News that AstraZeneca is looking to the automotive industry for advice on improving efficiency in its drug manufacturing operations reminds me of Ambrose Bierce's famous quip, "There is nothing new under the sun, but there are a lots of old things we don't know."
I cited Bierce back in early 2007 in an article I wrote for Bioprocess International entitled Lessons from the Auto Industry (click the link to download the PDF). In it, I advocated that biopharmaceutical firms could learn a lot of lessons inexpensively from the automobile industry's experiences. Concepts like "lean" and kaizen (continual improvement) are directly applicable to manufacturing, product development, and business support groups like Quality, Regulatory Affairs, IT, and Records Management.
Indeed, it was a year later, in 2008, when FDA officials like Kim Trautman and Deb Autor began to publicly encourage companies to adopt "continuous improvement" as a core component of good FDA compliance.
Examples of this lean, kaizen approach include FDA compliance process mapping, retention of the right records, a focus on electronic data integrity (as the goal as opposed to "computer validation"), cohesive compliance and quality programs, and so on - all strategies I've advocated (and consult on) for years.
If you're going to undertake your own lean project, here is the general outline I suggest you consider along with a few hard won tips:
- First, do a gap assessment - either yourself or through an independent, outside consultant. You may not want to do this as an actual mock FDA audit, but rather use the guise but make it more holistic, less QSIT-focused. You need to get the picture of gaps in your operations and how interwoven compliance is ... or isn't.
- Second, hold a process mapping workshop. Most people tends to do this as a stand-alone, "here's how you process map" training session. I think this is less valuable than dividing time between the basics and then applying it to your real-world. For instance, with clients, we'll spend 2-3 hours on "how to process map" and then we'll spend the rest of the day actually process mapping at least 2-3 of their current procedures (if you already have SOPs, then doing the process mapping is not only easier, but it will very, very quickly lead to improvements - it's a fantastic feeling to get such a quick ROI).
- Third, translate the process maps into actual SOPs - that can take a bit of work, but as you start to get in the swing of things, you'll see how much easier ... and more "followable" ... it makes your SOPs and policies.
A couple of further tips to consider:
- Try to keep your process maps at 20 steps or less - you want the map to fit on one page legibly (i.e., not 8 pt font)
- (I know this will upset the apple cart for some) This is not the time to tackle Six Sigma. It's so tempting but don't do this. Please. Here's what will happen: at best you'll dilute your efforts; at worst, you'll end up bogging down in an unintended, massive Six Sigma project. Reserve Six Sigma for your next big step - tackle that a year or two down the road when it's time to step up your lean game.
Good luck ... and get lean.
Are you ready?
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