (GMP)?
An activity or set of activities performed to ensure the food quality and food safety requirements are met.
What is a quality program?
These define the type of recall and what kind of correction they require.
What are the three classes of a recall?
When there is a mandatory recall, or a re-inspection, they are responsible to pay for it.
Who is the Company?
Before the Food Safety Modernization Act of 2011, these three food categories were the only ones federally required to have HACCP plans.
What are seafood, juice, and meat/poultry?
These programs support the HACCP plan by controlling general hazards in the processing environment, rather than hazards at specific critical control points.
What are prerequisite programs
An integrated set of documented food quality and food safety activities with clearly established inter-relationships among the various activities
What is a quality system?
"a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure"
What is a recall?
A recall plan must be included in a food safety plan when this condition is met.
What is when a hazard requiring a preventive control is identified?
In HARPC regulations, this term refers to someone with education, training, or experience (or a combination) necessary to develop and apply a food safety system.
What is a qualified individual?
Water quality, Extraneous Control, GMPs, Pest control
What are examples of prerequisite programs?
The purpose of this information page is to serve as a self reported early alert system for public health threats and track patterns in food safety incidents.
What is the Reportable Food Registry?
“… a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration, or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.”
What is a Market Withdrawal?
Used to boost yield and tolerate environmental stress, these crops have sparked debate over labeling and ecological effects.
What are GE or GMO products?
This term refers to the process of ensuring a HACCP plan is scientifically sound and capable of controlling hazards before it's fully implemented. This is not to be confused with This term, which refers to the ongoing process of confirming that a HACCP plan is being followed correctly and is working as intended.
What is validation and verification?
Every 3 years for high risk and every 5 years for low-risk.
This program has 8 key points of success and is based on the participation of all members of an organization. Companies using this system are up for award from the government for excellence.
What is Total Quality Management (TQM)
“… a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.”
What is a Recall Strategy?
This FDA guidance declared that genetically modified foods are generally treated the same as traditional foods unless they present new safety concerns.
What is the 1992 FDA Statement of Policy: Foods Derived from New Plant Varieties?
These are the 7 principles that form the foundation of HACCP.
What are:
Conduct a hazard analysis
Identify critical control points (CCPs)
Establish critical limits
Establish monitoring procedures
Establish corrective actions
Establish verification procedures
Establish record-keeping and documentation procedures?
Under FSMA, records for this program must be kept for at least 2 years and be available to the FDA upon request.
What is the Foreign Supplier Verification Program
This updated version of quality system applies specifically to food (while other versions apply to other companies) and maps out what an organization needs to do to demonstrate its ability to control food safety hazards to ensure that food is safe. It is voluntary and can be certified via 3rd party auditor.
What is ISO 22000
21CFR7.40-21CFR7.59
What is the section of the CFR with Recall Regulations?
This system, compared to HACCP, applies to nearly all FDA-regulated foods, includes radiological hazards, requires a written recall plan, focuses on preventive controls beyond CCPs, and mandates supplier verification.
What is HARPC?