After stirring up a discussion on QbD Risk Assessment, I went quiet. Here’s why.
Background: QbD at Risk
I couldn’t sit through another Risk Assessment meeting. I was tired of long meetings and “most attributes are high-risk” results. The worst part — scientists did not support the process. This skepticism was damaging the QbD initiative. Something was missing in the traditional FMEA approach.
3 Months to Draft a Risk Assessment?
A few weeks ago, I conducted a survey: How long did it take to complete a Risk Assessment? The answers ranged from 1 month to over 9 months with a median of 3 months. Why does it need to take such a long time? I asked myself.
Journey: Context Matters
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 QbD community members liked, commented, and shared the article. So I knew I wasn’t alone. Many of us were suffering from a Square-Peg-In-A-Round-Hole problem.
So I set out to seek a solution.
Aha Moment: QFD for QbD
Here is what I learned: many successful companies begin with the Voice of the Customer. In our industry, Voice of Patients or Physicians (Hint: QTPP). They translate this voice into Engineering Metrics (Hint: CQA). Finally, metrics are mapped to system components (Hint: CPP). How logical and intuitive! This approach is called QFD (Quality Function Deployment).
However just like the FMEA, QFD brings baggage from other industries. Sparked by this motif, I redesigned the process to fit our QbD needs in BioPharmaceutical industry. Then I put my programming skills to work. A prototype of “QbD Risk Assessment” was born.
How did it go? Below is a screenshot of the original prototype.
Well, it looked perfect for Windows 95. A light of hope was that it worked well…as long as I was the one using it.
This idea deserved a better execution. So I took my prototype to my best friend who happens to be a gifted enterprise software developer. He had much sympathy on me. After hard labor of love, here is the exclusive sneak preview:
Out came a clean and beautiful software (patent-pending) that any QbD practitioner can use. We’ve been working together on this project ever since.
Real World Validation:
So how did it work? Excited, I put it to test with R&D scientists, QbD practitioners and Quality and Regulatory professionals who usually conduct the risk assessment. Their feedback? They began using it with ease and commented on how effective and efficient the process went. With the feedback received, we continued to improve the process.
I myself experienced how this has halved the number of meetings without losing communication, gained scientists’ support by asking the relevant questions and eventually complete and update risk assessment much faster with practical results. Everybody was happy and continuous improvement was taking place.
On the next post, I will share why QbD Risk Assessment is so critical to the success of a QbD program and how I conducted Risk Assessment to save the program.
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