Controls and systems vendors continually watch for developments in standards and regulations. Automatically, vendors incorporate mandated changes into their products and make upgrades available to legacy systems. Usually, it’s up to you whether you wish to install such upgrades. However, when OSHA or the FDA makes a regulation, you may not have a choice but to upgrade.
This is the case with the FDA regulation 21 CFR Part 11 for anyone under FDA jurisdiction, notably food, beverages and pharmaceuticals. For others interested in using electronic record keeping or electronic signatures, or for improving their change management processes, this regulation is a good one to follow.
“FDA regulation 21 CFR Part 11 covers the acceptance of electronic records and electronic signatures, in lieu of paper, as valid documents for product quality, safety and regulatory compliance,” says Paul Moylan, pharmaceutical solution marketing manager, Rockwell Automation.
Ultimately this regulation will:
• Help companies more efficiently and less expensively handle documentation required by the FDA.
• For pharmaceutical companies, speed the release of drugs into the market.
• Overall, lower data collection costs and, thus, increase profits.
• Reduce the number of required FDA inspections.
This regulation will help transform companies into lean, efficient organizations. FDA-regulated companies do not have to use electronic records instead of paper. They can continue to gather and store data in paper form - they can continue with business as usual.
But if they choose to replace paper with electronic records, they may have to replace every control, PC and PLC in their facilities. A solid networking system will be needed. And software will need specific features. At the least, companies that choose to go electronic will have to upgrade many controls to meet the version control and audit trail features required by the Part 11 guideline as most older controls do not have these features. Depending on the vendor, there may be upgrade software or hardware available. Check with your supplier.
Regulation 21 CFR Part 11 may also be useful in thwarting bioterrorism. “We anticipate that food and beverage companies will adhere to the FDA regulations for safety reasons if nothing else,” said Bill McCarthy, Industry Solutions Group, Rockwell Automation. “just out of good manufacturing practice and general safety. From a security perspective, 21 CFR Part 11 helps users better handle change management.”
This regulation is the most recent change facing controls vendors. Other regulatory activity has been in the works for years. Here’s a status update on several of them:
• PLC programming. More than 10 years ago, PLC vendors created a programming standard that eliminated the need to train engineers on every new PLC version introduced. (Remember Ladder Logic?) This standard, IEC 1131, established the programming format displayed on terminals or operator interface devices. It’s finally reached the point where the majority of vendors are using it. Why did full acceptance take so long? The answer deals with factors common to all standards. “Standards are often a starting point,” says McCarthy. “For a long time, the IEC 1131 standard lacked granularity, from a control systems’ standpoint, for robust editing and development tools. You have to take that foundation and add a lot to it. Many vendors can say they were IEC 1131 compliant, but couldn’t offer a robust tool kit until recently.
“The FDA regulations are undergoing a similar process,” continues McCarthy. “They are so vague and interpretations are so broad. There’s still not a consensus on what electronic records are when it comes to control systems configuration files and network configuration files.”
“Proprietary vendors have resisted changing their products,” say Bill Lyndon, product manager, electronic products, Wago. “Now, though, there’s such a movement from end users choosing alternatives like Windows, that vendors have been forced to go with a common look and feel, eliminating the learning curve.”
• Recycling. Shortly after Y2K, regulators started focusing on what to do with all the old, outdated equipment. Computer boards and microprocessors often contain toxic material. Many state legislatures are discussing how to address this issue. A few Congress members are working on legislation that will tack on a recycling fee, payable by corporations, to help pay for the cost of their states establishing recycling programs.
MHM has written before about the need to recycle PCs, and most major corporations have programs in place for this purpose. But what about industrial controls like the PLC?
Surprisingly, few companies throw their PLCs into the trash. These devices often operate for 30 years or more. If one is pulled out of service, it’s broken down into parts for use as spares in other PLCs. Vendors will often buy back out-of-service controls and keep them for spares for their customers.
Distributed control strategies also reduce the need to replace PLCs, because you can build around them and not replace them. Until it’s an obsolescence issue, most users install them and don’t touch them. If the control finally has no further use, then it’s discarded into the trash. The difference between PCs and PLCs, however, is volume. More than two billion PCs have been sold. And people tend to replace PCs sooner than PLCs. More PCs are found in the trash than PLCs, thus the focus on recycling PCs.
• Noise. Complying with OSHA noise regulations means that system manufacturers are continually looking for ways to provide you with quieter equipment that can operate at faster speeds. “Bearing choices, rollers, and the way roller axles fit into frames all affect noise on conveyor systems,” says Phil Kaffenburger, vice president, HK Systems. “Presently, OSHA looks for noise levels to not exceed 80 dB. But we anticipate that they will lower that level to 70 dB in the near future, so we have been working on ways to lower the noise emitted from our systems.”
To accomplish this goal, vendors like HK Systems are looking at higher-precision bearings, new types of roller end fittings, and even different types of rollers in efforts to produce quieter equipment. Much of this development involves making equipment with very tight tolerances. The less vibration two mating pieces have, the quieter they are.
But it’s not just the equipment that makes noise. It’s also the parts that move on top of the equipment. “When we spec a system, we even select totes whose frame and material composition is sound dampening by nature,” continues Kaffenburger. “Hard totes make more noise as they come in contact with the roller.”
In other cases, equipment manufacturers are making different selections for parts that actuate a step, replacing mechanical (noise-producing) components with electric or electronic. “We use electric switches to eliminate air exhaust in some applications,” adds Kaffenburger. “And we’re using photoelectric controls for managing zone activities.”
• Safety. Safety is an ongoing issue with standards and regulatory agencies. The Conveyor Equipment Manufacturers Association (CEMA), for example, is focusing on two areas at the moment. One involves crossover equipment. “There have to be provisions for people to enter and leave areas containing conveyors,” says Kaffenburger. “At CEMA, we’re working on coherent guidelines for conveyor vendors. Egress still requires steps. And that means there’s a need for guide and guard rails. But the types vary with load and other factors. These issues need to be standardized within the industry, because currently everyone draws different conclusions.”
Then there are ongoing safety issues. Maintenance, changes, reconfigurations of equipment all have the potential to compromise safety. In Europe, there is documentation before, during and after installation that proves system equipment is safe and installed for maximum safety. In the U.S., there are no such requirements.
CEMA is addressing this issue. For conveyor manufacturers and users, CEMA would like to introduce regulations that require such documentation. This documentation would be a “snapshot” indicating that equipment was made to safety requirements, and installed to them as well. It would help remove questions of “what was done when” if changes occurred without vendor or installer knowledge.
“It’s a way to answer the question of how do we, as vendors, prove that when we finished, we complied with all the regulations, despite changes made after the fact,” says Kaffenburger. This issue could be voted on in the fall of 2003. Another issue with safety involves PLCs. Automakers are looking into a new type of PLC called a Safety PLC. These controls are highly redundant units with lockout features and access control restrictions.
• Software issues. The need for tighter data and information security may be the “critical app” that leads software vendors to improve the quality of their products. While there are no standards for dealing with software bugs, large customers are speaking out. Both the U.S. government and Sprint are making vendors test their software and prove that it passes these customers’ security tests. It’s a step in the right direction.
Controls and systems vendors make it easy for you to comply with regulations, new and changing. So easy, you almost don’t have to pay much attention. But it’s wise to keep abreast of rule developments, anyway. MHM
Regulations To Watch
How you automate
Programming. IEC 1131 is a standard that allows multiple languages to be used within the same programmable controller. This enables the program developer to select the language best suited to each particular task. Each program is structured, increasing its reusability, reducing errors and increasing programming and user efficiency. Go to www.plcopen.org.
Warehousing. Prior to the International Building Code, selection of rack components from a catalog was sufficient for designing major systems. This process is diminishing as home center stores have put storage racks in the limelight and expanded discussion of manufacturer liability for accidents. Members of the Rack Manufacturers Institute (RMI) voted that as a condition of membership all member companies should have their products tested to show compliance to the RMI specifications, which will be the rack design code nationwide when the International Building Code (IBC) is adopted. Go to www.mhia.org/bs/pdf/75047.pdf.
Scanning. The 2005 Sunrise Date refers to the adoption of a new 14-digit bar code, a suggested standard from the Uniform Code Council (UCC). The codes will be for goods intended for shipment to the U.S. and will more closely identify SKUs. The EAN 128 Standard creates an additional character to better identify items, including adding catch weight to meat products and other weighed goods. Go to www.uc-council.org.