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Lean Pharma: Is Your Company Missing the Big Picture?

Rachel Beavins Tracy
by Rachel Beavins Tracy on Thu, Dec 03, 2015


Lean Manufacturing, Six Sigma, Lean Sigma—all of these practices have the potential to create significant cost savings, increased efficiency and better performance overall. The problem is, many companies miss the big picture by focusing exclusively on elimination of waste, instead of examining how wasteful practices impact the bottom line.

So how can you tell if your company isn’t fully leveraging the power of Lean, and how can you tap into its full scope for better results? This post will talk about some of the areas companies commonly overlook, with tips on how to strengthen Lean practices in your organization.

Muda, Mura and Muri

Coined in 1990 by Toyota, Lean Manufacturing is typically defined as a systematic method for eliminating waste in manufacturing, delivering quality products at greater efficiency and lower cost.

The 7 wastes (or muda in Japanese) that Lean Manufacturing focuses on include:

  • Transportation: Moving product between locations isn’t something customers will pay more for, and it also risks damage to the product.
  • Inventory: Unused inventory represents an unnecessary capital outlay.
  • Motion: Excess movement of people or machines puts employees and product at risk.
  • Waiting: This includes whenever a product is waiting to be worked on.
  • Over-processing: Performing more work on a product, as well as using more expensive or complex parts than required, creates excess costs.
  • Over-production: One common example is large batch manufacturing, which in turn creates other wastes like excess inventory.
  • Defects: Rejected product increases costs in terms of labor, production and materials.

While working to eliminate the 7 wastes is a big step forward, focusing exclusively on muda ignores the categories of mura and muri, which are themselves underlying causes of muda.

Mura refers to unevenness in operations, such as when demand fluctuates or when organizations ramp up production to hit targets at the end of reporting periods (which are, essentially, arbitrary).

Muri represents the resulting overburden on the system and employees as they try to fill those orders, often setting aside those routine procedures that sustain long-term performance. Directly translated, muri means “unreasonableness,” such as the unreasonableness of expecting your staff to process more samples than is practical in a given timeframe. 

Now let’s look at how the pharmaceutical industry can better address not just muda, but also the mura and muri that contribute to waste.

What it Means for Pharma

Getting a handle on Lean principles isn’t as hard as it sounds when you consider that the goals are largely the same as the quality process. Of course, labs are different from auto manufacturing, meaning the solutions are sometimes applied differently.

I could get all technical on you and talk about different strategies like Heijunka, Kanban and Kaizen. Instead, I’ll keep it simple, framing it in terms of common quality management goals and activities.

Examples of key strategies to reduce both mura and muri include:

  • Consolidate Batches Where Possible: While you can’t always control a fluctuation in demand, you can seek to level out this unevenness (mura) by holding testing until an optimal batch size (or a must-start date for on-time delivery) is reached.
  • Standardize Your Processes: Standardizing SOPs through a well-defined Document Control program and thoughtful workflow design can help smooth out operational unevenness (mura), ensuring tasks are combined and staff time is used effectively. It also reduces muri by improving the reliability of processes and communication routes.
  • Improve Overall Equipment Effectiveness (OEE): This is the percentage of time equipment produces quality products at optimum speed, a metric that incorporates reduced production time from equipment failure, setup, idling, slowdowns and defects. Leveraging automated Calibration and Maintenance and Nonconformance Management tools within the GMP Compliance System is an ideal way to ensure your equipment isn’t creating mura.
  • Strengthen Employee Training Programs: A robust Employee Training program that includes periodic testing ensures everyone knows how to do their job effectively, meaning your staff can better handle fluctuations in workload (less waste from mura). It also reduces overburden (muri) due to unclear instructions or having employees execute processes they’re not fully trained on.

Ultimately, finding ways to smooth out process fluctuations and reduce overburden on your staff, equipment and processes will pay off, in some cases up to 5 times the cost of your efforts.

Remember, the goal is to improve flow and reduce waste. But you can’t just focus the end-points of waste—you also need to question whether their sources are rooted in your processes. Lean and Six Sigma have the potential to drive big cost savings throughout your supply chain. That is, if you get it right.

Competition in biotech shows no signs of slowing down anytime soon. Staying ahead of the pack requires strategic thinking, with a focus on establishing systems for reducing risk and ensuring quality. For some companies, it’s a big step, but it’s one that will pay off in the long run.

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Rachel Beavins Tracy
Rachel Tracy is a writer for ETQ with expertise in environmental, healthcare and technology topics. She has a master’s degree from Vanderbilt University and has been writing for businesses since 2008.
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