The Current Situation - Reliability & Quality

The need for the continuous improvement of product quality, reliability and safety arises from product recalls, government regulatory requirements, agency recommendations, legal implications and above all a company's desire to gain competitive advantage and improve its market position and customer satisfaction. These issues require product manufacturers to perform risk analyses that identify and minimize system failures throughout a product's life cycle. A number of methodologies, including Failure Mode and Effects Analysis (FMEA), Failure Mode, and Effects Criticality Analysis (FMECA), Hazard and Operability Analysis (HAZOP) and Fault Tree Analysis (FTA), are used to identify hazards, evaluate the associated potential consequences and their likelihood, and then estimate the risk.

Despite its use, maintaining quality in product design and production is a global problem, and product recalls are occurring every day. It is estimated that companies will spend as much as 40% of their annual revenue correcting existing quality problems. In other words, if your company earns $10 million annually, you might spend up to $4 million each year to fix quality problems.

To reduce these failures, many manufacturing companies use the (FMEA) methodology. FMEA is one of the risk analysis techniques recommended by international standards, such as the ISO 9000 series and ARP5580. It is a systematic process used to improve the product and process designs. FMEA is primarily adapted for material and equipment failures, but it can also include human errors, performance and software errors.

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