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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 They’re beginning to consider forward-looking projects that were previously on hold and review outdated processes, specifically software technologies.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.

Migrating up the CMS software stream

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.

Outsourcing calibrations

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 field data

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.

Understanding the latest technologies

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.

Benefiting from an enterprisewide implementation

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.

Standardizing within an organization

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.

About the author

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.