Risk and hazard analysis can be effectively used during design reviews to provide valuable feedback to the design to avoid failures. This article discusses the types of risks, namely, real risk, statistical risk, predicted risk, and perceived risk. It describes the principle and technical methods of risk/hazard analysis practiced in the industry to identify possible hazards and the resources necessary to avoid or reduce risks. These methods include the failure mode and effect analysis, fault tree analysis, event tree analysis, risk/benefit analysis, safety analysis, and probabilistic estimates.

Any threat to personal safety should be regarded as a hazard and treated as such. This article discusses threats from several sources, such as kinematic/mechanical hazards, electrical hazards, energy hazards, human factors/ergonomic hazards, and environmental hazards. It describes hazard analysis in terms of failure modes and effects analysis, failure modes and criticality analysis, fault tree analysis, fault hazard analysis, and operating hazards analysis. The article examines fail-safe designs, such as fail-passive designs, fail-active designs, and fail-operational designs. It also provides information on various types of warnings, such as visual warning, auditory warnings, olfactory warnings, tactile warnings, and tastable warnings.

This article discusses the organization required at the outset of a failure investigation and provides a methodology with some organizational tools. It focuses on the use of problem-solving tools such as a fault tree analysis combined with critical thinking. The discussion covers nine steps to organize a good failure investigation. They are as follows: understand and negotiate goals of the investigation, obtain a clear understanding of the failure, identify all possible root causes, objectively evaluate the likelihood of each root cause, converge on the most likely root cause(s), objectively and clearly identify all possible corrective actions, objectively evaluate each corrective action, select optimal corrective action(s), and evaluate effectiveness of selected corrective action(s). Common problems detrimental to a failure investigation are also covered.

This article reviews the most common reasons for failures and the purpose of a failure investigation. It discusses the nine steps for the organization of a good failure investigation. The three basic tools that are helpful in any failure investigation, namely, a fault tree, a failure mode assessment chart, and a technical plan for resolution chart, are reviewed. The article briefly describes failure investigation pitfalls and concludes with information on the other common tools used for failure investigation and root cause determination.

This article describes the methodology for performing a failure modes and effects analysis (FMEA). It explains the methodology with the help of a hot water heater and provides a discussion on the role of FMEA in the design process. The article presents the analysis procedures and shows how proper planning, along with functional, interface, and detailed fault analyses, makes FMEA a process that facilitates the design throughout the product development cycle. It also discusses the use of fault equivalence to reduce the amount of labor required by the analysis. The article shows how fault trees are used to unify the analysis of failure modes caused by design errors, manufacturing and maintenance processes, materials, and so on, and to assess the probability of failure mode occurrence. It concludes with information on some of the approaches to automating the FMEA.

Corrosion modeling is an essential benchmarking element for the selection and life prediction associated with the introduction of new materials or processes. These models are most naturally expressed in terms of differential equations or in other nonexplicit forms of mathematics. This article discusses the principles and applications of various models developed for understanding the corrosion mechanism. These models include mechanistic models, including Pourbaix model, thermophysical module, electrochemical module, and ion association model; risk-based models; and knowledge models. The risk-based model and knowledge models are illustrated with examples for better understanding. The article also describes boundary-element modeling and pitting corrosion fatigue models.

This article describes the historical background, uncertainties in structural parameters, classifications, and application areas of probabilistic analysis. It provides a discussion on the basic definition of random variables, some common distribution functions used in engineering, selection of a probability distribution, the failure model definition, and a definition of the probability of failure. The article also explains the solution techniques for special cases and general solution techniques, such as first-second-order reliability methods, the advanced mean value method, the response surface method, and Monte Carlo sampling. A brief introduction to importance sampling, time-variant reliability, system reliability, and risk analysis and target reliabilities is also provided. The article examines the various application problems for which probabilistic analysis is an essential element. Examples of the use of probabilistic analysis are presented. The article concludes with an overview of some of the commercially available software programs for performing probabilistic analysis.

Products liability is a legal term for the action whereby an injured party (plaintiff) seeks to recover damages for personal injury or property loss from a producer and/or seller when the plaintiff alleges that a defective product caused the injury or loss. This article provides information on the legal bases for products liability and definitions for two types of defects: manufacturing defects and design defects. It summarizes other possible defects in design as well as preventive measures.

This article discusses the three legal theories on which a products liability lawsuit is based and the issues of hazard, risk, and danger in the context of liability. It describes manufacturing and design defects of various products. The article explains a design that is analyzed from the human factors viewpoint and details the preventive measures of the defects, with examples. It presents four paramount questions relating to the probability of injury which are asked even when one executes all possible preventive measures carefully and thoroughly.

This article briefly introduces the concepts of failure analysis and root cause analysis (RCA), and the role of failure analysis as a general engineering tool for enhancing product quality and failure prevention. It reviews four fundamental categories of physical root causes, namely, design deficiencies, material defects, manufacturing/installation defects, and service life anomalies, with examples. The article describes several common charting methods that may be useful in performing an RCA. It also discusses other failure analysis tools, including review of all sources of input and information, people interviews, laboratory investigations, stress analysis, and fracture mechanics analysis. The article concludes with information on the categories of failure and failure prevention.

Concurrent engineering is product development that is done by concurrently utilizing all of the relevant information in making each decision. This article discusses the three aspects that must be taken into account for all product development decisions. The aspects include product functionality, production capability, and field-support capability. The concurrent process is carried out by a multifunctional team that integrates the specialties. The article schematically illustrates product design team configurations with subsystem teams and team of subsystem leaders. It discusses the three-step decision-making process, such as requirements, concepts, and improvement, followed by multifunctional product development teams. The article describes the two types of requirements development by multifunctional teams, namely, quality function deployment and functional analysis. It schematically illustrates the integration of product requirements and concept development. The article concludes with a discussion on the improvement of concepts in terms of robust design and mistake minimization.

This article reviews the concepts considered important for an understanding of the processes used for preparing cobalt-chromium alloy implants, the microstructures resulting from this processing, and the resulting material properties. The review includes solidification of alloys, diffusionless (martensitic) phase transformation as occurs with face-centered cubic to hexagonal close-packed transformation in cobalt-chromium alloys, and stacking faults and twins and their role in this transformation. It also discusses the strengthening mechanisms that are responsible for the mechanical properties of cast and wrought cobalt alloys. The article contains tables that list the commonly used cobalt alloys and their biomedical applications and chemical compositions. It discusses the mechanical and corrosion properties of cobalt alloys, and provides a description of the microstructure of cobalt alloys.

This article is a compilation of definition of terms related to materials selection and its integration with engineering design processes.