RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 65

situation is the result of a political decision, a function of the risk level that is
acceptable to the society on which the risk is imposed.”
The trigger level is based on the potential societal damage of the specific haz-
ard along with the amount of knowledge that exists of the hazard. The knowledge
would be primarily objective. If the knowledge shifts from objective to subjec-
tive, the principle would define it as having significant uncertainty. There are
different trigger levels for a low severity hazard that has a degree of uncertainty
and compared to a high severity hazard with equivalent uncertainty (Commission
of the European Communities 2000, 13).
The policy of regulators in using the precautionary principle shifts evidentiary
requirements to the suppliers. However, when looking at multiple stakeholders
in the process with varied perceptions, the amount of knowledge varies. These
stakeholders are not all within the company that provides the product. They
include regulators and the public. What does not exist in the literature is the
idea of asymmetry. The companies will always have more information about
a product's risks than regulators and the public. Society, however, places an
expectation on the provider to reduce the residual risk of a product to its lowest
possible level (Commission of the European Communities 2000, Breyer 2005).

3.3.4 Risk Regulation's Unintended Consequence:
Asymmetry of Risk Knowledge

The burden of proof creates an unintended consequence, which can be described
as Asymmetry of Risk Knowledge. There is an inherent amount of product knowl-
edge asymmetry because of the intimacy the manufacture has with the design
and production of the product it intends to provide to the market. The manufac-
turer naturally has more information regarding the product and process than the
regulators or the public.
As one of the stakeholders, the manufacturer makes judgments relating to
safety of the product including the acceptability of risks, taking into account the
generally accepted state of the art, in order to determine the suitability of the
product to be placed on the market [41].
As the guidances show, there are many stakeholders with interest in the process
although the manufacturer generally reviews and approves the risk. § With the
manufacturer owning the data used to determine risk as well as providing and
justifying the risk-benefit balance for a given product, the standing or value of
the other stakeholders' perception of risk may be reduced, but the responsibility
to society by the manufacturers increases.

3.4 INTEGRATION INTO ORGANIZATIONAL PROCESSES

For successful integration of risk management into the quality system, the orga-
nization must ensure that individuals engaged in risk management activities

§ These cGMP risks are now being reviewed during inspections.