MCQ About Quality Culture In Pharma » Flair Pharma The Knowledge Kit.

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Table of Contents

#1. Which of the following is NOT a core component of a strong quality culture in pharma?

A. Transparent communication

B. Leadership commitment

C. Profit maximization

D. Continuous improvement

#2. What principle underpins the idea that data must be accurate, legible, and complete in quality systems?

A. GLP

B. ALCOA+

C. ISO 9001

D. ICH Q3D

#3. Which of the following practices would undermine a quality culture in a pharmaceutical company?

A. Encouraging error reporting

B. Punishing employees for reporting deviations

C. Promoting GMP training

D. Involving QA in decision-making

#4. Which of these is NOT aligned with the goals of a quality-focused pharma environment?

A. Quality metrics dashboard

B. Cross-functional collaboration

C. Blame-free reporting culture

D. Prioritizing speed over safety

#5. A company introduces daily quality huddles, encourages deviation reporting, and enhances GMP training. What quality culture value is this strategy reinforcing?

A. Data retention

B. Operational secrecy

C. Employee empowerment

D. Automation focus

#6. . Which statement best reflects a strong pharmaceutical quality culture?

A. “Let’s fix it quietly before audit day.”

B. “We only follow SOPs when inspectors visit.”

C. “Everyone, from janitor to CEO, plays a role in quality.”

D. “Production comes first; QA will clean it up later.”

#7. You notice a technician skipping a step in an SOP. What is the best response aligned with a strong quality culture?

A. Ignore it—it’s not your department.

B. Inform management only if it causes a product issue.

C. Immediately document and report the observation.

D. Confront the technician aggressively.

#8. Which regulatory document highlights the importance of embedding quality into the pharmaceutical lifecycle?

A. ICH Q10

B. ISO 14001

C. ICH M7

D. CFR 11

#9. A company reports zero deviations for 12 months. What should a quality auditor suspect?

A. Perfect operations

B. Underreporting or fear culture

C. Exceptional training

D. Lean manufacturing excellence

#10. What is the primary goal of establishing a pharmaceutical quality culture?

A. Boost employee morale

B. Pass regulatory inspections

C. Improve stock price

D. Ensure patient safety and product quality

#11. What is the most likely negative consequence for quality culture?

A. Increased focus on patient safety

B. Encouragement of compliance with SOPs

C. Compromising quality to meet output targets

D. Better documentation accuracy

#12. What’s the best response that supports quality culture?

A. “Don’t report this. Just fix it next time.”

B. “Thanks for reporting—let’s document it and understand why it happened.”

C. “You should have been more careful; this will go on your record.”

D. “Ignore it. Management won’t notice.”

#13. Which root cause most directly reflects a weak quality culture?

A. Outdated machinery

B. Lack of proper training and supervision

C. Power failure

D. Change in supplier

#14. What does this indicate about the company’s quality culture?

A. Employees are overqualified

B. Training is optional in mature systems

C. Lack of emphasis on continuous learning

D. Culture is audit-proof

#15. Which of the following combination best builds a strong quality culture?

A. Strict penalties + secrecy + speed

B. Top-down blame + silence + output-driven rewards

C. Transparent reporting + training + leadership support

D. Ignorance of deviations + fear of audits

#16. Which should be the highest priority when cultivating a quality culture?

A. Meeting production quotas

B. Ensuring timely document submission

C. Creating a blame-free reporting environment

D. Reducing audit frequency

#17. Which organization reflects a stronger quality culture?

A. Company A: Prioritizes speed and rewards productivity, discourages deviation reporting

B. Company B: Promotes open communication, invests in GMP training, and encourages cross-functional collaboration

#18. Which rotating practice best reinforces shared ownership of quality?

A. Weekly batch record review by all department heads

B. Annual quality day with speeches only from senior management

C. A fixed QA-only deviation resolution team

D. Quality inspection only during regulatory visits

#19. Which of the following best reflects the definition of quality culture in pharmaceuticals?

A. A checklist used during audits

B. The set of SOPs guiding production

C. The shared attitudes, values, and behaviors toward quality at all levels

D. The process for cleaning equipment

#20. What is the most likely positive outcome of this initiative?

A. Increased fear among staff

B. Higher output but lower compliance

C. Improved error reporting and cultural openness

D. Decreased documentation control

Finish

MCQ about Quality Culture In Pharma