We have enjoyed years of collaboration with Insight who consistently provides creativity and innovation in ways that are aligned with our design control system and quality processes. Creating game changing delivery solutions while adhering to Quality System Requirements are what our customers expect of us.”
Risk Mitigation and Quality Management
Plan to succeed
There's project management, and then there's project leadership. The Insight team creates great project plans and manages their execution with the rigor necessary to ensure the success of any program while satisfying the requirements of the strictest quality system. One thing that makes us different, is our dedicated project leadership, not just project management. Our program managers know how to anticipate small problems before they become big ones. They know how to ask the difficult questions to ensure that what we’re doing today gets us where we need to be…next week, next month and next year.
This management philosophy makes the application of a Quality Management system that much more effective. It makes the risk assessment portion of the system that much more relevant. In short, it is the perfect example of risk mitigation across your quality system and product development processes.
Beyond the Basics
QMS at Insight
Insight has developed a successful QMS focused on continuous improvement, employee involvement and understanding and meeting client goals. Our QMS is fully described in our quality manual and our system is further organized with five guidelines corresponding to Sections 4, 5, 6, 7 and 8 of ISO 13485.
A critical element of our design controls are captured in the documentation found in the Product Realization Guideline (section 7) and its supporting procedures. Insight follows these guidelines which outline planning, inputs, outputs, review, verification, validation and transfer and how each of these are applied within a given project.
Insight's product development process is a collection of best practices and methods that our team leverages and integrates into design controls. The process is flexible yet rigorous, and helps the team outline day-to-day activities as well as adopts strategic perspectives that enable us to achieve our clients' goals.
Understanding and managing risk
Insight utilizes a formal, yet scalable approach to risk analysis that understands risk at different levels. Initiated with a fault tree analysis, Insight first looks at the overall affect of system errors which then drills down to understanding product and manufacturing failures coupled with user-based errors. This systemic approach to understanding risk clearly defines the most effective way to mitigate risk in the development of your next product.
Complex System Level Interactions (Fault Tree Analysis):
The creation of a detailed fault tree provides the framework for understanding potential failure in the subsequent risk analyses. Insight is very experienced in performing a comprehensive fault tree analysis that will drive the rest of the risk mitigation activities.
Design Initiated Failures (DFMEA):
Performing the DFMEA distills the functional, safety and performance requirements of the device, idenifying potential problem areas that essentially allow the team to look for creative and innovative ways to avoid possible design failures.
Manufacturing / Process Initiated Failures (PFMEA):
Once the potential design failures have been identified and solved for, it is critical to apply the same analysis to the manufacturing and assembly process. Insight’s extensive knowledge of manufacturing materials and processes gives the design team all the information necessary to solve for potential failures during the manufacturing cycle.
Human Error (HESRA):
Insight's Ph.D. level expertise in human factors and ergonomics ensures that the Human Error Safety Risk Analysis is accurate and comprehensive enough to predict all user based failures. This understanding of potential human error will ultimately inform the Insight design team with the detail necessary to design a “fool proof” final solution.
Potential Harm to Users / Environment (Hazard Analysis):
Anticipating the affect that the users’ environments and tasks have on potential risk is the last piece of the puzzle. Insight utilizes hazard analysis to understand the intended use of the device. Coupled with a complete understanding of the work flows and environments, the team anticipates, documents and ultimately “designs out” potential hazards to the user.
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