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Identifying and Managing Risk Definition: The term risk is defined as “the hazard or chance of an untoward, negative effect that affects the basic functioning of a system.” In the word of technology development projects, the term is more succinctly and pragmatically defined as “Anything that happens during a given project’s life cycle that impedes the project to the degree that it does not complete on time, within budget, and/or with promised/expected functionality.” In HL7’s world, risks can impact specification development, approval, implementation, and/or evolution as well as the health or reputation of the HL7 organization. Measuring Risk: Risks are somewhat subjective and discipline-specific. As such, a given project most productively addresses the issues of risk management through multi-disciplined assessments of the project’s risk throughout its life cycle as multi-discipline risk identification tends to “smooth out” some of the purely qualitative aspects of risk identification. Risk Identification: Several key points are essential in order for a project to reliably identify its risks, a critical requirement for effective risk management: 1. Risk identification must be done on a regular basis throughout the entire lifecycle of a project, i.e. performing a risk assessment once or twice over the course of a project’s life cycle is not sufficient to manage the project’s risks. Thus, inadequate attention to regular risk identification leaves the project vulnerable to risks which were not identified and therefore not managed. The single most important aspect of effective risk management is regular – weekly, bi-weekly, etc. – assessment of a project’s current risk profile. The term “current” is particularly important because risks can emerge or fade away as a project passes through its life cycle. 2. Risks should be described using a semi-quantitative scale that includes – at minimum – team assessments of both the: a. likelihood that a risk will occur (usually expressed as a percentage) b. impact that the risk will have on the project if it does occur (usually graded on a 4- or 5-level scale similar to that used in ranking software bugs, e.g. i. critical – impedes standards development, acceptance or adoption - no workaround available ii. serious – temporary workaround available, not sustainable iii. significant –workaround available - sustainable iv. low – may be fixed at some point in the future, workaround not necessary 3. In addition to the above metrics, it is often helpful to categorize risks as belonging to one of the following types: a. Requirements – project requirements are vague, changing, conflicting, or not well-defined in terms of “knowing when a project is done and whether it has succeeded.” b. Technology – project depends on tools/technologies in order to produce expected results i. Internal - within HL7 ii. External - external to HL7 organization c. Resources – project may face shortages financial, physical, and/or skill-set-appropriate resources i. Capacity - clinical/domain expertise must be recruited ii. Capability - lack of required skills d. Social-political – there may be forces that cannot be controlled by the project i. Internal - within HL7 ii. External - external to HL7 organization 4. Finally, it is important to document the following minimum meta-data about each risk identified: a. Date identified b. Identifier (person or discipline) c. Internal/External (risks which are internal to a given project team are obviously more easily managed/mitigated then those outside of the team’s direct control. Managing Risk: Risk management is proactive monitoring for trends, e.g. increasing likelihood or impact (or both). When a risk is “trending” in the “wrong” direction, the project team must take appropriate action to mitigate the risk. Thus, part of risk management is the development of a risk mitigation plan in at least outline form for every risk on the project’s “risk radar.” If either the likelihood or the impact of a given risk begins to increase, the team must develop a more finely granulated risk mitigation plan and start to manage to that plan so as to avoid the occurrence of the risk and subsequent disruption of the project’s planned trajectory. In addition, if a given risk is trending in the “wrong” direction, the project team needs to develop at least an outline of a contingency plan which will be implemented should the risk mitigation plan fail to prevent the occurrence of the risk. Summary: The discipline of doing regular, multi-disciplinary/team-wide risk identification and description using the meta-data defined above in combination with the development and execution of risk mitigation plans for those risks trending in the “wrong” direction in the risk profile enables a team to avoid most – if not all – of the untoward “surprises” that so often hinder a project’s smooth, effective, and efficient life cycle execution.