July 19, 2024
Process Analytical Techniques (PAT) and Lean Six Sigma

Pharmaceutical Companies: Synergies between Process Analytical Techniques (PAT) and Lean Six Sigma

Manufacturers are facing numerous challenges within their markets as the number of foreign competitors grows and increasing material costs impact margins. Business methodologies such as Lean Six Sigma working in tandem with Process Analytical Technologies (PAT) can increase the opportunity for 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 PAT Guidelines. PAT consists of four basic components 1) Process understanding, 2) Risk-based approach, 3) Regulatory strategy to accommodate innovation and 4) Real-time release. By implementing the techniques used in Lean Six Sigma, many PAT principals are automatically satisfied. For example, PAT guidelines state that organizations need to focus on their measurement analysis and control capabilities. PAT is a scientific program designed to reduce risk framework, and is, essentially, about improving processes for 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 the PAT goals and objectives. Examples of these tools would include SIPOC Models (Supply-Input-Process-Output-Customer) 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 great impact on the plant floor. By implementing Lean techniques, the pharmaceutical industry can realize the same success as other industries. Since PAT is basically a system for designing, analyzing, and controlling manufacturing it supports using any techniques that lead to successful completion that also lowers risk. Lean Six Sigma offers tools that monitor and mistake-proof the implementation process.Tools used in Lean Six Sigma are often simpler for an employee to grasp but serve the same purpose when dealing with risk management and quality assurance. A desired goal of the PAT framework is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process. Lean Six Sigma makes this easier.

Both PAT and Lean Six Sigma promote reducing production cycle times, preventing rejects, increasing automation and facilitating continuous process improvement. Lean Six Sigma can play an important role in the application of PAT by providing a simplified template. Continuous Improvement (CI) systems have always been used to boost operational performance. Areas that are commonly targeted include labor utilization, inventory levels, quality, asset utilization and cost of goods. In 2006, ARC Advisory Group, a leading research and advisory firm in manufacturing and supply chain solutions, reported that 80 percent of manufactures are applying one or more CI methodologies to 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 reason 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 information-gathering exercises where variation is present, whether under the full control of the experimenter or not.The purpose of SPC is to isolate the natural variation in the process from other sources of variation that can be traced or whose causes may be identified. DOE is used to study processes and products. In a purely scientific procedure, DOE would not care about optimization but rather simply the relationship between the variables. In Lean Six Sigma, as well as PAT, the goal would be to understand the complex relationship between several factors.The PAT approach encourages manufacturers to re-think their systems strategy both for infrastructure and applications integration.

Lean Six Sigma provides a bevy of tools to make this possible. These tools range from simple brainstorming to applying Failure Mode and Effect Analysis to the issues.There is clearly a synergy between PAT and Lean Six Sigma. They can be simultaneously implemented and have the ability to strengthen quality, reduce cycle time and increase profit.