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 about Predisys products and services, call +358 (0)9 439 3420 or visit the Web site at: http://www.predisys.com/
For more information about Nypro products and services, call +978-365-8337 or visit the Web site at: http://www.nypro.com/