CFSQA flashcards
CFSQA · 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.
- Audit definition
- Systematic, independent, documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
- Objective evidence
- Verifiable data, records, statements of fact, or other information that can be proven true. Opinions and hearsay are not objective evidence.
- Audit criteria
- Set of policies, procedures, standards, regulations, or requirements used as a reference against which objective evidence is compared.
- Independence in auditing
- Auditors must not audit their own work. A conflict of interest exists if the auditor had operational responsibility for the area audited within the past 12 months.
- Audit program
- Set of one or more audits planned for a specific time frame and directed towards a specific purpose, managed by an audit program manager.
- Risk-based audit planning
- Prioritize audit frequency, duration, and resources based on risk factors such as product risk, process complexity, past performance, and regulatory history.
- Audit plan contents
- Audit objectives, scope, criteria, dates, locations, audit team, schedule of activities, and allocation of resources.
- Opening meeting purpose
- Confirm scope, criteria, schedule, communication channels, and safety arrangements. Document attendance and provide an opportunity for questions.
- Evidence hierarchy
- Records and direct observation are stronger than interviews, which are stronger than hearsay. Corroborate interview statements with records or observation.
- Interview technique
- Ask open questions first, then probing questions; avoid leading questions. Confirm understanding by summarizing back to the interviewee.
- Audit sampling methods
- Random, systematic, stratified, and judgmental. Document the population, sample size, and selection method for each sample.
- Traceability exercise
- Select a finished product lot and trace forward to distribution and backward to raw materials; verify mass balance and records.
- Nonconformity classification
- Major (systemic failure, absence of control, food safety risk), minor (isolated lapse, documentation gap), observation (opportunity for improvement).
- Hazard categories
- Biological (pathogens, toxins), chemical (allergens, pesticides, cleaning chemicals, mycotoxins), physical (metal, glass, plastic, bone), and radiological.
- HACCP seven principles
- Hazard analysis, determine CCPs, establish critical limits, monitoring, corrective actions, verification, record keeping.
- Critical control point
- A step where control can be applied and is essential to prevent, eliminate, or reduce a food safety hazard to an acceptable level.
- Critical limit
- Measurable value that separates acceptability from unacceptability at a CCP (e.g., 72°C for 15 seconds, pH ≤ 4.6, water activity ≤ 0.85).
- Validation vs. verification
- Validation confirms the control measure can achieve the intended effect; verification confirms ongoing compliance through calibration, record review, and product testing.
- Prerequisite programs
- Basic environmental and operational conditions needed for food safety, including facilities, pest control, cleaning, personal hygiene, water quality, and waste management.
- Sanitation SOP
- Written procedures for cleaning and sanitizing food-contact surfaces, equipment, and environment; include frequency, chemicals, concentration, and responsible person.
- Clean vs. sanitize
- Cleaning removes soil; sanitizing reduces microorganisms to safe levels. Sanitizer efficacy depends on concentration, contact time, temperature, and pH.
- Environmental monitoring program
- Sampling of food-contact and non-food-contact surfaces for indicator organisms (e.g., Listeria spp., Salmonella) and hygiene indicators (e.g., ATP, coliforms).
- PDCA cycle
- Plan (establish objectives), Do (implement), Check (monitor and measure), Act (improve). Used for continual improvement in quality systems.
- Corrective action
- Action taken to eliminate the cause of an existing nonconformity and prevent recurrence. Distinguished from correction, which fixes the immediate problem.
- Root cause analysis tools
- 5 Whys, fishbone (Ishikawa) diagram, fault tree analysis, Pareto analysis. Verify root cause before implementing corrective action.
- Key performance indicators
- Measurable indicators such as nonconformity rate, on-time corrective action closure, and customer complaints, used to monitor process performance.
- FSMA preventive controls
- Process controls, allergen controls, sanitation controls, supply-chain controls, recall plan, and other controls as needed under 21 CFR 117.
- Codex Alimentarius
- International food standards, guidelines, and codes of practice; General Principles of Food Hygiene (CXC 1-1969) and HACCP Annex.
- GFSI-benchmarked schemes
- BRCGS, SQF, FSSC 22000, IFS, GlobalG.A.P. Each has specific requirements for audit frequency, scoring, and certification.
- Audit report contents
- Audit objectives, scope, criteria, dates, locations, audit team, findings (nonconformities, observations), conclusions, and distribution list.
- Nonconformity statement structure
- Requirement (what should be), evidence (what was found), and significance (why it matters).
- Corrective action request
- Requires root cause analysis, correction, corrective action, responsible person, and due date. Verify effectiveness before closure.