Preliminary Hazard Analysis (PHA) MCQs With Answer

Preliminary Hazard Analysis (PHA) MCQs With Answer

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Preliminary Hazard Analysis (PHA) MCQs With Answer

Introduction: This quiz collection on Preliminary Hazard Analysis (PHA) is tailored for M.Pharm students studying Hazards and Safety Management. It focuses on the fundamentals and applied aspects of PHA used in pharmaceutical operations — including identification of hazards, assessment of causes and consequences, estimation of likelihood and severity, use of risk matrices, and prioritization of corrective actions. Questions cover PHA methodology, team composition, documentation, relationship with other risk assessments (e.g., FMEA, HAZOP), and regulatory expectations. Use these MCQs to strengthen conceptual understanding and prepare for exams and practical safety evaluations in pharmaceutical process environments.

Q1. What is the primary purpose of a Preliminary Hazard Analysis (PHA) in a pharmaceutical process?

  • To provide a definitive failure mode ranking for maintenance scheduling
  • To identify potential hazards and prioritize them for further detailed study
  • To replace final design safety reviews and eliminate the need for FMEA
  • To document manufacturing yields and product quality metrics

Correct Answer: To identify potential hazards and prioritize them for further detailed study

Q2. Which phase of a project is PHA typically performed?

  • Only after operations have started and incidents occur
  • During early design or concept stage before detailed engineering
  • After commissioning but before routine maintenance
  • Exclusively during decommissioning

Correct Answer: During early design or concept stage before detailed engineering

Q3. Which of the following best describes the output of a PHA?

  • A detailed wiring diagram for control systems
  • A prioritized list of hazards with recommended follow-up actions
  • An environmental impact statement
  • A patent application for process design

Correct Answer: A prioritized list of hazards with recommended follow-up actions

Q4. What key elements are typically assessed for each hazard in PHA?

  • Supplier lead times and inventory turnover
  • Causes, potential consequences, likelihood, and existing safeguards
  • Color coding of equipment and ergonomic factors only
  • Marketing impact and cost of goods sold

Correct Answer: Causes, potential consequences, likelihood, and existing safeguards

Q5. How does PHA differ from HAZOP in scope and detail?

  • PHA is more detailed and examines piping deviations line-by-line compared to HAZOP
  • PHA is a higher-level, early-stage assessment; HAZOP is a detailed design-stage analysis
  • PHA focuses only on environmental hazards while HAZOP focuses on human factors
  • PHA eliminates the need for any subsequent safety analysis

Correct Answer: PHA is a higher-level, early-stage assessment; HAZOP is a detailed design-stage analysis

Q6. Which team composition is most appropriate for conducting an effective PHA?

  • A single auditor without operational or process knowledge
  • A multidisciplinary team including process engineers, operations, safety specialists, and quality
  • Only senior management representatives
  • External marketing consultants and legal advisors only

Correct Answer: A multidisciplinary team including process engineers, operations, safety specialists, and quality

Q7. In PHA, the term “initiating event” refers to:

  • The final regulatory approval for a drug product
  • An occurrence that can trigger the chain of events leading to a hazardous consequence
  • A routine maintenance task with no safety consequence
  • A non-operational administrative meeting

Correct Answer: An occurrence that can trigger the chain of events leading to a hazardous consequence

Q8. Which tool is commonly used to represent risk in PHA and aid prioritization?

  • Supply chain Gantt chart
  • Risk matrix mapping likelihood against severity
  • Histogram of daily production volumes
  • Color wheel for brand identity

Correct Answer: Risk matrix mapping likelihood against severity

Q9. What does ALARP stand for and how is it related to PHA?

  • As Low As Reasonably Practicable — a goal for reducing risks identified in PHA
  • Automated Logistic and Resource Planning — unrelated to PHA
  • Average Loss And Recovery Plan — a financial metric used post-incident
  • All Levels Are Reviewed Periodically — a scheduling guideline

Correct Answer: As Low As Reasonably Practicable — a goal for reducing risks identified in PHA

Q10. Which of the following is NOT usually an input to a PHA?

  • Process flow diagrams and basic process descriptions
  • Material safety data sheets (MSDS) for chemicals involved
  • Detailed shop-floor task times for payroll
  • Operating limits and regulatory constraints

Correct Answer: Detailed shop-floor task times for payroll

Q11. When a PHA identifies a serious hazard with insufficient safeguards, the recommended next step is:

  • Ignore it until an incident happens to save resources
  • Initiate a detailed study (e.g., FMEA, HAZOP) and implement additional controls
  • Reduce production targets permanently
  • Outsource the process immediately

Correct Answer: Initiate a detailed study (e.g., FMEA, HAZOP) and implement additional controls

Q12. Which documentation is essential to record during a PHA session?

  • List of attendees, identified hazards, causes, consequences, existing controls, and recommended actions
  • Only a photograph of the meeting room
  • Stock prices of raw material suppliers
  • Confidential patient records unrelated to process hazards

Correct Answer: List of attendees, identified hazards, causes, consequences, existing controls, and recommended actions

Q13. How is “likelihood” typically estimated in a PHA performed early in project development?

  • By precise statistical failure rates derived from detailed historical data
  • Using qualitative scales (e.g., unlikely, possible, likely) or broad quantitative bands
  • By asking only marketing staff to give a numerical opinion
  • Through product sales forecasts

Correct Answer: Using qualitative scales (e.g., unlikely, possible, likely) or broad quantitative bands

Q14. Which of the following best describes a control measure identified during PHA?

  • An action or design feature that reduces likelihood or severity of a hazardous event
  • A marketing campaign to improve product image
  • A financial incentive to increase production speed
  • A decorative label on packaging

Correct Answer: An action or design feature that reduces likelihood or severity of a hazardous event

Q15. In pharmaceutical PHA, process hazards often include which of these categories?

  • Chemical reactivity, cross-contamination, inadequate containment, and exposure to toxic agents
  • Only keyboard ergonomics for office staff
  • Advertising budget overruns
  • Solely customer complaints about packaging aesthetics

Correct Answer: Chemical reactivity, cross-contamination, inadequate containment, and exposure to toxic agents

Q16. Which statement about follow-up actions from PHA is correct?

  • Actions do not need owners or deadlines; they will happen organically
  • Actions should have assigned owners, priorities, and target completion dates and be tracked
  • All actions should be deferred until product launch
  • Only verbal commitments are sufficient; no formal tracking is necessary

Correct Answer: Actions should have assigned owners, priorities, and target completion dates and be tracked

Q17. Which regulatory expectations make PHA valuable in pharmaceutical facilities?

  • Requirements for proactive risk assessment, patient safety, contamination control, and design verification
  • Requirements to publish trade secrets in public registries
  • Regulations mandating only marketing claims validation
  • Obligations to standardize packaging artwork globally

Correct Answer: Requirements for proactive risk assessment, patient safety, contamination control, and design verification

Q18. When updating a PHA, which triggers should prompt a review?

  • Significant design changes, process deviations, incidents, or new regulatory requirements
  • Only changes in cafeteria menu options
  • Annual staff birthdays
  • When sales exceed a set target unrelated to hazards

Correct Answer: Significant design changes, process deviations, incidents, or new regulatory requirements

Q19. Which limitation is commonly associated with PHA?

  • It always provides exact probabilities and eliminates uncertainty completely
  • It is typically high-level and may miss detailed failure modes that later analyses must capture
  • It requires no expertise and can be done by a single untrained person
  • It guarantees 100% accident prevention

Correct Answer: It is typically high-level and may miss detailed failure modes that later analyses must capture

Q20. Which metric is most useful for prioritizing PHA findings when resources are limited?

  • Risk ranking combining consequence severity and likelihood (risk score) to focus high-risk items first
  • Chronological order of when each component was purchased
  • Alphabetical order of equipment names
  • Popularity of equipment among operators

Correct Answer: Risk ranking combining consequence severity and likelihood (risk score) to focus high-risk items first

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