The 6 Challenges in managing a Lean Sigma initiative in a GMP Environment

All industries have their own regulations and rules to follow. Companies in the Pharmaceutical industry are required to adhere to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and the Code of Federal Regulations (CFR); In this industry, compliance with existing documented processes (Standard Operating Procedures, or SOPs) is everything.

Here are 6 challenges when managing Lean/6Sigma projects in a GMP environment.

Lack of a Proper Rationale

Historically, the Pharmaceutical industry has suffered from a lack of “burning platform” for change, or a rationale for deploying Lean: the cost of goods was relatively small compared to the overall cost structure and profit margins were high, making the industry a Lean laggard. However, the current global Covid-19 pandemic is forcing the industry (vaccine manufacturing at the very least) to re-think its timelines and streamline its processes.

Lack of Senior Management Commitment

It is acknowledged as the main reason for the failure of business initiatives like Agile, Six Sigma, Re-engineering, cultural change management – Lean is equally not exempt from this. When Lean is deployed, it is done in an isolated manner (e.g. in one facility or in manufacturing only, rather than across the entire company). Pharmaceutical companies usually manage their operations in different geographical locations where API fabrication is done in one place, with the formulation & filling operations done in another location: deploying Lean as a piece meal approach (at site level / department level) is counter-productive: Lean must be deployed across the entire organization which falls under the company executives’ responsibility.

It is a Heavily Regulated Industry

The focus is on compliance rather than process improvement, with a heavy bureaucracy and a ton of procedures to follow. Some physical changes may take a while to implement, because they require a submission to the Health Authorities for the change to be authorized. It also needs to follow the company’s internal change management processes to implement it while also remaining compliant. It is therefore essential to include Regulatory Affairs and Quality Assurance departments in managing continuous improvement projects.

It is a Silo-Riddled Environment

Objectives, roles and responsibilities are clearly defined between the departments. Each will have their own ways of working, at their own pace with limited views of the impact a delay, a problem or an investigation will have on one another (it may actually take longer to release a batch than to produce it). As a result, deploying Lean means improving the communication flow between the departments, ensuring that product and information, flows from one department to another and the barriers between departments are reduced.

The need for a Cultural Change from within

As regulated and siloed as it is, going through the myriad of procedures requires expertise in the industry. Leaning an organization requires engagement of those people who have been in the industry for 20+ years, who know and understand the industry’s regulations, manufacturing procedures and documentation and can recommend ways of reducing this level of paperwork and ultimately reach the goals of a Lean organization. More than in any other industry, the Pharma industry needs successful people change management and cultural transformation efforts in complementing Lean Thinking.

It’s a Balancing Act

One cannot compete against the forces that drive the industry; The challenge is to try to implement lean while remaining compliant and following all the rules dictated by the industry. cGMP and lean must be equal partners: Lean is essential for cost reduction and waste elimination and GMP is also essential in order to keep the best quality of medication especially that we are delivering the products to people who need them. In 2004, the Food and Drug Agency (FDA) released its Process Analytical Technology (PAT) guidelines for addressing technical and regulatory issues, showing a cultural shift in the industry and an alignment with lean thinking, suggesting a positive outlook for lean pharma.

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