FSMA PCQI key terms

A written evaluation of known or reasonably foreseeable biological, chemical, and physical hazards for each food, including hazards that may occur naturally, be unintentionally introduced, or be intentionally introduced for economic gain.

A known or reasonably foreseeable hazard for which a person knowledgeable about food safety would establish a control because the hazard is reasonably likely to occur and its severity and probability justify action.

A risk-based, science-based control procedure, practice, or process that significantly minimizes or prevents a known or reasonably foreseeable hazard, established when the hazard analysis shows one is needed.

A control applied to a manufacturing step that affects the food itself, such as cooking, pasteurization, acidification, refrigeration, or metal detection, to prevent or eliminate a hazard or reduce it to an acceptable level.

A control that keeps the food-contact environment clean enough to prevent allergen cross-contact, pathogen growth or spread, or other contamination, commonly applied to food-contact surfaces and equipment.

A control that prevents allergen cross-contact or undeclared allergens in a finished food through measures such as dedicated lines, sequenced production, validated cleaning, ingredient segregation, and label verification.

A written program that ensures raw materials and other ingredients are received only from approved suppliers and, where needed, verified through supplier approval, audits, sampling, or other verification activities before use.

A supplier of a raw material or ingredient that has been evaluated and accepted under the facility's written supply-chain program procedures before the material is received and used.

An activity such as an onsite audit, sampling and testing, review of the supplier's food safety records, or another equivalent method used to confirm that a supplier controls the hazard identified in the hazard analysis.

A measurable maximum or minimum value that must be met at a control point to prevent, eliminate, or reduce a hazard to an acceptable level, such as a minimum cooking temperature or maximum line speed.

Scheduled, documented observations or measurements performed to confirm that a preventive control is operating as intended and that critical limits are being met.

A documented action taken to identify and correct a problem with a preventive control, reduce the affected food's hazard risk, prevent recurrence, and evaluate the food's safety before release.

A failure to meet a critical limit or other control requirement during production, which triggers corrective action, product disposition review, and possible reanalysis of the food safety plan.

The documented decision about what to do with food affected by a deviation, such as holding, reworking, reprocessing, diverting to a safe use, or destroying it, based on an evaluation of its safety.

Activities other than monitoring that confirm the food safety plan is implemented correctly and effectively, including record review, calibration checks, product testing, and environmental monitoring.

The scientific and technical evidence gathered before a control is relied on to show that it, as designed and implemented, will control the identified hazard when properly applied.

A required reevaluation of the food safety plan when a significant change occurs, when a preventive control fails, or when new information about a hazard emerges, performed by a qualified individual.

A program of sampling and testing food-contact surfaces and the surrounding environment, often for pathogens such as Listeria, to verify that sanitation controls are preventing contamination.

A microorganism whose presence signals that sanitation or process controls may be failing, even though the organism itself may not cause illness, such as generic E. coli or Listeria species on a food-contact surface.

A disease-causing microorganism such as Salmonella, Listeria monocytogenes, E. coli O157:H7, or Clostridium botulinum that can contaminate food and cause illness if not controlled.

A living source of foodborne illness risk, including bacteria, viruses, parasites, and their toxins, that must be evaluated in the hazard analysis and controlled when reasonably likely to occur.

A harmful substance that may enter food, such as cleaning chemicals, pesticides, mycotoxins, heavy metals, or unapproved additives, that is evaluated and controlled when reasonably likely to occur.

A hard or dangerous foreign object, such as metal, glass, plastic, bone, or stones, that could injure a consumer and must be evaluated and controlled when reasonably likely to occur.

The unintended introduction of a major food allergen into a food that does not declare it, occurring through shared equipment, utensils, air, or personnel, and requiring preventive controls.

The intentional substitution, dilution, or addition of a substance to a food to increase its apparent value or reduce cost, which the hazard analysis must consider as a potential hazard.

The written, facility-specific document that contains the hazard analysis and the preventive controls, supply-chain program, recall plan, and procedures needed to control identified hazards.

A person who has successfully completed training in developing and applying risk-based preventive controls, or has equivalent job experience, and who prepares or oversees the food safety plan.

A person or organization with recognized scientific expertise that establishes or validates a scheduled process, such as a thermal or acidification process, for a specific food and container.

A written procedure describing how to notify customers, retrieve or correct affected product, and conduct effectiveness checks when a food must be removed from the market.

The removal or correction of a marketed food that is unsafe or misbranded, classified by health hazard severity, and requiring documented effectiveness checks to confirm that recipients acted.

The ability to follow a food or ingredient forward to customers and backward to suppliers through lot-level records, so that affected product can be identified quickly during a recall.

The step at which incoming ingredients and materials are inspected and documented, including checking supplier approval, temperature, condition, and labeling before acceptance into the facility.

A check that the finished product label correctly declares all ingredients and major allergens and matches the formulation actually produced, helping prevent undeclared allergen recalls.

The baseline hygiene, personnel, plant, and process requirements that all food facilities must meet, forming the foundation on which preventive controls are built.

A hazard whose probability of occurring in the absence of controls is high enough, given the facility's experience and available data, that a preventive control is expected to be needed.

Any biological, chemical, or physical agent, or condition of food, that has the potential to cause illness or injury to the consumer if it is not controlled.

A documented evaluation of which ingredients or processes are most susceptible to intentional adulteration, used to decide whether mitigation strategies are needed under the intentional adulteration rule.

A verification activity in which a qualified individual reviews monitoring, corrective action, and calibration records within a set timeframe to confirm that controls worked as intended.

A person who, by education, training, or experience, is competent to perform a specific assigned task such as record review, monitoring, or corrective action decision-making.