Quality policy and quality objectives MCQs With Answer

Introduction: This quiz compilation on Quality Policy and Quality Objectives is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T). It covers core concepts such as the purpose and elements of a quality policy, the requirements for setting measurable quality objectives, alignment with ISO 9001:2015 clauses, and pharmaceutical-specific considerations like regulatory compliance, patient safety and process controls. The questions range from fundamental definitions to applied scenarios used in pharma quality systems, internal audits and management reviews. Use these MCQs to test your understanding, identify knowledge gaps, and strengthen practical skills required for implementing and maintaining effective quality policies and objectives in pharmaceutical organizations.

Q1. What is the most accurate definition of a quality policy in the context of a pharmaceutical quality management system?

• A general statement about product pricing and commercial strategy
• A formal statement by top management of the organization’s intentions and direction regarding quality
• An operational SOP describing laboratory procedures
• A list of routine maintenance activities for manufacturing equipment

Correct Answer: A formal statement by top management of the organization’s intentions and direction regarding quality

Q2. What is the primary purpose of a quality policy?

• To provide a framework for setting and reviewing quality objectives
• To replace SOPs and work instructions
• To serve exclusively as marketing literature for customers
• To document batch manufacturing records

Correct Answer: To provide a framework for setting and reviewing quality objectives

Q3. Who is responsible for approving and issuing the quality policy in a pharmaceutical company?

• Quality control analyst
• Production supervisor
• Top management (e.g., CEO/Managing Director)
• External regulatory consultant

Correct Answer: Top management (e.g., CEO/Managing Director)

Q4. How should quality objectives relate to the quality policy?

• Objectives should be independent and unrelated to the quality policy
• Objectives may contradict the policy if they are operationally convenient
• Objectives must be consistent with and derived from the quality policy
• Objectives should only reflect financial targets, not quality aims

Correct Answer: Objectives must be consistent with and derived from the quality policy

Q5. Which of the following best describes the characteristics quality objectives should have (commonly accepted in pharma QMS)?

• Vague, aspirational and unspecified timelines
• Specific, measurable, achievable, relevant and time-bound (SMART) and consistent with the quality policy
• Only qualitative statements with no monitoring
• Targets set solely by regulatory bodies without internal input

Correct Answer: Specific, measurable, achievable, relevant and time-bound (SMART) and consistent with the quality policy

Q6. Which ISO 9001:2015 clause specifically addresses the requirement for an organization’s quality policy?

• Clause 4.1 Context of the organization
• Clause 5.2 Quality policy
• Clause 6.2 Quality objectives and planning to achieve them
• Clause 7.5 Documented information

Correct Answer: Clause 5.2 Quality policy

Q7. Under ISO 9001:2015, which clause requires the organization to establish quality objectives?

• Clause 4.2 Understanding the needs and expectations of interested parties
• Clause 5.1 Leadership and commitment
• Clause 6.2 Quality objectives and planning to achieve them
• Clause 8.7 Control of nonconforming outputs

Correct Answer: Clause 6.2 Quality objectives and planning to achieve them

Q8. How should the quality policy be documented and managed in a pharmaceutical organization?

• Only verbally communicated during hiring sessions
• Documented, implemented and communicated to all relevant personnel and made available as documented information
• Kept confidential and accessible only to top management
• Posted on social media without internal communication

Correct Answer: Documented, implemented and communicated to all relevant personnel and made available as documented information

Q9. Who is typically accountable for ensuring departmental quality objectives are met?

• External auditors
• Process owners and designated personnel under top management oversight
• Only the quality assurance (QA) manager without involvement of other functions
• Customers and suppliers directly

Correct Answer: Process owners and designated personnel under top management oversight

Q10. Which tool is most appropriate to monitor progress toward quality objectives in pharma?

• Key Performance Indicators (KPIs) and measurable targets with periodic review
• Random anecdotal feedback only
• Unstructured meeting minutes with no metrics
• Outdated paper records stored off-site without review

Correct Answer: Key Performance Indicators (KPIs) and measurable targets with periodic review

Q11. Which of the following is an example of a measurable quality objective relevant to pharmaceutical stability testing?

• Improve stability trend awareness
• Reduce out-of-specification (OOS) stability results by 30% within 12 months
• Increase the number of stability samples arbitrarily
• Ensure all stability samples are stored randomly

Correct Answer: Reduce out-of-specification (OOS) stability results by 30% within 12 months

Q12. If a quality objective is not being achieved, what should the organization do?

• Ignore the shortfall until the next audit
• Initiate corrective and preventive actions (CAPA), review objectives and adjust resources or targets as needed
• Terminate the quality policy altogether
• Blame external suppliers without investigation

Correct Answer: Initiate corrective and preventive actions (CAPA), review objectives and adjust resources or targets as needed

Q13. How often should management review the continuing suitability of the quality policy and objectives in a regulated pharma setting?

• Never, unless forced by auditors
• At planned intervals, typically at least annually and whenever significant changes occur
• Only when a product recall happens
• Only during product registration with regulators

Correct Answer: At planned intervals, typically at least annually and whenever significant changes occur

Q14. Which statement best describes communication requirements for the quality policy?

• The policy should remain confidential and not shared with employees
• The policy should be communicated, understood and applied within the organization and made available to relevant interested parties as appropriate
• The policy only needs to be displayed in reception areas
• The policy should be communicated only to the QA department

Correct Answer: The policy should be communicated, understood and applied within the organization and made available to relevant interested parties as appropriate

Q15. How should the quality policy support risk-based thinking in pharmaceutical quality management?

• By ignoring risks and focusing on outputs only
• By explicitly promoting risk-based thinking and the prevention of nonconformities
• By delegating risk management exclusively to suppliers
• By ensuring that risks are documented but never acted upon

Correct Answer: By explicitly promoting risk-based thinking and the prevention of nonconformities

Q16. When establishing quality objectives, which of the following must be considered in the pharmaceutical industry?

• Only marketing goals and sales projections
• Regulatory requirements, patient safety, applicable statutory requirements and interested parties’ needs
• Only historical production volumes
• Only supplier convenience

Correct Answer: Regulatory requirements, patient safety, applicable statutory requirements and interested parties’ needs

Q17. Which of the following is a well-formed objective for reducing time-to-release of batches?

• Reduce time-to-release
• Reduce average batch release time from 7 days to 4 days within 9 months while maintaining compliance
• Publish weekly reports regardless of content
• Increase paperwork to speed release

Correct Answer: Reduce average batch release time from 7 days to 4 days within 9 months while maintaining compliance

Q18. What role do internal audits play with respect to quality objectives?

• Internal audits only check financial controls and ignore objectives
• Internal audits assess conformity and effectiveness of the QMS and verify progress toward quality objectives
• Internal audits replace management review and policy review
• Internal audits are performed only by external consultants

Correct Answer: Internal audits assess conformity and effectiveness of the QMS and verify progress toward quality objectives

Q19. How should departmental objectives be aligned within a pharmaceutical organization?

• Each department sets independent objectives with no linkage to corporate aims
• Departmental objectives should be cascaded, measurable and aligned with the overall quality policy and corporate objectives
• Departments should avoid setting objectives to reduce accountability
• Objectives should only address cost-cutting and ignore quality

Correct Answer: Departmental objectives should be cascaded, measurable and aligned with the overall quality policy and corporate objectives

Q20. Which management tool is most appropriate for planning, implementing, monitoring and improving quality objectives?

• Plan-Do-Check-Act (PDCA) cycle to plan, implement, monitor and improve objectives
• Ad-hoc changes without planning or measurement
• Randomized experiments without objectives
• Single annual meeting with no follow-up

Correct Answer: Plan-Do-Check-Act (PDCA) cycle to plan, implement, monitor and improve objectives

Download