HTWS 22: Risk Based Product Development
HTWS 22: Creating Your Own Traceability Strategy
Datum und Uhrzeit: Donnerstag, 03. März 2016, 09:00 - 13:30
Inhalt: Producing a quality, desirable product is the lifeblood of companies. Releasing buggy software can mean huge losses in revenue and a damaged reputation. Having a QA group test requirements does not guarantee results—but creating and following a rock-solid product development process that is integrated with an effective traceability strategy does.
Documenting and sharing requirements and changes with team members can be complex and costly when traditional, manual methods are used. Using real-time traceability software allows teams to deliver a collaborative and complex product easily by integrating the development process into a solution that automatically manages complex relationships and development artifacts.
When implemented properly, an effective traceability strategy provides:
- Visibility into design and development requirement changes introduced by other team members.
- Relevant contextual information based on each user’s role in the development process.
- More effective collaboration, which enables team members to stay focused on core tasks and requirements.
During this workshop, you’ll learn the foundations of an effective traceability strategy—the benefits, how to create a traceability roadmap, and how to maintain traceability throughout the product development lifecycle. We will also discuss how to perform gap analysis so you can quickly and easily determine test coverage and risk analysis, ensuring you are covering your verification and validation needs. Finally, you’ll also see how an automated tool can provide and enforce traceability from concept to product delivery.
Michael Sieve specializes in working with Life Science companies to help improve Product Development Processes. He has consulted with 100+ companies on improving requirements, testing, and issues management processes focused on quality and time to market.
SixSigma Master Black Belt and MBA for Life Sciences Professional Services. With over 10 years in compliance industries including: life science, government, utilities, and aviation.
He is well versed in Risk Management/Mitigation, FMEA, SixSigma and LEAN techniques for improving, implementing, and automating business processes to exceed regulations and expectations, while reducing costs. Michael has led 20+ and Managed 50+ Six Sigma Projects focusing on minimizing risk, defects, and time to market using both human and electronic enforcement controls.
Michael is a Certified Master Black Belt in Lean Six Sigma, Software Validation, Risk Management, and Negotiation. He is especially well versed in the General Principles of Software Validation, ISO 13485 & 62304 and Part 11 Compliance.
The attendees would learn how Real Time Traceability to requirements can help expose product risk areas, while through efficient GAP analysis they can ensure they are delivering a quality product. Risk based testing starts with the identification of high level "show stopping" requirements, priority requirements, and nice to have requirements; then moves into creating both verification and validation test cases to ensure that the product works from a functional and user perspective, and finally moves into issue management. They will learn how to create traceability between development assets to perform quick gap analysis. We will also explore when traces are necessary, and what the needs and benefits of traceability are. In addition, how to use tools to replace processes traditionally done on paper.
The main target would be anyone who is in a regulated environment or is in very quality critical industry.
An understanding of what requirements are and perhaps an interest in verification and validation.