by Janet Jacobsen
The cleaning procedure at Mallinckrodt Pharmaceuticals’ salts facility in St. Louis, Mo., was hindered by significant bottlenecks. The fill, boil, and drain method, used to clean the five 2,000-gallon production tanks, was highly inefficient, resulting in rework and reducing capacity.
In fact, production in this building had been on back order for more than a year; with an average change-over time between products of nearly three days, and a clean-out failure rate over 50 percent.
Company leaders set out to identify ways to improve the efficiency of the process.
-A team-based Lean Six Sigma project aimed to reduce equipment cleaning time.
-Using a variety of quality tools, including process mapping, brainstorming, and root-cause analysis, the team created a new cleaning procedure.
-Meeting all objectives, the project resulted in significant annual cost savings for the company.
Download the entire case study (PDF) or continue reading below for project highlights.
The ASQ case study collection contains more than 1,700 examples of quality solutions to real-world problems. Find other case studies in the manufacturing industry to learn about how organizations around the world are using quality tools and approaches to improve processes, save money and drive revenue, and increase customer satisfaction.
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.
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 wasted.”
Video demonstration of a sprayball (Gamajet spray machine)
Completing such an improvement project would achieve the following organizational goals, key performance indicators, and deployment strategies:
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|
To 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:
Screening experiments for different tank cleaning machines plotted the cleaning efficacy against time to determine whether a specific sprayball could achieve the required objectives. The data collected from these experiments prompted the purchase of multiple sprayballs and manways (used to access the tanks). Finally, benchmarking activities allowed team members to learn about past successes to create a foundation for determining the best solutions to decrease the clean-out cycle time.
Mallinckrodt Project Team
The 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.
(0) Member Reviews