Gemba Walks and Its implementation in Pharmaceuticals

Compliance quality and efficacy are non-negotiable in pharmaceutical industry. It is required to implement management practices to improve compliance and continuous process improvement. One such practice is Gemba Walk, which is a concept taken from lean management. In which team goes to the actual place where work is being done and engages with the people doing it.

In this post, we will explore what Gemba Walks are and their significance in pharmaceutical industry. We will understand how companies can implement Gemba Walks in pharmaceutical industry for better quality and regulatory compliance.

What Is a Gemba Walk?

The word Gemba is taken from Japanese language meaning “the real place”. In pharmaceuticals it refers to the shop floor or production area where the actual work happens and value is added. A Gemba walk is when a supervisor, manager or quality personnel walk through the production area to observe the process directly, engage with employees and identify risks and potential process improvements.

It is different from audits and self-inspection, which are compliance focused while Gemba Walks on observation and education focused in which new opportunities are uncovered by understanding the process.

Why Are Gemba Walks Important in Pharmaceuticals?

In pharmaceutical industry, errors and non-compliance can result in regulatory actions, product recall or present harm. Gemba Walks provide an opportunity to find and correct the issue before it becomes a non-compliance.

1. Real-Time Insight into Operations

Many problems in pharmaceutical manufacturing and quality control are not visible in reports. A Gemba Walk helps the leaders to observe reality that how equipment is used, processes are followed and teams operate. This direct observation helps in the validation of SOPs, whether they are practical and match the actual practice being followed.

2. Enhancing cGMP Compliance

Gemba Walks are an excellent tool to implement compliance with current good manufacturing practices. Regular walks can cover incomplete and inaccurate documentation, improper governing or hygiene practices, poor maintenance of equipment, cleaning and housekeeping.

Early detection of problem means early correction of problem that strengthens the compliance and prepares the organization for regulatory inspections.

3. Encouraging Employee Involvement

Operators have a clear understanding of issues that happen during manufacturing that affect productivity and quality of product. Gemba walks establish communication between leaders and real workers. When leadership communicates to employees on floor, it builds trust and motivates them to suggest improvements.

4. Driving Continuous Improvement

Observations noted during Gemba Walks help to take improvement initiatives, whether they are in equipment design, workflow, documentation practices or safety. These incremental changes improved efficiency and compliance over time.

How to Conduct a Gemba Walk in a Pharmaceutical Environment

A structured approach is required to implement Gemba Walks effectively in pharmaceutical industry. Here is a step by step process for its implementation in pharmaceutical manufacturing facilities.

Step 1: Define Your Purpose

Define the area where you want to focus before you start a Gemba Walk. It would be documentation, clean room behavior, equipment utilization, production workflow, material handling procedures or safety. Having a focus ensures that Gemba Walk is structured and aligned with goals.

Step 2: Create a Checklist or Observation Guide

Create a checklist to ensure the important areas are not overlooked during checking. It is just for remembering, not like an audit, because Gemba Walks are flexible. Your checklist may contain:

Are SOPs being followed?
Are operators filling logs in real time?
Are labels and material status tags proper?
Are equipment status updated?
Are governing procedures followed?

A checklist keeps us focused on the area we want to actually check.

Step 3: Schedule Regular Walks

Gemba Walk should be a routine activity, not a one time event. Consider daily short and focused walks, weekly thematic walks and monthly cross functional walks. You can create a Gemba Walk calendar and assign different departments to each week or month.

Step 4: Engage With the People

The main purpose of Gemba Walks is interaction between leaders and workers. You can ask some open ended questions like:
“Can you show me what you’re doing?”
“What challenges are you facing here?”
“Is there anything you think could be improved?”
“How do you ensure compliance in this step?”

Remember, the objective is learning and support, so listen carefully and do not correct or blame anyone.

Step 5: Take Notes and Record Observations

Document everything that you observe good practices as well as potential issues, which may include deviations from SOPs, safety risks, inefficiencies and employees’ suggestions. Avoid interrupting the workflow during your walks and be respectful.

Step 6: Analyze Findings and Take Action

After completion of works, consolidate findings and categorize them into following categories.

A) Quick wins — Easy fixes (e.g., adding labels, fixing lighting)
B) Process improvements — Those may require SOP changes or retraining
C) Systemic issues — Those need further investigation or CAPA

Assign responsibilities for completion, deadlines and track progress.

Step 7: Communicate Outcomes

Communicate real changes with employees made by their inputs during Gemba Walk. Share improvement actions and celebrate success with employees promoting a culture of openness.

Key Areas for Gemba Walks in Pharmaceuticals

1. Weighing & Dispensing: Proper gowning, material reconciliation, documentation accuracy
2. Granulation & Compression: Equipment cleanliness, batch record completion, in-process checks
3. Packaging Line: Line clearance, label control, operator alertness
4. Warehouse: Material status, FIFO compliance, segregation
5. QC Lab: Instrument calibration status, analyst practices, documentation timing
6. Cleanroom Areas: HVAC performance, pressure differential display, cleaning records

Best Practices for Successful Gemba Walks

1. Be Consistent – Irregular walks send the message that quality only matters sometimes.
2. Don’t Blame – Create a no-blame culture. Focus on the process, not the person.
3. Go in Pairs – Consider pairing QA with production for balanced observation.
4. Follow Up – The walk doesn’t end at observation. Action and feedback are key.

Gemba Walk is a powerful way to observe reality, engage with employees, ensure compliance and continuous improvement. When it is implemented with the right intent and structure it can transform culture and improve product quality and regulatory readiness.