The pervasiveness of configuration management (CM) across an organization can be daunting. Challenges arise due to CM’s impact on many organizations, processes, and supporting applications within an enterprise. Chief among them:
- Collaboration across the CM program teams. These teams include product development, manufacturing, service management, and regulatory. Each organization has their own mandates and goals, so getting them to elevate CM to a top-level priority can be difficult. In many cases, an executive mandate is needed.
- The current state and form of product and process design information. Since CM starts with approved product configurations that can be widely used by other functions, it is critical to have as-design data available in a form that can be easily accessed and used by downstream functions.
- Collaboration between product development and manufacturing for development of the Device Master Record (DMR). While a subset of the first bullet listed here, this collaboration is so critical that it merits being called out on its own. The DMR is essential in establishing manufacturing procedures, quality controls, and packaging and labeling specifications— what needs to happen in order for the product to be the approved configuration. Collaboration between these functions is essential for smooth design transfer and the effective development and evolution of the DMR.
- Isolation of product specifications. Product specifications are often embedded in drawings or test procedure documentation as opposed to captured in product data. They need to be made available as part of the product data.
- Integration of applications. Because of the number of applications that support each business function that plays a role in CM, integration is essential. The source for each type of product data must be understood across the CM ecosystem.
- Integration of third parties. In today’s manufacturing, the number of third parties involved in product design, manufacture, distribution, and service has proliferated. These parties, which include design organizations, contract manufacturers, and outside service providers, must be integrated to capture and communicate all necessary data for effective CM.