Quality Risk Management (QRM)

Based on basic principles, published decades ago by ICH, via their quality guideline documents Q8, Q9 & Q10, elaborate the use of Quality by Design (QbD) concepts in manufacturing. These very same principles are now being applied to the clinical research services albeit, with some adaptations and is evident in the new ICH-E6-(R2). This guideline has highlighted the use of objective measures to be used in the assessment of quality assessments and also risk assessment in managing projects through their life cycle namely: before, during and after.

Risk Assessment culture will bring in the need for pro-active planning and evaluation so that solutions can be pre-built to manage any of the risks identified and prepare the project managers as well as the project teams to manage these effectively and quickly, when the issue triggers, so that the quality and/or timelines do not get compromised, awaiting post-mortem by quality personnel or the operations team.

This needs that the project management teams and operations teams break their silos and create a project office concept which will visit and review risks in advance. This will help us move away from the usual "Issue management" which is usually waiting for the "fire" and then rewarding the one to puts-off the fires. This is encouraging managers and team members to intentionally hide risks identified, till they flag it when it is an opportune moment for them to do so. This is completely subjective and counterproductive behavior and a huge risk, as there is no transparency to the others on these matters and could have been avoided much earlier and even avoided the situations of "fire".

PiCRC will help your organization to build the culture of risk identification, assessment and review on a regular basis and then use it to build a live risk management plan weaved with project management plans and operational plans. This will reduce the issue management which is generally very emotional and quick and is in danger of using subjectivity to make decisions, where as the PRO-Active ⁱd³ methodology will help all to be focused on objectivity that the quality metrics as well as other operational metrics will bring to the table, for discussions and decision making, assisting the project teams to collaborate, understand and objectify the decisions based on facts and business analytics results rather than just the "gut feel". This behavior will also bring about the change to 2π+2π ( People & Professionalism + Performance & Profits) proving to be a mileage to project managing efficiently.

New concepts

PiCRC will help your organization to implement Risk-based Quality and Operations Management and make your Risk Management Plans come alive, using these two methods, namely, PRO-Active ⁱd³ ,2π+2π ( People & Professionalism + Performance & Profits)!

This approach also also help deep-dive into:

• Work-flow optimization

• SOP management and writing

• Process Improvement

• Monitor and improve people factors ( People & Professionalism + Performance & Profits)

Adapted Image Acknowledgements: To Originators, see Google Photos (@ quality-on.blogspot.com)