How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles


Life sciences manufacturing in 2019 is a dynamic, immensely competitive space in which new markets, ever-changing regulations and exponentially evolving technologies require the C-suite to look for ways to reduce overhead and create greater efficiencies on the shop floor. This imperative means looking for opportunities to improve levels of quality and harnessing new technological tools that will reduce delays and waste, speed up production processes, and help companies achieve greater ROI.  The implementation of greater efficiencies and more effective, faster processes on the shop floor translate directly to the continued solvency and profitability of your organization.

Years ago, when I was a manufacturing manager with medical device maker Danaher, I found that adapting to changes on the shop floor is a situational imperative and a critical part of production. There are specific goals executives and managers are trying to hit each year, but the overarching objective is to continuously improve product quality and the experience of the customer.

A key method manufacturing leaders use to keep operations tight is lean, the systematic school of thought for waste minimization in manufacturing processes that doesn’t sacrifice productivity. Based largely on the Toyota Production System, lean techniques can help manufacturers achieve gains through the reduction of non-value-added activities and costs.1

Lean Manufacturing Principles

Five primary concepts comprise the leading principles typically associated with 1990’s “The Machine That Changed the World”2:

  1. Specify value as perceived by the customer: Not just on the product you provide but the customers’ needs and wants.
  2. Identify the value stream: Rather than thinking in terms of departments, visualize the value stream as an interconnected flow of processes that derive value.
  3. Make the value flow through the value stream: Prioritize value-adding steps ahead of non-value adding steps.
  4. Pull the value from the value stream: Avoid inventory management waste by employing a single-piece flow to produce product on demand.
  5. Strive for perfection: The goal isn’t to surpass the competition in improvement but continuous improvement in all facets of your organization.

Based on a 2017 case study of Johnson Controls, a global electronic and HVAC component manufacturer, the comparative benefits of implementing lean production measures can be a game-changer.3 As a result of implementing lean production practices, the company experienced:

  • 22 percent reduction in safety affordable incidents;
  • 12 percent improvement in quality;
  • 68 percent improvement in employee retention;
  • A tripling of its energy savings; and
  • Exceeded target improvement in year-over-year conversion costs by 700 percent.

A manufacturer can reap significant benefits from lean practices, including waste reduction and increasing value-added production by upgrading equipment, training employees and implementing more efficient processes.

Lean and Technology: Upping the Ante

Yet for all the benefit that lean offers manufacturers, a lean program can only be as efficient and valuable as a company’s data management system. A manufacturer that relies on a manual paper-based or hybrid document manage is prone to systemic errors and delays stemming from incomplete, missing or unstructured documents.  For the life sciences or similarly regulated manufacturing, that translates into inefficient batch record processes, data tracking that can result in shipment delays, product quality issues and incompatible systems.

But manufacturers still must keep track of the batch paperwork, which necessitates extra time for operators to manually write deviations or nonconformances or physically walking a traveler to a shop floor computer to enter production information. In short, the product is complete but can’t be shipped because the paperwork is incomplete.

Contrast that with a fully digital, software-based document management system for your data, documentation, signatures and communications that breaks down silos, drives efficiencies and improves levels of quality and control. Along the same lines, a digital production records solution gives a manufacturer the ability for real-time batch record form validation, quality reporting and corrective action potential.

Manufacturers that pair an automated and integrated document control system with a lean production program can eliminate greater amounts of waste and experience much higher levels of quality than they otherwise could with the limitations of a paper-based system. To find out for yourself how much of an impact a digital production records solution could have on your company, try out this  ROI calculator for production record efficiency.

But despite all the investment and effort required on the lean journey, it’s surprising how many companies stop short of the end goal by failing to make the digital transformation.

Complementary Efficiencies: Lean and Digital

I identified the following key lean principles through which a manufacturer’s operational effectiveness can be significantly amplified when processed in a digital documentation system:

  1. Eliminating waste: Where many manufacturers still depend on paper-based systems to manually track critical production information, implementing lean measures remains problematic, time consuming and costly.

    For example, if you’re seeking to reduce the number of steps required by an operator to access a part needed in production or the time it takes to access a tool, employees must track down the correct paperwork and production records. A manufacturer can eliminate a much greater amount of waste by capturing production information digitally in real time with a system that automatically verifies accuracy and completeness of documents. The data is stored and readily available from a single access point for analysis and decision-making by stakeholders and managers.

  2. Just in Time (JIT): A form of lean production and a logistics method of inventory control.4 It’s a system of customer-based manufacturing on demand: what the customer wants, in the quantity the customer wants and when she wants it. The reduction or elimination of buffers or inventory is possible with JIT, and allows the use of delivered components within minutes of their arrival.

    However, a manual data system means that data is difficult to track and verify with the result being that product ends up sitting on the shipping dock awaiting the correct documentation rather than on its way to customers. Automation allows a manufacturer to review batches in minutes instead of weeks while simultaneously decreasing the amount of carried inventory to maintain short lead times and more on-time deliveries.

  3. Poka-yoke: A Japanese term that means to dummy proof your processes so that neither a production operator (nor a customer) will make a mistake. This data can include a range of critical information, including equipment calibration dates, tolerance measures, pass-fail qualification, etc.

            Using an electronic data capture ensures that operators follow the correct SOPs and processes   every time. A digital solution can also confirm that operators are trained and qualified to   upload product data into the system.

  4. Andon cord: Another term derived from the Toyota Production System, it refers to alerting shop floor managers and operators about production problems in real time for immediate corrective action and root-cause analysis. Initially, there was an actual cord that workers could pull to halt work.

Though employees may no longer pull a physical Andon cord, the lean concept remains that workers retain the ability to stop production when they don’t believe that quality measures are being met.

Manufacturers can create a quality environment and empower all employees to do their best work when combining the Andon cord principle and an automated data system. That’s because an electronic system requires operators to follow each step in the manufacturing process to the letter and won’t let them advance until each step is complete. The system can monitor progress and provide operators and managers the visibility to know that quality is being met.


In summary, lean manufacturing principles can only get a manufacturing organization using a legacy data system so far. To fully maximize the benefits of lean that can lead to greater ROI, manufacturers will need to invest in the digital transformation and take active steps not only to upgrade to an automated data solution, but also introduce a companywide culture where everyone contributes to improving quality and reducing waste.   

To learn more about how a digital production records solution could reduce delays and deviations and speed up production on your shop floor, read the free white paper “21st Century Manufacturing: An investment in Digital Data and Operational Efficiency” and try out the MasterControl Manufacturing Excellence ROI calculator to see how much production record times savings a digital solution could have.




Dave Edwards brings more than two decades of manufacturing, general business management, sales and customer service experience to MasterControl, a leading global provider of software solutions that enable life science and other regulated companies to deliver life-changing products to more people sooner. Edwards most recently served as the Chief Operating Officer at 3form, a leading manufacturer of translucent building materials in the architecture and design industry. Prior to 3form, he worked at Danaher Corp., a Fortune 500 manufacturing conglomerate, and at TenFold Corp., an enterprise software company. Edwards holds an MBA from Harvard Business School and a bachelor’s degree in economics from the University of Utah.

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