GSABC JOURNAL OF BLOOD SERVICES

Six Sigma culture as a management principle

Roxanne M. Tata and Gwen D. Jones

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n August 2007, our organization implemented the Six Sigma methodology to optimize current processes and production, increase viable units of red blood cells, and assist in overall efciencies and driving cost containment. Therefore, Six Sigma projects were chartered in recruitment, collections, component manufacturing, and distribution. During the implementation phase of the methodology, our management staff was refocused to drive accountability to sustain project results and use data to drive decisions in their respective departments. Managing during the economic downturn proved this to be an even more appropriate management decision. Six Sigma has proved to be the stabilizing factor in assuring that our leadership team has improved critical thinking skills necessary to continue to drive our organization forward in meeting strategic objectives. To ensure a dened culture change in our management team, each department head, with the responsibility of complex decision making and prot and loss accountability, was required to become either a Process Ownerthe individual who is responsible for process performance and resources and who provides support, resources, and functional expertise to Six Sigma projectsor a certied Green BeltSix Sigma Green Belts are part-time practitioners in process improvement; they lead small project teams to address problems using the Six Sigma methodology.

several key factors to promote a continuous Six Sigma culture. As reinforcement, Six Sigma is one of the strategic initiatives in our organization. The Six Sigma principles have become how we do business on a daily basis and are known to us as a part of our DNA. Including Six Sigma as part of our strategic plan ensures that the Six Sigma commitment remains present, highly visible, and is promoted throughout the organization.

Resistance to change
Like any new program, there will be employees and process owners who believe things are Fine just as they are, We have always done it this way, and It will never workwe tried that before when you start to role out Six Sigma. The divine beauty of Six Sigma is that data do not lie; it is based on exactness, so one has undisputable data and the opportunity to truly understand it to drive decision making.

Listening to past mistakes

Equally important is to allow discussion of what happened in the past. Oftentimes, without total commitment from the organization, a department head or a process owner encounters an uphill battle in implementing a needed change. With pilot data from a Six Sigma project, all process owners from staff to management are able to realistically see the impact of change, no matter how small. When applying Six Sigma principles and uncovering process defects, it is not unusual for a department head to state, Why didnt I see this before?

PROMOTING THE SIX SIGMA CULTURE

Getting onboard
The Chief Operating Ofcer (COO) acts as advocate, mentor, and a coach. The COO ensures management of
From the Department of Operations, LifeSource Chicagolands Blood Center; and Department of Process Improvement, Institute for Transfusion Medicine, Rosemont, Illinois. Address reprint requests to: Gwen D. Jones, Department of Process Improvement, Institute for Transfusion Medicine, 5505 Pearl Street, Rosemont, IL 60025; e-mail: gjones@itxm.org. Received for publication March 25, 2010; revision received October 13, 2010; and accepted December 8, 2010. doi: 10.1111/j.1537-2995.2011.03220.x TRANSFUSION 2011;51:1604-1608. 1604 JBSM Volume 51, July 2011

Highlights improved productivity

The COO has the responsibility to champion the communication in terms of project performance at all levels both internally and externally. Department heads see real live value in improved productivity leading to enhanced processes. As productivity improves, line staff is as equally engaged and proud of improved metrics.

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Encouraging overall awareness

Through a walking the walk approach, the COO continuously provides the needed level of awareness for the Six Sigma program. Once staff has experienced the difference Six Sigma makes, the culture change is contagious.

ROLES AND RESPONSIBILITIES

Key factors
The successful implementation of Six Sigma depends on the people who play key roles and assume the responsibilities for ensuring all barriers are removed, and that a clear and concise signal of support for the Black Belt is strongly communicated. Key players should know what is expected of them and how all the roles work together toward the Six Sigma initiative. Each role has a clearly dened set of responsibilities outlined in the control and reaction plans. The COO (Project Champion) requires that each process owner maintains sustained measurement (Specication Limit) after the closure of a Six Sigma project.

focus on alternative solutions to provide better feedback led to improved trust among the team. Team participation and engagement resulted in changed behavior. A few of those mistakes were as follows: not ensuring a full understanding of how to utilize the control plan, misinterpretation of some of the elements in the control plan, and underutilization post-project closure of the control plan. We were able to identify our mistakes through the utilization of a robust communication plan, which will be discussed as you read further.

Denition
Communication PlanThe communication plan is a clearly dened plan outlining the frequency of reporting project results versus the project specication limit, and the communication of corrective action if the specication limit falls outside of range.

APPLYING SIX SIGMA PRINCIPLES IN OUR BLOOD CENTER OPERATIONS

Six Sigma projects
1) Automated Red Blood Cell (RBC) (2R) Loss Rate Reduction. Problem Statement: Average 2R loss rate in FY07 was 8.5%. Objective: Reduce average 2R loss rate from 8.5% to 4.0%. Current Results: 2R average loss rate = 2.3%. Hemoglobin Deferral Rate Reduction. Problem Statement: Average hemoglobin deferral rate in FY07 was 9.8%. Objective: Reduce hemoglobin deferral rate from 9.8% to 7.0%. Current Results: Hemoglobin deferral rate = 6.2%. Component Optimization. Problem Statement: The number of units received to be manufactured into components versus what was actually manufactured into components represents lost opportunities to provide products to our customers. Objective: Improve manufacturing ability to create components from suitable units for further manufacturing to meet daily voice of customer. Current Results: Increased overall component manufactured by 21% and ability to meet customer demand. Transportation Optimization. Problem Statement: Transportation was unable to deliver 2287 units from March 08 to Nov. 08 in a timely manner to optimize component manufacturing opportunities. Objective: Reduce time exceed units to ve units or less weekly. Current Results: Zero time exceed units weekly.

Denitions
Black BeltIndividual trained and certied in the Six Sigma methodology, analytical problem solving, and change management methods, and who leads a project of signicant value to completion.1 Project ChampionThe Project Champion is accountable for the results of projects and the business roadmap to achieve Six Sigma results within their span of control.1 Control PlanA detailed assessment and guide for maintaining control of the process characteristics and associated variables to ensure capability of meeting the established specication limit.1 Reaction PlanA plan written, whereas when not meeting the established specication limit, it directs to drilling down to root cause, contributing factors, and necessary corrective action to drive the process back in control. Specication (spec.) LimitThe bounds of acceptable performance for a characteristic.1 To sustain improvements post-project closure, there are three key factors that are driven by the process owner: DMAIC Principles and focuses. (DMAIC principles to be discussed as you read further.) Daily Accountability for sustainability. This includes line managers, supervisors, and staff. Ensure management Engagement.

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4)

MAINTAINING THE SIX SIGMA CULTURE

Staying onboard
Although mistakes and errors were made in the initial management of the control plan, consistent vigilance and

DMAIC APPLICATION
There are ve phases of Six Sigma, known in short as DMAIC (duh-may-ick). DMAIC is a component of the Six Sigma methodology that is used to improve processes by
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eliminating defects, which certainly have applicability in blood center operations. The DMAIC term means dene, measure, analyze, improve, and control (Six Sigma Academy). DMAIC means: Deneset the context and objectives for the project; Measureprocess inputs (x) that may affect the output (y); Analyzestudy x to determine how, why, and to what degree they have an impact on your goal/output (y); Improveidentication and implementation of statistically validated improvements; Controlclearly dened, robust, and implemented plan to sustain success.

method and technician skills may vary, the concept is to identify the best possible vein for venipuncture (Fig. 2). A pilot study using the VRS was conducted over a 3-month period. Pilot groups included a community donor center (CDC), as well as a mobile environment. At the CDC, there was a 3.5% improvement, and the mobile pilot yielded a 4.1% improvement. Utilizing statistical tools, such as a capability analysis and a two sample t test, we compared baseline data (pre-) with pilot results (post) that showed a statistical signicant difference in pre-/ postresults minimizing defects and improving our automated collection loss rate.

What happens in the Dene/Measure phase?

The rst project chartered at our blood center was the Automated Double Red Blood Cell collection (2R) process. We decided to use the DMAIC principle to reduce controllable 2R losses.

Control phase
The Control phase is the last step in DMAIC. A control plan is written to assist in controlling the process to sustain your gain long term. The project improvements were nailed down in the control plan and fully implemented in collections. Once the improvements were implemented, the process owner signed off on the control plan and assumed full responsibility for sustaining the gain from statistically validate pilot results. Although the control plan captures all pertinent steps to sustain the process, continued measurement and analysis are warranted to keep the process on track and free of defects outside of the specication limits.

Dene/Measure phase
It is important to dene specic goals to be in alignment with the voice of the customer, as well as the voice of the business. In building the project charter, we determined the problem statement, project metric, and the project objective. To measure if defects are reduced in the improve phase, the 2R loss rate was established as the project baseline. Our baseline data revealed that our 2R controllable loss rate was 8.5% (output). In the absence of an industry standard for an automated collection loss rate, we reviewed historical data to evaluate improvement opportunities that would yield an output aligned with RBC demand, thus setting our objective at 4.5%. A project team was identied consisting of automated collections process experts, and the 2R process was mapped out (Fig. 1).

NOT MEETING PROJECT SPECIFICATION LIMIT

It happens
There are a variety of reasons a project specication limit is not met. It could be that the control plan was not followed precisely as written. Maybe the control plan was followed, the project still fell out of range, but the reaction plan was not utilized to drill down to root cause in which to correct the problem. Although there are many reasons a project could fall out of its expected range, there are steps taken to bring a project back in control.

Analyze/Improve phase
Utilizing the Cause and Effects matrix and Failure Mode and Effects Analysis, we determined relationships and the factors of cause for defects in our automated collections process. Those tools revealed that one of the most critical steps (x) in our 2R process was improper vein selection for venipuncture contributing to an unsuccessful collection and resulting in what is known as Quantity Not Sufcient. In drilling down further, we found that we did not have a training plan nor conducted any training in phlebotomy specic to vein selection and/or the anatomy of the vein to support proper vein selection. As a result of using the aforementioned tools, the team had a better understanding of how to x the problem. The team piloted a vein rating system (VRS). Using this system, the staff is required to check each vein in each arm, applying a 1, 2, or 3 rating based on the anatomy of the vein (depth, location, size, and stability of vein), with a rating of 1 being the best rating and 3 being the most difcult rating. Although this is a subjective
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Steps taken
Project results falling outside of the agreed upon specication limit warrants clear and concise actions outlined in the control and reaction plans directing the investigation, research, and correction of the root cause of specication limit variance (Fig. 3). In the control phase, you will have already determined your process inputs (x) that are affecting the output (y), implemented statistically validated improvements, and written a control plan to sustain your gain. The control plan outlines the project focus, the specication requirements, method of measurement, who is responsible for measuring, frequency of measurement, where recorded, and corrective action.

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Fig. 1. ALYX process map. Y = reduction of ALYX loss rate. ALYX = double RBC collection instrument.

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orous communication plan to report on project results. Each person responsible for reporting on his/her project reports the following: Prior months results versus specication limit; Corrective action if specication limit falls outside of range and lessons learned Necessary support needed to meet specication limit; and Follow up actions if warranted.

Fig. 2. Using the vein rating system.

The monthly communication meeting is very interactive, includes peer exchange of best practices, and is also a way for process owners to take pride in sustaining the gain for their project(s) long term. The thought is whod want to report that theyre making an F on their report card? Even more so, it has become very competitive to be a process owner with a track record of meeting project specication each month. To ensure that this is the case, should the process owners have a concern regarding project results mid month, the process owner schedules a meeting with the resident Black Belt to ensure that all variables are identied and addressed to meet the specication limit at the end of the month.

SIX SIGMA BENEFITS

The benets of implementing a successful Six Sigma program and establishing a Six Sigma culture are plentiful. However, it does not matter how many benets are derived from projects; constant reinforcement, encouragement, and collaboration are warranted to maintain that culture. Currently, we have closed ve Black Belt projects and 11 Green Belt projects since April 2008 with an estimated impact of over 62,612 units. As important as the units and dollars, the demonstration of signicant improvement and sustained results has empowered the management team to continue to look for new ways to teach the benets of Six Sigma as a management strengthening tool. True process change is now the goal of each project. The management team feels empowered to challenge the status quo and relies on the success of our Six Sigma program and process owners to help them feel comfortable with the next project. Over time, an organization is able to shift its way of thinking and change that paradigm, making the presence of defects no longer acceptable.
CONFLICT OF INTEREST

Fig. 3. Steps taken when specication limits are not met.

When the control plan is used in the appropriate manner and the project specication limit is still out of range, the process owner then uses the reaction plan. The reaction plan is utilized to drill down to the root cause of a problem and corrective action to x the problem. Directions in a reaction plan are derived from how the resident Black Belt/Green Belt reacted and tweaked the process during pilot to yield statistical signicant results. Simply, the reaction plan consists of actions taken while in the analyze and improve phases of the Six Sigma project.

REPORTING MONTHLY PROJECT RESULTS

There are no conicts of interest.

Six Sigma project visibility

Department heads and designated staff meet with the COO each month to review the prior months project results and resolve any outstanding issues by using a rig-

REFERENCE
1. Brue G. Six Sigma for Managers (BriefCaseBooks).

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