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Thursday, April 15, 2010

Risk management

Risk management accompanying the development of products and methods saves you time and costs

In several industrial sectors risk management for products and methods is stipulated through norms and principles. One example for this are medical products for which risk management is regulated in the international norm DIN EN ISO 14971. Although this norm is only to be applied compulsively for medical products the here proposed process and system could be installed in other sectors with advantage.

Independent of the prescriptions the consequent practice of risk management offers tangible advantages:

  • The time until the successful market launch is significantly abbreviated through the identification of product and process risks and the realisation of measures to control these risks in early stages of development precociously.
  • Expensive erroneous trends and further developments can be avoided.
  • Producers direct the input of their available resources on the activities which are decisive for the security of their products and the success of these.
  • You can defuse significantly the risks of liability through consequent and documented risk management.

Why Risk management at all?

Every day you can read in the newspaper about examples of missing or insufficient risk management. In this connection the most different areas are touched. It is reported about avoidable damage caused to environment, spectacular products recall or subsequent improvement (“Elchtest”) at products. All these occurrences have in common that they are highly inconvenient and expensive for the responsible manufacturers and operators of products and facilities as well as for the economics – not to mention injuries or cases of death, with which you have to bargain for at the worst.

Manufacturers and operators are obliged to avoid or at least minimize risks which come along with products, methods and processes as much as possible. A systematic risk management helps all parties, to gain insight in potential risks and to find a remedy at an early stage.

Risk management in laws, regulations and standardisation

For a variety of products and methods it is nationally and internationally prescribed for the manufacturers to accomplish an analysis of risks and hazards. Examples for this are the valid directive for machines (98/37/EG) which is effective throughout Europe or the regulation for pressure tanks (97/23/EG).

In the German, European and American law for medical products there is agreement about the demand of a risk management for medical products and in-vitro-diagnostics. How the accomplishment of risk management has to be organized and executed for these products is explained in the international norm ISO 14971 which currently resides in a harmonisation process in Germany and Europe. This norm will displace all previous regulations of risk management for medical products after a period of change.

Why Risk management saves time and money

It is really simple. On the credit side there are overall short development periods because the time and cost consuming actions of fault diagnostics and correction shortly before delivery of products or also a redesign of already delivered products are redundant. Consequently the result is low total costs of development until the readiness for marketing and during the product life time at the market.

The expenses adjourn in the early stage of the product lifecycle through an accurate procedure regarding the formulation of requirements, their specification, verification and validation measures in every stage under comprehension of the risk management as an integral part of development right from the beginning.

In conclusion a significant saving of time and money is to be expected notwithstanding of an alleged additional expenses for unbeloved things like risk management and documentation.

Authors: Dr.-Ing. Kira Stein and Dipl. Ing. Hans-Werner Einicke (VDI, IEEE)

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