Once a new or retrofit project reaches mechanical and electrical completion, all eyes turn toward the instrumentation and control system as being the last obstacle that's preventing start up. Well, perhaps it's not quite that dramatic, but no matter how hard we try, all control and instrumentation systems eventually end up on a project's critical path.

It's been repeatedly documented that applying good project management skills to a well-defined project life-cycle methodology will deliver the lowest cost, highest quality implementation.

To illustrate that point, consider the theorem IBM development engineers evolved years ago known as the "1:10:100 Rule." IBM's rule states, "Any defect that can be removed for $1 during the design phase will cost $10 to remove during testing, and $100 to remove once it has been delivered to the customer."

Granted the dollar values are outdated, but the 10X ratios remain legitimate benchmarks, and the rule represents sound reasoning for applying a well-defined methodology to all instrumentation and control system implementations.

Early identification of user and supplier responsibilitires helps eliminate surprises.

Most U.S. manufacturing and processing facilities must comply with a number of U.S. Environmental Protection Agency (EPA, www.epa.gov), U.S. Food and Drug Administration (FDA, www.fda.gov), and/or U.S Occupational Safety and Health Administration (OSHA, www.osha.gov) regulations. These agencies' mission statements reveal two significant similarities.

• Each agency addresses various forms of safety and protection; and
• Many regulations, regardless of issuing agency, include "validation" requirements.

For many readers, the word "validation" only applies to FDA-regulated industries, such as pharmaceuticals, and is not applicable to chemical, pulp and paper, and refining industries. In fact, it's not uncommon for non-FDA regulated industries to distance themselves from the word "validation," choosing instead to use the word "verification."

In reality, depending on how and where the words validation and verification are used, both can have legal implications. (See "Validation or verification?" sidebar.)

It's true that some FDA-regulated validation activities could represent over-kill for non-FDA regulated industries. However, similarities make it worthwhile to utilize a common methodology to prove to any inquiring government inspector that instrumentation and control systems are performing as intended, designed, and stated.

There's a business reason, an added bonus, for adopting and applying existing, robust methodologies and practices: commissioning goes faster.

Organizing and compartmentalizing helps ensure activities receive proper attention.

Need help in developing an instrumentation and control system life-cycle methodology?

International Society of Pharmaceutical Engineers' (ISPE) contribution to a more consistent implementation of control, automation, and instrumentation systems is GAMP (Good Automated Manufacturing Practices). The fourth edition is titled GAMP 4. (See "GAMP: ensuring automated systems' performance" sidebar.)

The Institute of Electrical and Electronics Engineers' (IEEE) contribution is a four-volume collection titled, "Software Engineering Standards Collection." (See, "Software engineering standards collection" sidebar.)

Because software development is complex and continuously evolving, IEEE's software engineering's standards offer organizations a viable alternative to the time-consuming and often error-prone activities of developing standards from scratch.

Over time, using IEEE standards provides the added benefit of regular standards reviews and updates—something many organizations intend to do, but rarely find the time to complete.

Carnegie Mellon University's Software Engineering Institute (SEI) helps improve software engineering practices, such as through establishing a software architecture backbone on which to build robust, software-intensive systems.

Selecting and applying an appropriate software architecture is paramount to ensuring a system's quality attributes are consistently applied. Once established, a robust software architecture provides sufficient abstraction to allow deployment of reusable modules between systems.

On the surface, establishing software architecture appears to be more appropriate for instrumentation and control system manufacturers than for end-users. That is, until faced with a large project and short schedule. Having chosen a single control system supplier, the end-user decides to "crash the schedule" by hiring multiple integrators to implement different process areas.

In such a case, following startup and after the integrators moved on, the end-user's staff typically need to modify some of the application software. What they often discover is that similar software modules have been developed, named, tested, and documented in entirely different ways. What should have been a single module used multiple times, turned out to be multiple modules used once or twice each.

Considering the control system would be in place for a very long time, the seemingly minor software anomalies created by the system integrators, unnecessarily increase the end-user's life-cycle costs of maintaining the application software.

There are two lessons here. First, software anomalies will occur and recur unless someone from the end-user organization accepts responsibility to monitor, review, and control software module development activities—a key element of a robust software architecture.

Second, ensuring a system integrator's software development methods and practices are consistent and aligned with end-user expectations requires melding the software architectures of the system integrator and end-user.

Methodologies, such as GAMP, IEEE, and SEI, accelerate commissioning of instrumentation and control systems when equipment manufactures jump in with "canned" solutions.

Unknown to many end-users, many instrumentation and control system manufacturers offer documentation consistent with GAMP guidelines.

For example, Invensys' Eurotherm division offers a CD-ROM containing validation templates for its 5000 Series (which also serves as the technology base for Foxboro's A2 automation system) products.

Included on Eurotherm's CD is functional specifications, installation qualification (IQ) specifications, and test result forms.

Layout and content of the Eurotherm validation templates is consistent with the sample functional specification procedure detailed in Appendix D2 of the GAMP 4 guide, but with information specific to Eurotherm products.

Similarly, Rockwell Automation's Propack Data EPM solution is available with IQ and operationally qualified (OQ) documentation designed to ensure quick and efficient product commissioning.

Working with several large end-user companies, Emerson Process Management's Micro Motion and Rosemount Analytical divisions have developed a "Certified Factory Calibration" service, designed to accelerate the IQ/OQ process. Emerson calibrates sensor and electronics as a system, completes appropriate documentation with required signatures, seals the device in a special shipping container using tamper resistant tape, and ships the device and documentation separately.

Documentation is shipped directly to a designated "responsible party" within the customer's organization. When it's time to install equipment, the customer follows unpacking procedures for matching documentation and equipment. The Emerson service is designed to eliminate field calibration activities, which are often less accurate than factory calibrations.

Likewise, Honeywell's POMS solution provides a number of pre-engineered modules designed to meet specific application requirements, thus some amount of testing and documentation is included.

By following GAMP 4 guidelines, instrumentation and control system manufacturers can more easily and cost effectively help end-users accelerate the commissioning process, regardless of industry or application.

Michael Kolba, senior director of validation operations at Aker Kvaerner Pharmaceuticals says, "In an FDA-regulated instrumentation and control system deployment, factory- and site-acceptance tests [FAT and SAT], IQ, OQ, and performance qualification [PQ] activities are required. Those same activities, though with different names, are also performed when deploying instrumentation and control systems in non-FDA regulated industries, with one exception—the level of completeness applied to the witnessing and documenting of what's been done."

One of the things that makes GAMP an effective tool is its emphasis on minimizing testing, witnessing, and documentation overlap from FAT to SAT, IQ, OQ, etcetera. The architecture encourages testing, witnessing, and documenting things as early as possible. When this is combined with the minimization of testing overlap, elements get off the critical path early while still ensuring a robust, timely implementation.

The terms FAT and SAT are commonly understood; however, in other industries, IQ and OQ might be combined and called installation testing and water batching, final testing, or simply process commissioning may be used in place of PQ. The point is, there are a lot more similarities than differences in what's meant and achieved among these terms.

Kolba adds, "The definition of terms and what's required as part of each isn't something to be brushed off lightly, especially when interviewing installation contractors. It's important to ensure the installation contractor's staff understands and follows IQ and OQ procedures, or whatever you call them, including the need for witnessing, documentation, and sign-off. Otherwise all the anticipated savings in dollars and time are lost."

That's sound advice. And when extended across the entire instrumentation and control system life-cycle methodology, it makes accelerating the commissioning process achievable without jeopardizing long-term instrumentation and control system support activities.

Comments?E-mail dharrold@reedbusiness.com