Case: Nypro

Plastics Manufacturer Can Save U.S.$8 Million with Global Data Solution

Global plastics manufacturer Nypro has 37 plants in 17 countries. Until recently, each plant used its own application to capture product quality control information. Michael Kilday, Corporate Director of Quality Assurance and Regulatory Affairs at Nypro, wanted to consolidate the company’s data and standardise the collection process, making it easier for business managers to gain insight into product quality at various locations. He also wanted to ensure regulatory compliance and reduce the amount of paper used. Microsoft® Gold Certified Partner Predisys helped Nypro develop a centralised solution based on Predisys Manufacturing Analytical Suite and Microsoft Office SharePoint® Server 2007. The new solution has the potential to save the company U.S.$8 million annually and makes it easy for employees to gain real-time data.

Situation

Nypro is a global plastics manufacturer with headquarters in Massachusetts, United States (U.S.). Established in 1955, the group employs more than 9,000 people and has 37 manufacturing plants in 17 countries across the world. Nypro manages processes that span the entire product life cycle—from product design and mould making to assembling and packaging.

A key business challenge for Nypro is to ensure that every stage of the production process is managed and recorded in keeping with the U.S. Food and Drug Administration (FDA) requirements for medical product manufacturing. Eric Pettes, Vice President of Quality and Regulatory Affairs at Nypro, says: “In addition to our compliance responsibilities, we need to demonstrate that the production process always reflects the customer’s wishes—from obtaining raw materials to transporting a product to its final destination.” Maintaining compliant and centralised records is also an advantage for the sales teams, who can use the data to prove to existing and potential customers that the company consistently works to specification.

Until recently, each of the company’s manufacturing plants ran a statistical process control (SPC) application that had limited capabilities and used a local database server. On the local application, employees recorded data, including material specifications, production quantities, and the different stages of product development.

With the company’s valuable business data locked into local applications, employees—including operations managers and sales and marketing teams—could not easily gain insight into the performance and activities of each manufacturing location. Kilday says: “We were inundated with data, yet starving for useful business information.

“Managers couldn’t view data in real-time because at the majority of plants it had to be printed or scanned first, and then sent to various locations by fax or e-mail. Our sales and marketing teams couldn’t easily demonstrate our process control capabilities to customers because it required looking through large paper reports.”

In mid-2006, Kilday began looking for a solution to manage the company’s information requirements more efficiently. A key requirement was that the system could provide a centralised view of information from all the manufacturing sites, and tools for employees to share data easily. He says: “We wanted to streamline our measurement and inspection processes, and, in addition, reduce the amount of paper we used to cut operations overheads. At the same time, we wanted to give all of our technical community controlled Web access to the information, even for those working outside the plant where the product was made.”

Solution

In September 2006, Kilday began working with Microsoft® Gold Certified Partner Predisys, which specialises in developing Web-based business intelligence and SPC software technology for the manufacturing industry. Predisys customised its Manufacturing Analytical Suite to create a solution for Nypro that connects data from all of the company’s local manufacturing and quality data collection sources—and presents it through a Microsoft Office SharePoint® Server 2007 interface. Kilday says: “We investigated a number of providers but quickly realised that Predisys was committed to creating a solution tailored to our specific information requirements.”

The Predisys solution takes advantage of Microsoft Office InfoPath® 2007—part of Office SharePoint Server 2007—to create FDA-compliant electronic records that document the required steps in a manufacturing process and meet customer specifications. Microsoft SQL Server® 2005 database software manages SPC data, while Predisys Statistical Analytics works with SQL Server Analysis Services, to process and analyse data efficiently.

Using a single sign on, employees can access data with a Web browser from any of the company’s SPC applications, through Office SharePoint Server 2007. Operational data is aggregated and displayed in real time through performance dashboards that Predisys created with Web Parts in Windows® SharePoint Services.

From the SharePoint Server interface, employees can deploy interactive Web-based reports for customers and partners. Active Directory® services controls user permission levels and ensures that employees or customers can only access the information appropriate to their roles and responsibilities.

With SQL Server Reporting Services, all employees—from sales managers to operation directors—can create customised business reports from data stored in a SQL Server 2005 database.

Using Office InfoPath 2007, employees can easily follow and record all the required steps in the manufacturing process. The forms provide real-time validation of data, and connect employees to the appropriate information source.

Nypro and Predisys completed the first phase of the solution deployment in mid-2007. Kilday says: “We plan to deploy the solution company-wide by the end of 2009. The initial deployment success is inspiring us to look at other business areas that can benefit from integration with Office SharePoint Server 2007. With help from Predisys, we will continue to develop our environment and take advantage of Microsoft technologies to support business operations.”

Benefits

The company has already realised more than U.S.$700,000 of cost savings associated with data collection efficiencies and reduced paper consumption. In addition, it has used new services, such as online product data management and account tracking to acquire new customers. While an increase in business is a significant benefit, Kilday predicts that once the Predisys solution is deployed globally, it will deliver even greater return on investment. With the Predisys solution and Office InfoPath 2007, employees can use quality data more efficiently and create reports in real time. Kilday says: “The new system will help us recognise problems faster and reduce the amount of product scrap. It has the potential to save us U.S.$8 million a year.” 

Sales Potential Enhanced with Online Account Feature

Nypro is now at the forefront of some of the new, emerging business paradigms—an example being collaborative manufacturing. One of the company’s biggest customers currently accesses product quality information online with the Predisys solution. By the end of 2009, this feature will be available to most customers, and will prove a significant sales advantage for Nypro. Kilday says: “Increasingly, customers want to verify that their product complies with specified requirements and check the status of their product development online. Now that we can provide this option, it will become part of the Nypro Experience for current and potential customers.”

Employees Reduce Costs and Save Time with Electronic Records

Previously, employees used paper forms to gain handwritten approval at various stages of product development. “Although it seems a small thing, using paper forms across the company was expensive. With InfoPath, we can significantly reduce the amount of paper we use, saving us up to U.S.$2 million a year,” says Kilday.

Employees can also save time using the electronic forms process. Instead of physically locating the right people to sign-off on pieces of equipment, request new materials, or organise transportation, the form is automatically sent to the appropriate person, who can then sign-off electronically and send the form to the next stage of approval.

Each stage of approval becomes part of the manufacturing documentation and the ‘Device History Record,’ which is electronically stored in SharePoint Server 2007. The Device History Record is compliant with 21 CFR Part 820 and 21 CFR Part 11 regulations for the manufacture of medical devices.

Managers Gain Insight into Operations with Real-Time Data

Managers can view production dashboards on SharePoint Server and compare the output of different locations. This helps them gain insight into the processes and environments that support optimum manufacturing output.

Kilday says: “Our corporate managers can easily access operational data at all our plants, which helps them to keep track of production costs, outputs, and general plant activity.”

Auditors Easily Monitor Legal Compliance

With Office InfoPath 2007, it is easy for the company to fulfil its legal requirements. Employees cannot accidentally miss out required processes or documentation. Moreover, with the information stored electronically on SharePoint Server, auditors can easily verify that processes reflect the stages relating to FDA legal compliance.

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For More Information

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For more information about Predisys products and services visit the Web site at: http://www.predisys.com/

For more information about Nypro products and services visit the Web site at: http://www.nypro.com/