RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 45

Risk evaluation Compares the estimated risk against defined risk crite-

ria using a quantitative, qualitative, or semiquantitative
scale to determine the significance of the risk

Risk management Systematic application of management policies, proce-

dures, and practices to the tasks of analyzing, evalu-
ating, controlling, communicating, and monitoring risk
throughout the product life cycle

ACKNOWLEDGMENT

The author thanks the International Electrotechnical Commission (IEC) for per-
mission to reproduce information from its International Standard IEC 61882
ed.1.0 (2001).
All such extracts are copyright of IEC, Geneva, Switzerland. All rights
reserved. Further information on the IEC is available from www.iec.ch. IEC
has no responsibility for the placement and context in which the extracts and
contents are reproduced by the author, nor is IEC in any way responsible for
the other content or accuracy therein.

REFERENCES

1. International Conference on Harmonization, Q9 Quality Risk Management, Guidance
for Industry, Rockville, MD: U.S. Department of Health and Human Services Food
and Drug Administration, 2006.
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Wiley, 2005.
3. Hyatt N. Guidelines for Process Hazards Analysis, Hazards Identification and Risk
Analysis. Boca Raton: CRC, 2005.
4. International Electrotechnical Commission,. Analysis Techniques for System
Reliability—Procedure for Failure Mode and Effects Analysis (FMEA), Technical
Standard. Geneva, Switzerland: International Electrotechnical Commission, 2006.
5. Tague NR. The Quality Toolbox. 2nd ed. Milwaukee: ASQ Quality Press, 2005.
6. McDermott, Robin E., Raymond J. Mikulak, and Michael R. Beauregard. The Basics
of FMEA 2nd ed New York: Productivity Press, 2009.
7. International Electrotechnical Commission. Hazard and operability studies (HAZOP
studies)—Application guide IEC-61882. Geneva, Switzerland: International Elec-
trotechnical Commission, 2001.
8. International Electrotechnical Commission. IEC 61025—Fault Tree Analysis (FTA),
International Standard. Geneva, Switzerland: International Electrotechnical Commis-
sion, 2006.
9. T. Frank et al. Quality Risk Management Principles and Industry Case Studies, (Dec
2008), sponsored by the Pharmaceutical Quality Research Institute Manufacturing
Technology Committee (PQRI-MTC).