References

Introduction of the FMECA approach in the innovation and product development process

PROJECT OUTLINE

  • At the start of new product and process development projects, the validation plan is based on a risk analysis which is currently insufficiently complete and systematic to guarantee the robustness of validation reviews.
  • The customer must strengthen its risk analysis:
    • Need to comply with the group quality policy.
    • Need to adapt to the innovation pipeline.
    • Need to integrate the customer’s new role as an integrator.
  • The client wishes to introduce the FMEA approach for products and technologies in its innovation and development process Stage | Gate.

PROJECT APPROACH

  • Explanation of the main benefits of launching a thorough review of the risk management process.
  • Identification of the project information flow along the Stage | Gate process: inventory | sorting of all project information that may be required by the tool (input) or from the tool (output) (documents | project deliverables, other management tools, quality databases, standards).
  • Definition of the “risk management tool” specification:
    • Description of the different stages of the FMEA: information, specifications, database structure, interaction with development products and tools, workflow.
    • Collection, structuring and formalization of appropriate data related to functions, solutions, processes, controls.
    • Construction of a FMEA management model.
    • Pre-validation with key users: key stakeholders involved in risk management at concept, feasibility, development, launch and support levels.
  • Evaluate the costs, advantages, and potential disadvantages of different solutions.
  • Collect, structure, and formalize appropriate data related to functions, solutions, processes, controls.

RESULTS

  • “Sales pitch” to gain buy-in.
  • Support from top management to sustain the approach (sponsorship).
  • Functional diagram: functional links upstream and downstream of risk management.
  • Functional architecture | technical architecture (mock-up).
  • Cost × value matrix of different technical solutions.
  • Structured and pre-populated databases.

Pagamon is a strategy and transformation consulting firm founded in 2013. We support major players in the industry, services and life sciences sectors in their search for balance. Helping them structure their strategic vision, transform their operational and/or digital model, and drive change. To support profitable, sustainable and responsible growth. As a committed player, Pagamon leads the Observatory of the Balanced Organization™, articulated around a "think tank" and an annual survey. In order to provide an innovative, sometimes offbeat, perspective on the strategic and operational implementation of transformations to support the growth of companies.