Regulatory Focus™ > News Articles > Risk History, Probability and Management

Posted 01 May 2009

Risk History, Probability and Management

"When conducting a risk analysis manufacturers are expected to identify possible hazards associated with the design in both normal and fault conditions. The risks associated with the hazards, including those resulting from user error, should be calculated in both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to acceptable levels by appropriate means."

 

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