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Question 1Fundamental principles and concepts of a food safety management system
In ISO 22000, what is the primary purpose of a food safety management system (FSMS)?
- To certify the nutritional quality of products for labelling purposes
- To replace statutory regulatory inspections with internal audits
- To guarantee that finished products are free of all microbiological hazards
- To systematically control food safety hazards across the food chain to ensure safe food Correct answer.
Explanation
An FSMS is a structured framework of policies, processes and controls intended to manage food safety hazards consistently along the food chain. It does not promise zero hazards, nor does it substitute for regulators or address nutrition. Its focus is hazard control and continual improvement of food safety performance.
Question 2Fundamental principles and concepts of a food safety management system
Which concept describes the degree of control an organization has over a food safety hazard at a given step of the process chain?
- Risk communication
- Control measure
- Hazard level
- Acceptable level Correct answer.
Explanation
The acceptable level is the maximum level of a hazard that may be present in the end product for it to be considered safe. It is defined for the product and drives the design of control measures. Control measures are the actions taken; the acceptable level is the target they achieve.
Question 3Fundamental principles and concepts of a food safety management system
According to ISO 22000, what is a food safety hazard?
- An administrative error in food labelling documentation
- Any deviation from a customer specification that affects product quality
- A biological, chemical or physical agent in food with the potential to cause an adverse health effect Correct answer.
- A business risk that could reduce profitability in the food chain
Explanation
ISO 22000 defines a food safety hazard as a biological, chemical or physical agent in food with the potential to cause an adverse health effect. Quality deviations, business risks and documentation errors are not, in themselves, food safety hazards. The definition is intentionally limited to agents harmful to consumer health.
Question 4Fundamental principles and concepts of a food safety management system
Which term describes the outcome of a hazard analysis that identifies a hazard requiring control measures because it could reasonably be expected to occur at unacceptable levels?
- Critical limit
- Operational prerequisite programme
- Significant food safety hazard Correct answer.
- Prerequisite programme
Explanation
A significant food safety hazard is one identified by hazard analysis as reasonably likely to occur at an unacceptable level and therefore needing control. Prerequisite programmes are the environmental and hygiene controls that support the system. Critical limits are measurable boundaries applied at critical control points.
Question 5Fundamental principles and concepts of a food safety management system
What is the role of prerequisite programmes (PRPs) within an ISO 22000 food safety management system?
- They are optional and apply only to catering operations
- They provide the basic hygiene and environmental conditions needed for safe food production Correct answer.
- They replace hazard analysis for low-risk products
- They define the critical limits for each critical control point
Explanation
PRPs establish the foundational hygiene and environmental conditions, such as cleaning, pest control and personnel hygiene, on which the whole FSMS depends. They do not replace hazard analysis or set critical limits. They apply across the food chain, not only to catering.
Question 6Fundamental principles and concepts of a food safety management system
Which pair correctly distinguishes a critical control point (CCP) from an operational prerequisite programme (OPRP)?
- A CCP is optional, while an OPRP is mandatory in every food operation
- A CCP uses critical limits with measurable parameters, while an OPRP uses action criteria to control a significant hazard Correct answer.
- A CCP is monitored by observation only, while an OPRP requires continuous instrumental measurement
- A CCP applies only to chemical hazards, while an OPRP applies only to microbiological hazards
Explanation
Both CCPs and OPRPs control significant hazards, but a CCP is managed with critical limits against measurable parameters, whereas an OPRP is managed with action criteria. The distinction lies in the measurability and the nature of the limit applied, not the hazard type. Neither is inherently optional.
Question 7Fundamental principles and concepts of a food safety management system
How does ISO 22000 relate to the Codex Alimentarius HACCP principles?
- It incorporates HACCP principles within a broader management system structure Correct answer.
- It applies only to primary production and excludes HACCP
- It replaces the HACCP principles with a purely risk-based financial model
- It prohibits the use of HACCP in favour of end-product testing
Explanation
ISO 22000 builds on the Codex HACCP principles and embeds them in a full management system with leadership, planning and improvement requirements. It does not discard HACCP, nor does it rely on end-product testing alone. Its scope spans the whole food chain.
Question 8Fundamental principles and concepts of a food safety management system
In ISO 22000 terminology, what does the 'hazard analysis' step primarily determine?
- Which hazards are significant and what control measures are needed Correct answer.
- The number of employees required for each shift
- The shelf life stated on the product label
- The marketing strategy for each product line
Explanation
Hazard analysis identifies hazards, evaluates their significance and determines the control measures needed to prevent, eliminate or reduce them to acceptable levels. It is a technical food safety activity, not a commercial or staffing exercise. Shelf life may be an input but is not its primary output.
Question 9Fundamental principles and concepts of a food safety management system
A dairy plant pasteurizes milk and monitors the outlet temperature continuously. Which element of the FSMS does the temperature set point represent?
- An action criterion at an OPRP
- A critical limit at a CCP Correct answer.
- A prerequisite programme
- An acceptable level in the end product
Explanation
Pasteurization is typically a CCP because it is essential to eliminate pathogens, and the temperature set point is the critical limit that must not be breached. An action criterion applies to an OPRP, not a CCP. The acceptable level concerns the end product, not the process parameter.
Question 10Fundamental principles and concepts of a food safety management system
Why does ISO 22000 require communication with suppliers and customers as part of the FSMS?
- To negotiate prices for raw materials
- To reduce the number of internal audits required
- To transfer food safety information along the chain so hazards can be controlled at each link Correct answer.
- To satisfy advertising regulations only
Explanation
Effective communication ensures that relevant food safety information flows between the organization and its suppliers, customers and other interested parties. This supports hazard control across the chain and enables timely action on unsafe product. Pricing, advertising and audit reduction are not the rationale.
Question 11Fundamental principles and concepts of a food safety management system
What does the concept of 'continual improvement' require of an ISO 22000 certified organization?
- Replacing the entire FSMS every three years
- Ongoing enhancement of food safety performance through review and corrective action Correct answer.
- Reducing the number of PRPs over time
- Achieving zero nonconformities before certification
Explanation
Continual improvement means the organization systematically enhances its food safety performance, for example through management review, corrective actions and updated hazard analysis. It does not require wholesale replacement of the system or elimination of all nonconformities. Reducing PRPs would weaken, not improve, the system.
Question 12Fundamental principles and concepts of a food safety management system
Which statement best describes the 'food chain' concept in ISO 22000?
- All stages from primary production through to consumption Correct answer.
- Only the transport and storage stages
- Only the retail stage of distribution
- Only the manufacturing stage within a single facility
Explanation
The food chain encompasses all stages from primary production through processing, distribution and consumption. ISO 22000 recognizes that food safety depends on controls applied at each link. Restricting the concept to a single stage would overlook upstream and downstream hazards.
Question 13Fundamental principles and concepts of a food safety management system
In hazard analysis, what does the term 'severity' refer to?
- The seriousness of the harm a hazard could cause Correct answer.
- The frequency of internal audits
- The likelihood that a hazard will occur
- The cost of controlling a hazard
Explanation
Severity describes the seriousness of the adverse health effect that could result from a hazard, while likelihood concerns the probability of occurrence. Together they inform the significance assessment. Cost and audit frequency are unrelated to severity.
Question 14Fundamental principles and concepts of a food safety management system
An organization identifies a significant hazard that cannot be controlled by a CCP because no measurable critical limit can be set, but control is achievable through a defined programme with action criteria. What is the appropriate classification?
- An operational prerequisite programme Correct answer.
- An acceptable level
- A critical control point
- A prerequisite programme
Explanation
When a significant hazard is controlled by a defined programme using action criteria rather than measurable critical limits, it is classified as an OPRP. PRPs address general hygiene conditions, not specific significant hazards. A CCP requires measurable critical limits, which are unavailable here.
Question 15Fundamental principles and concepts of a food safety management system
Which of the following best explains why ISO 22000 requires validation of control measure combinations?
- To verify that employees have attended training sessions
- To replace the need for monitoring activities
- To document the financial cost of each control measure
- To confirm that the selected controls can actually achieve the intended acceptable level Correct answer.
Explanation
Validation confirms that the combination of control measures is capable of achieving the intended acceptable level before implementation. Verification and monitoring then confirm ongoing effectiveness. Training records and cost documentation are separate concerns and do not substitute for validation.
Question 16Fundamental principles and concepts of a food safety management system
What distinguishes verification from validation in an ISO 22000 FSMS?
- Validation confirms the controls can achieve the acceptable level, while verification confirms the system is implemented and effective Correct answer.
- Validation is performed only after certification, while verification is performed before
- They are identical activities with different names
- Verification confirms that controls achieve the intended outcome, while validation confirms the system meets legal requirements
Explanation
Validation establishes, before implementation, that the chosen control measures can achieve the acceptable level. Verification confirms, during operation, that the FSMS is implemented and effective. They are distinct activities performed at different stages.
Question 17Fundamental principles and concepts of a food safety management system
A catering company introduces a new ready-to-eat salad line. Which action best reflects the principle of designing control measures based on hazard analysis before launch?
- Rely on customer complaints to detect problems after sale
- Increase the frequency of internal audits only
- Add more staff to the packaging line
- Conduct a hazard analysis and validate the controls for the new process before production Correct answer.
Explanation
ISO 22000 requires hazard analysis and validation of control measures before new processes are implemented. Relying on complaints is reactive and unsafe, while audits and staffing changes do not by themselves control hazards. The system must be designed to prevent hazards before product reaches consumers.
Question 18Fundamental principles and concepts of a food safety management system
Which statement correctly reflects the principle of a 'safe product' in ISO 22000 terms?
- A product that carries a certification mark
- A product that contains no detectable hazards at any level
- A product that has passed a single end-product test
- A product in which hazards have been reduced to defined acceptable levels Correct answer.
Explanation
A safe product is one in which food safety hazards have been controlled to defined acceptable levels, not one that is necessarily hazard-free. A single end-product test is not sufficient evidence of safety. Certification marks indicate system conformity, not the safety of each unit.
Question 19Fundamental principles and concepts of a food safety management system
Which of the following is an example of a physical food safety hazard?
- A piece of metal from worn equipment Correct answer.
- Aflatoxin produced by mould
- Cleaning chemical residue
- Listeria monocytogenes
Explanation
Physical hazards are foreign objects such as metal fragments, glass or stones that can cause injury. Bacteria are biological hazards, chemical residues are chemical hazards, and mycotoxins such as aflatoxin are also chemical hazards. Correct classification guides the choice of control measures.
Question 20Fundamental principles and concepts of a food safety management system
What is the purpose of monitoring at a critical control point?
- To schedule preventive maintenance of equipment
- To record employee attendance
- To calculate the cost of raw materials
- To determine whether the critical limit is being met and enable timely action Correct answer.
Explanation
Monitoring at a CCP provides planned measurements or observations that show whether the critical limit is being met, allowing corrective action before product is affected. Maintenance scheduling and administrative records serve different purposes. Timely monitoring is essential to process control.
Question 21Fundamental principles and concepts of a food safety management system
Which element belongs to the foundational concepts that a food safety management system is built on?
- Shareholder dividends
- Product pricing strategy
- Marketing segmentation
- Interactive communication Correct answer.
Explanation
ISO 22000 identifies interactive communication as a key element, ensuring food safety information flows internally and along the food chain. Dividends, marketing and pricing are commercial matters unrelated to the food safety framework. Communication supports hazard control at every link.
Question 22Fundamental principles and concepts of a food safety management system
An auditor finds that a significant hazard is controlled by a step with a measurable parameter and a defined limit that must not be exceeded. How should this step be classified?
- An operational prerequisite programme
- A critical control point Correct answer.
- A verification activity
- A prerequisite programme
Explanation
A step controlling a significant hazard through a measurable parameter with a defined limit that must not be exceeded meets the definition of a CCP. OPRPs use action criteria rather than critical limits. Verification activities confirm effectiveness but do not themselves control the hazard.
Question 23Fundamental principles and concepts of a food safety management system
Why does ISO 22000 emphasize a process approach rather than relying solely on final product testing?
- Final product testing is always more reliable than process control
- Testing is prohibited under the standard
- Process control prevents hazards earlier and is more effective than testing finished product Correct answer.
- Process control eliminates the need for documentation
Explanation
The process approach focuses on preventing hazards at each step rather than detecting problems only at the end. End-product testing is limited by sampling and cannot guarantee safety. Process control does not eliminate documentation requirements.
Question 24Fundamental principles and concepts of a food safety management system
What does 'withdrawal' mean in the context of ISO 22000 food safety management?
- Withdrawing the certification of a supplier
- Removing unsafe product from the market or from the supply chain Correct answer.
- Withdrawing employees from a shift
- Reducing the number of control measures
Explanation
Withdrawal refers to removing unsafe product from the market or supply chain to protect consumers. It is a planned response supported by traceability and communication. Supplier certification and staffing decisions are unrelated to this food safety concept.
Question 25Fundamental principles and concepts of a food safety management system
Which statement best captures the relationship between hazard analysis and the selection of control measures in ISO 22000?
- Control measures are selected randomly to satisfy auditors
- Control measures are chosen first, then hazards are identified to justify them
- Hazards are identified and assessed so that appropriate control measures can be selected and validated Correct answer.
- Hazard analysis is performed only after a recall occurs
Explanation
Hazard analysis identifies and assesses hazards, and its outcome determines which control measures are needed and how they must be validated. Selecting controls before analysing hazards would be unsystematic. Hazard analysis is proactive, not a post-recall exercise.
Question 26Fundamental principles and concepts of a food safety management system
In an ISO 22000 food safety management system, what is the intended role of a prerequisite programme (PRP)?
- It replaces hazard analysis whenever the product is considered low risk by the organization
- It documents customer complaints and the corrective actions taken in response
- It establishes the basic hygiene and environmental conditions that keep general contamination risks under control across the operation Correct answer.
- It sets the critical limits that must be monitored at each critical control point
Explanation
PRPs create the foundational hygienic environment (cleaning, pest control, personnel hygiene, maintenance, layout) on which the whole hazard control system rests. They are identified before and independently of hazard analysis and apply broadly to the operation rather than to a single significant hazard. Critical limits belong to CCPs, not to PRPs.
Question 27Fundamental principles and concepts of a food safety management system
A frozen-vegetable processor defines a control measure whose effect can only be confirmed by testing the finished product over several weeks. Why does ISO 22000 still require this control measure to be validated before it is relied upon in the hazard control plan?
- Because validation demonstrates, before implementation, that the chosen control measure is capable of achieving the intended hazard reduction Correct answer.
- Because validation is a customer requirement that applies only to exported products
- Because validation confirms that operators have been trained on the control measure
- Because validation replaces the need for any monitoring once the process is running
Explanation
Validation is an evidence-gathering activity performed before or during implementation to show that a control measure, or combination of measures, can actually deliver the intended effect on the identified hazard. It answers whether the design works, whereas monitoring answers whether it is working now. Training and customer expectations are separate matters.
Question 28Fundamental principles and concepts of a food safety management system
An ISO 22000 auditor is assessing how an organization decided which hazards are 'significant' for its hazard control plan. Which basis is most consistent with the standard?
- The frequency with which the hazard has previously caused a customer complaint
- The cost of the control measure compared with the value of the affected product batch
- The estimated likelihood of occurrence combined with the severity of the adverse health effect, evaluated against defined acceptance criteria Correct answer.
- The number of similar hazards that were identified during the same brainstorming session
Explanation
Hazard analysis evaluates each identified hazard using the likelihood of its occurrence and the severity of its health consequences, judged against criteria the organization has established. Hazards exceeding those criteria become significant and must be addressed by the hazard control plan through CCPs or OPRPs. Commercial and historical factors may inform context but do not define significance.
Question 29Fundamental principles and concepts of a food safety management system
A ready-to-eat producer introduces a new ingredient supplied by an unfamiliar vendor. Which action best reflects the ISO 22000 principle that food safety hazards should be anticipated through the food chain rather than detected at the end?
- Increase finished-product sampling frequency for the first month of production and review the results afterwards
- Evaluate the new supplier and the ingredient's hazard profile, and update the hazard analysis and control plan before the ingredient enters production Correct answer.
- Rely on the ingredient's accompanying certificate of analysis as sufficient evidence of safety
- Ask the retailer to communicate any consumer complaints related to the new ingredient
Explanation
ISO 22000 treats the food chain as an interacting network, so information about incoming materials and suppliers must feed into hazard analysis before changes take effect. Updating the hazard analysis and control plan proactively prevents hazards from entering the process. Downstream detection or reliance on a single document does not replace this systematic evaluation.
Question 30Food safety management system (FSMS) requirements
Under ISO 22000, which document must the organization establish to show the expected end use and intended consumer of the product?
- Verification schedule
- Product description Correct answer.
- Recall procedure
- Hazard analysis worksheet
Explanation
The standard requires product characteristics, including intended use and consumers, to be described as an input to hazard analysis. This description covers raw materials, ingredients and finished product, and feeds the hazard assessment directly.
Question 31Food safety management system (FSMS) requirements
In ISO 22000 terminology, what distinguishes an operational prerequisite programme (OPRP) from a critical control point (CCP)?
- An OPRP is controlled by an action criterion without a critical limit, while a CCP is controlled by a measurable critical limit. Correct answer.
- An OPRP is validated by measurement of a parameter against a critical limit, while a CCP is controlled by general hygiene measures.
- An OPRP is optional for certification, while a CCP is mandatory for every process step.
- An OPRP applies only to the environment, while a CCP applies only to raw materials.
Explanation
OPRPs are control measures whose effectiveness is assessed by an action criterion rather than a critical limit; exceeding the criterion triggers correction. CCPs, by contrast, are controlled through critical limits that separate acceptable from unacceptable product.
Question 32Food safety management system (FSMS) requirements
Which statement correctly describes the relationship between the hazard analysis and the selection of control measures in an ISO 22000 FSMS?
- Control measures are limited to those already used by competitors in the same sector.
- Control measures are selected after hazard assessment, with their effectiveness validated before implementation. Correct answer.
- Control measures are chosen only for hazards rated high by the food safety team leader.
- Control measures are selected first, then the hazard analysis is written to justify them.
Explanation
Hazards are identified and assessed, then appropriate control measures are selected and combined into a control plan. The selected measures must be validated to confirm they can achieve the intended food safety outcome before being put into operation.
Question 33Food safety management system (FSMS) requirements
What does ISO 22000 require regarding the validation of control measure combinations before they are implemented?
- Validation is only needed when a customer requests it.
- Validation must be repeated every production batch.
- Validation must confirm the control measures achieve the intended food safety outcome. Correct answer.
- Validation is required only for CCPs, not for OPRPs.
Explanation
The standard requires the food safety team to validate that selected control measures, alone or in combination, are capable of achieving the intended control of identified hazards. Validation is performed before implementation and repeated when changes occur.
Question 34Food safety management system (FSMS) requirements
A bakery identifies that metal fragments from worn blades could reach the finished bread. Which element of the ISO 22000 control plan is most appropriate for the metal detector at the packing line?
- A critical control point with a defined critical limit for rejected product Correct answer.
- A supplier approval requirement for blade manufacturers
- A general hygiene measure recorded in the cleaning schedule
- An operational prerequisite programme with no measurable criterion
Explanation
A metal detector that removes contaminated product is typically a CCP because failure leads to a significant food safety hazard. Its critical limit is defined, monitoring is continuous or frequent, and corrective action is taken when the limit is exceeded.
Question 35Food safety management system (FSMS) requirements
Which of the following best describes the purpose of the preliminary steps before hazard analysis in ISO 22000?
- To establish the process flow, layout and product characteristics needed for a reliable hazard analysis Correct answer.
- To finalize the food safety policy for top management
- To calculate the cost of each control measure
- To certify suppliers before any production begins
Explanation
Preliminary steps gather information such as product characteristics, intended use, process flow diagrams and site layout. These inputs make the subsequent hazard identification and assessment accurate and complete.
Question 36Food safety management system (FSMS) requirements
During hazard assessment, the food safety team evaluates the likelihood of occurrence and the severity of adverse health effects. What is the required output of this assessment?
- A schedule for internal audits
- A financial estimate of the cost of recalls
- A list of all possible hazards regardless of significance
- A determination of which hazards need to be controlled and to what extent Correct answer.
Explanation
Hazard assessment determines, for each identified hazard, whether control is needed and the level of control required to ensure food safety. The result feeds directly into selection of control measures and their categorization.
Question 37Food safety management system (FSMS) requirements
What is the role of the food safety team leader under ISO 22000?
- To approve every customer contract without review
- To manage the organization's entire operations budget
- To conduct all external supplier audits personally
- To manage the food safety team and organize its work, including its establishment and operation Correct answer.
Explanation
The standard requires a designated food safety team leader with responsibility to manage the team, ensure its competence and organize its activities. The leader may also coordinate with external parties on FSMS matters.
Question 38Food safety management system (FSMS) requirements
Which activity is an example of verification rather than validation in an ISO 22000 FSMS?
- Establishing the critical limit for a chilling step from scientific literature
- Testing a new pasteurization step to prove it achieves a five-log reduction
- Designing the HACCP plan for a new product line
- Reviewing monitoring records to confirm CCPs stayed within critical limits Correct answer.
Explanation
Verification confirms that the FSMS as implemented is working, for example by reviewing monitoring records and checking that critical limits were met. Validation, by contrast, demonstrates before implementation that a control measure can achieve the intended outcome.
Question 39Food safety management system (FSMS) requirements
ISO 22000 requires that monitoring of CCPs provide information in a timely manner. Which design choice best satisfies this for a continuous pasteurization process?
- Checking the thermometer calibration annually
- Installing a continuous temperature recorder with alarms and automatic flow diversion Correct answer.
- Recording the temperature manually once per shift
- Reviewing temperature data only at the monthly management review
Explanation
Timely monitoring means deviations are detected quickly enough to prevent unsafe product from moving forward. Continuous recording with alarms and automatic diversion provides immediate detection and response.
Question 40Food safety management system (FSMS) requirements
When a critical limit is exceeded and affected product has already been produced, what does ISO 22000 require before the product can be released?
- Release after the customer is informed verbally
- Release once the next batch passes monitoring
- Evaluation to determine whether the product is safe, with release only if safety is demonstrated Correct answer.
- Release after the shift supervisor signs the batch record
Explanation
Product produced while a critical limit was exceeded is potentially unsafe and must be evaluated to determine whether it can be released. Release is permitted only when safety is demonstrated, for example by testing or by other evidence.
Question 41Food safety management system (FSMS) requirements
What is the minimum content that ISO 22000 requires for corrective action when a critical limit is exceeded?
- Only a record of the deviation
- A copy of the customer complaint
- A revised product label
- The cause of the deviation, the correction, the corrective action and verification of effectiveness Correct answer.
Explanation
Corrective action records must capture the nature of the nonconformity, its cause, the action taken to correct it and to prevent recurrence, and verification that the action was effective. This supports continual improvement of the FSMS.
Question 42Food safety management system (FSMS) requirements
Which statement accurately reflects ISO 22000 requirements for the process flow diagram?
- It must be verified by the food safety team on site for accuracy and completeness. Correct answer.
- It must be drawn only after the first certification audit.
- It must be prepared by an external consultant.
- It must include only the steps inside the production hall.
Explanation
The flow diagram must be verified by the food safety team through on-site checking to confirm it reflects actual operations. Accuracy matters because the diagram is the basis for hazard identification at each step.
Question 43Food safety management system (FSMS) requirements
An organization changes a supplier of a raw material that introduces a new allergen. What does ISO 22000 require the food safety team to do first?
- Wait until the next scheduled management review
- Assess the change for its impact on the hazard analysis and control plan Correct answer.
- Ask the supplier to certify the product as allergen-free
- Immediately update the product label without analysis
Explanation
Changes that affect food safety, including new raw materials or suppliers, must be assessed before implementation. The hazard analysis and control plan are updated as needed, and the FSMS is kept current.
Question 44Food safety management system (FSMS) requirements
Which of the following is a required element of the communication arrangements in ISO 22000?
- Communicating only through the marketing department
- Sharing internal audit reports with all competitors
- Publishing the full hazard analysis on the company website
- Communication with external interested parties such as suppliers and customers on food safety matters Correct answer.
Explanation
ISO 22000 requires effective communication with external parties, including suppliers, customers and regulators, on food safety issues that affect them. Internal communication across functions is also required.
Question 45Food safety management system (FSMS) requirements
How does ISO 22000 address emergency situations such as a fire, flood or deliberate contamination?
- The organization must establish procedures to manage them and to test the arrangements where practicable. Correct answer.
- Emergency situations are excluded from the FSMS scope.
- Emergency situations are handled only by the local authority.
- Emergency situations are covered only by insurance policies.
Explanation
The organization must identify potential emergency situations that can affect food safety and establish procedures to manage them. The arrangements should be tested and reviewed, and relevant interested parties informed as appropriate.
Question 46Food safety management system (FSMS) requirements
Which requirement applies to the organization's traceability system under ISO 22000?
- Traceability must be electronic for all products.
- Traceability must cover only the final product, not incoming materials.
- Traceability records must be kept for a defined period and the system tested. Correct answer.
- Traceability is required only for exported products.
Explanation
The organization must maintain a traceability system covering product lots and their relationship to raw materials and distribution, and must test the system periodically. Records are retained for a defined period.
Question 47Food safety management system (FSMS) requirements
What is the purpose of the management review in an ISO 22000 FSMS?
- To approve individual batch release decisions
- To replace internal audits
- To conduct supplier audits
- To assess the continuing suitability, adequacy and effectiveness of the FSMS and decide on improvements Correct answer.
Explanation
Top management reviews the FSMS at planned intervals to evaluate its continuing suitability, adequacy and effectiveness. Inputs include audit results, verification results and feedback, and outputs include decisions on improvement and resource needs.
Question 48Food safety management system (FSMS) requirements
Which of the following best describes how ISO 22000 treats the concept of acceptable level of food safety risk?
- It is identical for every product and process.
- It is determined solely by the legal limit for pathogens.
- It must be defined by the organization when assessing hazards and selecting control measures. Correct answer.
- It is set by the certification body during the audit.
Explanation
The organization defines the acceptable level of risk for its products when assessing hazards, taking into account legal requirements, customer expectations and scientific information. This level guides selection of control measures.
Question 49Food safety management system (FSMS) requirements
A food manufacturer has an OPRP for sifter mesh integrity. Which record best demonstrates the OPRP is operating as intended?
- The floor plan showing the sifter location
- The daily inspection log showing mesh checks against the action criterion Correct answer.
- The purchase invoice for the sifter
- The training certificate of the maintenance technician
Explanation
An OPRP is controlled by monitoring against an action criterion, so the relevant record is the inspection log showing results compared with that criterion. Records of correction when the criterion is not met also support this.
Question 50Food safety management system (FSMS) requirements
What does ISO 22000 require concerning the competence of persons doing work that affects food safety?
- Competence is required only for the food safety team leader.
- Competence is assumed after one year of employment.
- Competence must be ensured on the basis of education, training, skills and experience, with records retained. Correct answer.
- Competence is verified only by external certification of individuals.
Explanation
The organization must ensure that persons whose work affects food safety are competent, based on appropriate education, training, skills and experience. Evidence of competence must be retained as documented information.