Regulatory Compliance

As the politics of greenhouse gas emissions in Washington and other capitals around the world continue to unfold, process manufacturers must continue to meet the regulatory mandates that come their way. They are also challenged to improve safety, security, and their operating margins to address global competitive pressures.

Emerson's Patrick Truesdale, a refining and chemical industries senior solution consultant, will be presenting at the March 21-23, 2010 NPRA Annual Meeting. His presentation is entitled, Benefits in Achieving Regulatory Compliance. At first blush, it seems counterintuitive that achieving regulatory compliance would have financial benefit. But, for refiners, energy is the largest operating expense. Patrick notes that energy efficiency projects not only reduce these operating costs, they also aid in regulatory compliance and improve safety.

In the U.S., the new greenhouse gas mandatory reporting rule (GHG MRR) mandated that monitoring begin January 1, 2010 with the first report due on March 31, 2010. The report specifies levels of carbon dioxide (CO₂), methane (CH₄), and nitrous oxide (N₂O) emitted based on industry accepted measurement standards and procedures from ASTM International, the American Petroleum Institute (API), and others. The reporting rule defines strict quality assurance (QA)/quality control (QC) standards and associated documentation. Non-compliance to these reporting rules includes civil and possible criminal penalties.

Patrick points to three ways to most economically meet the GHG MRR regulations. The first is to put the business processes and procedures in place to enhance loss control. It's a good idea to follow well-established measurement standards and fiscal controls such as Sarbanes-Oxley, custody transfer, foreign trade zone (FTZ) customs and excise, etc. Loss control can also be enhanced through mass and energy balances as well as the establishment and ongoing monitoring of key performance indicators (KPIs).

The second way to help meet GHG MRR regulations is to enhance key equipment performance such as control loops, measurement devices and systems, and leak identification and repair. The third way is to improve the energy efficiency of key combustion units such as furnaces, heaters, and distillation columns. As you focus on these energy efficiency opportunities, it also means you're reducing emissions, as I described in an earlier post. Benefits can also come in safer operations from reduced variability, increased equipment reliability, better utilization of assets, improved quality, and improved loss management.

Patrick presents a path forward based on the strategy of "low-hanging fruit" first. Start with the low capital cost items in terms of funds and time to implement that have the highest potential savings. The good 'ol 9-box grid with high-medium-low potential savings versus high-medium-low capital costs is a good way to organize the projects to execute.

For instance, making procedural changes, monitoring KPIs, improving instrumentation and controls might be low in capital costs yet deliver medium-level potential savings. Fixing insulation, steam traps & leaks, etc. may be low in both capital costs and potential savings. Redesigning the process and upgrading process equipment may be high in capital costs yet yield significant savings.

In the presentation, Patrick offers numerous examples such as suggested KPIs to establish and track, measurement of fuel flows by mass instead of volume, adding wireless devices to improve energy monitoring, resizing pump outflow control valves, and using advanced multivariable control on fired heater units to operate at optimum combustion levels.

There are more examples than I can fit into this post, but I hope these give you a flavor of the experience that Patrick plans to share in this presentation. If you'll be in Phoenix for the NPRA Annual Meeting, it may be worth your time to check out Patrick's presentation. It would be a great thing if you could take some of his thoughts back to your plant to improve energy efficiency and reduce energy costs, while helping meet the regulatory reporting mandates and improving process safety.

MP3 | iTunes

You only have to do a Google News search on EPA greenhouse gas reporting rules to know this is a large issue on the minds of U.S. process manufacturers.

The U.S. Environmental Protection Agency (EPA) has released a mandate, 40 CFR Part 98 requiring the monitoring and reporting of greenhouse gas (GHG) emissions effective January 1st 2010. These regulations are more than 1200 pages in length. Emerson's Micro Motion division has highlighted some of the key considerations in an EPA Greenhouse Gas (GHG) Reporting Rules FAQs web page. Tom O'Banion, chemical industry director for the Micro Motion team, shared some of the key issues these regulations introduce.

The most significant parts of the new regulations for most manufacturers apply to the emissions of carbon dioxide (CO₂) and nitrous oxide (N₂O) resulting from the burning of fossil fuels. Methane (CH₄) is another source typically caused by leaks in pipelines, caverns, etc. In addition to combustion, N₂O is produced from other sources including landfills and feedlots. Some of the carbon dioxide equivalents (CO₂e) sources that manufacturers now must measure include fuel oil, fuel gas, natural gas flow and BTU, refinery fuel gas, landfill gas, and black liquor. Other sources that may be measured include refrigerant gases such as chlorofluorocarbons (CFCs) and perfluorocarbons (PFCs), which have extremely high GHG values.

The CO₂e concept is described in the FAQs:

GHGs each have their own heat‐trapping ability. GHG's other than CO₂ have a multiplier associated with them that accounts for their greater ability to trap heat. (This multiplier is called "Global Warming Potential" or GWP). For example, CH₄ has a multiplier of 21, meaning 1 metric ton of CH₄ is the same as 21 metric tons expressed in CO₂e. Customers will convert emissions of each GHG to CO₂e and add them together to see if they exceed the reporting threshold.

The 40 CFR Part 98 regulations impact approximately 10,000 U.S. facilities. On its impact:

Every Emerson end‐user customer in the U.S. will have to follow the "applicability" instructions [EPA applicability calculator] within the new rules to determine if they have to report. It seems the vast majority of large end‐users will have to create and implement a reporting system. ALL Refineries and Petrochemical manufacturers are subject to the new rules, regardless of their capacity. The same is true of any plant making: Adipic Acid, Aluminum, Ammonia, Cement, Lime, Nitric Acid, Phosphoric Acid, Silicon Carbide, Soda Ash, Titanium Dioxide, and several other chemicals. Most other plants have several "stationary combustion units" and will have to report if the aggregate emissions of all these units (boilers, furnaces, etc.) exceeds 25,000 metric tons/year CO2e.

Micro Motion Coriolis flow and density meters measure direct mass flow of both liquid (to 0.05% accuracy) and gas (to 0.35%) from a single device. The guidelines currently call for 5% or better but are expected to tighten in the coming years. The vast majority of these measurements are made on fuel lines to boilers and furnaces.

To help satisfy the regulation's "manufacturer recommended best practice", these devices have on-line meter verification. This verification process helps you determine the performance of the sensor and electronics while the meter remains on line. Compared with conventional off-line verification approaches, this can also significantly reduce ongoing maintenance and calibration costs. Records management required for on-line regulatory reporting as well as routine calibration and troubleshooting is streamlined.

Given the significance of these regulations to U.S. process manufacturers, I'll do future posts looking at some of the other technologies that can be applied to help comply with these reporting rules.

MP3 | iTunes

One of my Google blog search RSS feeds on batch processes alerted me to an article, The New Recipe for Pharma Success. It describes how many Life Sciences manufacturers use low-tech tools like spreadsheets, flow charts, and other unstructured documents to create and maintain the process definitions. It concludes:

Bottom line, unstructured documents needlessly increase expenses and prolong time to market. Bad data may be introduced--or good data may be overlooked--at any stage of the product lifecycle, requiring companies to repeat one or more stages.

I ran this post by Joanne Salazar (perspective21 for you Twitterers out there.) Joanne has many years of experience with Emerson and is extremely knowledgeable of the regulatory compliance challenges pharmaceutical and biotech manufacturers face. She is currently focusing her efforts on the Compliance Suite manufacturing operations software, which joined the Emerson family last summer.

Joanne wrote back such a great reply, I thought it best to include in its entirety:

Pharma companies spend lots of money and lose valuable time bringing drugs to market as the patent expiration dates move ever closer. The data involved in defining the "recipe" for the drug is voluminous and needs to be managed throughout its lifecycle. Companies are gaining efficiencies to quickly startup production facilities in several ways:

• integrating change control between development and operations as a drug facility is brought online
• creating reusable libraries of process operations using S88 and S95 standards as a basis
• integrating commissioning and qualification efforts
• using .NET framework to minimize validation efforts, by ensuring functionality of applications once then deploying to various clients

In regards to managing the information and documentation, several additional practices are evolving:

• more structured documents upstream in the drug development cycle enable pertinent data to be easily imported into manufacturing systems - resulting in faster time to market
• the technology and ability to easily interface various systems in a manner that is maintainable is becoming a reality due to S95 and other standards; therefore, pharma manufacturers can readily produce a complete electronic batch records that include recipe, formulas, manual, and automated actions, comments, required data to be gathered during processing, prompts, alarms, deviations, signatures, approvals, etc.
• easily accessing current and approved reference documents (SOP, MSDS) for plant floor work instructions to ensure proper actions are taken
• verifying the training certification of operators at point of action
• managing documents throughout their life cycle: document check-in and check-out, version management, automatic routing, storage, single- and multi-document change control, archived records management, and printing

Helping process manufacturers solve these documentation, maintainability, training and change management challenges is simplified with software like Compliance Suite and project teams who can automate these manual processes.

ModelingAndControl.com's Greg McMillan and Solutia's Mark Sowell will be presenting at the upcoming ISA 54th International Instrumentation Symposium. Their paper, Advances in pH Modeling and Control, describes the use of embedded simulation, coined "Virtual Plant" and model predictive control to improve the control of pH levels in a plant waste water treatment application.

The authors begin by describing the challenge of pH control:

The pH electrode offers by far the greatest sensitivity and rangeability of any industrial process measurement in terms of the measurement of concentration (hydrogen ions). To realize the full potential of this opportunity requires extraordinary performance of mixing equipment, control valves, reagent delivery systems, flow meters, control system design, and controller tuning.

The virtual plant is described:

A virtual plant can be used to sort out fact from fiction important for insuring performance and reducing capital and operating costs. The virtual plant consists of a download of the actual control system configurations and displays, embedded advanced control tools, and a dynamic process model running on personal computer...

The articles details the control strategy used:

We developed and prototyped model predictive controllers (MPC) to replace the fuzzy logic control system. MPC-1 adjusted the 1st stage pH set point to keep the second stage reagent valve at a minimum position for good response and reliability. MPC-2 trimmed the 2nd stage set point to keep the pH in the tank at an optimum pH.

The authors describe the interaction of the virtual plant with the real plant. They write:

In order to study and improve performance of the control system and the fidelity of the process model for actual process conditions, we put the virtual plant in a read-only mode online running real time. A simple interface module was configured that used object link[ing and] embedding for process control (OPC) to read indicated waste flows, controller set points, and controller modes from the actual plant.

If you are battling pH control in a waste water treatment application, you'll want to give this paper a read. You might also want to get your hands on one of Greg's books, Advanced pH Measurement and Control, if pH control is currently vexing you.

Update: Greg wrote me that the presentation went well and the room could have been bigger to hold all the folks interested in hearing about this topic. He has done a slight revision on page 1 to better tie in the results to the general situation with pH systems. This version is now posted on the original hyperlink above.

My spy utility, WatchThatPage, alerted me to another good article, this time on the Fisher control valves and regulators area of the Emerson website. The article, Getting ready for the nuclear renaissance, from the April issue of Valve World magazine, features Bill Fitzgerald, director of the Fisher Valves nuclear business unit.

As more and more people around the world climb the economic ladder, the global demand for energy continues to grow. A nuclear power renaissance is underway, according to Bill driven by:

...issues like global warming and a desire for energy independence... It can never be the only solution, but it is a logical part of the solution.

Bill describes his team tracking forty U.S. projects. He estimates two-thirds of these will actually be built. The first ones may come on-line as soon as 2015. Bill describes the large engineering firms as well as the U.S. Nuclear Regulatory Commission (NRC) staffing up anticipating the work required to completely design, build and commission the first wave of these plants over the next seven years. This expected growth is by no means limited to the U.S.

As part of this process, the engineering firms' procurement people need to identify and begin to purchase the long-lead items like reactor vessels, which may take three years from order to delivery. Control valves also fall into this long-lead item category. As Bill explains:

...control valves have long lead times because the ASME has just issued new qualification requirements. So to use a valve in a given safety related application will probably require 18 months of qualification testing. We also have to factor in ever-tighter seismic requirements. Then materials procurement, machining, assembly and testing will probably take an additional 9-18 months, depending on valve type. So, we believe that if we get an order today for a nuclear grade valve it could take as long as three years to actually deliver it to the end user.

And Bill notes that these valves are used in safety critical areas. Not having them will delay the startup of the plant. Based upon this expected global increase in nuclear power plants, Emerson and other automation suppliers are increasing their capabilities to meet this demand.

Technology has changed greatly since these types of plants were built in the U.S. a generation ago. Bill describes digital technologies like Foundation fieldbus, which can be used in the balance of plant applications to provide better control and diagnostic information. Devices like digital valve controllers have completed Electric Power Research Institute (EPRI)-certification for use in this demanding application.

As energy producers seek ways to meet the increasing global energy demand, these preparatory activities are critical to meet challenging project schedules.

Update: I was just pointed to a great Béla Lipták article, The Third Industrial Revolution by a member of our DeltaV Twitter community. Béla describes the post fossil fuel world based on solar power and the role of process automation. It's well worth your read and I look forward to his book due out in August.

A colleague recently pointed me to a Manufacturing Business Technology article, Red alert: Increase in process automation heightens need for safety-related systems. The article points to a recent Frost & Sullivan study which predicts the market for safety-related systems used by process manufacturers will more than double from 2006.

Quoting from the account of this research report:

It says users will welcome systems that address the underlying challenge of minimizing the trade off between process uptime and process safety. In addition, users will favor vendors that have significant technical experience in installing complex integrated safety solutions that monitor safety and non-safety functions while reducing the costly channels of diversified communication.

Over the past several years of blogging, I've discussed safety instrumented systems and the associated global standards, IEC 61508 and IEC 61511 on numerous occasions. Newer architectures like Emerson's smart SIS incorporate digital communications so that the complete safety instrumented function (SIF) can be continuously diagnosed to help the function perform when it should and not when it shouldn't.

Rather than being prescriptive and instructing process manufacturers what to do, the safety standards are performance-based. IEC 61511 allows you to investigate the alternative solutions for the right safety instrumented function for the safety integrity level (SIL). This means that more engineering work may be required to investigate these alternatives to find the best solution.

I think this where the "technical experience" part of the quote from above comes in. Emerson's Len Laskowski said it best in an earlier post:

This is great news for the engineering community because they get to do the engineering. However the bad news is they must do the engineering.

As process manufacturers address their risk-mitigation strategies and comply with the IEC 61511 standard, they will continue to work closely with those that can provide the technical expertise required throughout the safety lifecycle, from front end engineering and design to ongoing system maintenance.

Emerson technologist and ModelingAndControl.com blogger, Greg McMillan, coauthors with Solutia's Mark Sowell an article, Virtual Control of Real PH in the November issue of Control magazine. The wonderful thing about Greg's writing is that it seems to always include experienced-based rules of thumb, a lack of sugarcoating the facts, and large amounts of humor.

In this article, the authors waste no time in mentioning why we should be interested in reading the article. Most plants have pH control applications, even if in their waste-treatment areas. These areas usually have environmental compliance issues and for applications like crystallizers, fermenters, reactors, and strippers, pH control is critical.

My example of Greg not sugarcoating the facts is:

While we tend to focus on the configuration of the DCS, achieving the full potential of the pH measurement requires exceptional attention to every aspect of the system design. Deficiencies in the equipment, piping, valves or sensor selection or installation can cause the system to fail miserably.

This advice alone may save someone loads of troubleshooting time by first looking at the field equipment and installation before fiddling with the automation system's configuration and tuning.

He's also very good at simplifying the approach to pH control problem solving by helping the reader form a quick mental picture:

The name of the game with pH is to minimize the loop dead time to minimize the excursion along the highly nonlinear titration curve.

The solution described in the article is to use a virtual plant--a dynamic simulation of the waste-treatment system--based on a first-principle dynamic model of the pH system and control system configuration. These all run in the same PC. Dynamic simulations can be quite complex but here's where Greg's rules of thumb based on his experience come in. The key is to focus on simplification and attention to the details that really matter. An example of a rule of thumb:

For pH modeling for process control of environmental systems, about 20 acids and bases cover about 90% of the applications. The physical properties requirements are much less (just molecular weight, density and dissociation constants of each acid and base). The waste treatment systems are normally dilute enough so that activity coefficients are not needed.

They used the virtual plant to see if the existing fuzzy logic control could be replaced with a straightforward model predictive control (MPC) strategy. You'll have to read the article to see the full approach but the bottom line was that:

The MPC did a much better than expected job of chasing the acid concentration... We confirmed later that the production unit that was the source of most of the strong acid was having issues. A comparison of the virtual plant and actual plant control valve positions and pH response revealed there was no flow going through one of the second-stage reagent valves. The problem cleared a day after a phone call.

I had to wrap up this post with an example of Greg's ever-present humor that engineers can appreciate:

It takes more and more interesting opportunities to get weathered engineers excited. However, the almost limitless opportunities to explore advanced control ideas make us downright tingly.

If you've been fighting pH control, the article is well worth it as is the "Extra-Credit Reading" they cite.

In an earlier post, I discussed maintaining compliance of hazardous area certified equipment, from a paper given by Emerson safety consultant, Bob Baker.

At the recent AIChE Spring National Meeting Process Plant Safety Symposium, Bob gave an updated paper, Safety & Regulatory Compliance of Reconditioned Equipment (presentation).

He sums up the pressures that process manufacturers face:

Responding to challenges of seemingly unending reductions in capital and maintenance budgets, the process industry has increasingly turned toward the purchase of lower cost, recycled equipment including salvaged control valves and instrumentation.

The market for salvaged and reconditioned control valves expanded from onshore and offshore oil and gas producers in the early 1990s to onshore chemical, petrochemical and refiners today due in large part to declining maintenance budgets and financial pressure on small, locally engineered capital projects.

Unless appropriate equipment purchase specifications are specified and followed, exposure to potentially significant safety risks may occur when using salvaged, new-surplus, refurbished, or remanufactured equipment (considered "reconditioned" equipment):

Although it equipment may be acceptable from a functional perspective, depending on equipment age, repair history, application severity and other factors, such "reconditioned" equipment may be out of compliance with safety standards, or with manufacturer's specifications as originally designed to applicable industry codes, for safe use in hazardous locations.

One of the U.S. Occupational Health and Safety Administration (OSHA)-accredited Nationally Recognized Testing Laboratory (NRTL) is FM Approvals. The paper notes that FM Approvals' position for reconditioned and new-surplus instruments for use in hazardous locations:

It is FM Approvals' position that only the original manufacturer of the Approved product or an FM Approved remanufacturer whose facilities are part of the FM Approvals follow-up audit program, can remanufacture a product and reissue the FM Approvals certification mark. Any suggestion, practice or inference to the contrary is wrong and must cease... Any salvaged, remanufactured or new surplus electrical instrument cannot be labeled or relabeled as FM Approved for use in a classified hazardous location unless the refurbishing/new surplus supplier entity is audited and approved by FM Approvals, LLC, for that specific type of instrument.

FM Approvals presented the issues, challenges, and its position at several safety symposiums in late 2006 and early 2007.

Bob offers this recommendation for process manufacturers:

Vendor qualification and technical awareness is critical, requiring initial education of all plant personnel associated with the specification, purchase, inspection or repair of reconditioned and new-surplus equipment. Further, ever-changing organizational structure and new personnel requires a sustained education program, including ongoing emphasis at safety meetings. End user issuance of specific corporate policy and guidance could be an effective method to appropriately emphasize and establish requirements for purchasing reconditioned equipment.

Regulatory organizations such as OSHA and EPA typically put the burden of sustaining compliance to safety and regulatory requirements on the end user.

If you are using or considering using "reconditioned" instrumentation in hazardous locations or "reconditioned" control valves in applications within your plant's Process Safety Management (PSM) program, make sure to read the entire paper. Bob provides suggestions for vendor qualification requirements, suggests work processes, and describes the applicable standards.

In a recent Pharmaceutical Processing magazine article, PAT Searches for its Identity, author Bikash Chatterjee discusses the seemingly slow pace of Process Analytical Technology (PAT) implementations. The article states:

What the FDA has provided is a bold chance for our industry--long mired in historical inefficiencies and product failure--to reinvent and improve existing processes for superior cycle-time, consistency and yield.

Given the change in regulatory climate the article questions why we haven't seen a glut of PAT applications to help achieve better operational results. The author points to challenges in the details to implement. Also the traditional emphasis on product and compliance orientation needs to shift as the article states:

...toward an understanding of critical processes to achieve the significant PAT benefits that have worked so well in other sectors.

Given the complexity of this undertaking the author suggests going forward with an approach like Six Sigma as an operational excellence project management framework.

I caught up with Michalle Adkins, a consultant in Emerson's Life Sciences Industry Center, whom you may recall from an earlier post on five strategies for mitigating project risk. She agrees with the author that a PAT initiative should be managed as part of an overall Operational Excellence program. This is because more structure and process can be provided to the initiative.

Michalle believes that by using the Six Sigma methodology, the right tools can be applied at the right time for evaluating, managing, and implementing PAT projects. The Six Sigma structure of define, measure, analyze, improve, control provides the structure for managing the PAT initiative.

It's interesting to note that some of the same tools in the Six Sigma toolbox are already inherently part of PAT such as design of experiments (DOE), statistical process analysis, and methods development. These are all very much related in terms of the types of statistical tools that are used.

Given that the PAT guidelines are still relatively new, pharmaceutical and biotech manufacturers are recognizing that the proven Six Sigma tools along with the analytical tools already used for methods development can help organize the PAT process and move these initiatives forward. It will be interesting to see how these PAT implementations begin to accelerate in the coming years as structured methodologies are applied.

OK, you've done all the engineering, installation and commissioning and have field electrical and electronic equipment that is certified for the hazardous location in which it operates. In North America, this equipment has been tested and approved to appropriate codes and standards by OSHA-accredited NRTLs (Nationally Recognized Testing Laboratories) like FM Approvals, UL, CSA, and MetLabs to name a few. Other countries may have similar requirements through entities such as PTB of Germany, LCIE of France, KEMA of the Netherlands, and UC (formerly UCIEE) of Brazil.

So what about the certification if the equipment has been salvaged from a plant that has been shut down, and then refurbished, reconditioned, or remanufactured and resold? Or what about equipment that is resold as "new surplus" or after installed equipment has been repaired?

Bob Baker, a Safety Consultant to Emerson Process Management presented with FM Approvals' Cheryl A. Gagliardi at the recent Mary Kay O'Connor Process Safety Center 2006 International Symposium. Their presentation, Maintaining Certification Compliance of Equipment Used in Hazardous (Classified) Locations, discusses what happens (or should happen) should a device be changed in some way, even unknowingly.

When ownership transfer occurs, as in the case of equipment that has been resold as new surplus or after being salvaged, refurbished, remanufactured, or reconditioned, there typically is no historical awareness of whether or not a device has ever been "changed" in any manner by the prior owner, resulting in potential non-compliance. Such a "change" could have been as simple as touching up the threads of an explosion-proof device's galled terminal box housing or cover, or it could be the use of non-OEM parts, the accidental scratching of a flame path surface or damage to a flame arrestor, etc. These same types of issues could also occur during the repair of a device even though it may never leave an original owner's site.

The FM Approval mark is a statement of conformity that a product is in compliance with defined standards at the time the product leaves the manufacturing and/or repair facilities audited and approved by FM Approvals. Once the equipment is placed into use, continued compliance with the applicable codes and standards becomes the responsibility of the process manufacturer, i.e. the end user.

FM Approvals listed its definition of repair as "work performed to the unit that would bring it back to its original condition approved by FM Approvals, with repair including refurbished, remanufactured, reconditioned, salvaged, and new surplus." FM Approvals also presented that process manufacturers have several choices when making repairs on equipment with hazardous area approval certifications including:

• Returning the equipment to an original equipment manufacturer (OEM) or any of its repair facilities that are approved and audited by FM Approvals. The OEM has the design control and knowledge of the FM Approvals certification requirements to return the equipment to its originally certified condition
• Having the equipment repaired by a third party facility that is approved and audited by FM Approvals in accordance with its repair standard 3606:1998 - Repair Service for Process Control Equipment Used in Hazardous (Classified) Locations
• Performing the repair in-house if the process manufacturer's repair facility is similarly approved and audited by FM Approvals to its repair standard 3606.

FM Approvals recommended that its certification marks be removed from non-compliant equipment resulting when the repair work is done by a facility which is not audited and approved by FM Approvals. Since the burden is on the process manufacturer that the equipment is approved for the hazardous location in which it operates, the process manufacturer should insist that either:

• The repair (all types as noted above) be done by a facility that is audited and approved by FM Approvals to recertify the equipment (and prove it, by submitting FM Approvals documentation to the end user, that is specific to the brand and model)
• Have the FM Approvals certification mark removed if the facility is not an FM Approved repair facility.

Removing the certification mark or the entire nameplate should help eliminate confusion about a device's NRTL approval status, and reduce the chance of inadvertent installation into a hazardous location that requires an NRTL approved device.

Bob recommends that process manufacturers develop corporate policies and guidance directing inspection, engineering, maintenance, and procurement to ensure the installation of compliant devices for their intended hazardous locations. He also recommends that stringent supplier qualifications be established to prevent introduction or re-introduction of non-compliant equipment, and that identification and abatement processes be developed for potentially non-compliant equipment already installed.

In summary, it is important that industry understand whether the purchase of products for use in hazardous locations, as defined by the National Electric Code and OSHA, can give rise to product safety and regulatory compliance issues.

Ms Gagliardi and Mr. Baker will again be presenting this topic on Thursday, January 25, 2007 at the Texas A&M Instrumentation Symposium (Jan 23-25).

Many process manufacturers have flow metering stations where ownership of incoming raw materials, intermediates, and/or outgoing products change. This custody transfer process is common with oil and gas producers, refiners, and chemical/petrochemical manufacturers.

Accuracy is critical since these measurements impact the bottom lines for both the seller and buyer. And, with the introduction in the U. S. of the Sarbanes-Oxley (SOX) Act of 2002, companies are required to put the controls in place to prove the accuracy of these measurements. Other countries have similar regulations requiring these documented proof-of-accuracy processes.

Robert Fallwell, a regional manager in Emerson's Metco Services business, has written an excellent article, Sarbanes-Oxley audits: coming soon in the July issue of Control Engineering magazine.

Robert shares his expertise on how process manufacturers need to prepare for the SOX auditors. He boils it down to:

...they ask for proof that flow measurements are accurate, that you have procedures to ensure measurement accuracy, and that the plant's operators, engineers, and production accountants have been trained in the correct procedures for the measurement control process.

If your business is impacted by SOX or similar regulations, you'll want to incorporate some of the ideas presented in this article.