The ability to respond to customer complaints in a structured and accountable manner is the goal of a process that has been especially successfully implemented in the automobile industry. This so-called 8D-Process is increasingly becoming the standard response to customer complaints in other industries. A new approach is also to use this process internally, when – for example – planning mistakes or weak process design result in significant non conformances or in other damages and accidents.

One typical management challenge is to deal not only with existing problems, but also to identify, and thereby avoid, future problems. The motivation to do so is obvious as such problems can have a significantly negative fiscal impact upon the organization. The ability to consistently and effectively deal with such problems and to implement systems to avoid their recurrence is one of the requirements for a satisfied customer base and continued commercial success.

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Evidence of a Risk Management is not a one-time event; instead there is an obligation to define a planned procedure, and - amongst other steps - continuously collect and evaluate relevant information from production as well as from the many product phases that follow. Manufacturers of medicinal products must, within the framework of a conformity assessment procedure, demonstrate Risk Analysis and Risk Management and be able to document a systematic procedure to evaluate experiences gathered from production to marketing, that utilizes this information to implement necessary corrections. A more in-depth description of these two aspects is well worth while.

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It's not as simple for manufacturers of medical products: laws and regulations require a very careful identification and evaluation of the so-called "remaining risks". Only after making a comparison to the "medical benefit" products may be released for commercialization.

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Originally developed in the USA, APQP has evolved into an indispensable part of the automotive industry. This systematic process is one of the most important factors contributing to the success of Product and Process Development that result in the attainment of quality and cost objectives. Failures in design and production often result in expensive fixes, cost objectives are not realized and there is a threat of product recalls and of product liability.

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Technical risks are often the consequence of complex interactions. When these appear they can trigger small and large damages. These consequences can be limited to financial losses, but can also result in substantial damage to the reputation of the business, and/or result in legal consequences for management and others involved.

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Nuclear energy, aviation and space industries remind us constantly about the immense efforts made to avoid risks, without having the absolute assurance that serious incidents will never occur in spite of these efforts.

When risks cannot be totally avoided, then one must learn to live with them.

The Manager must know these risks, must be on top of them, evaluate and control them, if he wants to avoid expensive suprises.

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The Failure Mode & Effects Analysis (FMEA) has been established as a valuable tool to avoid failures in companies in many different industries. In the real world, however, there are often difficulties that interfere with the effective and efficient implementation of this methodology.

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