Right First Time (RFT) – Steps to Success

Right First Time (RFT) – Steps to Success. Pharmaceutical Industry Quality and Compliance Strategy.

Leadership Commitment. Establish clear support and accountability from senior management Define and communicate the importance of RFT Integrate RFT goals into strategic plans and KPIs.

Training & Competency. Train employees in RFT principles and GMP Provide ongoing coaching and development Validate personnel competency through assessments.

Standardization & Documentation. Use clear, accurate SOPs Apply consistent methods across teams Follow ALCOA+ principles in documentation.

Process Understanding & Control. Map critical processes and identify error points Use tools like FMEA to address risks Implement in-process controls and quality checks.

Error-Proofing (Poka-Yoke). Introduce fail-safes and automation Design systems to prevent incorrect operation.

Root Cause Analysis & Continuous Improvement. Use RCA tools like 5 Whys and Fishbone diagrams Implement and track CAPAs Encourage a learning culture.

Performance Monitoring & Metrics. Track key RFT metrics (e.g., batch RFT %, deviation rates) Review trends with dashboards Celebrate improvements and success stories.

Cross-Functional Collaboration. Promote QA, Production, Engineering, and R&D teamwork Include RFT in product and process design Share knowledge across departments.

Quality Culture & Ownership. Empower employees to own quality Encourage issue reporting without fear Embed quality in daily operations.

Customer Focus. Prioritize patient safety and regulatory compliance Minimize rejections and recalls Deliver consistent, high-quality products on time.