Biomedical Engineering Reference
In-Depth Information
Does this mean that an organization can ignore deviations
in processes that have been assessed as low risk? Hardly. The
business case for an organizational activity is complemented
by the compliance case for that same activity. Continuing
cGMP training not only periodically reminds employees of the
effect of deviations, rework, etc. on the bottom line, but is a
regulatory requirement as well, and reminds employees about
the organization's commitment to the regulatory requirements.
This commitment carries over to all aspects of regulation.
There are several independent assessments of risk for
any process or system in regulated industry, no matter
how low or high the level of risk. One is the assessment
made by various decision makers of the organization
including employees as well as managers, another is the
assessment made by regulatory investigators. Both sides are
weighing the criticality and complexity of the given process
in making their independent risk assessments.
4
The decision
makers in the organization must constantly be aware of this
intricate interaction between their own business risk
assessments and the quality risk assessments of the regulatory
investigators, and factor the latter into their own calculation
of risk.
The quality risk assessment tends to be refl ected in the
topics to be presented in continuing cGMP training. The
topics refl ect in part a quality risk assessment made by
various decision makers in the organization, perhaps other
decision makers than those making the business risk
assessments. Those making the quality risk assessment will
be addressing the risk to the SISPQ of the product, and how
that topic can be presented as a training topic. The level of
risk associated with a process or system that is subject to a
given regulation is based on the criticality and complexity of
that process.
5
The risk assessment represents the level of risk
as well as the acceptable melioration of that risk.
