RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 50

Additional potential areas of application for risk management implementation
have been suggested in areas such as [11]:
• multipurpose facilities;
• equipment design and installation;
• process controls;
• HVAC containment strategies;
• cleaning regimes;
• campaign manufacture;
• environmental monitoring plans;
• services and equipment monitoring; and
• maintenance and calibration intervals.
The expectations for individual risk assessments are more detailed and tie back
to how well the policies and procedures were written and implemented. Table 3.2
provides a detailed list of risk assessment level expectations and practical con-
siderations for meeting the expectations.
3.2.2 Establishing Risk Communication and Reporting Mechanisms
Risk communication is the “ sharing of information about risk and risk manage-
ment between the decision makers and others ” and is one of the most important
parts of a fully functioning, life cycle approach to QRM [15]. It is a “ continual
and iterative processes that an organization conducts to provide, share, or obtain
information and to engage in dialog with stakeholders regarding the management
of risk ” [16]. Without robust risk communication and reporting, integrated risk
management is not possible.
The process requires multiple stakeholders to engage in multilateral discus-
sion regarding the “ existence, nature, form, likelihood, significance, evaluation,
acceptability, and treatment of the management of risk ” [17]. This process is an
input into the decision to accept or reject a risk, although not the acceptance
process itself.
Setting up clear flows for the communication of risk up and down an organi-
zation is important for many more reasons than just meeting the expectations of
international guidance documents. Effective communication of risk:
• encourages accountability and ownership of risk;
• ensures information from risk management exercises is available at right
levels of the organization and at the right time;
• promotes a mature culture of risk management; and
• creates a level of risk awareness that may assist in reducing the overall
residual risk of an organization. †
† This idea that making people aware of a risk can help reduce that risk is a concept that directly
relates to risk communication activities during Quality Risk Management work. This is one reason
why Risk Communication is so important, and any action that serves to help reduce risk should be
considered. Dr. Kevin O'Donnell, Irish Medicines Board, 2010.