How to Achieve Zero Retained Foreign Objects with DMAIC Part V

Over the past several issues we've discussed the Define, Measure, Analyze and Improve phases in achieving zero retained foreign objects. In this article, we will examine the critical but often overlooked fifth step in the Six Sigma DMAIC process, the Control phase.

The Control Phase of the Six Sigma DMAIC Model

In the Control phase, the project is transitioned from the Six Sigma project team to the operational owner. For the transition to be smooth and successful, the Six Sigma project team has to ensure that checks and balances are built in the process to sustain the gains. The project team needs to work closely with the operational owner to develop the control plan. The control plan identifies the what (what needs to be monitored, what is reported), who (who does the monitoring, reporting), how (how often, how to monitor such as sampling method, analysis, interpretation guidelines) and when (frequency of monitoring, hourly, daily, monthly, etc.). The Six Sigma project team should also include the what if (what are the reaction plans when things are not in control, who will execute the reaction plans, where to find the related documents, etc.).

One can imagine the resistance to taking ownership of the process, if the operational owner is brought into the picture in the Control phase. The operational owner will be hard pressed to take accountability for a process that he/she is not familiar with and will assume the gains made are not sustainable once the Six Sigma project team disengages. Hence, it is very important to identify the operational owner earlier in the process (Define, Measure, Analyze or Improve phases). This will give the team credibility with the operational owner and also addresses the concerns earlier in the process (eliciting the Voice of the Customer upfront).

The Six Sigma project team utilizes the Control phase to debrief what worked well, to show what could be done differently for future projects and to make recommendations for next steps (i.e. Six Sigma DMAIC projects that were out of scope for this project, but would be the logical next steps). If the Improve phase was to test a hypothesis in a small scale (pilot) then the next steps would be to roll it out throughout the department, division, company or enterprise. This would require project management skills; and a project manager is appropriate as the operational owner in this scenario.

The Six Sigma project team should not overlook some of these additional key deliverables before closing out the project. The team should validate the savings/improvements made, quantify the gap between the goal of the project and the results (met expectations, or if partially met expectations, what prevented the team in accomplishing goals), sharing of the knowledge gained and celebrate the success of the project. By closing out the project, the Six Sigma project team members can successful disengage from managing the project day-to-day and take on new projects. Often teams fail to do this and take additional Six Sigma projects without fully disengaging from previous projects, thus impending subsequent projects’ progress.


Tools common to the Control phase include Pareto charts (to show the difference between pre- and post-implementation improvements), control charts (to detect if process is meeting specifications), process capability (to verify new process), control plans (to define operational range, reaction plans, monitoring frequency), training for new process (to develop training materials, format, frequency, intended audience, validation of knowledge transfer) and gap analysis (to validate the new process and quantify how far from ideal process, for future continuous improvements).

The Control Phase of the Retained Foreign Objects Project at the Mayo Clinic

For the retained foreign objects project, the team identified the operational owners in the Define phase. The operational ownership was transferred to the surgical committee. The metrics implemented included days since last retained foreign objects posters in the hospitals, notification of events or near misses to all surgical staff within 24 hours and control charts using a G-chart to monitor if the number of events occurring was outside of control limits. The team also developed a training program for new staff and easy to use templates (decision tree) for incorrect counts in the OR. Recommendations made included piloting new technological aids to help with the counting process and streamlining the policies and procedures across all the sites.

The results were presented at the American College of Surgeons conference, Mayo Quality Conference and published in the Joint Commission’s Journal. The team members’ contribution was recognized with the Excellence Through Teamwork Award in 2009.

Summarizing the Control Phase of the Six Sigma DMAIC Model

To summarize, in the Control phase the project team should be able to "bank" the gains by identifying the operational owner, developing control plans, making reaction plans when process is out of control, developing training procedures and making recommendations for next steps. Teams should disseminate the knowledge internally and externally as appropriate, debrief on lessons learned and celebrate the successes.