The Role of Reliability in Risk-Based Decision-Making

Jim Breneman
Jim Breneman worked for Pratt & Whitney, Division of United Technologies for almost 35 years before retiring in 2008. At retirement he was an ACE mentor, as well as the Manager of Engineering Technical Excellence. Jim formed and guided P&W’s Engineering Technical University, was responsible for all P&W Research & Development Agreements with Universities, as well as the P&W In...read more



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As most of you are well aware, ISO 9001:2015 is a risk-based standard. In addition to the Quality Systems Management that must recognize risk and opportunities in all aspects of a business (Sections 4.1 & 4.2 of ISO9001-2015); Section 6 states that the organization shall “determine risks and opportunities that need to be addressed.” Thus we have arrived at the need for Risk-Based thinking and Risk Management. But since there are typically too many risks, and not enough money to address all of them, how and what do we do? First you have to set a Risk “goal” (in terms of Reliability & --possibly Safety—depending on the product). Allocate this top-level Risk goal among the sub-systems (and lower if that makes sense). This will set the Design Reliability (& Safety) goals. This presentation will illustrate some examples of how to model reliability via Weibull Analysis, Reliability Growth Modeling, Fault Tree Analysis, FMEA and Monte Carlo Analysis to project Risk (and achieve a reliable and safe product). Of the Risk Management processes this presentation will concentrate in the areas of Qualitative risk analysis Quantitative risk analysis Examples using various Reliability & Statistical tools (FMEA, Weibull Analysis, Monte-Carlo Simulation, and others) will illustrate “calculating” risk and how to prioritize risks against a “standard.”… even when your data is sparse (or possibly non-existent). In addition, you’ll see some methods to help in telling the Boss bad news: “We can’t do this project in the time frame (a budget – time risk to the company) as quickly as you want.” (without getting thrown out of his office, or worse).


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