1. risk PROCESS

Risk process and tools can be built  into Agile systems and designed to minimize the time required of senior line manager engagement.  The goal is to recognize Agile is not only more effective but also it is different than traditional models. The result requires functional teams to ensure risk officers, ie, project management and function leadership already embedded within each business unit, to adapt to proactive frequency of communication while using agile tools and methods to account for continuous assessment of risk for their business units.

Most traditional business units run semi-annual workshops, but the central (corporate) unit runs only an annual workshop since most corporate risks, such as legal and regulatory matters, evolve slowly over time. In traditional project management, your approach to risk management is important, but it is not as active or ever present as you find in an agile environment. The embedded risk officers need to continually update their risk assessments through daily face-to-face discussions with managers in their unit, and by the issues escalated upwards from front-line life science matrix teams collaborating on preclinical and clinical phase activities.

…Superficially both Agile and Traditional process look the same, both are robust. However they differ in the frequency of reiterations ie, continuous communication and resolution of risks. The layers of management in the organization and communication pathways determines efficiency. They should be positioned to help the organization resolve risk proactively thereby giving empowerment to the functional and mid level management team to resolve issues and avoid working in silos.

2. approach and risk environment

Risk management in Agile takes on a more active and reactive role which is important to factor into daily activities.

Traditional business process consistently used by many business sectors but more so in life science business,  utilizes typical pathways. Teams are given time to plan per standard process, using timelines for length of projects providing for  the  environments that do not proactively change or adapt to diversifying project workload or priority programs that promote efficiency within the company pipeline.

In traditional project management, the approach to risk management is important, but it is not as active or ever present as you find in an agile environment. The Agile  approach can successfully transform risk management function from an exercise in checking boxes to a bona fide management process that employees, managers, and executives can all embrace as part of their everyday lives

3. risk Planning and mitigation

In Traditional risk management processes, more up front planning is done, including prioritization of risks. Whereas in Agile (being inherently iterative) risk is also prioritized and mapped out using a matrix rating  (ie, categorization by costs, schedule, impact etc.). However Agile risk management goes through a more cyclical and repeated risk planning exercise. The process is very dynamic and in many cases democratic and self organizing, which is very different than traditional R & D business in life science which are driven by traditional processes and procedures.

Identifying and managing strategic and emerging risks is very different from managing the audit and compliance functions. Agile risk identification, assessment, and mitigation requires a continuous flow of information  to leverage risk planning early and often,

typically validating the risks, surfacing the risks and re-quantifying the risks at each stage of the lifecycle.

Failure to infuse risk management into the daily (sprint) project cycles decreases the opportunity to ensure success or to help a team to stop spinning their wheels and leads to their inability to focus on higher priority features. Ignoring risk is a huge missed opportunity and tends to increase project costs by the team having to learn through failure.  

For agile teams to complete their objectives sustainably while maintaining agility and minimizing operational costs, an equally adaptive risk management framework is needed.  Overall, aligning risk management with agile execution enables companies to improve customer experiences quickly, giving organizations a competitive advantage.


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