8.1. McKinsey’s business case for QbD

McKinsey identified a strong business case for QbD with savings of US$30 billions for the industry and “huge potential long term value incremental annual profit”. The report also “demythed” two of the most commonly cited factors opposing QbD - cost and time.

• They found costs for implementation to be “minimal” and cited that in some cases QbD reduced “technical development costs by up to ~25% per program.” QbD was found not to increase development timelines, as it hardly increases time (~2 FTEs over 2 days) needed during early development, has no effect on time requirements on the critical path, and actually often reduces time needed for tech transfer and scale up by about 10% in each phase.⁷⁵
• Reduction of COGS and capital expense, increased technical development productivity, improved quality (and lower risk), and increased sales can summarise in up to US$20 - $30 billions of profit growth for the industry according to this business case prepared by McKinsey on the economic impact of QbD.⁷⁶

Thus they viewed “QbD is evolving, gaining momentum and passion throughout the industry” and claimed to be supported in this view of a strong business case by more than half of companies interviewed.

However, they also acknowledged that there was still scepticism on the benefits of QbD and that companies were at different levels of maturity in its adoption, which they defined as “novice, pilot, rollout, or fully implemented”.

Though this business case presented by McKinsey claims a potential for substantial savings, these obviously had not been converted into real life by the industry as a whole by August 2011, the time when I launched my own survey. The majority of the responses did not consider QbD to provide substantial savings yet – far away from the billions of dollars in savings, hypothesised by McKinsey in 2009.

⁷⁵ Fuhr; State of Implementation; 2011; slide 15-16
⁷⁶ Fuhr; Why quality-by-design should be on the executive team’s agenda; 2009; p 198