learnings and evolutions of risk assessment quality control within statistical programming group...
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Learnings and Evolutions of Risk Assessment Quality Control within Statistical Programming group
PhUSE October 2014
Tim Barnett
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Agenda
• Introduction
• Original Conception
• Learnings
• Business Changes
• Landscape Changes
• The Future
• Conclusion
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Introduction
• PhUSE Conference of 2007 - “Validation of Programs developed using SAS”, employing a Risk Management Strategy to the validation approach
• Enabled programmers to assign risk levels to programs
– level of quality control could be determined
– appropriate resources (in relation to that risk) could be assigned.
• A journey from ideal scenario beginnings to current version, and beyond!
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Risk Assessment – Original Conception
Risk Management Strategy
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Risk Assessment – Original Conception
Risk evaluation – Reporting event, report object, program
Full documentation of risk level chosen
Three levels of risk available – High, Medium and Low
Factors including intended use, audience, criticality of data, formality of analyses, complexity of code and the likelihood of identifying an error.
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Risk Assessment - Learnings
• It works!
• Adjustment to Risk Levels – Goodbye Medium.
• Revision of concept of low risk – More responsibility on 1st Line
• Help influence culture and mindset to risk – Incorporate a quota
• Simplify determination of risk, and increase transparency of documentation
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Risk Assessment - Learnings
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Risk Assessment - Learnings
What can go wrong?
How likely is it to be wrong?
What is the impact?
Risk Assessmen
t
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Risk Assessment – Business Changes
• Smart Risk – A Business Initiative
– Risk-Based Monitoring
– Data Quality
• Evolution of the Statistical Programmer
– More time analyzing, less time programming
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Risk Assessment – Landscape Changes
• Data Transparency – increased exposure
• Submissions to Health Authorities where the request for our programs can be made as a deliverable in their own right
• The scrutiny on our work is now increasing as the number of customers to our work increases beyond the recognized stakeholders
• Perception (both internal and external) - can lead to misunderstandings. Communication is critical when discussing Risk Assessment
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Risk Assessment – The Future?
• In the Short Term
– Review of documentation and clarity of our process
– Stronger guidance documents for consistent risk assessments
– Incorporate risk assessment capture into standard tools
– Possible increase in High Risk assignment as we understand the impact of Data Transparency as the evaluation of the impact of an error increases.
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Risk Assessment – The Future?
• In the Long Term
– Increase of standards across data capture, tabulation and analysis should eventually lend itself to a more standard risk assessment
– High risk programs will be those controlling the meta-data around a standard suite of programs, and thus having quality control incredibly stream-lined.
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Conclusions
• Viewed as an asset to the group in assigning resource to the areas of most value, whilst maintaining levels of quality
• Adaptations required, including simplification, more emphasis on the 1st line development, and in helping adjust mindset and set documentation levels for the approach.
• For future of risk assessment
– more efforts to align risk levels across teams
– increase of standards allowing more low risk assignments
– increase of external scrutiny may cause a swing to more higher risk in the short term, but increase in dataset standards and standard reporting tools should balance this out over time.
• As long as risk assessment has clarity and transparency in its use, it is a process to stay for the future.
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