For Blood / Biologics

What's in Your Toolbox?
Choosing the Right Tool for Quality Improvement
by Bonnie Messinger

Quality improvement tools are like any other tool set. Each basic tool has a brood of new and improved versions intended for increasingly specialized applications. A seasoned facilitator may have literally hundreds of tools at her disposal. However, finding a few basic favorites and learning them well is sufficient for most applications.

The most important question to ask when selecting a quality improvement tool is, “What am I trying to do? What is my purpose?” There are five fundamental purposes of an improvement team effort--break down, link together, build up, compare and innovate. For each purpose there are one or two basic tools that make those tasks simple.

The break-down step allows the team to examine and analyze all of the factors that are affecting the process under review. Two of the best tools for this task are the flow chart and the fishbone diagram. The basic flow chart is a highly versatile tool and is the springboard for many other improvement tools, such as the swim lane (deployment) flow chart, the Value Stream Map and a simulation model. The flow chart turns a process into a picture, using symbols for actions, delays, or decisions linked in sequential order by arrows. The starting step is the first point of control and the last step is the point where control is relinquished. To better manage a flow chart for a complex process, start with a high level flow chart. Find the most problematic step and flow chart that step first. It may be that addressing the variables in a single step will dramatically improve the entire process.


The fishbone is another break-down tool—again a stepping stone to a multitude of other improvement tools. With the fishbone, a team can discover and classify all possible causes of a single outcome, all possible “why’s” and “what if’s” for a single step in a process, or all the variables that could affect the performance of a whole process. Classifying the causes in this way shifts team focus from blame to discovery. Again, for a very complex problem, create a high-level fishbone and then apply the tool to each of the bones. Bring all the fishbones together to discover common causes.

Once the break down is complete, link-up tools help the team define and understand the relationships between the variables they have identified. The matrix is an all-around tool for exploring relationships. The basic, L-shaped matrix compares one set of data with one other set. From this simple matrix, a myriad of tools have grown—the C, X and T-shaped matrices, the House of Quality, the Quality Function Deployment matrix, the Is/Is Not matrix, and the Failure Modes and Effects matrix are the most common. The intersecting point between any two items in the lists is the judgment point and is denoted by a number or a symbol—is the relationship between these two items strong or weak, weighted or neutral, existing or not? Assigning numbers to intuition helps the team validate their judgment, but obtaining consensus on that number can be difficult. Arguments over the distinction can be avoided by using numbers that are clearly different (i.e. 1= weak, 5=neutral, 9=strong). Using symbols for relationships is another way to move from opinions to counts.

Understanding relationships makes the re-build process easier. The building process takes the pieces from the break-down process and puts them back together. The affinity diagram is a tool for “bringing together.” Team members sort items from lists, intuitively, into groups, building on the ideas of fellow team members. When the sorting is complete, the team names each group. The one cardinal rule of the affinity diagram is silence during the sorting step; discussion is encouraged during the naming step. The affinity diagram may be used to re-order or align the steps in a process or to bring order to the ideas generated in a brainstorm. The affinity diagram is best done with sticky notes and a large surface.

After a newly-designed process has been in place for a period of time, managers will want to know if anything has changed. The essential value of statistical analysis is answering that question with a fair degree of confidence. Even without an in-depth knowledge of statistics, a team can evaluate post-change performance with a few simple charts. The run chart plots continuous data over time. This is a good tool for establishing a baseline before any changes have been made. The team can determine if the process is stable and if the source of variation is “common cause” or “special cause.” The control chart is a run chart with upper and lower control limits added to the chart; it allows the team to clearly see when something changes. The bar graph compares related groups of data. A special type of bar graph, the Pareto chart, shows the rank order of these groups and helps the team focus their improvement efforts on the most significant causes. Another type of bar graph, the histogram, shows how groups of data are distributed across a range of measures. The scatter plot, evaluates the strength of the relationship between paired samples. Charts and graphs are the movie stars of the improvement tool kit—they show well to decision makers. If the data is accurate and the representation truthful, the charts and graphs will not lie—even if the team wants them to!

The final and most exciting task for the improvement team is innovation. Thought surprises are a source of delight; thus, this creative step is often playful. With the building blocks of process review behind them, the team is ready to unleash their creative energy. Harnessing this energy drives the team to completion. The brainstorm is a tool for eliciting and harnessing creative ideas without the tyranny of criticism, judgment and group-think. Usually, the brainstorm is truly a storm of ideas, but at times, the flow is a trickle. Seeding the storm with random words and encouraging radical ideas are ways to boost the flow to a torrent.

There are more tools in the process improvement tool box than one facilitator could use in a lifetime. However, a facilitator needs to master only a few of those to be successful. With a few modifications and a little creativity, these basic tools can be used for most improvement applications. Remember, the right tool will be the one that works.

Bonnie Messinger is the Quality Manager for ARUP Laboratories. She has worked for ARUP for over 25 years, the last 18 in Quality. Ms. Messinger administers ARUP’s quality management, improvement, and assurance programs; facilitates and trains teams seeking to optimize processes and lower error rates; and oversees the training of ARUP’s workforce on the tools and techniques of quality. Ms. Messinger is certified as a Healthcare Quality Professional and is an active member of the Clinical Laboratory Management Association and of the National Association for Healthcare Quality and its local chapter.

Read more about software tools available for quality improvement:

White Paper:
Achieving Quality Across the Global Manufacturing Network
Case Study:
Iowa Blood Type Q: One Pint Can Make a Difference


Click here to view all available resources.

FDA Link:

Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance http://www.fda.gov/cder/guidance/5815dft.htm

Additional Article:

"Cause & Effect Diagrams: Identifying the Likely Causes of Problems" http://www.mindtools.com/pages/article/newTMC_03.htm