GXP & Lean
As many of you who study the principles of lean theory already know, the key strategy that forces continuous improvement and investing in employees is the one-piece flow cell (continuous manufacturing). Employing a one piece flow forces management to rely on continuous improvement and the ability of their employees to solve complex problems rapidly as they happen, due to no build-up of inventory. No inventory between process steps means a deviation in the workflow causes a paralysis of the line and idle downstream workers. It is definitely a risk and will most certainly cause short-term pain, but the long-term payoffs are immense: higher quality products, cost savings, better employee retention, and facilitating a [real] great place to work. No need to add any references or case studies here, this has been proven over and over again since the 1950’s.
The issue I would like to address in this blog is that most of us working within the GXP world do not deploy one piece flow cells (this can also be services/etc., it does not need to be a drug component/substance/product). In fact, a one piece flow may not always make sense in our GXP universe, due to a variety of complex factors. As a result, however, we are not forced to focus on the two key pillars of lean:
Continuous Improvement
Employee Engagement and Empowerment
As a result, we need to find another ‘forcing function’ that directs management to treat the two key pillars above as necessary for survival. The regulators are well aware of this reality, many of which are masters of lean theory, and have as a result tried their best to update regulation (Annex 11) and guidance (QMM) to ‘force’ us to embrace the components of lean where we can. Lean processes are not an ‘all-or-nothing’ endeavor. We can extract the strategies (pull vs. push) where we can, and just do the best we can with what we have.
Data Governance, written into the new Annex 11, EU GMP Chapter 4, and ICH E6(R3), is a theory that ‘forces’ us to embrace a “risk-based approach” to GXP workflows. When the site is able to create a mental map of a “risk-based approach” via data governance and lean theory, they will find serious overlap. In fact, I would argue there is no principle of lean that cannot be deployed within a “risk-based approach”. You may never be lucky enough to work within a truly lean organization deploying continuous flow cells.
That’s OK, if you instead replace this (continuous processes) with the common aim/key corporate strategy of data governance, which if understood at its core (join us in an upcoming workshop to explore the concept in depth), will ‘force’ management to embrace the two pillars listed above as necessary for survival.
