Risk Management: Unique EHS Strategies for R&D Equipment
Fessler, Mark
(Tokyo Electron U.S. Holdings, Inc.)
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LoginSEMI S2 adequately defines product safety requirements for semiconductor production systems. The product safety requirements of R&D tools (concept/feasibility, alpha tools, beta tools), however, are usually left up to the company’s “internal” tolerability of risk. As you all know, it is not reasonable to require R&D equipment to be fully SEMI S2 compliant, so the risk assessment approach lends itself very well to prioritize how to attack an audit of R&D equipment. Unlike full production equipment’s larger Engineering and Manufacturing Departments, our R&D groups are much smaller, and while they have great expertise in Process Engineering, they do not necessarily understand the infrastructure required for adequate checks/balances for equipment safety during the rapid design / process changes of R&D. Remember that proof of concept is important, before going and designing for full safety compliance. Sometimes 1st Order failure to “danger” is possible on R&D tools. Heavy administrative controls are sometimes the only justification to protect until hazard can be engineered out of the design, or new safety interlocks and protective barriers can be designed in. The presentation describes one possible solution to help manage R&D equipment safety by ensuring that you are addressing and communicating the most severe risks. We have attempted to streamline the sometimes cumbersome engineering change control process, but it still ensures a strong emphasis “residual risk” communication. Such concepts are further elaborated in the latest Machinery Directive (2006/42/EC) which requires full implementation across the EU on December 29th, 2009. We recognized that R&D equipment sometimes exposes our Process engineers to chemical and electrical and mechanical hazards which may be MEDIUM, HIGH, or VERY HIGH risks. Our internal R&D risk assessment process can be considered similar to the old Mobile Army Surgical Hospitals (MASH unit) or a modern day triage units which provides rapid response/care to the most severe injuries (High Risk), but allows lower risk issue to be addressed later, when more time can be devoted. The presentation will introduce a proposed flowchart for decision making and describe how the Residual Risk Register (RRR) Program was created to specifically capture and communicate potentially high risks in a controlled way.