The process approach to quality is a strategy used by many manufacturers and service providers to identify and manage the interaction between systems that comprise an organization. A process can be defined as an integrated set of activities that use various resources to convert inputs to outputs. When adopting the process approach, it is equally as important to identify each process as it is to characterize it. Characterization usually includes defining the following six (6) universal process affecters:
- Method: establishes a procedure to describe how to carry out the process (e.g. standard operating procedure, work instruction, etc.).
- Human Resources: identifies the competency qualifications (e.g. education, training certification, etc.) required.
- Machines/Instrumentation: defines what type of machinery or instrumentation (e.g. injection molding equipment, ICP-MS, pH meter, etc.) is required.
- Materials: defines the materials (e.g. laboratory reagents, raw materials, etc.) required.
- Environment: defines the environmental conditions required.
- Metrics– describes how the success of the process is measured.
Often times the outputs of one process are the inputs of another, and if your system is rather complex, keeping tabs on how they’re all interrelated may prove to be a challenge. Flowcharts serve as a useful tool for understanding and visually representing how all of these processes are interconnected. These interconnections or ‘links’ are what essentially comprise the quality management system (QMS).
How the process is measured for success is an area that is often overlooked, but is key for ensuring control and improvement. Defining quality objectives such as meeting a percent yield, manufacturing a specific number of units, or meeting set turnaround-times, can serve as a measure of success in certain areas. Defining metrics in other areas may not be as straightforward. Sometimes an indirect measure, like an internal auditing program, is the only way to determine whether or not a process is under control. Regardless of the process, one way or another its success must be measured.
In summary, a QMS is made up of many simple or complex linked processes through a series of input-output relationships. Taking a process approach to your QMS can help manage these processes— no matter what the level of complexity.
Coming up in the next Quality Corner: how an effective corrective action program can help improve the effectiveness of your QMS.
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Tricia Wood has more than 20 years of experience working in quality-related positions for several regulated industries, including pharmaceutical development and manufacture, medical device manufacture, and analytical services.