Lean Manufacturing Is the Process

Lean manufacturing is the process of eliminating waste in production in order to guarantee quality and maximize efficiency" (Lean Production: A jaguar case study). It is based on continuous monitoring to develop new working processes and perceptions about continuous quality improvement. The process transforms working relationships where every team member is held accountable for their own work and creates a continuous flow system based on the just-in-time approach. Just-in-time is based on forecasted demand and only orders to receive inventory as needed to reduce inventory and overhead costs (Hunt).

Lean manufacturing also uses visible management where every member understands how all the system parts work to contribute to meeting performance requirements. It also includes an identification process to evaluate for problems and determine where problem areas are and how they can be improved. The pharmaceutical industry uses cGMP, which focuses on manufacturing as a means to produce safe and effective products (Green). Where cGMP focuses on ensuring controls are in place for assurance of safety and efficiency, lean focuses on reducing and eliminating waste and creating value.

This has created a new prospective of lean called lean pharma. It is devised of four rules of standard work, clear relationships and communications, simple flow, and scientific method where guidance is from teachers at the lowest level of the organization. The essence of lean pharma is to determine how operational procedures can be modified to bring short-term improvement while maintaining quality in standards. Standard operating procedures and other manufacturing instructions would be viewed to expose problems and encourage improvement. Technical standards are placed in line with regulatory requirements.

Other operational procedures are evaluated and standardized for time, sequence, content, and outcome. The challenge is to design new operational procedures, comply with external regulatory requirements, and support continuous improvement all at the same time. Cycle time and quality is equally important. Any deviation in the cycle signals potential quality issues. For work time standards, a call for help is made when standards are not met to reduce upstream process issues. The challenge is to reduce grey zones of responsibility, slow response and late calls for help.

Transformation of patterns for working relationships are important to hold the team member responsible for their own work. The team leader has the responsibility of evaluating response time and calls for help. Team members should be held accountable and encouraged to use the team leader for support. Visible management is also important where everyone knows and understands how all the system parts work where they know how to contribute to meet performance requirements.

Identification is set up where leaders can evaluate how many problems occur during a shift to determine where problem areas are. Open information in the work area, called the three-minute management approach, enables employees to know work related visions and goals as well as issues and problem areas. Communications should be clear, simple, and direct in a shared responsible and shared management approach. The pathway for product and service must be simple and direct, creating one way to move forward without loops, forks, or fast paths.

Products and services flow to specific persons or items of equipment to enforce economies of repetition. Each time a product takes the same path, variation and problems are exposed. The focus would be to reduce batch size, move toward a single flow, and improve responsiveness to changes in customer demand. The challenge is to introduce simple flow and expose areas needing improvement to reduce cycle time and costs. Signals need to be designed for calls for problems and help when needed.

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 and other financial institutions routinely apply the management principles of lean manufacturing to help standardize straight forward business procedures, such as the straight-through process of securities transactions" (Meyer). The advantages are.