Pharmaceutical Companies: Synergies between Process Analytical Techniques (Pat) and Lean Six Sigma
Manufacturers are facing numerous challenges within their markets as the estimate of foreign competitors grows and increasing material costs impact margins. Firm 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 management (Fda) and the European Medicines branch strongly encourage pharmaceutical fellowships to bind to Pat Guidelines. Pat consists of four basic components 1) Process understanding, 2) Risk-based approach, 3) Regulatory strategy to adapt 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 diagnosis and control capabilities. Pat is a scientific schedule designed to reduce risk framework, and is, essentially, about improving processes for effectiveness and efficiency. This religious doctrine is also prevalent in Lean Six Sigma. However, Lean Six Sigma offers easy to understand tools that can facilitate or heighten the Pat goals and objectives. Examples of these tools would consist of Sipoc Models (Supply-Input-Process-Output-Customer) and Fmea (Failure Modes and Effects Analysis). Lean Six Sigma, using a appropriate Dmaic Model
(Define-Measure-Analyze-Improve-Control) controls process and product inequity by identifying, recognizing and defining problems. It then characterizes, measures and analyzes the data. This optimizes potential control in the manufacturing process and improves production rates, enhances innovation, and reduces cycle times. Practicing Lean Six Sigma in the pharmaceutical manufactures can have great impact on the plant floor. By implementing Lean techniques, the pharmaceutical manufactures can realize the same success as other industries. Since Pat is basically a theory for designing, analyzing, and controlling manufacturing it supports using any techniques that lead to prosperous 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 worker to grasp but serve the same purpose when dealing with risk management and potential assurance. A desired goal of the Pat framework is to establish and establish processes that can consistently ensure a predefined potential 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 foremost role in the application of Pat by providing a simplified template. Continuous revision (Ci) systems have always been used to boost operational performance. Areas that are commonly targeted consist of labor utilization, catalogue levels, quality, asset utilization and cost of goods. In 2006, Arc Advisory Group, a foremost study and advisory firm in manufacturing and furnish chain solutions, reported that 80 percent of manufactures are applying one or more Ci methodologies to their plants. The most beloved Ci programs consist of Lean Six Sigma, Six Sigma, Total potential management (Tqm), and theory of Constraints (Toc). Of these Ci methodologies, Lean Six Sigma is the strongest candidate to partner with Pat. One fancy for this is that Lean Six Sigma encourages the use of Statistical Process control (Spc) and establish of Experiments (Doe). Spc is an sufficient formula of monitoring a process straight through the use of control charts.
Doe includes the establish of all information-gathering exercises where inequity is present, either under the full control of the experimenter or not.The purpose of Spc is to isolate the natural inequity in the process from other sources of inequity 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 plainly the connection between the variables. In Lean Six Sigma, as well as Pat, the goal would be to understand the complex connection between some factors.The Pat coming 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 straightforward brainstorming to applying Failure Mode and ensue diagnosis to the issues.There is clearly a synergy between Pat and Lean Six Sigma. They can be simultaneously implemented and have the potential to improve quality, reduce cycle time and increase profit.
