Failure modes and effect analysis (FMEA) is a tool that works to prevent process and product problems before they occur.
I like to define FMEA’s as an organized brainstorm. The process examines a product or process and asks what could go wrong. Then the team systematically determines and rank orders for each failure mode: – the severity of the problem when it occurs – the probability of the problem occurring – the ability to detect the problem before it occurs. Continue reading
NSAI (National Standards Authority of Ireland) hosted a meeting of ISO TC 176 in Galway Ireland on November 19th, 2014 on the rewrite of ISO 9001:2015. NSAI developed a series of videos on ‘What Happens Next?’ Continue reading
There’s a mighty black and white, six minutes long documentary film enclosed to the Italian progressive rock band PFM / Premiata Forneria Marconi Stati di Immaginazione (States of Imagination) music album. Its title is La Conquista (The Conquest). It shows how a savage Indios tribe succeeds in building, with very poor means, a bridge crossing a very dangerous river, to ensure its survival. Continue reading
The authors of ISO 9001 recognize that dealing with risk is part of management, including quality management. The 2015 standard will require risk-based thinking (RBT) as part of systemic quality management, just as the process approach is part of systemic quality management. Good news: application of RBT, like that of the process approach, comes naturally to successful management personnel. Continue reading
In his book Decision Making: Risk Management, Systems Thinking and Situation Awareness, Dr Alan McLucas introduces the concept of the Risk Management Paradox: Continue reading