CONTROLLED ENVIRONMENTS: Quality Systems

Minding the Cs and Qs

When one thinks about contamination control and quality management, one may not realize they share similar traits. Upon closer review, a few items surface as mutual attributes. Both contamination control and quality management indicate the need for structured planning and consideration of customer requirements, as well as statutory and regulatory needs. Both are achieved by conforming to process approach; certification and recertification; understanding and examination of process variations; and employee involvement.

Conforming to Process Approach

One of the surest ways to conform to a process approach is often done by using the PDCA methodology. That's plan, do, check and act. This cycle provides a strategy-led process approach to move organizations from desire to execution. The process approach provides a breakdown of transformation steps into phases, which subsequently help to achieve efficient use of activities and related resources into a manageable process.

The figure covers the PDCA model that is often used by organizations to conform to many standard requirements such as ISO 14644, ISO 9001:2001, ISO 14001 (International Organization for Standardization), and IEST (Institute of Environmental Sciences and Technology) guidelines. Both contamination control and quality management activities rely on technical guides to maintain compliance and quality assurances.

Certification and Recertification

Certification and recertifications are carried out in both contamination control and quality management activities. Cleanrooms are certified to requirements for temperature, cleanliness, humidity, and pressurization. After an initial certification, they are then recertified periodically to ensure that process control and operational parameters meet specifications. Quality management systems such as ISO 9000 and 14000 are initially certified to requirements standards and, within six-months to a year later, recertified by virtue of a surveillance audit. An accredited audit agency approved by the registrar accreditation board performs certification of quality management systems, similar to a cleanroom certification agency reviewing contamination control activities.

Process Variations

Another interesting observation is that with both contamination control and quality management, the sources of variation must be understood to optimize desirable results. In the case of contamination control, when additional persons or equipment are implemented within a cleanroom, variation in the processes occurs (mechanical and human). Actions are then taken to eliminate those items that have the greatest impact on the ability to meet requirements. Some of the tools that are utilized in either contamination control or quality management may include cause-effect diagrams, Pareto and control charts as well as scatter diagrams and other tools.

Employee Involvement

Employee involvement is paramount for either a contamination control system or quality management system to operate at its full potential. Employee involvement represents the cornerstone of productivity gains and process improvements. One of the surest ways to develop informed and concerned thinkers in both the contamination control and quality management disciplines is to provide risk and control consciousness. Understanding and discussing risk management coupled with internal controls serves as a "joystick" to establish fine grain control and enable speed and effectiveness of problem solving. Prevention, compliance and improvement apply to both contamination control and quality management systems. If we listen more and continue to follow a structured approach and plan, do, check and act success, and compliance are sure to follow. �

Derick O. Edwards is the quality/continuous process improvement manager, while Grant Merrill is the lead systems sales engineer at AES Clean Technology Inc. (Montgomeryville, Pa. Reach them at 215-393-6810.