Simply put, structured risk management provides tools that enable effective prioritization of actions. It is, however, critical
that risk-assessment tools be used appropriately. Tools such as FMEA, for example, typically use an assigned number scale
(e.g., 1 to 10) to assess the severity, probability, and detectability of the risk associated with identified hazards. Multiplying
these numbers results in a risk priority number (RPN) for each risk. Even though it may be tempting to set thresholds for
the RPN, this approach is too simplistic and can lead to inappropriate decision-making. The real value of the RPN is that
it allows the relativities between risks to be assessed and subsequent risk-control decisions to be made.
The hope behind ICH Q9 is that industry will take the opportunity to make greater use of a structured approach to quality
risk management. An implementation strategy is key to achieving the guideline's business benefits. Some important tips for
implementation are outlined below.
1) Make sure you have sufficient expert knowledge to assess risks. Any assessment of risk and related decisions can only be
as good as the information available and the knowledge and expertise of the people who assess the information. Structured
risk assessment should be a team activity with the most effective team assembled.
2) Ensure that your company understands ICH Q9 and the opportunity it affords, including the benefits and limitations of risk-management
tools and techniques.
3) Encourage an open, risk-aware culture. The pharmaceutical industry, and those who regulate it, have long misunderstood
the concept of risk. Comments such as "We are a zero-risk company" or "all risks must be eliminated" are heard too frequently.
"Zero risk" cannot exist. All risks must be identified and assessed so that rational decisions can be made.
4) Keep quality risk management simple.
5) Integrate quality risk management with your existing quality systems. Risk management is not a "bolt-on" or "plug-in" to
existing quality systems. Rather than establish separate risk-management departments within your company, educate personnel
about all risk elements and, if necessary, revise the elements of your quality system to embed risk management in each.
ICH Q9 provides the pharmaceutical industry with an opportunity to be more proactive about managing risk in a structured way
that will be understood by regulators. Combined with ICH Q8 Pharmaceutical Development and Q10 Pharmaceutical Quality System, Q9 will enable a new, more effective approach to the management of product quality and regulatory mechanisms. This approach
will, in turn, benefit industry as a whole, regulators and, most importantly, patients.
Peter H. Gough, part of the expert working group on ICH Q9 Quality Risk Management, is a partner at David Begg Associates, tel. 617.342.3652 (US headquarters) and +44 1751 432999 (UK headquarters), phg@DBA-global.com
1. ICH, Q9 Quality Risk Management (Geneva, Switzerland, Nov. 9, 2005).