Op Ex & Lean Six Sigma

The Visual Pharmaceutical Workplace

Imagine a highway system without signs and you’ll understand why so many drug manufacturing facilities fail to reach their potential. Visuality is key to achieving operational excellence.

By Gwendolyn Galsworth, President, Quality Methods International, Inc.

It’s no secret that the drug industry has one of the longest cycle times of any industry today. Judged by any of the usual metrics — Six Sigma (where manufacturers score an average of 2.5 out of 6) or OEE (where their average, outside of packaging, is 40 vs. a benchmark of 80) — drug makers have a long way to go before achieving the quality and the manufacturing efficiencies of, say, electronics or consumer goods manufacturers.

people can use colors to create a more effective workplace
Drug makers have much to learn about Visuality from other industries. Here, an apron developed by Lockheed Martin Aerospace assembler John Casey holds the tools and spare parts required for assembling an intake valve. This Visual invention incorporates color-coding and makes maximum use of existing architecture: The blue platform holds in place both the valve and the Visual mini systems.

Establishing a “Visual” workplace, where information is immediately accessible and part of the work process, is the foundation for improving efficiency. At too many GxP-compliant facilities, operators, mechanics, scientists and engineers waste hours each day looking for documentation, locating spare parts, tools or the right labels, moving from one part of the floor to another, or running error-prone equipment or processes.

The result? Longer changeovers, wasted time and rework, all of which can add up to millions of dollars in losses each year. You may already be familiar with 5S (see A 5S Primer, below) and Error Prevention, which are key parts of any Visual methodology. However, the Visual workplace goes far beyond these tool sets by establishing a culture of openness, alignment, and transparency even as it attacks errors and error-causing conditions.

This article will outline the requirements of a Visual workplace that will help you get started on developing a Visual work culture wherever you work, whether on a pharmaceutical production floor or packaging line, or in a quality control laboratory.

The road to excellence

In a truly effective workplace, information is so thoroughly infused into the environment that it has become an integral part of the work process. Consider any advanced highway system. At every step of the way, Visual information keeps the system functioning, helping drivers do the right thing, at the right time, in the right way, safely. And yet, drivers rarely give thought to this rich array of Visual devices, because the information has “become” the system. The fact that we take these Visual systems for granted is proof that they work.

A Visual workplace speaks to its workforce continually, telling employees how and when to use it properly, alerting them to where tools and materials are, at a glance, and warning them when processes are off-track. Because it explains itself, a Visual workplace engages the workforce, which makes the workplace self correcting. Visual organization reduces stress in the workplace, and empowers people who work there to be more “in control” of their work processes.

The building blocks of Visual thinking

Visual thinking is each employee’s ability to notice his or her own motion and the information deficits that trigger it, and eliminate both. Eight building blocks must be in place for this outcome to result:

  1. Missing answers to “information deficits" that are vital to accurate, complete and safe work. Seeking those missing answers can consume much of the work day.
  2. Six core questions: Where, What, When, Who (or which machine, tool or person), How Many, and How. Workplace Visuality installs answers into the physical work environment in the form of Visual devices and mini-systems.
  3. An understanding of motion, the chain of negative events that leads to “moving without working” (see Corporate Enemy Number One: Motion, below).
  4. A clear understanding of work, which may be defined as “moving and adding value” — or engaging in value-enhancing activity.

    Whereas work adds value, motion reduces it, blocks it or makes it impossible. Let’s say, for example, you need a spare part for the case packing machine, so you walk to the stockroom and look through several cabinets in order to find it. All three of these activities are examples of motion — two of them can probably be completely eliminated through Visual devices, and the third (the need for the spare part) can probably be reduced through them as well.
  5. A motion metric that shows how much time you spend away from your value field, or the location where value is added. Start collecting data for this metric. Get a stopwatch and just click it on as you walk away and click it off when you get back. At the end of the day, have you racked up an hour away from your value field — or is it 2.5 hours? Or use a pedometer and put it on your belt each time you leave your value field and see how far you travel during the course of any day. You are in for a surprise.

    And it’s not just you, it’s every one around you. Information deficits rule our days and eat up corporate profits — in every department, and even the board room. Noticing motion and determining its sources opens up a doorway to Visuality. Once you find the missing answer, you can translate that into a Visual device.
  6. Answers to the two unanswered questions for every process or procedure:

  7. What do I need to know? What information do I need in order to do my work?

  8. What do I need to share? What information do I have for others to do their work?
  9. Creating an I-driven environment. Notice that the two basic questions are anchored in “I” rather than “we.” The Visual workplace links each individual with his or her own information deficits and therefore puts him or her in charge of creating a Visual answer to them.

    Activate these building blocks of Visual thinking and you create a work environment that is self-ordering, self-explaining, self-regulating, and self-improving where what is supposed to happen does happen on time, every time, day or night, because of Visual devices.

    Once 1 through 7 are in place, you can move on to:
  10. Establishing technical standards (specifications, values, dimensions) and the step-by-step process by which they are achieved — standard operating procedures, or SOPs.
In a workforce of Visual thinkers, people apply these eight building blocks to invent Visual solutions regularly, as a usual part of the workday. When they do, they liberate information that used to be hidden and restricted to just a few. The result over time is an aligned and empowered workforce of continuous improvement.

A Visual blueprint: 5S and beyond

The journey to a fully-functioning Visual workplace crosses no less than five major levels of Visual information sharing. That process begins with preparing the physical environment to hold Visual information: clearing the clutter, making things clean and safe, and then designating a home for each item left in the area through a home address, and, if applicable, an ID label. In short, this means installing the Visual answer to the “where?” question. This is the work of what is commonly called 5S or workplace organization (see A 5S Primer, below).

Shown here, assembly instructions are color-coded based on subject and placed in a central location where they are easy to retrieve.

The next step is to implement Visual standards, displays, metrics, problem solving, and controls and pull systems, each a method that creates a given outcome. This system of methods culminates in the most refined Visual application: Visual guarantees or error-proofing, which is imbedding vital information so deeply in the process of work that it becomes the work itself. These poka yoke devices override personal choice, and prevent inadvertent individual error from inhibiting performance excellence. Consider the automatic loom invented by Toyota’s predecessor, Toyoda, which was designed to shut down automatically when a misfeed or other error occurred.

Where 5S imposes Visual order onto the floor, workbenches, cabinets, shelving, and tools, poka yoke demonstrates the mastery of cause on the attribute level, adeptly translating the tiniest performance requirement or specification into a mechanical or electronic device. Each device ensures that requirements will be met, repeatedly, flawlessly, whether or not the person performing the specific function wants them to be or not.

What to do?


There is much you can do in your own enterprise to reap the rewards of workplace Visuality:
  • Begin a 5S project, only instead of making it primarily about “clean and neat,” expand its scope to include Visual information sharing. Go beyond lines and labels. Make a point of challenging people to invent Visual solutions that answer their own need-to-know questions.

  • Support “I-driven responses,” unless you already have authentically empowered teams. Make it okay for people to invent things that do not require official sanction.

  • Challenge staff to find Visual answers to each of the six core questions. You will notice a new level of excitement and focus as people transform information deficits.

  • Track results. Watch your performance metrics! Introduce a new metric on employee engagement or Visual inventiveness and track that as well.
The learning process will take time. Be sure to factor overtime into your budget, or sanction operator time off for Visual efforts; and think of it as an investment in the future, rather than lost production time. People cannot improve processes and make product at the same time, so providing creative time is essential.

What benefits to expect


An investment in a Visual workplace can pay off in terms of improved throughput at 15% or better; a 30% increase is not uncommon. Duracell recently reported a 40% increase in productivity and quality, attributed directly to workplace Visuality. Just as importantly, people will be riveted on motion and the information deficits that trigger it. Suddenly, instead of 30 managers being needed for 300 direct employees, 330 employees will be responsible for themselves and for each other. Together, these individuals will spot abnormalities with ease and eliminate them with Visual solutions.

Implemented alone, Visual methodologies can accomplish huge improvements in both day-to-day performance and in strengthening, realigning — or even creating — a culture of systematic improvement. Yet they are best implemented with Lean. Just as a bird needs two wings to fly, a company needs both Visual and Lean if its journey to operational excellence is to be sustainable.



About the Author

Gwendolyn Galsworth, Ph.D. is founder and president of Quality Methods International, Inc. and the Visual-Lean Enterprise Institute. A Baldrige and Shingo prize examiner, she has been implementing, researching, and codifying the field of workplace Visuality for nearly 25 year. Dr. Galsworth is author of four books on the Visual approach, including her most recent, “Visual Workplace/Visual Thinking: Creating Enterprise Excellence through the Technologies of the Visual Workplace” (Visual-Lean Enterprise Press, 2005). The Visual-Lean Enterprise Institute, opening in January 2006, will train, license and certify companies in these technologies. More information can be found at www.Visualworkplace.com.


Corporate Enemy Number One: Motion

Motion is often misunderstood. Managers may mislabel as motion some important activities that build community, safety and personal comfort in the workplace. Below are some guidelines for determining what motion is and isn’t.

Motion

IS:

Motion IS NOT:

Searching Recounting Taking a break
Wandering Asking Going to lunch
Wondering Answering Calling home
Guessing Interrupting Going to the restroom
Checking Waiting Chatting with a friend
Rechecking Reworking  
Handling Retesting  
Rehandling Stopping  
Counting    

Whatever form it takes, though, motion indicates the presence of information deficits, and almost always looks like “business as usual,” resulting in the seven deadly wastes defined by the Toyota Management System: “making defects, delays, overprocessing, excessive motion on the plant floor, overproducing, making inventory WIP, material handling and missed opportunities.”

Information hoarders can exacerbate motion problems, forcing employees to hunt them down to obtain information they need.




A 5S Primer

5S has typically been translated from Japanese as: Sort (Seiri), Set in order (Seiton), Shine (Seiso), Standardize (Seiketsu) and Sustain (Shitsuke). A more helpful definition might be:

  • S1: Sort Through/Get rid of the junk.

  • S2: Shine/Make it clean (and look for ways to prevent dirt).

  • S3: Secure Safety/Make it safe (and look for ways to prevent risk).

  • S4: Select Locations/ Implement smart placement based on an accelerated flow.

  • S5: Set locations/Install automatic recoil — the Visual "where" — through borders, home addresses and ID labels.


Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.