Amef

Fail-Safe

FMEA
by José Rodríguez-Pérez and Manuel E. Peña-Rodríguez
In 50 Words Or Less
• Failing to manage risk puts consumers and entire organizations in jeopardy. • Using failure mode and effects analysis (FMEA) can help identify risk but isn’t enough to avoid potential disaster. • By combining FMEA with other tools, organizations can ensure their products won’t harm thepeople they’re supposed to help.

Combination of quality tools keeps risk in check

Quality risk management principles are
used effectively in many areas of business and government— including finance, insurance, occupational safety and public health—and by the agencies regulating these industries. Risk management’s widespread use isn’t a surprise because every product and every process has anassociated risk. But while there are some examples of the use of quality risk management in the medical product manufacturing industry, they are limited and do not take full advantage of what risk management has to offer. After all, inadequate or ineffective quality risk management can harm patients, product users and company value.

1

Risk ManageMent

January 2012 • QP 31

Thecurrent focus of the U.S. Food and Drug Administration (FDA) on risk-based determination requires that regulated industries dramatically improve their understanding and use of hazard control concepts. The appropriate use of quality risk management can help organizations comply with regulatory requirements, such as good manufacturing practices or good laboratory practices. Quality risk management is avaluable component of an effective quality system’s framework. It can, for example, help guide the setting of specifications and process parameters for manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of deviation investigations and corrective actions. An effective quality risk management approach can ensure a high-quality product byproviding a proactive means to identify and control potential quality issues during development and manufacturing. Additionally, it can improve decision making if a quality problem arises.

harms, computes different probabilities and assigns different severities. In relation to medical products, although there are many different stakeholders—including patients, medical practitioners, government andthe industry as a whole—protecting the patient by managing risk should always be of the utmost importance.1 The manufacture and use of any medical product necessarily involves some degree of risk. The risk to product quality is just one component of overall risk. Product quality must be maintained throughout the product life cycle so the characteristics that are important to product quality remainconsistent. Effective quality risk management can also facilitate better and more informed decisions, assure regulators of a manufacturer’s ability to deal with potential risks, and positively affect the extent and level of regulatory oversight. Manufacturers of regulated products are required to have a quality management system and processes for addressing product-related risks. These processesfor managing risk can evolve into a standalone management system. While manufacturers may choose to maintain these two management systems separately, it may be advantageous to integrate them because doing so could eliminate redundancies and lead to a more effective management system.

explaining risk
Risk combines the probability of occurrence of harm with the severity of that harm. Quality riskmanagement supports a scientific and practical approach to decision making during the life cycle of a product. It provides documented and reproducible methods to accomplish the quality risk management process based on current knowledge about the probability, severity and detectability of the risk. But each stakeholder perceives different potential

to each their own
Risk management is a...