Risk management – Use legal obligations for
the advantage of your company
What is risk management?
Risk management has been developed tin the sixties as logical and necessary
addendum of the Total Quality Management in the USA and Japan. The initial
point is the analysis and assessment of potential risks for persons, property
or assets with the objective target to enhance the quality of structures,
processes and results through appropriate measures. Especially banks and
insurances use risk management since a lot of years to evaluate financial
risks.
Risk management in the industry of medical products
Medical products are applied or operated in or at the human being –
in the most cases at sick persons. Regarding these products a significantly
high level of protection is essential. The objective target of the EG
directive about medical products is therefore the high-grade protection
of health and life of human beings. Possible risks have to be minimized
as much as possible compared with the beneficial impact. From the constitutional
demands which are defined in the directive the obligation to implement
a risk analysis for medical products and to realize the measures for risk
control arises for every produces in Europe. This process which comprises
risk analysis and risk control is characterised as risk management.
The initial point for the risk management process is the risk management
plan in which the cognizances and the definition of the parameter of methods
are determined among other things. Risk management should in every case
be accomplished as an interdisciplinary instrument by a project team with
members from different departments. The quantification of risks takes
place with the aid of the portfolio technique whereas the assessment matrix
is determined by the axis “extent of loss” and “probability
for appearance”. Regarding the area of medical technique these parameters
cannot be declared mathematically exact. Therefore it is reasonable to
work with relative scales und to concretise the appropriate categories
through criterias and examples. The assessment matrix is subdivided in
three different regions according to the risk acceptance:
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- the widely acceptable area – risks
in this area can be – compared to the beneficial impact
of the medical product - accepted without further measures.
- the so-called ALARP area (As Low As Reasonable
Practicable) – if risks exist in this area it has to be
inspected if the risk is reasonably already minimised as much
as possible. Otherwise appropriate measures have to be apprehended.
- the not acceptable area – further
measures for risk minimisation are in every case necessary.
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The risk analysis in fact examines hazards
for persons and property as well as their reasons and assesses these by
means of the determined parameters. A further objective target is, to
minimise the risks which are identified as not acceptable as much as possible
through appropriate measures. The effectiveness of the chosen solutions
can be proven through a new risk assessment after the implementation of
measures.
Risk management as management instrument
Risk management is an essential part regarding
the security of medical products. Furthermore risk management is as management
instrument a valuable tool to enhance to quality of products and processes
within a company. Therefore risk management has to be understood as continued
process. Through the integration in the processes design guidance and
market observation development costs can be saved and synergy effects
can be uses in an optimal way. The portfolio technique for risk assessment
allows the cognition of risks which are relevant for admission. The development
of new products and the advancement of existing products can be directed
in a cost minimal way. It is possible to simulate different scenarios
to detect the best solution for a problem. The process of risk management
should not be closed with the market launch of new products. Synergy effects
result from the consequent integration in the market observation system
of a company. Messages about possible risks are by this registered systematically,
assessed and, if necessary, appropriate measures initiated and regarding
their effectiveness evaluated.
Fazit
Regarding the valid legal position in Europe
producers of medical products are obliged to accomplish a risk analysis
for their products. This obligation can be used for the advantage of the
company if it is seen as process for continued enhancement of the quality
of products and processes with which development costs can be saved. Therefore
the methods design , market observation and risk management have to be
co-ordinated in an optimal way.
Author: Dr. Matthias Hoffmann
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