Case Study: Assembling a Comprehensive Risk Management Approach

February 2, 2017

Our customer, like many medical device manufacturers, had numerous risk management activities occurring in isolation. Risk management was addressed in design, manufacturing, validation, CAPA, complaints, and other areas, but there was no comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – the company was not updating the files with post-production, post-market, and other relevant data.

Through a combination of training and coaching, our customer’s in-house team learned how to build a systematic, dynamic risk management process and risk management files.

Getting Started – Establish a Solid Knowledge Base and a Common Risk Management Language

Traditional classroom training was used to teach the process of risk management; regulatory and ISO 14971 risk requirements; how to identify, estimate, and minimize hazards and risks; risk management file requirements; and how to use specific risk analysis tools and methods. The training concluded with an on-line assessment designed to measure knowledge retention.

Building Upon the Base

Classroom learning was the critical first step to establishing a common understanding of risk management at the company. The next step involved applying this understanding to real issues.

Coaching is a cost-effective option to ensure that an in-house team correctly applies new concepts and tools. This guided application increases the retention of new knowledge and skills, improves the sustainability of the changes, and ensures the successful transfer of knowledge from the classroom to the organization.

During the coaching engagement, our customer’s in-house team updated a sampling of risk management files with current post-production and post-market experiences, clinical benefits, and other data. As questions arose, the in-house team had immediate access to expert help. The coach, as an objective outsider, also posed questions that helped the employees identify the gaps in their risk management efforts.

Sustaining the Gains

Upon the conclusion of the coaching, the in-house team members had practical experience and newfound confidence in their ability to develop and improve the organization’s risk management process and risk management files.

Coaching vs. Consulting

The key distinction between coaching and consulting is that coaching keeps the power with the employees, who perform tasks with immediate access to expert advice and guidance. This situation is different from a typical consulting engagement, in which the consultant prescribes and may even perform the tasks. Both options are effective, depending on the needs and objectives of the company.

Need Support for Your Risk Management Program?

Learn more about how Oriel STAT A MATRIX can help your company craft an effective risk management program and satisfy the demands of ISO 14971.

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