RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 46

FURTHER READING
1. Risk management—principles and guidelines, ISO 31000:2009
2. Risk management—risk assessment techniques, ISO/IEC 31010: 2009
3. Risk management—vocabulary, ISO 73:2009
4. Medical devices—application of risk management to medical devices, ISO 14971:
2007
5. Risk analysis of technological systems—applications guide, IEC 60300-3-9:1995
6. Project risk management—application guidelines, IEC 62198:2001
7. Pharmaceutical Development Q8, International Conference on Harmonization, pub-
lished in the Federal Register, 9 June 2009, ICH Q8
8. Quality Risk Management Q9, International Conference on Harmonization, published
in the Federal Register, 2 June 2006, ICH Q9
9. Pharmaceutical Quality Q10, International Conference on Harmonization, published
in the Federal Register, 8 April 2009, ICH Q10
10. Guidelines for Hazard Evaluation Procedures: with worked examples, 2nd edition,
1992, American Institute of Chemical Engineers (AIChE), Center for Chemical Pro-
cess Safety (CCPS).
11. Guidelines for Auditing Process Safety Management Systems, 1993, AIChE CCPS.
12. Plant Guidelines for Technical Management of Chemical Process Safety, 1992, AIChE
CCPS.
13. The Quality Toolbox, 2nd Edition by Nancy R. Tague.
14. The Basics of FMEA, 2nd Edition by Robin McDermott.
15. Failure Mode and Effect Analysis: FMEA from Theory to Execution, D H Stamatis
(1995).
16. The Basics of FMEA, McDermott, Mikulak & Beauregard (1996).
17. MIL-STD-1629A. Procedures for Performing a Failure Mode, Effects, and Criticality
Analysis (1980).