This standard establishes uniform requirements and criteria for a performance-based, product Failure Mode, Effects and Criticality Analysis (FMECA). The performance-based aspect of this standard requires that the organizations FMECA capability be rated according to predetermined criteria for process capability and data maturity.

Purpose

The primary purpose of the product FMECA is to collect and evaluate the necessary system design information to identify and eliminate or control all failure modes that pose unacceptable risk. Depending on how it is performed, the FMECA can be used for many purposes, but its most important use in systems engineering is to aid the improvement of design reliability before the product is manufactured. For this standard, a failure mode is defined as the consequence of the mechanism through which the failure occurs, i.e., the manner by which the failure is observed. Accordingly, a failure mode that poses unacceptable risk is a failure mode whose effect, either singularly or in combination with other failure mode effects, violates a system design requirement or goal. The FMECA is a systematic methodology that is widely used to evaluate the effects on systems and interfaces caused by the failure modes of functional or physical components, to estimate the criticality of each failure mode in terms of its endeffects, and to evaluate the appropriate failure compensation methods for mission critical failure modes. The S-102 Product FMECA is comprised of three components:

— failure mode and effects analysis (FMEA),

— criticality analysis (CA) and risk priority analysis (RPA), and

— critical item analysis (CIA) and failure compensation analysis (FCA).

The FMEA answers system failure questions regarding the what's, how's, wheres, when's, and why's. The CA and the RPA answer system failure questions regarding relative significance. The CIA and the FCA answer system failure questions regarding failure mitigation. The minimum activities that constitute the baseline practice for the product FMECA are the following:

— timely establishment of the requirements and analytical ground-rules for the product FMECA;

— timely establishment of product FMECA technical performance metrics (TPM);

— timely collection and evaluation of the necessary system design information to identify and eliminate or control all inherent, singular hardware (H/W) failure modes that pose unacceptable risk across the system life cycle;

— timely creation of a product FMECA dataset for each postulated system failure mode;

— timely application of reliability critical item (RCI) selection criteria and the evaluation of RCI failure modes;

— timely calculation of the criticality number (CN) and detection risk priority number (RPN);

— timely identification of scheduled project activities that are intended to help reduce the failure likelihood or manage the consequences of the failure;

— timely identification and documentation of all non-credible Severity Classification 3 (i.e., Marginal) or higher inherent, singular H/W failure modes;

— timely validation of each product FMECA dataset; and

— timely development and documentation of the product FMECA report.

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