Editor’s Note: This is the final post in our 7 part series on Process Risk Assessments. The series is also available for download as a whitepaper.
So far in the series we’ve covered:
- The Common Structure
- The ISO 14971 Standard
- Focus on FMEA
- The Impostors: Uncertainty and Detectability Risk
- The Non-Linear Factor: People
- QbDVision – Risk Management Plan Configuration
From these prior discussions, we hope you have gained insight into the structures and benefits of a progressive and layered risk management plan.
While an all-encompassing definition of risk in the Pharma industry does not exist, QbDVision assembles best practices from the various industry approaches into a common and effective structure. Our approach builds risk in discrete layers that are designed to be updated and managed throughout the development lifecycle thus capturing the evolution of risk. This approach aligns nicely with the principles of FMEA/FMECA and ensures compliance with the recommendations outlined in ICH Q8 to ICH Q12, along with ISO 14971.
These fundamental constructions are packaged together in a configurable Risk Management Plan (RMP) section within QbDVision. By providing you with discrete and calculated layers within your RMP, the system provides the flexibility to implement existing RMP structures or help your organization leverage a more streamlined approach. Our built-in normalization system makes it easy to overcome common challenges with assessing risk across the different layers of Criticality, Process, and RPN.
Of course, it can often be challenging to get started. How many layers to use? How should we define each layer? Is our terminology consistent? Should we keep our risk matrices symmetric or asymmetric?
If your organization already has an existing risk management approach, it should be straightforward to fit it into the flexible constructs discussed throughout this series of articles.
If your organization is at an earlier stage and starting from the beginning, then you can start with the preconfigured RMPs provided by default when you first create your QbDVision account. Three predefined RMPs are provided out of the box in QbDVision that we think fit 80% of most known cases. Our 4-level and 5-level designs tend to be more commonly used in the industry. The 3-level design may be more attractive for initial risk assessments at the R&D stage. Or, perhaps the asymmetric approach is more desirable. In practice, the 4-level design can result in a constrained range of uncertainty and more than 5 levels may cause the distinction between a risk impact of ‘very high’ or ‘severe’ to become less significant. This challenge of distinguishing between levels becomes more apparent as your risk matrix grows larger. In these cases, asymmetric design can provide the required flexibility.
QbDVision’s RMP functionality provides a firm place to get started and explore the possibilities before deciding on the best approach for your project and your organization. And, when you’re ready to draft and sign-off your new Risk Management Plan within your organization, try out our Risk Management Plan Report built right into the RMP module. With the click of a button, QbDVision will automatically generate a fully constructed, ready-to-go risk management plan with all the appropriate references and links. Export this document in Word or PDF and circulate easily for review and approval across your organization.
Try it today and let us know what you think.
This blog post series is also available for download as a whitepaper.
