2 Uncommon QbD Practices — Why You Should Pay Attention
I reveal 2 secret practices today – 2 practices that will set your QbD initiative up for success. I call them secrets because they are the most uncommon QbD practices – especially in the United States, where I work and reside.
As facilitators of QbD risk assessment meetings, not only do we have control over this but this is an area we can add tremendous value. If you’ve observed many QbD Risk Assessment meetings, you will agree that most of the time is wasted waiting for others to think and talk in group meetings. Read this Story to feel the pain.
In part 1 and part 2, we witnessed how you saved $15 M and 3 months of time just during QbD risk assessment activity. How did we make this possible? By curating information and meetings with a smart tool.
What’s better – our colleagues now support your QbD initiative – thereby setting up QbD for a smooth launch. How did this happen? Through a positive experience. Everyone appreciates your effort to save time for them.
Let’s further dissect what took to accomplish these 2 outcomes:
- Eliminate unnecessary group meetings and save time for everyone
- Colleagues now support your QbD initiative
The purpose of the first principle is to attack the life-sapping archenemy at our workplace – unnecessary group meetings. (Disclaimer: Yes, some are necessary)
1. SMED (AKA: Gather Necessary Information before Group Meeting)
SMED (Single-Minute Exchange of Die): What does the Biopharma industry have to do with Dies? This may be a foreign concept to those who are fresh to Lean manufacturing. In 1950’s, Shigeo Shingo of Toyota in Japan developed the concept of SMED (Single-Minute Exchange of Dies) or quick changeover.
Although the concept was developed by an automotive engineer, we can still apply the principle. Simply, in QbD risk assessment, SMED means preparing all necessary parts before the assembly step. Shingo encouraged using templates to facilitate this process.
In QbD Risk Assessment, individual parts were: List of QTPP’s, CQA’s and CPP’s; a Scored Impact Assessment (sub-assembly), a Scored Occurrence Assessment (sub-assembly). The assembled product is the Control Strategy.
As QbD facilitators, we’ll assemble these parts using 2 different approaches. First, using a meeting-driven approach and second, facilitating it using SMED. Let’s see the difference between the two.
The fishbone diagrams below show the “Before” and the “After” processes of QbD risk assessment. In the “Before” process, we needed 19 meetings because the group met at every node.
In the 2nd approach, we assembled these individual parts using:
- a template within the QbD Risk Assessment software
- the SMED principle – prepare the parts (info) before the assembly
This is the result: 3 meetings! Compare that to the previous 19 group meetings.
Here, we simply prepared the necessary information (impact and occurrence assessments for each process from process owners) –without involving the entire factory (group in our case)–before the final assembly (Control Strategy).
You, the risk assessment facilitator and the QbD Risk Assessment software were the enablers, curating the the right pieces of information.
So far we discussed the principle of pre-assembling necessary information (Lists of QTPP’s, CQA’s and CPP’s; Impact Assessment, Occurrence Assessment) before group meetings. To dig deeper, how do we facilitate this information gathering process?
2. Nemawashi (AKA: Pre-communicate to build Votes and Ideas.)
I’ve worked and lived in Japan for 2 years. As a freshly PhD-minted professor at Keio University, I proposed a new program where much resistance was expected from the faculty. Nemawashi was what I had to practice at the time. Little did I know Nemawashi would be helpful back in the US.
In the US, many folks try to achieve everything through meetings. So people tend to batch process info-gathering, info-processing and decision-making in meetings. They collect every thoughts, all ideas, into a big bucket and they bring that bucket to the meeting. Then they dump everything out of the bucket onto the meeting table.
This is analogous to an operator in a factory buying generic tool sets, nuts and bolts from Ace Hardware store and trying to assemble a car in his garage. First he must sort through the pile of parts to find the right ones. This is what we are doing at meetings.
Due to this behavior, we tend to spend a considerable amount of time in distilling what the right information is during the meeting. What’s more, consensus for decision does not happen effectively when there are many social dynamics (ego, cronyism, job security, want to impress others, etc.) going on.
Compare this to a Japanese meeting where the data is presented and decision takes place soon afterwards. You may be surprised that very little discussion takes place during the meeting before the decision.
What is hidden in this picture? All of the pre-decision work was done before the meeting.
This is called Nemawashi.Nemawashi translates as “digging around the roots of a tree, to prepare it for a transplant”, from 根 (ne, root) and 回す (mawasu, to go around).
Often translated as “laying the groundwork,” Nemawashi practice builds rapport and also function as lobbying participants and decision makers.
In addition, Nemawashi’s mini-communication is deeper and more focused than large group meetings. By the time your QbD team is in Control Strategy, QTPP’s, CQA’s CPP’s are clearly defined, impact and occurrences are assessed by subject matter experts and there are well-developed justifications, and all the decision makers have had their say.
Thus the actual decision making in a meeting can take only 5-10 minutes. The decision for all practical purposes was already made before the meeting. This is a powerful secret for any meeting.
Conclusion:
The 2 key principles behind saving meetings: SMED and Nemawashi.
Our lesson for QbD Risk Assessment? Don’t schedule a group meeting unless you have the necessary parts (or information) to assemble your product (Control Strategy).
Use a template and Nemawashi technique to facilitate a successful QbD Risk Assessment.
May the QbDWorks be with you on your QbD journey.