Team:UNebraska-Lincoln/Integrated Practices 6

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How to Build a Safety Case


How to Develop a Safety Case:


Developing safety cases can be a daunting task, but it really does not have to be. Safety arguments should be thorough, but by a simple step by step process, clear and thorough safety arguments can be developed and can help guide the design and engineering of the project. Once a team has determined a real world problem to focus on they can begin developing a safety case.

Fundamental Steps to Build a Safety Case:


  1. Identify potential environmental hazards
  2. Design a BioBricks to help solve the problem & engineer them
  3. Toward the end of the design phase, it should be possible to determine specific environmental hazards and the engineered organism’s dependability requirements
  4. As the design evolves, update potential environmental hazards
  5. Understand requirements for reliability of the parts
  6. Obtain evidence to strengthen safety argument claims from wet lab results, previous iGEM results or results in literature
  7. Perform lab simulations and test the system
  8. If refactoring is required to accomplish team goals, refactor the design of the BioBricks as needed and jump to Step 3
  9. Create a clear succinct presentable format for the safety case
    1. A diagram form following Goal Structuring Notation would be appropriate
  10. Evaluate the strength of safety arguments


The following figure is the diagram view of a sample safety case Dr. Myra Cohen and Dr. Massimiliano Pierobon have developed for the 2012 iGEM Food Warden project.

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B. Cohen, J. Firestone, M. Pierobon, The Assurance Timeline: Building Assurance Cases for Synthetic Biology, International Workshop on Assurance Cases for Software-intensive Systems (ASSURE), to appear, September, pp. 75-86, 2016.



For more information on the publication for safety cases being applied to the biological domain go page  here.


Here are some pertinent resources for developing safety cases:

Resources:

 

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