NIKKISO CO., LTD.

Background

Urgent needs to improve conformity with strict domestic and overseas regulations,
to enhance quality and operational efficiency, and to visualize the production site

Since its establishment in 1953, NIKKISO has created markets as a pioneer in fields that require high expertise. It has explored harsh conditions under which no failure is tolerated and technically challenging areas, such as specialized industrial pumps, aviation parts made of carbon fiber reinforced plastic (CFRP), hemodialysis machines, and products that use Deep UV-LEDs, and the company has contributed to solving social issues by employing creative ideas and advanced technologies.

In 1969, NIKKISO made it possible to manufacture hemodialysis machines in Japan. The achievements made by its medical equipment business in tandem with the development of dialysis constitute the history of dialysis in Japan. The company holds a greater than 50% share in the hemodialysis machine market in Japan and operates its business worldwide. What is required to drive further growth in the medical equipment business is to improve conformity with domestic and overseas regulations, to enhance quality and operational efficiency, and to visualize the production site. Mr. Izumi Takayoshi, General Manager of the company's Kanazawa Plant Medical Factory, noted that departing from a paper culture was crucial for solving these important challenges.

"As this factory manufactures hemodialysis machines, it is necessary to store an enormous number of documents, such as manufacturing records and processes, and to strengthen traceability. It was difficult to meet the requirements imposed by strict regulations with conventional paper-based manufacturing operations. Utilization of IT is crucial for responding to global environmental changes in the dialysis business in a speedy, flexible manner. It was urgent for us to realize data-based manufacturing in order to enhance quality and operational efficiency as well as to visualize the production site by utilizing IT."

In 2016, NIKKISO began to consider the introduction of a manufacturing execution system (MES) that visualizes production site information and computerizes procedure manuals and records through digitization in order to transform the manufacturing that supports its dialysis business.

Key points for adoption

Focus on five points for selecting an MES product
including the minimization of development man-hours and a flexible production system

There were five key points for NIKKISO when selecting an MES product to solve its problems with paper-based manufacturing.

First was to minimize the development man-hours required to integrate with the backend system with the MES. "As we had already introduced SAP ERP, we selected SAP^® Manufacturing Execution (SAP ME) / SAP^® Manufacturing Integration and Intelligence (SAP MII), which is an SAP MES, as the first candidate from the perspective of reducing the development man-hours. In addition, manufacturing in coordination with manufacturing equipment and automated collection of inspection data were also advantages." (Mr. Sugimoto)

Second was to support variant configuration for flexible build-to-order and planned manufacturing in order to meet the different specifications required by medical institution customers. "Though there are standard models for hemodialysis machines, specifications vary depending on the customer's objective and system environment. The key point was whether the variant configuration that we had used thus far could be used in the system. We appreciate that the close coordination of SAP ERP and SAP ME, including masters, makes it possible to automatically select appropriate work procedure manuals and checklists for different specifications, and variant configuration can be achieved by following procedure manuals." (Mr. Sugimoto)

Third was to visualize the production site. "An advantage of SAP MII is that it can retrieve data from SAP ME and SAP ERP and visualize it in real time," said Mr. Miyawaki Kazuyoshi of the Global Information Management Department, who is in charge of the project management office (PMO).

Fourth was to prevent tampering with the electronic records. "SAP ME logs requests, including who accessed what at which dates and times, and permits only authorized people to make changes, thereby making it possible to prevent tampering," noted Mr. Haraguchi Akihiro, Project Manager, of the Molding Department.

Fifth was the efficient system introduction. "The key point was whether the standard functions of SAP ME were suitable for our tasks." (Mr. Haraguchi)

Benefits of the solution and future outlook

Standardized tasks as well as enhanced quality and productivity
Dramatic reduction in man-hours expected

In December 2019, the SAP^® Manufacturing Execution (SAP ME) / SAP^® Manufacturing Integration and Intelligence (SAP MII)-based manufacturing execution system went live for some products at the hemodialysis machine production site, where high quality is required. Mr. Nakao said that the workflows changed dramatically upon the transition from paper to digital. "At the production site, a task is carried out by following a procedure manual displayed on a tablet. Workers have to tap ‘Task completed' for each step; otherwise, they cannot proceed to the next task. In addition, we were able to standardize tasks by carrying out procedures appropriate for the various steps, thereby enhancing quality and productivity throughout the entire factory."

Mr. Nakao said that they were seeing progress with visualization of the production site, which has been a pending issue. "As supervisors and group leaders as well as workers at the production site can see the progress of tasks using tablets and submonitors, work decisions can be made swiftly depending on the site’s situation. In addition, we made it possible to visualize the production site for factory visitors by viewing a large monitor, which also serves to foster trust."

As digitization has made it possible to search for various items and to utilize needed information immediately, NIKKISO can now promptly confirm quality conditions and respond to customers inquiries. The company also expects a dramatic reduction in the number of man-hours thanks to the elimination of the need to prepare work procedure manuals and checklists as well as to post inspection data. In addition, the paperless system has helped to reclaim some space inside the factory.

Regarding future prospects, Mr. Izumi commented, "The complete application of SAP^® Manufacturing Execution (SAP ME) / SAP^® Manufacturing Integration and Intelligence (SAP MII) is yet to begin. We will also pursue ease of use by reflecting the production site’s opinions. In addition to improving the accuracy of procedure manuals, we are also considering means to convey procedures in an easier-to-understand manner by using 3D graphics and video. Further enhancing quality and strengthening improvement activities by utilizing accumulated data is another important topic. I expect Fujitsu to provide prompt support in close coordination with SAP, proactively make proposals that utilize SAP^® Manufacturing Execution (SAP ME) / SAP^® Manufacturing Integration and Intelligence (SAP MII) functions, and keep us up-to-date with the latest information, such as other companies' cases."

NIKKISO uses innovative technologies to create new value and solve social issues. Going forward, Fujitsu will continue to support NIKKISO's initiatives by utilizing its advanced technologies and comprehensive strengths.