As a QbD facilitator, I could not sit through another long Risk Assessment meeting…
Then I remembered–during my PhD research at Stanford University–I conducted more than 50 FMEA sessions for Fortune 500 companies and learned why it fails when used in the wrong context. I shared my learning on this article.
Instantly, 107 scientists liked, commented, and shared the article. So I knew I wasn’t alone and many of us were suffering from a tool mismatch problem.
So I decided to do something about it for our QbD community.
Here are 3 reasons why doing Risk Assessment incorrectly during development stage may slow down or even jeopardize your QbD initiative.
- When you use a generic FMEA template, QbD Risk Assessment sessions require long sessions of full-team meetings–when only a few talk most of the time. One confessed the first risk assessment draft took 12 weeks just to learn the tool. His story represents the results from a survey.
- Inflated Risk Calculation results in (unnecessarily) too many “Critical” quality attributes and process parameters. This means higher costs to manage them and delay in market launch.
- Lose scientists’ support by asking irrelevant questions and wasting their time by using inappropriate ordinal scale.
For further details, please refer to this article.
How can we Prevent This?
We experienced the same problem. So we redesigned the FMEA process to follow follow the ICH Q8 (R2) guideline. We embedded the process into this QbD Risk Assessment Tool. It is a simpler FMEA tool designed for BioPharmaceutial industry (and not the automotive industry’s FMEA standards). You can:
- Save Time by more than 80%
- Save Frustration
- Results in better Risk Assessment Results and Control Strategy
This is the most important tool you are missing in Risk Assessment. Why?
Here are 2 reasons why it is critical to do Risk Assessment correctly.
- First Impression Matters. As the first step in QbD, if Risk Assessment is not a pleasant experience for the team, you will lose scientists’ support and the QbD momentum may fizzle.
- Risk Assessment is the backbone of QbD.
Risk Assessment is what links QTPP-CQA-CPP to Control Strategy.
How to define “Critical” discussion happens during the Risk Assessment.
Output of Risk Assessment is a priortized list of QbD projects — Design Space studies.
How QbD Risk Assessment will help you:
- Simplifies the over-complicated Risk Assessment process
- Eliminates non-value-add meetings
- Gain scientist’ support by saving their time and asking the right questions.
- Facilitate QbD meetings with ease and shorter preparation time
- Share and communicate risk assessment results visually
- Updating Risk Index is easy throughout the development lifecycle.
- Save time by using the Best-Practice Risk Assessment Templates.
- …and ultimately lead your QbD Initiative to a Success”
What is inside the Product:
- QbD Risk Assessment Software
- a QTPP-CQA-CPP template: Immediate-release Tablet Template
- a QTPP-CQA-CPP template: aMab Template for Biologics (Available for Purchase)
- More Templates
These templates will help you save hours of meetings to collect the candidate QTPP, CQA, and CPP’s. These templates are built from FDA and Industry case studies which you can easily edit for your projects.
Voice of QbD Experts & Customers
“Risk assessment is not only a very well received risk software, but also a QbD instructive for beginners with showing how to link QbD terms as QTTP, CQA and CPP. I can whole heartily recommend it for anyone looking for a well coordinated guiding QbD software.”
– Mehtap Saydam (Sanovel)
“I tried your trial version and liked it very much so I ordered the software.”
– Roger Harrington, PhD (Process Development Director of Medtronic)
“The impact of a poor risk assessment can be severe.” Tim of Clayton CMC Consultancy“
“I completely agree with you that FMEA, especially in the early development, is not the ideal tool” – F of PTM Consulting”
It is like a loop I always have to dealt with, everytime!” – S of Angelini
“The first part of your blog literally had me laughing out loud. This is so true and relevant.” -I of Teva
“How refreshing to see this. Thank you so much for noting that the FMEA emperor may be missing some clothing.” – D, Statistician
” My first impression for this software is very informative, easy to use and well-designed.”
– Gary Lo (enTrace Technology Limited)
Who are the Users of Lean QbD Risk Assessment?
Our growing number of QbD pioneers include: Medtronic, Merck, MedImmune, Eli&Lilly, Dr.Reddy’s, Intravaccine, Hanhwa, LG Life Sciences, CJ, Viromed, Green Cross, Daewoong, Medytox, Sanovel, EntraceTech, Biotech, Mylan, University of Alberta, MISR University, etc.
Will you be left behind or will you join us to be one of the QbD innovators?