Critical hazard management systems MCQs With Answer

Critical hazard management systems MCQs With Answer

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Introduction: This quiz set on Critical Hazard Management Systems is designed for M.Pharm students to deepen understanding of process safety, risk control layers, and systematic approaches used in pharmaceutical and chemical process industries. It covers hazard identification techniques (HAZOP, FMEA, Bow-Tie), safety instrumented systems (SIS), LOPA and SIL concepts, emergency preparedness, and human factors. Questions emphasize application, interpretation of safety layers, and regulatory expectations relevant to pharmaceutical manufacturing. Working through these MCQs will help students link theoretical safety concepts to practical risk control decisions essential for preventing major incidents and ensuring patient‑focused product integrity.

Q1. Which technique is primarily used for systematic examination of process deviations by applying guidewords to process parameters?

  • Failure Mode and Effects Analysis (FMEA)
  • Hazard and Operability Study (HAZOP)
  • Layer of Protection Analysis (LOPA)
  • Event Tree Analysis (ETA)

Correct Answer: Hazard and Operability Study (HAZOP)

Q2. In Layer of Protection Analysis (LOPA), what is the purpose of an independent protection layer (IPL)?

  • To increase production throughput by modifying setpoints
  • To provide an independent action that reduces risk when an initiating event occurs
  • To replace process safety management (PSM) documentation
  • To record near‑miss incidents for auditing

Correct Answer: To provide an independent action that reduces risk when an initiating event occurs

Q3. Which document or guideline is most directly associated with setting requirements for Safety Integrity Level (SIL) for safety instrumented functions?

  • ICH Q7
  • IEC 61511
  • ISO 9001
  • GMP Annex 1

Correct Answer: IEC 61511

Q4. What does a Bow‑Tie diagram primarily illustrate in process safety management?

  • Quantitative consequence modelling of gas dispersion plumes
  • The chronological sequence of events leading to failure
  • Causes (threats) leading to a top event and the barriers (controls) preventing consequences
  • Design specifications for safety instrumented systems

Correct Answer: Causes (threats) leading to a top event and the barriers (controls) preventing consequences

Q5. During HAZOP, which type of personnel are essential to include in the multidisciplinary team?

  • Only process operators and maintenance staff
  • Process engineers, operations, maintenance, instrumentation, and safety specialists
  • External auditors exclusively
  • Sales and marketing representatives

Correct Answer: Process engineers, operations, maintenance, instrumentation, and safety specialists

Q6. Which of the following best describes a Safety Instrumented System (SIS)?

  • A system that monitors product quality and adjusts formulation automatically
  • A control system component that performs a specific safety function to achieve required risk reduction
  • A maintenance scheduling database
  • An administrative policy for incident reporting

Correct Answer: A control system component that performs a specific safety function to achieve required risk reduction

Q7. In LOPA calculations, the frequency of a dangerous scenario is estimated by multiplying the initiating event frequency by the probability of failure of which elements?

  • All process operating procedures combined
  • Independent protection layers (IPL) failure probabilities
  • Environmental monitoring frequencies
  • Number of employees on shift

Correct Answer: Independent protection layers (IPL) failure probabilities

Q8. Which method is most appropriate for identifying potential failure modes, their effects, and their criticality in a pharmaceutical manufacturing step?

  • Bow‑Tie Analysis
  • Failure Mode and Effects Analysis (FMEA)
  • Event Tree Analysis (ETA)
  • Quantitative Risk Assessment (QRA)

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q9. What is the main objective of inherently safer design (ISD) in pharmaceutical process development?

  • To add more administrative controls to the process
  • To reduce hazards by applying strategies such as minimization, substitution, moderation, and simplification
  • To increase automation to eliminate operators entirely
  • To defer hazard control until after commissioning

Correct Answer: To reduce hazards by applying strategies such as minimization, substitution, moderation, and simplification

Q10. Which analysis technique is predominantly quantitative and used to estimate probabilities and consequences of different accident scenarios by moving forward from an initiating event?

  • Hazard and Operability Study (HAZOP)
  • Event Tree Analysis (ETA)
  • What‑If Checklist
  • Bow‑Tie Diagram

Correct Answer: Event Tree Analysis (ETA)

Q11. In a Safety Integrity Level (SIL) assessment, which statement about SIL is correct?

  • SIL indicates the functional safety performance required of a safety instrumented function in terms of probability of failure on demand or risk reduction factor
  • SIL is a measure of environmental impact of a chemical release
  • SIL defines the number of operators required per shift
  • SIL only applies to mechanical equipment, not software or electronics

Correct Answer: SIL indicates the functional safety performance required of a safety instrumented function in terms of probability of failure on demand or risk reduction factor

Q12. Which of the following is NOT typically considered an independent protection layer (IPL)?

  • Safety instrumented function (SIF)
  • Relief vent sized and routed to safe area
  • Operator action that is the only control and is not independent
  • Physical safety barrier (firewall, dike)

Correct Answer: Operator action that is the only control and is not independent

Q13. For pharmaceutical facilities, which regulatory or guidance document emphasizes process safety and management of hazardous chemicals used in manufacturing?

  • ICH Q9 – Quality Risk Management (supports process risk thinking)
  • Pharmacopoeial monographs only
  • Labeling guidance for patient leaflets
  • Guidance on clinical trial design

Correct Answer: ICH Q9 – Quality Risk Management (supports process risk thinking)

Q14. Which dispersion factor is most important when assessing release consequences for a toxic vapor in a pharmaceutical plant?

  • The molecular weight of the active ingredient only
  • Atmospheric stability, wind speed, release height and release rate
  • The number of operators on duty
  • The batch size irrespective of release conditions

Correct Answer: Atmospheric stability, wind speed, release height and release rate

Q15. In a quantitative risk assessment (QRA) for flammable releases, what is typically estimated for consequence analysis?

  • Frequency of regulatory inspections
  • Heat radiation contours, overpressure zones, and toxic concentrations as a function of distance
  • Amount of product yield loss during campaign
  • Number of SOPs required

Correct Answer: Heat radiation contours, overpressure zones, and toxic concentrations as a function of distance

Q16. Which human factors consideration is critical when designing alarms for a control room to support hazard management?

  • Maximizing the number of alarms to ensure coverage
  • Prioritizing alarm relevance, reducing nuisance alarms, and ensuring clear operator guidance
  • Ensuring alarms only trigger during night shifts
  • Configuring alarms to sound identical for all events

Correct Answer: Prioritizing alarm relevance, reducing nuisance alarms, and ensuring clear operator guidance

Q17. Which practice is a key element of emergency preparedness for a critical hazardous release in a pharmaceutical facility?

  • Relying solely on external emergency services without internal drills
  • Developing and exercising emergency response plans, clear evacuation routes, and communication protocols
  • Keeping emergency plans confidential and untested
  • Assuming no hazardous events will occur and focusing only on product quality

Correct Answer: Developing and exercising emergency response plans, clear evacuation routes, and communication protocols

Q18. Combustible dust hazards in pharmaceutical powder handling are mitigated primarily by which measures?

  • Increasing humidity to 100% in the entire plant
  • Source control, dust confinement, good housekeeping, proper ventilation, and explosion venting or suppression
  • Removing all electrical equipment from the facility
  • Ban all powder processing and only use liquids

Correct Answer: Source control, dust confinement, good housekeeping, proper ventilation, and explosion venting or suppression

Q19. Which feature distinguishes a safety critical alarm from a basic process alarm in hazard management?

  • Safety critical alarms are always audible but never displayed
  • Safety critical alarms indicate conditions that, if not corrected, could lead to major accident hazards and typically require defined operator actions
  • Basic process alarms are only used during commissioning
  • There is no difference; all alarms are treated equally

Correct Answer: Safety critical alarms indicate conditions that, if not corrected, could lead to major accident hazards and typically require defined operator actions

Q20. Which of the following best describes the role of management of change (MOC) in critical hazard management systems?

  • MOC is used to approve changes in company branding
  • MOC ensures that technical, procedural, and organizational changes are reviewed for safety, risk, and regulatory impact before implementation
  • MOC replaces training requirements for new processes
  • MOC is only applicable to construction projects and not to operations

Correct Answer: MOC ensures that technical, procedural, and organizational changes are reviewed for safety, risk, and regulatory impact before implementation

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