A global manufacturer operates a clean room used in the manufacturer of goods. The system includes proprietary processes for which specialty equipment is required. Because the manufacturer operates in several countries, the equipment must be able to ship anywhere in the world. Therefore, the equipment in the room requires CE marking, which in turn requires a risk assessment. The manufacturer desired an in-house capability to perform risk assessments to accommodate its ongoing process and equipment improvements. The company management has set explicit requirements for implementing the risk assessment process against a specific time schedule.
In this situation, the risk assessment process is being used in the machinery design and process development to ensure both its safety and its ability to ship anywhere in the world. Safety professionals are engaged in leading the effort and design and maintenance engineers share ownership of the process. Management has set the criteria and all are working to meet these requirements.