The Current Context of the Pharmaceutical Industry

The pharmaceutical industry is constantly evolving and faces a series of challenges that require continuous adaptation and innovation. The increasing complexity of regulations, the pressure to reduce costs and improve efficiency, and the need to develop new drugs more quickly are just a few of the obstacles that companies in this sector must overcome. Additionally, globalization and strong competition force these companies to seek ways to differentiate themselves in order to maintain their competitiveness in the global market.

Current Challenges in the Pharmaceutical Sector

The pharmaceutical industry is currently facing several significant difficulties. These companies must comply with increasingly stringent regulations and cope with the globalization of markets and cost management while consistently maintaining high standards of quality and safety. Below are some of these challenges and their respective improvement approaches:

Increasing Service Level and Reducing Inventory

Improving customer response and product availability through inventory optimization strategies and demand forecasting, guaranteeing a higher service level. This involves analysing and adjusting safety stock levels to balance the risk of stockouts, optimizing inventory management, and reducing stock costs.

Reducing Lead Time

Streamlining quality control processes by simplifying and automating workflows allows for faster response in product analysis and approval, significantly reducing the time to market.

Reducing Maintenance Costs

Lowering operational costs with preventive and predictive maintenance programs increases equipment lifespan and reduces the frequency of costly interventions.

Improving Quality

Reduce recurring deviations and eliminate variability by establishing a strategy for classifying and mitigating deviations that occur more than once in a given period. This, combined with the implementation of quality control methods and statistical tools, minimizes variability in production processes, ensuring greater product consistency and compliance.

Promoting Digital Transformation

Adopting digital transformation solutions to modernize management systems, from process automation to the integration of advanced analytics platforms, boosts operational efficiency.

The Importance of Continuous Improvement in the Pharmaceutical Industry

Continuous improvement is crucial for the pharmaceutical industry as it allows companies to optimize processes, reduce waste, and increase efficiency. By adopting continuous improvement practices, companies can respond quickly to market changes, improve the quality of their products and services, and remain competitive. This approach not only addresses immediate operational issues, but also establishes a culture of excellence and innovation that sustains long-term success.

Operational Challenges Based on Case Studies

Pharmaceutical companies face challenges that directly affect their ability to operate efficiently and profitably. These challenges range from operational and production issues to the need to adapt to new technologies and regulatory changes. Effectively addressing these challenges is crucial for ensuring long-term sustainability and growth. Below are some of these challenges.

Operational and Production Problems

Operational and production problems are some of the biggest obstacles faced by pharmaceutical companies. These include:

• Machine Downtime: Frequent and prolonged machine downtime resulting in production delays and significant additional costs.
• Non-compliance with Production Plans: The inability to meet production plans affects the ability to respond to market demand and can result in financial losses.
• Stock Management: Ineffective stock management can result in high levels of stockouts and excess inventory, both of which are detrimental to operational efficiency.

To be effectively resolved, these operational and production problems require systematic and structured solutions, and this is where the Kaizen Institute’s approach adds value.

Root Causes of Identified Problems

• Setup Tasks by Maintenance Team: Instead of the operators, the maintenance team is often in charge of carrying out machine setups, causing significant delays and reflecting an excessive dependence on the maintenance team.
• Poor Tool and Maintenance Management: The lack of effective tool management and regular machine maintenance causes frequent downtime and operational inefficiencies.
• Lack of Structured Problem-Solving Methods: The lack of a structured method for solving operational problems results in continuous failures and the inability to meet the production plan.
• Inadequate Operating Standards: Outdated or inadequate operating standards for production, setups, and maintenance contribute to low efficiency and productivity.
• Inefficient Material and Information Flows: Inefficiencies were identified in material and information flows, from raw materials to finished products, causing production delays and problems in stock management.

Kaizen Institute’s Approach to These Challenges

Transferring Setups to Operators

One of the main approaches adopted in this context involves transferring machine setups to operators. This approach increases operator autonomy and significantly reduces machine downtimes, resulting in greater operational efficiency.

Implementing Kaizen Methodologies

Implementing the Kobetsu Kaizen methodology helps reduce unplanned downtime and machine micro-failures, as well as the SMED tool to improve setup times. Workshops and projects using the PDCA cycle are also key to identifying and solving operational problems.

Improving Tool and Process Management

Implementing 5S practices and visual management significantly improves tool organization and accessibility, resulting in greater production efficiency. Effective tool management and regular maintenance are crucial to reducing setup times and increasing productivity.

Implementing Daily Kaizen

Implementing Daily Kaizen programs involves all teams in continuous improvement. This program promotes regular meetings and data analysis, allowing a quick reaction to deviations and the implementation of immediate countermeasures. This systematic process helps to consolidate a culture of continuous improvement at all levels of an organization.

Results Achieved with the Kaizen Approach

Improvement in Performance Indicators

The implementation of Kaizen methodologies results in significant improvements in the performance indicators of companies in this sector. Here are some of the results achieved:

• Increased OEE: Overall Equipment Effectiveness increased by 9.2%, reflecting greater operational effectiveness.
• Reduction in Setup Times: A 37% improvement in setup times enabled faster and more efficient production.
• Reduction in Stockouts: More effective management of tools and production processes reduced stockouts by 46%.
• Reduction in Lead Time: Reference change times were reduced by 29%, and external warehouse use was reduced by 46%.
• Stock Reduction: Raw materials and packaging materials inventory was reduced by 58%, and finished product inventory was reduced by 46%.

Impact on Organizational Culture

Kaizen’s approach not only improves performance indicators but also has a profound impact on companies’ organizational culture:

• Greater Operator Autonomy: Empowering operators reduces dependence on third parties and promotes greater autonomy and responsibility.
• Culture of Continuous Improvement: The implementation of Daily Kaizen practices and the holding of continuous improvement workshops consolidate a culture where the pursuit of excellence and innovation is constant.
• Employee Involvement: Training and active employee involvement help overcome resistance to change and promote a dynamic and collaborative work environment.
• Sustainability of Improvements: Regular audits and Kamishibai routines guarantee the sustainability of achieved results, maintaining a focus on continuous improvement.

Still have some Questions About the Role of Continuous Improvement in the Pharmaceutical Industry?

How Can Continuous Improvement Benefit the Pharmaceutical Industry?

Continuous improvement enables process optimization, waste reduction, and increased operational efficiency. Specific benefits include reduced setup times, decreased stockouts, increased OEE (Overall Equipment Effectiveness), and better stock management. Additionally, promoting a culture of innovation and operational excellence makes companies more agile and adaptable to market changes.

How Can Kaizen Institute Help My Company?

Kaizen Institute can help your company implement continuous improvement methodologies that address your specific challenges. This may include empowering operators, using 5S and visual management practices, and using methodologies and tools like Kobetsu Kaizen and SMED. Through Daily Kaizen, KI promotes the active participation of all employees, establishing a culture of continuous improvement that ensures sustainable results and a quick response to operational issues.