Common Pitfalls of QbD Initiatives – Shotgun Approach and Hype Cycle

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I’ll begin sharing some common pitfalls of QbD initiatives that I have observed over 10 years.

Meet Andy, a director who has been recently hired to kick off a Quality-by-Design initiative for PlaSeeBo Pharmaceutical Inc.’s R&D organization. He comes from Quality Assurance and Operations background. He is highly motivated to transform how R&D scientists work. He feels scientists have been hiding in dark labs for ages. It is time to show these scientists – the QbD light. Andy is a man on a mission.

He begins creating a list of activities that his team could start doing right away. The list includes: process improvement projects, training programs for Design of Experiments and SPC, risk assessments, weekly lunch sessions, and even 5S projects. He puts his small team of two black belts and a biostatistician to work on multiple projects immediately.

Andy can feel the good vibe in the organization. Some people are curious about the newly formed team and the new initiative. He assures himself this is going to work out.

1 year later…

Working on developing multiple programs at the same time is taking longer than planned. VP of Manufacturing (who hired Andy) is curious about the big promises that Andy made when he joined the company. Andy assures this is a long term investment.

Yet, Andy and the team do not give up. They know this hard work will pay off in 2~3 years.

2 years later…

Andy’s team is experiencing a serious burn-out. There were 4 waves of trainings, 24 lunch sessions and 5 process improvement projects (still ongoing). Andy’s boss has not seen a tangible ROI yet. Andy is getting anxious and desperate.

But a good sign… manufacturing folks are asking for more help with their projects. He feels this is a positive sign and can’t say No.

So he asks his team to tackle 3 more cost savings projects for manufacturing – an area Andy is most comfortable with. He is sure he can show a tangible payoff from a lean or six sigma project.

3 years later…

A flurry of new projects come down the pipeline for the R&D organization. Scientists are too busy to change their current processes and workflows and adopt to the “better way”. They pause all of their “improvement” projects. Slowly the momentum fizzles.

Andy updates his resume and gladly returns calls from recruiters.

Common Pitfall #1: Shotgun Approach

When you begin a new movement, excitement and optimism is high. As humans, this is natural.

At this stage, possibilities seem limitless. The long list of activities a team must do to accomplish an exciting mission seems quite feasible in a short time.

Here is where most initiatives fail and QbD is no exception.

A common path is the “shotgun approach” – launching everything all at once. This approach gets much appraisal from the executives because it promises many things and make a loud fanfare.

The result?

Shotgun approach for a small team ensures that nothing gets done.

At the initial stage, it is very easy for the team to over-commit beyond their capacity.

Why woudn’t they? There is so much energy and interest in the organization. You should harvest this buzz. The organization is new, the initiative is new. People are drawn to the “shiny new object” due to its novelty for a short time. You have a limited window of time to ride this wave.

This phenomenon is visually explained in Gartner’s “hype cycle.”

credit (Gartner)

It is natural to have this hype or a bump or overoptimism at the beginning of … well anything.

From Shotgun To Laser Gun

At the beginning of this hype cycle, you should harvest the endorphin-fueled energy and take advantage.

Instead of the usual shotgun approach, use a laser-focused approach to make significant progresses in a few areas.

When your team focuses on a few projects, you can iterate faster. Of course the management doesn’t like this approach. To them it may appear like too many FTE’s (full time equivalents) are working on only few things.

Corporations explicitly or implicitly like to measure “how busy employees are.” This KPI (key performance indicator) of “utilization rate” is measured by how many projects they are working on – not by how much progress they are making towards the bigger goal. This misleading metric is the main reason why most of the workforce can’t get much done. Many folks in corporations want to look just “busy.” (I’ve been also guilty.)

When starting a QbD initiative, there are many lessons that you can learn from the startup world.

The one metric a startup obsesses over is “growth” at the launch phase. Growth can mean adoption rate for the QbD initiative. One way to measure adoption rate is by the number of scientists using QbD framework and tools.

Sam Altman of Y-Combinator (startup incubator in Silicon Valley) states the importance of focus on this one metric.

Don’t waste your time on stuff that doesn’t matter (i.e. things other than building your product, talking to your users, growing, etc.). In general, avoid the kind of stuff that might be in a movie about running a startup—meetings, going to lots of conferences, grabbing coffee with people, sitting in lots of meetings, etc.

Focus intensely on the things that do matter. Every day, figure out what the 2 or 3 most important things for you to do are. Do those and ignore other distractions. Be a relentless execution machine.

Conclusion

In the beginning, a new QbD initiative is much like a startup trying to find a product-market fit. Product is the systems, tools, language, culture, workflow, etc. – specific to the R&D organization and the company.