The Community for Technology Leaders
RSS Icon
Issue No.03 - May-June (2013 vol.30)
pp: 58-66
Patrick Mader , Ilmenau Technical University
Paul L. Jones , US Food and Drug Administration
Yi Zhang , US Food and Drug Administration
Jane Cleland-Huang , DePaul University
To support any claim that a product is safe for its intended use, manufacturers must establish traceability within that product's development life cycle. Unfortunately, traceability information submitted to regulators and third parties is often weak, casting doubt rather than confidence in a product's integrity. This article evaluates traceability information for 10 submissions prepared by manufacturers for review at the US Food and Drug Administration. The authors observed nine widespread traceability problems that affected regulators' ability to evaluate the product's safety in a timely manner. To address these problems, the authors present a set of guidelines for implementing strategic traceability in a way that supports safety assessments.
Safety, Software development, Software reliability, Software architecture, Product safety, documentation, requirements traceability, safety critical, assessment, traceability strategies, software and system safety
Patrick Mader, Paul L. Jones, Yi Zhang, Jane Cleland-Huang, "Strategic Traceability for Safety-Critical Projects", IEEE Software, vol.30, no. 3, pp. 58-66, May-June 2013, doi:10.1109/MS.2013.60
1. P. Bishop and R. Bloomfield, “A Methodology for Safety Case Development,” Proc. 6th Safety-Critical Systems Symp., F. Redmill, and T. Anderson eds., Springer, 1998, pp. 194–203.
2. J., Cleland-Huang et al., “Trace Queries for Safety Requirements in High Assurance Systems,” Proc. 18th Int'l Conf. Requirements Eng.: Foundation for Software Quality (REFSQ 12), Springer, 2012, pp. 179–193.
3. O. Gotel and C. Finkelstein, “An Analysis of the Requirements Traceability Problem,” Proc. 1st Int'l Conf. Requirements Eng., IEEE CS, 1994, pp. 94–101.
4. B. Ramesh and M. Jarke, “Toward Reference Models of Requirements Traceability,” IEEE Trans. Software Engineering, vol. 27, no. 1, 2001, pp. 58–93.
5. J. Cleland-Huang, O. Gotel, and A. Zisman, “Software and Systems Traceability,” Springer, 2011; doi:10.1007/978-1-4471-2239-5.
6. P. Mäder, O. Gotel, and I. Philippow, “Motivation Matters in the Traceability Trenches,” Proc. 17th Int'l Conf. Requirements Eng . (RE 09), IEEE CS, 2009, pp. 143–148.
7. P. Mäder and J. Cleland-Huang, “A Visual Language for Modeling and Executing Traceability Queries,” J. Software and Systems Modeling, Apr. 2012; doi:10.1007/s10270-012-0237-0.
8. ANSI/AAMI/IEC 62304:2006, Medical Device Software—Software Life Cycle Processes, Assoc. Advancement Medical Instrumentation, 2006.
9. A. Frisoli et al., “Arm Rehabilitation with a Robotic Exoskeleleton in Virtual Reality,” Proc. IEEE 10th Int'l Conf. Rehabilitation Robotics (ICORR 07), IEEE, 2007, pp. 631–642.
10. J. Cleland-Huang et al., “Best Practices for Automated Traceability,” Computer, vol. 40, no. 6, 2007, pp. 27–35.
25 ms
(Ver 2.0)

Marketing Automation Platform Marketing Automation Tool