Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center

Abstract

This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

Keywords: Baldrige criteria; ISO 21500 guideline standards; ISO 9001 and 15378 standards; Integration of quality systems; Organizational project management maturity model; Quality hierarchy.

Fig. 1

The figure illustrates the number of Center sections, standard operating procedures (SOPs), and approved methods and procedures (AMPs) related to the key work system and key work processes along with core competencies.

Fig. 2

The quality hierarchy illustrates four management systems that represent the core competencies along with integrated quality systems, strategic elements and goals. These foundations represent TIPES.

Fig. 3

The figure represents the linkages between each of OPM3's domains of portfolio and program/project management along with an organization's strategic plan and operations. It also represents the relationship of strategic challenges, strategic opportunities, and innovation with strategic advantages, and how they trigger intelligent risk taking and their contribution to the realization of the mission-vision-values. This culminates in the development of strategic goals and objectives and consequently the strategic plan.

Fig. 4

The figure illustrates the committee hierarchy including leadership, reporting structure and Baldrige Category assignments.

Fig. 5

The figure illustrates the heart of organizational culture that is constructed around the passion and commitment for the organization's Mission, Vision, Values and Ethical Expectations. The figure also shows the importance of strategic challenges, advantages, opportunities and objectives in realizing an organizational vision and the significance of innovation and intelligent risk taking in that process.