S11-901: Stop Thinking About Risks, Manage Them

Track: Test Strategy and Design

Why is it so hard to talk about risks when it comes to testing? Especially if you are in a regulated industry, such as the pharmaceutical industry, where the discussion of risks sometimes comes down to a matter of life and death of the patient. Why is it so hard to stop talking about risks and manage them instead? Especially since we all agree that it would make us more efficient and develop better systems. During this presentation you get a roadmap for “going riskbased”. You will be introduced to both small- and large-scale methods for planning, executing and improving risk-based testing. It includes methods like requirement classification, quality risk assessment, master test plan for the full test process, and maintaining a risk catalogue for the system’s operational lifetime. Also while focussing on the discipline of testing, especially test management and planning, we will go beyond and show how risk-based testing is just one leg of being more efficient. If you don’t understand the business or the computer system, how can you understand the risks involved? If you don’t have a well defined system development lifecycle, how can you claim to be in control, thus managing the risks appropriately? Get some attempts on answering these questions, but just as important – get inspiration on how to “go risk-based” at your own company. 


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Session Speaker:

Morten Max AndersenMorten Max Andersen – Lead Compliance Consultant, NNIT
Morten Max Andersen is Lead Compliance Consultant at NNIT, one of Europe’s leading consultancies in IT development, implementation and operations. He has more than seven years of experience in the IT industry, initially working with usability testing at a large Danish telecom company. Later, after moving into more traditional test and quality management, Morten Max has worked with implementing risk-based testing in various European based international pharmaceutical companies. Morten Max holds a certification in ISTQB Test Foundation as well as extensive training in regulatory compliance and risk-based computer systems validation in the pharmaceutical industry.