Lean Is the Cornerstone of Quality

Mark Crawford

Eliminating waste in a process is essential for reducing complexity, lowering risk, increase productivity, improving quality, and reducing overall costs—savings that can be passed on to the client through lower pricing. A simpler, more streamlined process also makes reproducibility and validation easier.

There are lots of ways to tackle quality improvement, including monitoring equipment and software. But one of the easiest and least-expensive ways to improve quality and reduce risk is value stream mapping (VSM), one of the key principles of lean manufacturing. In fact, VSM is so simple it just requires a pencil and a piece of paper.

If you aren’t really up on lean and value stream mapping, you’re not alone; many companies in a variety of manufacturing industries, including medical devices, are just catching on to this proven, highly-effective system that the automotive industry has used for decades.

According to the Lean Enterprise Institute (www.lean.org), the five-step thought process for guiding the implementation of lean techniques is:

  1. Specify value from the standpoint of the end customer by product family.
  2. Identify all the steps in the value stream for each product family, eliminating whenever possible those steps that do not create value.
  3. Make the value-creating steps occur in tight sequence so the product will flow smoothly toward the customer.
  4. As flow is introduced, let customers pull value from the next upstream activity.
  5. As value is specified, value streams are identified, wasted steps are removed, and flow and pull are introduced, begin the process again and continue it until a state of perfection is reached in which perfect value is created with no waste.

Value stream mapping is a good way to give lean a test run. This pencil-and-paper exercise identifies all the actions that take a product through any process. Although it is intended for manufacturing and production, VSM can be applied to any process, including procurement, HR, administration, delivery, customer service, and vehicle maintenance. A process is a process, whether it’s in a factory or a professional office building. Typically every process has some element of waste—eliminating waste from all the processes that drive a business adds up to significant overall savings.

The idea behind VSM is to draw, on one page, a “map” of the flow of material/product through the process, and then identify ways to eliminate the unnecessary steps and waste that suddenly become apparent. Going through this exercise also invariably results in a better understanding of the entire business operation.

Value stream mapping is just the first step of an on-going lean experience. Lean never ends—ideally it becomes part of the corporate culture, a process, a way of thinking. Most lean consultants agree that a process is not really lean until it has gone through at least seven periods of value-stream mapping.

One industry that is relatively new to lean is health care. Under extreme pressure to reduce costs, health care organizations have embraced lean initiatives and are generating impressive results. For example:

  • Surgical prep time reduced by 60% at Caldwell Memorial Hospital in Lenoir, NC
  • Royal Bolton Hospital in the UK reduced turnaround time for blood test results from two days to 40 minutes
  • Henry Ford Health System reduced the number of steps involved in producing test results from 35 to 24, so now 85% of test results are delivered within three hours of specimen arrival time
  • Quebec’s provincial health-care costs are projected to drop from 5.7% to 5% over the next three years because of lean
  • Barnes-Jewish Hospital has reduced door-to-needle delivery time for delivering clot-busting drugs for stroke victims from 60 minutes to 30 minutes
  • Two years of lean implementation at Miami Children’s Hospital resulted in $500,000 in recurring savings and $1 million in avoidable capital

Sometimes impressive gains can be seen within a matter of days of starting lean. Once employees get it, lean starts to snowball and lots of good ideas and advice are received. Every employee should be involved, which creates ownership of the changes and a deeper camaraderie develops for achieving these new goals.

A fully lean operation makes risk management and quality management systems less complicated, less costly, easier to manage, and simpler to validate. Lean can also be applied with equal success across the entire supply chain (and even cleaning out your garage!).

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 20 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.

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