Promoting Sustainability: How Automation Technologies Impact Compliance

Whether for traceability, electronic record-keeping, or emissions monitoring, automated controls and software systems help facilities meet regulations—and let control engineers rest easier at night. Regulations involve monitoring and managing process emissions, tracking and tracing the manufacture of a food or pharmaceutical product, or other operation or process, failure to comply with them—and the consequences of downtime, product waste, costly fines, or worse. Control Engineering October issue feature article.


Every control engineer who’s been on the job for any length of time most certainly has encountered compliance regulations. (See resource list at bottom of article.)

Whether those regulations involve monitoring and managing process emissions, tracking and tracing the manufacture of a food or pharmaceutical product, or other operation or process, failure to comply with them—and the consequences of downtime, product waste, costly fines, or worse that may result—keep many control engineers up at night, or at least give them cause for concern.

A dizzying array of laws governs industry here and abroad, ranging from U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) monitoring and record-keeping regulations to Global Reporting Initiatives (GRI) for sustainability reporting. Thankfully, an abundance of automation technologies and software systems are available to help comply with them.

Even with automation, compliance is not as simple as it may appear. Consider this scenario: A few years ago, a refinery operation spilled a liquid pollutant into a nearby river. When regulatory authorities investigated, they found the sensor on the tank that was supposed to hold the liquid until it could be disposed of properly had been disconnected. Information from the sensor, linked to an historian, showed a “bad quality” flag, and the refinery had procedures in place for responding to and handling this type of situation, including who should be notified and work orders for doing something about it. Unfortunately, none of these things were done. As a result, the EPA tried—unsuccessfully—to press criminal charges against the refinery’s top management. But an instrument technician was fired, and staff control engineers were in trouble. That’s what keeps control engineers awake at night.

This event is particularly disturbing because technology—when conscientiously and correctly applied—can help prevent such incidents. From sophisticated controls to intelligent sensors to electronic monitoring and record-keeping, modern equipment facilitates regulatory compliance across manufacturing. From food and beverage and pharmaceuticals to refineries and chemical plants, a variety of options keep systems up, running, and in compliance. Let’s take a look at a few.

Automation for tracking, tracing

In the life sciences, recent changes in the FDA’s approach to compliance seem to be shifting the balance of how regulatory systems are installed and applied in food and beverage, pharmaceutical, and other biotech industries. Historically, explains Frank Offenbacher, life sciences marketing manager at Honeywell, the FDA took an install, test, and document approach. Now it is driving industry to be more science based, asking companies to achieve a quality product by looking at the design process and using tools such as SPC (statistical process control) to determine which variables contribute to quality and to monitor those variables in particular using statistical methods. “If manufacturing can target which parts of its operation have an impact on product quality from a risk perspective, it won’t have to waste time, effort, and money validating areas that don’t affect quality,” he said. “This change in perspective helps companies better understand their processes and achieve quality based on design.”

Offenbacher said he believes this science-based approach will foster a wider application of new sensor technologies, more data capture and analyses, more SPC, and more advanced control. Historically, systems documented and in place were forgotten, said Offenbacher. “Once a company could manufacture and validate a product, it didn’t want to change it. Such a philosophy curbs innovation. You can’t improve efficiency if you are not interested in changing anything. This new direction should help alleviate that.”

Offenbacher said he feels compliance costs are what keep control engineers up at night and that automation goes a long way toward helping curb those costs. In the pharmaceutical industry, he points out, patent expiration is negatively impacting the bottom lines of many major drug companies. As a result, companies are trying to tighten their belts by improving productivity as well as how they comply with laws and regulations by making the same or better product at lower cost. Software monitoring and control applications are helping to achieve these goals. Scalable, Web-based systems such as MES (manufacturing execution systems) help ensure products are manufactured correctly every time by controlling and tracking all aspects of production, including quality, and providing a thorough regulatory compliance history.

Automated systems that facilitate regulatory compliance also help increase production agility and flexibility, said Offenbacher. “The biotech industry historically built one huge plant to make one drug,” he said. “Today, as blockbuster drugs are less common, plants must be designed to make many products, a situation that creates a much more complex regulatory environment. Automation tools and technologies help manage those environments, not necessarily making them more compliant, but simplifying how they achieve compliance.”

Systems that simplify change maintenance within a control system help maintain an audit trail of modifications and configurations. Others help plants more easily run products concurrently and/or change them out more frequently. Reconfiguring a system to run different drugs and still be in compliance is complex and involved, Offenbacher continued. “Technologies like wireless technology can help by promoting mobility. Mobile equipment can be more easily rearranged and adapted for quicker product changeovers. Control networks that incorporate wireless operator consoles and wireless transmitters attain significant flexibility in terms of operator movement in particular, and in reconfiguring a line overall.”

Automation for emissions monitoring

Automation and control systems also play an important role in emissions regulation compliance, especially in today’s challenging economy. Stan DeVries, director of energy management solutions, Invensys Operations Management, cited a case where production process changes forced a large petrochemical plant to change from operating at a constant maximum to a 2.5:1 demand ratio. “Many refineries, in fact, are now running at much lower rates,” said DeVries, “making it difficult to maintain operational efficiency. At first glance, this may appear to have little to do with emissions regulations. However, every time an energy intensive operation stops running, the emergency relief of that energy could send all kinds of emissions into the air. Further, enormous amounts of energy are expended, and subsequent emissions could be generated, when operations resume. Such starts and stops, unplanned stoppages and outages, contribute enormously to the need to reduce—and control—energy and emissions.”

Techniques exist for automatically and manually managing these emissions. Among the offerings are scalable and configurable MES products for automatic data gathering from product tracking and tracing activities throughout the enterprise. “When it comes to automatically gathered data,” said DeVries, “we automate data quality management. That means we monitor if anybody changes the configuration of a system, from the software that takes the information from the control system to the software that does the actual reporting. On the manual data gathering side, mobile solutions can gather and monitor data for production tracking and compliance applications on equipment that is not instrumented. There are records then of when a user was notified of an occurrence, so that activity around manual data entry is captured as well.”

Another way software advances have helped with emissions compliance monitoring is through software CEMs (continuous emissions monitoring systems). “They are not appropriate for every application,” said Richard A. Hovan, manager of environmental solutions, Rockwell Automation. “But as long as the fuel is stable and the fuel value can be determined, they work well. They offer a real-time method for predicting what’s going in terms of maintenance and in meeting compliance parameters. And cost advantages can be significant. On a boiler or turbine, for example, savings of 50% are possible on the initial investment and up to 60% to 70% savings in maintenance over 10 years.”

This automated technology uses upfront sensors in a boiler or other combustion system to measure all normally monitored parameters and feed them into the plant control system to determine performance. “We can build a model to predict NOx levels off upfront sensors, then monitor and validate those sensor readings every minute so that in real time we know if they are correct—and if and when they start to fail,” Hovan explained. “They trigger an alarm and automatically notify maintenance if a sensor goes out of spec. Because the system is Web based, a technician can go online whenever and from wherever he is, access a current view of what is happening, and determine what action needs to be taken. It is a real-time maintenance tool for determining the functional stability and sustainability of all emissions-related process parameters.”

When it comes to compliance feedback control, said Hovan, a facility must know in real time that a problem exists and what is causing it. “With a hardware CEM, if a sensor fails calibration and is only checked every 24 hours, all data back to the previous calibration is invalid, as is everything moving forward until the sensor is validated and the system is back running properly. This is expensive. With a software system that monitors in real time, and validates every minute, only a minute of data is lost.”

Look beyond software, systems

Although automated technology and software has helped facilities make significant strides with regulatory compliance, systems, software, and equipment cannot do the job alone. They carry cultural and personnel ramifications that must be addressed as well—issues that may be as critical to performance as equipment configuration. Automation typically still requires human response. “Everything cannot be computer controlled,”  Hovan noted. “Automated systems suggest action, especially when it comes to compliance, then either triggers an automated response or prompts a human to take action.”

Environmental and energy management issues, added DeVries, involve more than the application of automation. At the petrochemical plant mentioned earlier, management took pains to meet with its operators and control engineers to let them know they trusted their decisions and their actions. “That was a big culture change,” said DeVries. “For the first time, they were given near-real-time management of energy emissions and throughput so that they could see actual performance. Within two months, their way of operating had changed so much that the company reported saving 6% on utilities costs, 4% on internal conversion efficiency, and up to 10% overall energy efficiency. The improvement came entirely from a change in behavior by operators coupled with the application of existing controls in a better way.”

Plants need to have realistic expectations of how much automation can do to achieve compliance or generate savings, and recognize that the people factor is significant. “I’ve seen improvements of up to 17%,” said DeVries, “but they had to do absolutely everything right in terms of the technology and the plant culture. In one case, management planned a system to achieve optimum benefits and then had a staff member say, ‘I know what you need and why you need it, but also I know that our culture can’t do it.’ Those cultural aspects are critical. In the future, I think management must realize that a portion of every automation system needs to be directly related to regulatory reporting. There is always a way to do it, whether automated or not, to determine what a reading is, to comply with the law.”

Have a restful night!

For more on the automated technologies and software systems for regulatory compliance mentioned in this article, visit these vendors’ Websites:

- Related reading from Control Engineering:

Dealing with Undocumented Field Device Changes

Securing Legacy Control Systems

The Art of Instrumentation

MES use helps achieve sustainability goals

Predictive Emissions Monitoring for Regulatory Compliance

Emissions control;

Complying with EPA requirements;

Chemical data management via MSDS management;

Regulatory Compliance for Food Safety;




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