• CAPA in practical use – listening to the market place

    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.

  • Sustain­ability or Firefighting?

    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.

    But even this well-known 8D-Process has its vagaries: often the process is not fully followed to its conclusion; instead one tends to be satisfied with the implemen­tation of containment actions, without internal learning and preventing the causes of the customer complaint; and too often the resultant documen­tation is inadequate and insufficient to meet legal or account­ability standards.

  • There will always remain a risidual risk

    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.

  • Risk management in Medical Industry

    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.

  • APQP - the basis for a successful stratgy of Zero Failures

    Originally developed in the USA, APQP has evolved into an indispensable part of the automotive indtry.

    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.

  • Risk Management - an essential investment

    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.

  • Up to Date Risk Management

    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.

  • FMEA: Moderation to enhance Success

    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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