Introduction

Fully integrating QRM principles into an R&D organization is complex and cannot be done with just the creation of new QRM policies. It takes special knowledge and set of unique skills to determine how best to adopt the principles and establish them into workflows and documents within a particular function.  A special organizational support should be established to guide QRM integration. Listed below are recommendations on how to establish QRM experts in an organization to help guide mature integration. The adaptation of these recommendations should be customized to the company’s organization.

QRM Champion

The champion is fluent in QRM principles and understands its application across the product lifecycle. That person should be in a leadership role within the organization and has knowledge of activities where a QRM approach would be recommended as well as the go to person within the organization who could recommend whether a project justifies a risk assessment and who could facilitate that session in addition to recommending a potential QRM tools.  The champion would also coordinate QRM facilitators and their development. In addition, the champion would represent the center of excellence for QRM. That entails helping to develop policy, process and procedure level documents where needed and participating in community of practice events to guide QRM integration. Typically the QRM champion role is not their only responsibility, and the individual has other leadership responsibilities within the organization.

QRM Facilitator

For more complex risk evaluations it is often important to have a facilitator to properly manage the risk assessments. They are experts on the different tools that can be applied to manage risk and can help select the best tool for the risk evaluation. They are skilled on how to run a risk evaluation team meeting. They work with a project manager to ensure that the right people are on the team and help ensure the correct information is assembled and prepared for a risk evaluation. They understand how to keep the team moving and not get bogged down in unnecessary details and help bring the evaluation to a conclusion and ensure that the output is delivered. The facilitator role is not typically a full time role and does not have to be an expert on the subject involving the risk. Indeed it is often better that the facilitator is somewhat removed from the risk specifics being evaluated as not too basis the evaluation.

Training

In order to develop champions and facilitators to support different functions it is highly recommended that a training program be established. Here is a description of recommended training modules for QRM champions and facilitators.

o    General QRM overview training module: This training provides basic understanding of QRM concepts, how QRM protects our patients and how QRM is integrated into the daily activities. It provides numerous examples on how the principles are applied throughout the product lifecycle. Although designed for the QRM champion role it should also be required for QRM facilitators.

o    QRM facilitator training modules: Skilled QRM facilitators must possess a number of important skills. These include a strong working knowledge of QRM concepts, how QRM protects our patients and how QRM is integrated into the daily activities and is applied throughout the product lifecycle especially the development lifecycle. They need to be skilled the use of all of the standard tools applied within the R&D functions. Finally they must possess strong team facilitation skills that include aspects and techniques of facilitation, managing conflict, and running a risk assessment team.