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November 2000
Managing Documents With Lives In the Balance
By Debra Haverson and Gordy Hoke
Most business leaders are struggling to bring their companies
up to Internet speed, yet they can't take shortcuts when it comes to
regulation and, more importantly, public safety. These sometimes
conflicting challenges are perhaps most acute for high-tech
manufacturers that deliver products upon which our very lives
depend.
In the aerospace industry for example, cybermarkets are fast
becoming the way to go to do business. Aircraft parts supplier Middle
River Aircraft Systems found its e-commerce initiative to be a
competitive necessity. The effort required fast, easy access to
up-to-date parts information, yet the company had to ensure continued
compliance with the Federal Aviation Administration's mandates regarding
airworthiness documentation. Safety and regulatory demands were equally
important at Hollister, a medical products manufacturer that generates
14,000 documents per day.
While speed to market and regulatory compliance are two powerful
motivators, these two manufacturers paid attention to regulation,
customer service and consumer safety. After all, no matter how
cybersavvy and e-commerce enabled a company might be, quality, accuracy
and customer satisfaction are still the ultimate gauges of business
success.
Parts Catalogs Drive Online Transactions
According to Ralph Reed, e-commerce leader at Baltimore-based
Middle River Aircraft Systems, the customers' critical requirements must
serve as the starting point for any initiative. A manufacturer of thrust
reversers and other aircraft parts, Middle River has several types of
customers, including the engine manufacturers GE Aircraft Engines and
Pratt & Whitney, the aircraft manufacturer Boeing, and the more than 750
airlines and airline overhaul facilities worldwide. Middle River is
targeting this latter customer group for the first projects in its
e-commerce initiative.
The vision, says Reed, was to develop a business-to-business
(B2B) e-commerce strategy to stay ahead of the competition, and it was
imparted in 1999 by no less an authority than Jack Welch, CEO of General
Electric, the parent company of GE Aircraft Engines as well as Middle
River Aircraft Systems. It helped that GE Aircraft Engines had already
initiated its own B2B efforts by making the component maintenance
manuals and illustrated parts catalogs for its CF6 engine line available
through a customer support portal. Naturally, Middle River couldn't copy
the solution of the larger company, but it had confidence in selecting
Enigma, Burlington, MA, and SpaceWorks, Rockville, MD, the vendors
chosen for the original project. GE Aircraft Engines and Middle River
have many common customers, so having a parallel solution for the parts
supplier's CF6 thrust reverser product line made sense. Customers would
gain a single view when accessing information on this crucial engine
component.
At press time, Middle River's portal-based maintenance manual and
parts catalog were set to go live in early October, and they are
expected to provide instant, round-the-clock access to documents
exceeding 5,000 pages, each requiring semiannual data revisions. When
mechanics access these documents online instead of using bulky paper
manuals, they gain the ability to search the data, use hotlinks to
related illustrations or applicable service bulletins, and, most
importantly for the e-business initiative, generate parts shopping
lists. The mechanics can forward the lists to their purchasing
departments or to an online order management system as required.
The project also involved General Graphics, York, PA, the
provider of Middle River's hard-copy manuals, which will continue to be
published. General Graphics takes the raw data revision feeds, updates
the digital masters that reside in its publications system and prepares
hard-copy reproduction masters for scheduled distribution. It also
provides XML coding and performs the final quality checks needed before
the information is passed to Enigma's CommerceSight application, which
is priced at about $150,000 per server.
CommerceSight creates the electronic publications, links to
bulletins and searching capabilities, and creates the shopping cart
feature. The shopping cart interacts with order management software from
SpaceWorks' WebBusiness Manager Suite. The online order management
system furnishes real-time pricing and availability information as part
of the process of supporting the online transactions. Customers gain
efficiencies by using tools such as saved order lists and wildcard
searching. They can also use features like alternate parts information
and configuration histories to find alternatives for specific needs.
At the back end of this process, the order management system will
pass information to Middle River's planned Oracle ERP system, which is
to be rolled out by mid-2001. The company expects the entire system to
feed useful information to the capacity planning function on the plant
floor.
"It's important to have a clear understanding of responsibilities
and a common overall project schedule among the players," says Reed. "We
have a weekly conference call to update status and resolve project
issues. This works pretty smoothly because Enigma and SpaceWorks have
already collaborated on similar projects."
Most computer-savvy users have become accustomed to - perhaps
even spoiled by - the ease and instant access that online searching and
retrieval delivers. It's easy to imagine the value and peace of mind
that a busy airline mechanic finds in knowing that he or she can set
aside paper manuals and easily locate the documentation for a part, and
also the most current related service bulletins. Reed says Middle River
will make it a priority to add safety documents when posting updates to
online documents.
In the future, Middle River expects to economize on paper-based
publishing, which currently exceeds 1.6 million pages printed and
distributed annually, but legal issues still make this impossible today.
Reed says the Federal Aviation Administration (FAA) has legitimate
concerns about replacing the paper publications it approves as
"airworthiness documents" with purely electronic versions. GE Aircraft
Engines has worked with the FAA for nearly a year to gain approval for
online versions of manuals, but they must still carry the disclaimer
that they are reference documents only, not the official FAA-approved
documents.
Pending further resolution, the FAA remains concerned about:
- Security: that document content cannot be changed without
required review and approval.
- Maintenance: that an audit trail is created, tying maintenance
actions to the documentation used.
- Access: that technical data can be accessed by foreign
countries in accordance with current data-export regulations.
The need to provide both paper and electronic catalogs prevents
immediate cost savings on print prepress production, however, Reed says
the company expects at least to reduce the number of multiple copies per
customer by at least half.
The real payoff of this application lies in its ability to bring
parts ordering online. Middle River anticipates a reduction in manual
administration of customer orders by 40 percent to 60 percent.
"From a strictly bottom-line point of view, we expect it will
take several years to recover our investment, but it's hard to quantify
the final tally, because it depends on how quickly we gain customer
acceptance," says Reed. "We are taking a conservative stance, but the
more paper that goes away and the more orders that are processed online,
the greater the reproduction and administrative savings."
Middle River will gain additional speed and efficiency once these
Internet applications are integrated with ERP.
"The real power of Web-enabled ERP," he adds, "is the systemic
interaction between outside events and internal planning. New demand
pushes the planning system that in turn reschedules production activity
to optimize the production system. Not every demand will be satisfied
all the time, but exceptions will automatically fall out for further
review. Order status will be automatically updated and available to the
customers online."
This implementation represents only the first of three portals
planned by Middle River. The other two will be an intranet employee
portal and an extranet supply chain portal that will allow for
collaborative design and manufacture using the Web to request bids or
other information from suppliers.
Medical Manufacturer Brings Docs Under Control
Medical devices play a vital role in health care, but getting
them to market is an arduous task. Health and safety precautions and
Food & Drug Administration (FDA) regulations require painstaking
documentation of meticulous procedures. This was a critical concern of
medical manufacturer Hollister of Libertyville, IL, when it moved from a
mainframe to a client/server environment. As part of its effort to
resolve Y2K concerns, the company was implementing an ERP (enterprise
resource planning) system from SAP.
"We were under a lot of time pressure, and we had so many changes
going on," says Bill Ferguson, Hollister's corporate director of quality
management. "We had our own custom application on the mainframe, so we
looked to migrate to a very compatible system."
Preferring something that would require minimal coding, Hollister
chose a turnkey enterprise compliance management system from Qumas,
Florham Park, NJ.
Hollister manufactures nearly 2,000 products, including ostomy,
wound care, patient identification and OB/GYN devices. Even though the
company avoids such high-drama items as defibrillators and pacemakers,
the risk of liability is high. Precise documentation can minimize that
risk.
"Our 450 [system] users generate about 14,000 documents a day -
each three to four pages in length," says Ferguson. "The demands come
from our four plants plus corporate headquarters. Everything has to be
documented: calibration methods, quality assurance, descriptions of
microbiological test methods, assessments, sterilization records and
other matters. We also have product and component drawings on the Qumas
system."
Six categories of users, from a system administrator to workers
on the manufacturing floor, are connected to Qumas through a WAN. The
central repository resides at the home office. Security is ensured with
ascending levels of privileges, from viewing to creation and revision
rights.
Drawings and requests for changes originate at Change Councils at
the plant and corporate levels, and a Corporate Approval Panel reviews
new and revised documents before they take effect on the system. Qumas
manages the entire change control process, including version control,
electronic approval, and transmission of documents and archives. The
system also delivers reports about changes and maintains an audit trail
for every stage and access.
"With our document management system and database, companies can
review all aspects of their record creation and management over a period
of years," explains Qumas president Kevin O'Leary. "Companies like
Hollister must retain and be able to retrieve records for the life of
the product and far beyond. We provide for the daily management of
records in their native file format, plus a PDF rendition for FDA
regulations."
The Qumas audit trails offer complete histories. "I can tell you
every person who has read and/or changed a document, anywhere, at any
time," O'Leary says. "[The system] can tell you not only that it was
changed but also what was changed, why it was changed, who initiated the
change, who the author was, who executed the change and everyone who
approved the change. We want to give our users every possible bit of
information that relates to a given document."
User Tip: Let Customer Needs Drive E-Commerce
E-commerce leader Ralph Reed of Middle River Aircraft Systems,
Baltimore, recommends a customer-centric approach to e-commerce. Start
by developing a clear understanding of the customers' critical
requirements. Then, devise a plan to identify, prioritize and implement
the appropriate solutions to meet the requirements.
It may be necessary to seek some outside assistance. Middle River
looked first to its larger parent organizations, General Electric and GE
Aircraft Engines, but it also consulted with the University of
Maryland.
Reed offers a few more tips to manufacturers aspiring to enter
e-commerce:
- Start with the low-hanging fruit - those solutions that have
the most value, clearest feasibility, and fastest, easiest
implementation.
- Build a success story while developing your e-business
strategy. It helps to understand and sell your concepts.
- Speed is important, so make certain you have top management
buy-in to ensure rapid follow-through.
- Remain flexible. This technology is very dynamic.
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