If you’ve experienced Risk Assessment sessions, you will be familiar with how much time is spent at the beginning — just trying to collect the QTPP, CQA and CPP’s.
The good news is that most products (biologics and small molecules) share similar manufacturing processes. Accordingly, they share similar sets of QTPP’s, CQA’s and CPP’s. We can take advantage of this. So “don’t re-invent the wheel” as I have in the past.
Having spent time on more risk assessment sessions than I’d like, I sought for ways to eliminate unnecessary work, shorten meetings, while improving the outcome — Design Space planning and Control Strategy. I share my personal recipe on QbD Risk Assessment. It saved me much time and pain. Hopefully it will do the same for you. Just apply the Recipe below to your situation.
Recipe for QbD Risk Assessment Without Many (Unnecessary) Meetings
Risk Assessment Template, Project lead, Development Scientists (Process Owners), Regulatory Affairs Rep, Quality Assurance Rep
Optional but Highly Recommended (because they are not always available):
Manufacturing Scientists, QbD Risk Assessment Software
Step 1: Build your List of QTPP-CQA-CPP based on a Template
- Email out the process map for your product. Generic process maps are fine (unless you have the latest one from the development team). It’s important to kickstart the Risk Assessment process with a tangible vision. What you should write in the e-mail is discussed below.
In the email, ask the process owners to edit their sections based on the template as pre-work — (before the 1st meeting). (saved 3 meetings!)
- QTPP: Assign to the Project Lead
- CQA: Assign the process owners to edit their list of CQA’s
- CPP: Assign to the process owners to edit their CPP’s
Time-Saving HINT: You just shortcut the QTPP, CQA and CPP & CMA collection process. (saved 12 hours of work, 3 group meetings and 3 weeks of lead time)
- Now use the template (like the Generics or A-Mab)
Below, I used the A-Mab Template from the QbD Risk Assessment Software. The first screen prompts me to modify an existing template (or create a new one). I choose the A-Mab Template for a monoclonal antibody project.
As you can see, the lists of QTPP’s, CQA’s, and CPP’s (grouped by process) are pre-filled. I can edit them further here.
After you get the edited list back,
- Compile the edits into the template.
- Email the compiled list for a review and feedback before the first meeting.
We just saved saved 12 hours of work, 3 group meetings and 3 weeks of lead time – and no meetings so far. Step 2 will save us more time.
Step 2: Assess Impact Without Unnecessary Meetings
Can you believe we had 0 group meetings so far. Now we are ready to have our first group meeting. In this meeting, present the updated list of QTPP’s, CQA’s and CPP’s. Most folks should’ve reviewed this list before this meeting. After final comments and edits have been reviewed, let’s move on to the next step since this list can easily be revisited and edited later.
It is now time to assess “impact” portion of risk. (Risk Index = Impact x Occurrence) During or after the first meeting, give assignments to process owners to evaluate the impact relationships between QTPP-CQA and CQA-CPP&CMA using a simple “none-low-med-high” scale. When rating, anyone can add comments to each cell for literature review, clinical study results, RA or QA justification, etc.
Below is a screenshot ofQTPP-CQA impact assessment in action.
Below is a screenshot of CQA–CPP impact assessment in action. You have 4 choices:
- No impact (score: 0)
- Low Impact (score: 1)
- Medium Impact (score: 3)
- High Impact (score: 9)
Assign the process owners to evaluate the relative impact between CQA and CPP of their own processes. Surprisingly, this usually takes less than 30 minutes per person.
If the process owners want paper-based template, we can print them out so they can mark the ratings with pens or pencils. Below is the paper printout version. Either they can do this on their own or you can do a 1:1 to accelerate the process. This approach can be faster and fail-proof.
Now you can collect these marked templates and compile them into the master template. (We just saved another 6 group meetings!) Typical risk assessment meetings would require group meetings to assess the impact — in a conference room late into the afternoon. This is a form of waste since the process owner usually does the rating of their processes while others sit quiet until it’s their turn to rate.
To be Continued…
So far we saved 9 unnecessary group meetings, 12 hours of individual work and a minimum of 3 weeks of waiting.
As you see, the big gain is in the reduction of unnecessary group meetings. Group meetings are costly. They are disruptive. They rob of many folks’ time when they should be doing value-add work.
Count the number of people in the room and multiply it by the number of hours they are sitting together without saying anything (i.e. waiting for their turn or process).
Also this is one of the primary reasons why scientists don’t like risk assessment sessions — too many (unnecessary) meetings.
If you want to try the Template, go Here.
In the next post, Step 3 will cover the Occurrence assessment and Control Strategy to save more time and get better results. In the mean time, what are your hacks for saving time on Risk Assessment meetings?