When the job can be done consistently, then improvement can be made. The scientific methodology is the driving force to quality. The challenge is the need to implement FDA's risk approach. Process analytical Technology (PAT) is a scientific risk-based framework to help pharmaceutical companies design, develop, and implement new efficient tools for use during product manufacture and quality assurance while maintaining or improving the current level of product quality assurance (FDA). PAT consists of two general components: 1) a set of scientific principles and tools supporting innovation and 2) a new regulatory strategy for accommodating innovation. It includes the PAT team approach. The primary focus of scientific manufacturing is to find new ways to use knowledge acquired during the processes and risk-based decisions. It is important for all team members to fully understand the processes and how they work.

With the team approach, work is standardized so each one knows their responsibility and can ensure high quality standards. The worker responsibility is outlined in a series of work elements with value added activities stating the time needed for each element (seconds or minutes) to make it possible to distribute work fairly. Teams should discuss their work to identify ways to reduce time spent on non-value added activities to cut out waste.

Opportunities to cut waste include sticking with customer requirements to reduce conveyance, or moving things around. This would require good forecasted demand. It would also include improving work plans to reduce wasteful movement. Looking for ways to cut down on time spent waiting on needed supplies is another opportunity to cut down on waste. Cutting inventory levels reduces unsold product and space needed for products that are selling. Good machine and equipment maintenance reduces repair costs and time waiting for repairs to be done.

Can lean be implemented in the banking, or service, industry? The answer is yes. "Many corporate banks...

The advantages are speedier operations, lower costs, better products, and improved customer experience.
The core concepts and methods is to customize process steps with good judgment. Multifunctional loan teams can implemented for industries of major clients. Team leaders are responsible for the team's effectiveness and business output measured by success of loan decisions, team collaboration, and problem solving. The team leader implements the visible management of lean to hold each team member accountable and help them understand the processes for effective contribution of performance goals.

Processes can be streamlined by assigning loans to one of four standard tracks based on risk and regulatory factors. The value stream is created by keeping momentum going through clear milestones and deadlines using visual aids, such as electric whiteboards, to identify bottlenecks and areas needing improvement. The goals are to reduce transaction time and increase productivity. The key is to focus on operational manifestations of the problem, such as tailored processes and ineffective handoffs, and organizational shortcomings that cause issues with collaboration, accountability, and a sense of common purpose.

Bibliography

FDA. Pharmaceutical cGMPS for the 21st century -- a Risk-Based Approach: Second Progress Report and Implementation Plan. 17 Aug 2009. Article. 14 May 2013.

Green, a. & O'Rourke, D. "Lean Manufacturing practise in a cGMP environment." Pharmaceutical Technology Europe, Vol 18 Issue 10 (Oct 1, 2006). Article.

Hunt, J. The "Just-in-Time" Method. 2013. Article. 11 May 2013.

Lean Production: A jaguar case study. n.d. Article. 11 May 2013.

Meyer, R. Lean Banking. 3 Sept 2008. Article. 12…