| by Maria Sbihli
Now that the manufacturing
economy has begun to climb out of its downward spiral, companies
are apt to act less cautiously. They’re beginning
to consider forward-looking projects that were previously
on hold and review outdated processes, specifically software
technologies. State-of-the-art systems are a possibility
now that resources are available for investment. One such
resource, the calibration management system, brings together
a number of the latest trends in calibration management
technology, including:
Migrating to next-generation software
Outsourcing calibrations
Collecting field data
Understanding new technologies
Benefiting from an enterprise implementation
Standardizing within an organization
Calibration management is the process of controlling calibration
and maintaining measurement instrumentation. It’s
no longer an optional function but rather a mandated requirement
driven by quality standards such as ISO 9000, ISO/IEC 17025,
QS-9000, ISO/TS 16949 and FDA GMP.
Historically, a CMS provided basic tracking, scheduling
and reporting functions. Modern packages offer flexibility
along with a robust feature set to fit into any current
calibration process, including:
Tracking both calibration and maintenance data
Tracking full measurement data
Scheduling multiple events
Attaching standard operating procedures, certificates, charts
and forms to asset records
Signing records via electronic signature
Providing multiple levels of security
Compliance to ISO/IEC 17025 drives many manufacturing
requirements. This standard is mandated by QS-9000 and ISO/TS
16949 for calibration service providers and followed by
original equipment manufacturers. It’s a robust set
of requirements that include not only the basics but also:
Environmental conditions
Measurement uncertainty
Proper certificate preparation
Calibration technician training and technical competence
Proper standard operating procedures, including change control
Although the ability to track many of these functions
wasn’t available in products used as recently as the
late 1990s, new CMSs can handle all these and more.
There’s never been a better time to upgrade an obsolete
CMS. As regulations become more defined and internal processes
are re-evaluated, a modern CMS will increase productivity,
manage compliance and ultimately maximize your company’s
return on investment.
The first step in migrating to a new system is evaluating
needs through a user-requirement specification. This is
a simple statement of what’s required of the system.
By defining upfront the requirements necessary for the calibration
management process, an organization can find a CMS best
suited to it. Guidelines for this process include:
Emphasizing the required function rather than the method
for implementing it
Writing a URS for each function the software will perform
Ensuring the URS will distinguish between regulatory requirements
and desirable features
Once the URS is completed, it can be evaluated against
different CMS packages, and an educated decision can be
made about which is most suitable. Although the process
does take time, it helps to ensure a match between the user’s
requirements and a CMS. Other considerations include flexibility,
ease-of-use, reliability and, most important, the technology
upon which it’s based.
The technology a CMS vendor uses to develop a software
package is crucial. Verifying the CMS is designed for Microsoft
SQL Server or Oracle isn’t enough; organizations shopping
for a CMS must look at the type of architecture used and
evaluate whether it’s scalable. A CMS is a large investment,
of both time and money, and one that can’t be changed
every year in order to optimize productivity. Manufacturing
companies must evaluate the vendor’s development practices
to see that they’re developing not only for today
but tomorrow as well. Some terms to look for in this regard
are Web-based and n-tiered, both of which are discussed
in this article.
One of the biggest trends in manufacturing is outsourcing
calibrations. Deciding to do this is usually driven by a
lack of time and people-power. A company might outsource
all or only a few calibration services, which fall into
several categories. The first outsourcing option consists
of using a particular company to calibrate specific equipment,
which is gathered and routinely sent off-site. The second
involves having a company, such as the manufacturer, service
and calibrate the equipment. The third is contracting a
calibration service company to calibrate the entire inventory
on-site. Most companies use a combination of these categories.
Regardless of who provides the calibration services, the
manufacturing company is responsible for managing and recording
calibrations. A state-of-the art CMS provides the tools
to do so. It should be able to track scanned certificates
of completed calibrations, equipment status and location,
and reports of money spent on outside calibrations. Metrics
on service provider performance also are important factors.
Collecting and managing off-site data is an integral part
of today’s calibration process. A CMS must provide
the capabilities to easily record such data.
One of the best ways to collect field data is via a notebook
PC. Calibration technicians can transfer subsets of instrument
records from the main CMS into the notebook-based CMS module.
Calibration activities and events are recorded in the field
on the notebook PC. When finished, the data is transferred
to the main CMS. This process eliminates redundant data
entry and paper, and consequently, the chance for error
greatly decreases. The notebook PC is ideal because it’s
an easy form and powerful enough to include standard operating
procedures and capture measurement data.
A technologically driven CMS provides a variety of security
features and user options with a data-collection utility.
This trend is becoming more popular as the cost of notebook
computers declines and the tremendous advantages of eliminating
pen and paper are realized. For paperless calibrations in
regulated industries, robust electronic signatures are also
required.
A popular trend is CMS vendors taking advantage of technology
to produce state-of-the-art systems. Such software packages
not only provide best-in-class feature sets but also the
ability to share data in seconds with hundreds of users
from Detroit to Singapore.
The technology best equipped to enable this is an n-tiered
Web model. A Web-based, n-tier approach distributes the
necessary user interaction, computation and storage tasks
between the layers of the architecture. Although some latitude
exists in the exact number and structure of layers, a CMS
is typically broken up into a client tier, a middle tier
and a data store. The data store is further segmented into
a data abstraction layer and a database server.
Client tier. This tier is responsible for interaction
with the user. In the past, all users of an application
saw the same interface. Today’s users access their
data from a variety of devices with various screen sizes
and input methods. The client tier must accommodate the
user regardless of the device bridging the user to the system.
Middle tier. Also known as the business logic layer,
the middle tier is where data are interpreted and business
rules applied. Certain types of security and access checks
are also performed at this level. The middle tier is considered
the brain of the n-tiered system; a Web server offers the
best performance.
Data store. This tier includes the task of data
storage and retrieval. Once the choice of a database server
has been made, a data abstraction layer is created to provide
the interface between the middle tier and the database itself.
Some popular databases include Microsoft SQL Server and
Oracle. MSDE is now frequently used instead of Microsoft
Access for reliability.
By utilizing a Web-based, n-tiered architecture, the software
greatly reduces network traffic and the burden on client
resources while maintaining security and data integrity.
Users aren’t directly bound to the data store as in
a traditional client-server application. Instead, the middle
tier utilizes connection pooling to enhance both the network
and software resources. The result is improved performance.
In traditional Microsoft Access database applications,
the system would slow down as more users logged into the
software. Data corruption was typical. With this modern
architecture, a CMS can handle hundreds of users without
affecting the performance. Moreover, as an organization
grows, so must its CMS. Application scalability is very
important; among other things, it means tremendous cost
savings when multiple sites are rolled into one system.
The enterprisewide concept makes the best use of CMS technology.
For example, an enterprise CMS enables an organization to
host the application centrally while allowing worldwide
access to separate departments and facilities. In a typical
installation, the database application is hosted on centralized
IT servers, configured and controlled by a corporate quality
or metrology group, and used by working groups throughout
the global enterprise. The software enables each working
group to have its own dataset configured to its specific
needs--including its own field labels, languages or time
zones--while centralizing the overall implementation configuration.
An enterprisewide CMS can reduce calibration procedure
writing and management, standardize calibration measurement
data collection and retention, and allow for instant communication
of management and productivity metrics. The enterprisewide
CMS can also act as a platform for collaborative problem
solving, which is especially important in cases in which
the required human resources are dispersed throughout the
enterprise.
Companies that must follow standards or regulations will
quickly realize the advantages of an enterprisewide CMS.
All FDA-compliant companies must validate the software they
use when making products for public consumption. Validation
is an expensive and time-consuming task. With a single enterprisewide
implementation, only one validation needs to be performed
at the central host site. If a CMS had been installed at
each individual site, then validation is necessary for each
implementation. The enterprisewide CMS can reduce validation
costs by up to 90 percent.
An enterprisewide CMS can add to the bottom line. Through
cost reductions in application licensing costs, corporate
IT resources, internal auditing and training, the enterprisewide
CMS provides the lowest total cost for corporate calibration
compliance.
Although the enterprisewide approach standardizes throughout
an organization, it’s also possible to implement a
CMS using a site-by-site method.
Not all companies can deploy a centrally hosted enterprisewide
application initially. Divisions might want to remain separate
from other divisions, an organization might be too diverse
or the infrastructure might not be ready to support enterprisewide
implementation. However, companies still want a single CMS
solution for all departments. Standardization is the answer.
Individual departments within an organization purchase
the same CMS, but each site hosts its own copy. This can
be beneficial in several ways: Each facility in a corporation
can purchase on its own schedule and within its own budget
constraints. Also, policies, procedures and processes per
department can be completely customized. Finally, each site
can benefit from the knowledge and experience of other sites
within the corporation. Software vendors typically work
with the corporation on special volume pricing for licenses
and training.
For companies whose ultimate goal is an enterprisewide
solution, the site-by-site approach with one CMS is a good
start. With the right standard technology, all sites can
later be easily merged into one comprehensive package.
Maria Sbihli is the marketing coordinator at Blue
Mountain Quality Resources Inc. She has written articles
on calibration software and compliance. Sbihli, who holds
a bachelor’s degree in journalism, is also a member
of the American Marketing Association.
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