🌍 What is a Gemba Walk?

• Gemba is a Japanese term meaning “the real place” — where the actual work happens.

• In pharmaceuticals, the Gemba is the production floor, laboratory, warehouse, QC lab, cleanroom, or sterile area where processes are executed.

• A Gemba Walk is when managers, quality leaders, or supervisors go to the workplace to observe, engage with employees, and understand the real processes instead of relying only on reports or meetings.

🎯 Objectives of a Gemba Walk

1. Understand the process – Observe operations, equipment use, and personnel practices.

2. Ensure compliance – Verify GMP (Good Manufacturing Practices) and data integrity practices.

3. Identify waste – Look for inefficiencies (time, material, energy).

4. Support employees – Engage with operators to understand challenges.

5. Improve quality culture – Build trust and encourage continuous improvement.

6. Enhance safety – Ensure adherence to safety and hygiene standards.

🏭 Implementation in Pharmaceuticals

1. Planning the Gemba Walk

• Define the purpose (safety, quality, efficiency, compliance).

• Schedule regular walks (daily, weekly, or monthly).

• Select areas: production (granulation, compression, coating), packaging, microbiology lab, QC lab, warehouse, sterile filling area, utilities (HVAC, purified water systems).

2. Execution – What to Do During the Walk

🔎 Observe

• Personnel gowning and hygiene practices.

• Adherence to SOPs (equipment cleaning, line clearance, sampling).

• Environmental conditions (cleanroom differential pressures, temperature, humidity).

• Data integrity in labs (entries in logbooks, audit trails).

• Handling of deviations, OOS/OOT results.

• Equipment maintenance and calibration status.

💬 Engage with Employees

• Ask open-ended questions: “What challenges do you face with this equipment?”

• Encourage operators to share improvement suggestions.

• Reinforce good practices noticed on the floor.

📝 Document Findings

• Record observations (good practices + improvement areas).

• Classify issues as critical, major, minor.

• Take photos/screenshots if applicable (without breaching data integrity or GMP rules).

3. Post-Walk Actions

• Share feedback immediately with the team.

• Raise Corrective and Preventive Actions (CAPA) for deviations.

• Align findings with QMS elements (Change control, deviation management, risk assessment).

• Recognize and appreciate employees who maintain high compliance standards.

• Follow up on action closure in the next Gemba walk.

✅ Benefits of Gemba Walks in Pharma

• Strengthens GMP compliance and regulatory readiness (FDA, EMA, WHO).

• Builds a culture of ownership and accountability.

• Early detection of non-conformities (before inspections).

• Enhances process efficiency and employee morale.

• Supports continuous improvement and lean manufacturing initiatives.

• Improves data integrity assurance across manufacturing and QC.

📌 Example:

During a Gemba Walk in a sterile manufacturing area:

• A manager observes an operator not performing media fill gowning steps correctly.

• Immediate feedback is provided, a deviation is raised, and retraining is arranged.

• Preventive action: Revise gowning SOP + refresher training across the team.
  ➡️ This prevents a potential regulatory non-compliance during an FDA audit.

🎓 Discover one of the best Complete Pharmaceutical Production Course available —click below to explore the course that’s shaping future Production Course  skills.

https://trcjw.on-app.in/app/oc/338669/trcjw