Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. The company’s Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide and commercial presence in roughly 70 countries. The company’s fiscal 2013 revenue totaled $2.2 billion.
Selecting the project
The proposed project focused on procedures for cleaning equipment
after one product was made and before employees could start manufacturing a
different product. The process was so time consuming and ineffective that it was
viewed as low-hanging fruit. “Any improvement in the process would shorten the
timeline and allow additional time for manufacture of actual product,” said Lead
Validation Engineer Cindy Duhigg, “which is profit rather than time
Video demonstration of a sprayball
(Gamajet spray machine)
Completing such an improvement project would achieve the following
organizational goals, key performance indicators, and deployment
- Significant cost savings
- 20 percent waste reduction/five years
- No negative audit findings
- 10 percent cost-of-poor-quality
- 20 percent increase in schedule
- 75 percent decrease in backorders
- Promote zero defect culture
Using quality tools to improve
The first step in developing an effective improvement strategy involved pinpointing issues in the current process. Some of the quality tools used to accomplish this task are highlighted in the table below. Of these tools, root-cause analysis identified key drivers for the first-time right issues and revealed a 62 percent cleanout failure rate the team needed to address.
|Quality tool used||What data was analyzed||How analysis was performed|
|Process map||Flow chart of entire process including cycle times||Visual observation to detect excessive complexity|
|Waste walk||Facility and process were observed during operation||Team documented areas of waste, prompted by a standardized form|
|Brainstorming||Group knowledge and experience||Team and technical subject-matter experts met to identify potential improvements|
|Benchmarking||Industry standards and practices||Subject-matter experts provided insight into most current solutions|
|Root-cause analysis||Process history and flowchart||Causal relationships between inputs and outputs identified|
Developing strategiesTo bring greater focus to possible improvement actions, three evaluation methods were used: value stream mapping, screening experiments, and benchmarking. The maps clarified the steps needed to achieve the project’s objectives. They also verified the location of the bottlenecks in the process and where non-value added waste was occurring, such as the time needed to clean out the tanks.
The value-stream mapping for the current process allowed the team to determine that an entirely new procedure was necessary to satisfy the project’s objectives. Team members developed a five-part strategy, which consisted of the following changes:
- Converting from a batch process where each tank was filled and dumped sequentially to a continuous process where tanks could be jet-sprayed with a tank cleaning machine (from Gamajet).
- Externalizing process tasks such as using a heat exchanger to provide hot water, instead of filling the tanks, then heating the entire volume; and draining the tanks continuously while cleaning, instead of having to wait until agitation was complete before draining.
- Separating sample collections.
- Utilizing other water sources.
- Standardizing the process, labeling the lines, and providing more detailed batch records.
Mallinckrodt Project Team
ResultsThe reduced change-over time helped the Mallinckrodt focus factory to introduce an additional product, not originally produced on this line. This added $700,000 in increased absorption, or new product manufactured.
The results had a direct impact on organizational goals as the improvements reduced the number of cleaning failures nearly to zero, eliminating as many as two to three cleaning reworks per month. The project goal of promoting a zero-defect culture with a first-time right measure of 100 percent was reached, showing a 62 percent improvement. Also, nearly $2 million in backorders were completely eliminated at this focus factory.