Risk Analysis

Risk management is an important aspect of the product development process in a design control environment. Its importance is recognized under ISO13485 as well as by the FDA. Risk analysis is one of the fundamental methodologies for assessing risk.

There are a variety of product-related risk analysis techniques, including Preliminary Hazard Analysis, various types of Failure Mode and Effects Analysis, and Fault Tree Analysis.

The most common form of risk analysis is the Preliminary Hazard Analysis, also known simply as Hazard Analysis. This technique is suitable for use throughout the development process and is most effective when used early in the process. It quantifies risk using a top-down, or black box, approach that postulates possible hazards, the level of harm they represent, and the likelihood that they will occur.

The next most common form of risk analysis is the Failure Mode and Effects Analysis, which is more accurately identified as a Failure Mode and Effects Criticality Analysis (FMECA) in the form most often used. FMECAs are used later in the development process, as the design is established. FMECAs are a bottom-up, or white box, approach that evaluate, for a specific design, the potential failure modes for each function or component. FMECAs are used in several areas of application, including design (dFMECA) and process (pFMECA).

dFMECAs are used to assess the risk that design flaws will be present in the final released product. In addition to assessing the impact of a design flaw and the likelihood that it will occur, it also quantifies the likelihood that the flaw will go undiscovered. When created and used properly, they can guide the use of appropriate development practices and the planning of an efficient design verification and validation program.

pFMECAs are used to assess the risk that manufacturing defects will be present in product shipped to the customer. In addition to assessing the impact of a manufacturing defect and the likelihood that it will occur, it also quantifies the likelihood that the defect will go undiscovered. When created and used properly, they can guide the development of appropriate manufacturing processes and the planning of an efficient manufacturing program.

We invite you to review some case studies that are representative of the work done by our consultants...

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