Quality excellence is the commitment to consistently meet standards by continuously improving processes, reducing errors, and delivering high-quality products to ensure patient safety, regulatory compliance, and operational efficiency.
However, achieving quality excellence doesn’t always require major overhauls; small, strategic adjustments can make a powerful impact. Here are some actionable tips to boost quality performance today!
1. Follow Good Documentation Practices (GDP)
-
Write clearly, legibly, and in real-time
-
Never use correction fluid; strike-through errors and sign/date
-
Remember: “If it’s not documented, it didn’t happen.”
2. Be Audit-Ready at All Times
-
Keep SOPs, logbooks, and records updated and accurate
-
Ensure cleanliness, calibration, and compliance in workspaces
-
Perform self-inspections regularly
3. Know Your SOPs and Follow Them
-
Don’t improvise—read and understand SOPs before performing any task
-
If an SOP is unclear or incorrect, raise a change request instead of deviating
4. Practice Data Integrity (ALCOA+)
-
Attributable, Legible, Contemporaneous, Original, Accurate
-
-
Complete, Consistent, Enduring, Available
-
-
Avoid data backdating, pre-filling, or overwriting records
5. Understand Critical Quality Attributes (CQAs)
-
Know the key parameters that affect product quality (e.g., assay, dissolution, sterility)
-
Monitor and control them with precision and care
6. Use Risk-Based Thinking
-
Apply risk assessment (FMEA, HACCP, etc.) in decisions
-
Focus resources on critical processes and systems
7. Stay Trained and Competent
-
Never perform tasks you’re not trained for
-
Keep your training up to date, and request refreshers if needed
8. Embrace CAPA Culture
-
Report deviations honestly and early
-
Investigate root causes (not just symptoms)
-
Implement Corrective and Preventive Actions (CAPAs) that are realistic and monitored
9. Engage in Continuous Improvement
-
Suggest ideas via Quality Circles or Kaizen
-
Learn from audit findings, complaints, deviations
-
Use tools like 5 Whys, Fishbone Diagrams, etc.
10. Communicate and Collaborate
-
Quality is everyone’s responsibility
-
Speak up when something seems wrong
-
Work cross-functionally to prevent silos and enhance understanding
