- Mitigated (or enhanced)
- Avoided (or exploited)
- Transferred (or shared)
We’ve built a set of risk response plans to ensure we are continuing to treat these risks. And now we need to monitor the effectiveness of our risk plan and to ensure that the risks are behaving in the manner anticipated during risk treatment.
The living risk assessment is designed to conduct reassessment of risks after treatment and continuously throughout the life cycle. However, not all systems and risks need to be reassessed continually, and the organization should prioritize which systems should be reassessed based on a schedule.
Identify indicators that inform the organization about the status of the risk without having to conduct a full risk assessment every time. The trending status of these indicators can act as a flag for investigations, which may result in complete risk assessments.
This risk indicator is then a metric that indicates the state of the level of risk. It is important to note that not all indicators show the exact level of risk exposure, instead providing a trend of drivers, causes or intermediary effects of risk.
The most important risks can be categorized as key risks and the indicators for these key risks are known as key risk indicators (KRIs) which can be defined as: A metric that provides a leading or lagging indicator of the current state of risk exposure on key objectives. KRIs can be used to continually assess current and predict potential risk exposures.
These KRIs need to have a strong relationship with the key performance indicators of the organization.
KRIs are monitored through Quality Management Review.
A good rule of thumb is as you identify the key performance indicators to assess the performance of a specific process, product, system or function you then identify the risks and the KRIs for that objective.
Strive to have leading indicators that measure the elements that influences the risk performance. Lagging indicators will measure they actual performance of the risk controls.
These KRIs qualitatively or quantitatively present the risk exposure by having a strong relationship qirh the risk, its intermediate output or its drivers.
Let’s think in terms of a pharmaceutical supply chain. We’ve done our risk assessments and end up with a top level view like this:
For the risk column we should have some good probabilities and impacts and mitigations in place. We can then chose some KRIs to monitor, such as
- Nonconformance rate
- Supplier score card
- Lab error rate
- Product Complaints
As we develop, our KRIs can get more specific and focused. A good KRI is:
- Measurable (accurately and precisely)
- Can be validated (have a high level of confidence)
- Relevant (measuring the right thing associated with decisions)
In developing a KRI to serve as a leading indicator for potential future occurrences of a risk, it can be helpful to think through the chain of events that led to the event so that management can uncover the ultimate driver (i.e., root cause(s)) of the risk event. When KRIs for root cause events and intermediate events are monitored, we are in an enviable position to identify early mitigation strategies that can begin to reduce or eliminate the impact associated with an emerging risk event.
These KRIs will help us monitor and quantify our risk exposure. They help our organizations compare business objectives and strategy to actual performance to isolate changes, measure the effectiveness of processes or projects, and demonstrate changes in the frequency or impact of a specific risk event.
Effective KRIs can provide value to the organization in a variety of ways. Potential value may be derived from each of the following contributions:
- Risk Appetite – KRIs require the determination of appropriate thresholds for action at different levels within the organization. By mapping KRI measures to identified risk appetite and tolerance levels, KRIs can be a useful tool for better articulating the risk appetite that best represents the organizational mindset.
- Risk and Opportunity Identification – KRIs can be designed to alert management to trends that may adversely affect the achievement of organizational objectives or may indicate the presence of new opportunities.
- Risk Treatment – KRIs can initiate action to mitigate developing risks by serving as triggering mechanisms. KRIs can serve as controls by defining limits to certain actions.