Pharmaceutical Companies: Synergies between Process Analytical Techniques (PAT) and Lean Six Sigma
Manufacturers face numerous challenges within their markets as the number of foreign competitors grows and rising material costs impact margins. Business methodologies like Lean Six Sigma working in conjunction with Process Analytical Technologies (PAT) can increase the chance of success, especially in the pharmaceutical industry. Both the US Food and Drug Administration (FDA) and the European Medicines Agency strongly encourage pharmaceutical companies to adhere to the PAT Guidelines. PAT consists of four basic components 1) Understanding the process, 2) Risk-based approach, 3) Regulatory strategy to adapt to innovation, and 4) Real-time release. By implementing the techniques used in Lean Six Sigma, many PAT managers are self-satisfied. For example, the PAT guidelines state that organizations should focus on their measurement analysis and control capabilities. PAT is a scientific program designed to reduce the risk framework and is essentially about improving processes to achieve effectiveness and efficiency. This philosophy is also prevalent in Lean Six Sigma. However, Lean Six Sigma offers easy-to-understand tools that can facilitate or enhance PAT goals and objectives. Examples of these tools would include SIPOC (supply-input-process-output-customer) models and FMEA (failure modes and effects analysis). Lean Six Sigma, using a standard DMAIC model
(Define-Measure-Analyze-Improve-Control) controls process and product variation by identifying, recognizing, and defining problems. It then characterizes, measures, and analyzes the data. This optimizes quality control in the manufacturing process and improves production rates, enhances innovation and reduces cycle times. Practicing Lean Six Sigma in the pharmaceutical industry can have a huge impact on the plant. By implementing Lean techniques, the pharmaceutical industry can achieve the same success as other industries. Since PAT is basically a system for designing, analyzing, and controlling manufacturing, it supports the use of any technique that leads to successful completion that also reduces risk. Lean Six Sigma offers tools that monitor and correct errors in the implementation process. The tools used in Lean Six Sigma are often simpler for an employee to understand, but serve the same purpose when it comes to risk management and quality control. . A desired goal of the PAT framework is to design and develop processes that can consistently guarantee a predefined quality at the end of the manufacturing process. Lean Six Sigma makes it easier.
Both PAT and Lean Six Sigma promote the reduction of production cycle times, avoiding rejections, increasing automation and facilitating continuous process improvement. Lean Six Sigma can play an important role in the PAT application by providing a simplified template. Continuous Improvement (CI) systems have always been used to drive operational performance. Common areas of focus include labor utilization, inventory levels, quality, asset utilization, and cost of goods. In 2006, ARC Advisory Group, a leading manufacturing and supply chain solutions research and advisory firm, reported that 80 percent of manufacturers are applying one or more CI methodologies in their plants. The most popular CI programs include Lean Six Sigma, Six Sigma, Total Quality Management (TQM), and Theory of Constraints (TOC). Of these CI methodologies, Lean Six Sigma is the strongest candidate to partner with PAT. One of the reasons for this is that Lean Six Sigma encourages the use of Statistical Process Control (SPC) and Design of Experiments (DOE). SPC is an effective method of monitoring a process through the use of control charts.
DOE includes the design of all data collection exercises where there is variation, whether under the full control of the experimenter or not. Causes can be identified. DOE is used to study processes and products. In a purely scientific procedure, DOE would not be concerned with optimization but simply with the relationship between variables. In Lean Six Sigma, as well as in PAT, the goal would be to understand the complex relationship between various factors. The PAT approach encourages manufacturers to rethink their systems strategy for both infrastructure and application integration.
Lean Six Sigma provides a group of tools to make this possible. These tools range from simple brainstorming to applying failure mode and effect analysis to problems. There is clearly a synergy between PAT and Lean Six Sigma. They can be deployed simultaneously and have the ability to strengthen quality, reduce cycle time, and increase profit.