RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 47

RISK MANAGEMENT: REGULATORY
EXPECTATION, RISK PERCEPTION,
AND ORGANIZATIONAL
INTEGRATION

MIKE LONG

3.1 INTRODUCTION

Quality risk management (QRM) is an enabling process that supports the product
life cycle and the pharmaceutical quality system of an organization. Organizations
that have fully functioning mature QRM systems in place have a solid founda-
tion in the regulatory guidance and expectations set down by the global health
authorities and administrations. These organizations also have a solid foundation
in understanding how those charged with creating, maintaining, and assessing
the risks of their medical products approach risk from a cognitive and social
standpoint. These foundational elements are embedded throughout the organiza-
tion through policies and procedures and reinforced via effective training. This
chapter provides an overview of these foundational risk management elements
and is broken down into three basic sections. The first section outlines the basic
regulatory requirements for embedding QRM within a company's quality sys-
tem and life cycle. The second section provides a high level overview of the
cognitive and social aspects of risk that impact the way we react to and con-
trol risk. These are important to understand when creating new QRM policies
and procedures within an organization. The third section of the chapter discusses