FSMA PCQI flashcards
FSMA PCQI · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Hazard requiring preventive control
- A hazard identified in the hazard analysis as reasonably likely to occur and that must be controlled by a preventive control to prevent illness or injury.
- PCQI definition
- Preventive Controls Qualified Individual: a person who has completed training or has experience to develop and oversee a food safety plan and its preventive controls.
- Process control
- A preventive control that affects a manufacturing parameter, such as a thermal kill step, pH, water activity, or metal detection, to control a hazard.
- Sanitation control
- A preventive control that addresses hazards from the environment, food-contact surfaces, or cross-contact, typically specifying cleaning frequency and verification method.
- Allergen cross-contact
- A chemical hazard in which an allergen unintentionally enters food, controlled by segregation, dedicated lines, cleaning validation, and label verification.
- Hazard analysis requirement
- A documented evaluation of biological, chemical, and physical hazards that identifies which hazards are reasonably likely to occur and require controls.
- Reasonably likely to occur
- A risk-based determination that a hazard can occur absent controls, based on experience, data, and the nature of the ingredient or process.
- Preventive control parameter
- A measurable value, such as temperature, pH, or water activity, that, if met, ensures the preventive control is effective.
- Supply-chain control
- A preventive control applied when a hazard in an ingredient is controlled before receipt by the supplier, requiring supplier approval and verification.
- Reanalysis trigger
- A required review of the hazard analysis at least every three years and whenever a significant change or new hazard information occurs.
- Monitoring procedure
- A written procedure specifying what is monitored, how, at what frequency, and by whom, to provide evidence a preventive control is implemented.
- Monitoring record
- A documented observation made at the time of the activity that provides evidence a preventive control is consistently implemented.
- Deviation
- A failure to meet a control parameter or critical limit that requires corrective action and evaluation of the affected product.
- Monitoring frequency
- The interval at which a preventive control is observed, set so that a deviation is detected before product is affected.
- Environmental monitoring
- Testing of food-contact surfaces or the environment for pathogens to verify sanitation controls are effective in controlling environmental hazards.
- Validation
- The process of establishing that a preventive control, as designed and implemented, is capable of controlling the identified hazard.
- Verification
- Activities that confirm a preventive control is implemented as designed, including calibration, product testing, record review, and supplier verification.
- Corrective action
- The action taken to identify the cause of a deviation, correct it, reduce recurrence, and evaluate the affected product for safety.
- Affected product evaluation
- A documented assessment of product produced during a deviation to determine whether it is safe, requires rework, or must be disposed of.
- Calibration
- A verification activity that confirms a monitoring instrument, such as a thermometer or pH meter, provides accurate readings.
- Supplier approval
- A documented determination that a supplier can control a hazard in an ingredient, based on audits, testing, or records.
- Supplier verification activity
- An activity such as an onsite audit, sampling and testing, or record review used to confirm a supplier controls a hazard.
- Written supply-chain program
- A documented program covering supplier approval, verification activities, and corrective actions for supplier nonconformance.
- Supplier audit
- An inspection of a supplier's facility by a qualified auditor to verify control of the hazard of concern, conducted at a risk-based frequency.
- Food safety plan
- A written plan including the hazard analysis, preventive controls, monitoring, corrective actions, verification, and recall plan.
- Record retention period
- Records must be kept at least two years after they are made, and product-specific records for two years after the product's shelf life.
- Record review
- A PCQI or qualified individual's documented review of monitoring and verification records to confirm implementation and effectiveness.
- Plan reanalysis
- A documented review of the food safety plan at least every three years and after significant changes, with updates as needed.
- Recall plan
- A written procedure for notifying customers, retrieving product, and conducting effectiveness checks when a product must be removed from distribution.
- Recall classification
- A classification of recalls as Class I (serious health risk), Class II (temporary or reversible risk), or Class III (unlikely to cause harm).
- Traceability records
- Records that identify the source of ingredients and the destination of finished product, supporting one step back and one step forward.
- Recall effectiveness check
- A verification activity confirming that consignees received recall notice and removed the affected product from distribution.