Jan Wijand certified as lean six sigma green belt
This summer, Sr. Consultant Jan Wijand finalized his lean six sigma green belt certification project. For his customer and with his team, Jan reduced the relative number of rush changes within a secondary packaging department from 58% to 35% using lean six sigma DMAIC methodology. Jan made a dashboard to visualize the workload. Furthermore, the process for requesting and preparing for changes has been improved. New standards have been agreed with stakeholders within Operations, Engineering and Quality. Although the project is finished, the performance will be monitored to further decrease rush changes.
Why is it important to minimize rush changes in packaging?
In packaging operations within the pharma industry, changes require documented verification to make sure the change does not lead to a process or product that does not meet expectations. Changes to equipment or packaging configurations can be categorized as planned or unplanned.
- Planned changes are, well…, planned. All activities are planned. You prepare for the change to be executed. You have written a test protocol, have it approved in time, requested downtime for executing the test, requested test material and it is available when the change needs to be tested. You have planned time for changes in setup sheets and SOP’s and you have planned for the approval for the executed test protocol. Maybe operators / technicians need to be trained, which you have also accounted time for in your plan. When executed as planned, these changes should not lead to delays in supply.
- Unplanned changes usually happen to you. These are unexpected and cause delay in operations and supply. These changes are usually caused by a piece of equipment that fails or a component that does not meet requirements. Sometimes, the organization or the customer cause an unplanned change to surface overnight. We would like to prevent unplanned changes at all times.
Sometimes planned changes are impacted by organizational issues and can behave as unplanned changes. Too much work entering the funnel, incomplete or incorrect information, lack of resources, no prioritization lead to extended lead times for writing, pre-approving, executing or post approving the change. Both technical failures or organization issues result in rush changes. Rush changes will lead to disruption in the stability of the packaging process.
Why? Most packaging operations work with rhythm wheels and a frozen time fence. A rhythm wheel means that packaging configurations are packed in a defined sequence to reduce downtime (change overs, cleaning) on the packaging line. A frozen time fence is an agreed time period on the planning horizon. Within the frozen time fence the plan should not be changed to prevent disruption within operations and other functions of the organization. By default, rush changes disrupt the packaging plan. If a rush change is forced into the frozen time fence, it will cause all sorts of waste: rework for the warehouse (order picking), operations (changes in setup times / cleaning), planning (schedule may no longer adhere to rhythm wheel), quality release and possibly an unhappy downstream partner or – worse – the patient.
Planning time fences
By default, rush changes disrupt the packaging plan. If a rush change is forced into the frozen time fence, it will cause all sorts of waste: rework for the warehouse (order picking), operations (changes in setup times / cleaning), planning (schedule may no longer adhere to rhythm wheel), quality release and possibly an unhappy downstream partner or – worse – the patient.
Jan followed the lean six sigma DMAIC (Define-Measure-Analyze-Improve-Control) methodology to improve the process. The diagram shows the major activities carried out during this project. An important step in the measurement phase is to agree an objective measurement of the current state performance (big Y). If this is not done correctly, we cannot measure our process improvements. Within this improvement project, a rush change is defined as a change that needs to be executed within 10 working days after the change has been initiated. The current state performance was measured for all change documents from 2020 by calculating lead times from the initial creation date and last modification date of the document.
The change request and approval process was improved by the project team. A pilot was run to see if the new process would result in fewer rush changes. After confirmation, the new process was implemented and shared with the local sponsors. New responsibilities were agreed and documented. Performance indicators were defined and are monitored frequently. In 2021, the relative number of rush changes was reduced to 35% YTD, where this number was 58% in 2020. By decreasing the relative number of rush changes, the stability of the packaging plan is increased.
With this result, Jan was certified for his greenbelt by his mentor Remco Massaar from the Lean Six Sigma Groep. Jan will now proceed with his next improvement project, which will help him certify as lean six sigma black belt. Congratulations on this achievement, Jan!
How can we help you?
Progress-PME has multiple experienced greenbelt and blackbelt improvement specialists on board. Do you want to know more of our lean six sigma services? Our team likes to put their knowledge and skills at work in order te help you and your organization. Let us know and we are more than happy to help.