Golden Batch
In the cafeteria during a recent on-site visit, I observed staff indulging in a wonderful buffet including a full spread of appetizers, mains and deserts… along with some nice drinks. Of course I had to inquire: what’s this all about? The answer was that the site had recently achieved a “Golden Batch”. I congratulated the team on a job well done, but the GXP Quality side of my brain had some serious lingering concerns, which I chose to keep to myself, obviously… Let’s get into it here.
The idea of a Golden Batch is a popular concept within the lean manufacturing camp (I am permanently camped out here…), and can be roughly defined as ‘the ideal production run where each parameter that may be susceptible to variability such as materials, temperature, pressure, mixing speed, time, etc., meet their ideal values within the specification range to produce the highest quality product with the lowest waste and therefore lowest cost.’
Problem #1: Most of us do not know the ideal range within our specifications that achieve the goal of highest quality at lowest price…
Problem #2: The definition is silent with regard to deviations. In fact, a Golden Batch in lean theory can still experience multiple deviations during the production run. The Golden Batch is all about measuring process/parameter variability (it is solely process parameter data-driven)! Unfortunately, however, for whatever reason we in GXP have also tagged on the idea of “zero deviations” (this makes me cringe), which is the exact opposite of the lean mindset. This is added goal is excess overweight baggage, and will incur significant penalties! To be fair, in theory, this is not a bad endeavor, but it requires a very, very high level of QMM to realistically achieve its goals within the highly regulated GXP manufacturing space. Without a mature Quality Mindset, the “Gold” in Golden will be as elusive to your organization as a leprechaun’s treasure at the end of the rainbow (for reference: it’s not real).
Why? Because in my experience most GXP manufacturing sites still treat deviation investigations, for example, as a failure (negative metric) instead of an opportunity for growth. Deviations as a key ingredient for continuous improvement and growth is a foundational principle for lean manufacturing sites. In their perspective, it would be impossible to achieve a Golden Batch without a mature investigations process… This perception of a negative metric within the GXP community, combined with the rewards that come with the Golden Batch, are a recipe for disaster in sites that have not yet set foot on FDA’s QMM ladder. These sites may skip the hard part (continuous improvement over months/years) that is an absolute prerequisite to achieve the Golden Batch. Anyone can achieve a Golden Batch (on paper), but does it really meet the spirit within the lean mindset?
Pete
