Traceability Training Program

Pattern Attributes

Intervention Process
Domain Medical
Work Programme SPRTMDRC
Research Area Any
Evidence Type Survey, Lit. review
Evidence Source Multi-nationals, SMEs, literature;
Evidence Strength Very strong
Trigger product_domain == medical, lifecycle_phase > 0


Traceability of requirements through the software development lifecycle is essential in the development of safety critical software. Organisations such as the Food and Drug Administration and the Federal Aviation Authority in the United States require traceability as part of their approval process.

However, despite its criticality there is extensive digression in the practices and usefulness of traceability across development projects. Many projects’ traceability efforts are simply focused on satisfying regulations and do not leverage the many benefits of traceability


Traceability plays an important role in defect management, change management and project management and global software development It is fundamental for change impact analysis, requirements validation and regression testing among others. In the safety critical domain traceability is essential to producing safe software.

Numerous reasons have been identified for reluctance in implementing traceability including stakeholders within an company have differing perceptions as to the benefits, barriers and best practices for implementing traceability.


Provide a training program for traceability. The training program will consist of modules on

  1. Medical device standards requirements for traceability
  2. Benefits of traceability
  3. Barriers to implementing traceability and possible solutions
  4. Best practices for implementing traceability

Impact Metrics

  1. Training program assessment
  2. Level of compliance before and after the training program

Document Templates


  1. Regan, G., Mc Caffery, F., McDaid, K., Flood, D. (2012) Traceability-Why do it?. In: International SPICE Conference Process Improvement and Capability dEtermination/ Majorca, Spain

  2. Regan, G., Mc Caffery, F., McDaid, K., Flood, D. (2012) Impact of Standards on the Role and Application of Traceability in the Medical Device Domain. In:European Systems and Software Process Improvement and Innovation Conference, EuroSPI/ Vienna, Austria

  3. Regan, G., Mc Caffery, F., McDaid, K.,Flood, D., (2012)The Barriers to Traceability and their Potential Solutions: Towards a Reference Framework. In: 38th EUROMICRO Conference on Software Engineering and Advanced Applications (SEAA) Cesme, Izmir, Turkey