Sunday, October 2, 2011

Developing Product Requirements Criteria at bioMérieux - SDM Pulse Fall 2011


Lisa Steinhoff
For her capstone project in MIT’s System Design and Management (SDM) program, Lisa Steinhoff, SDM Certificate ’10, created a common product requirements document (PRD) and optimized systems engineering document templates. She also prepared a proposal for integrating these documents into the product development and design controls process at her company, bioMérieux. The purpose of the PRD was to provide a set of generic requirements that would remain consistent across all systems. The common PRD would allow the global company to improve its system development efforts, focus on what is specific to each new product, and transfer knowledge from site to site.
Most bioMérieux products consist of:
• a biologic disposable
• application PC software
• instrument hardware and firmware
These areas often are referred to as the subassemblies or components of the system. Defining what levels of documentation are required for each is helpful to project planning, verification and validation planning, and traceability. The documentation structure Steinhoff developed will be used across development sites to improve communication around planning, traceability, usability, and risk analysis. Steinhoff credits SDM’s class in system architecture with helping her to identify the need for a common PRD as well as the organization of documentation.
This chart shows what documents are required for each level of the system as well as which
ones will serve as inputs to verification and validation testing. This documentation structure is
designed to help development sites to speak the same language in terms of planning, traceability,
usability, and risk analysis.
The requirements count for each project examined illustrates the need for some commonality
and more efficiency.
About bioMér ieux
A world leader in the field of in vitro diagnostics, bioMérieux maintains a presence in more than 150 countries through its 39 subsidiaries and large network of distributors.
Criteria to Consider
The process Lisa Steinhoff used to develop generic requirements for bioMérieux products included evaluating each requirement against the following criteria:
• Is the requirement at the system level?
• Is the requirement design independent?
• Is the requirement generic?
• Does the requirement relate to usability aspects of the system?
• Is the requirement SMACCable, that is:
• Specific: unambiguous and understandable, having only one interpretation or meaning
• Measurable: defined in quantifiable terms that can be verified or validated by an objective method of analysis, inspection, or testing
• Attainable: achievable with existing technologies or demonstrated as feasible through research of new technologies
• Consistent: not in conflict with any other requirement
• Complete: all elements are identified, adequately defined, and can be approved for use in subsequent design activities
About the Author
Lisa Steinhoff has been an engineering manager in the Research & Development Engineering group at bioMérieux since 2001. She holds a BS in biomedical engineering and an MS in engineering management, and just completed SDM's one-year Graduate Certificate Program in Systems and Product Development.

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