Standards: Are They Really Standard?

By definition, “standards” relate to “fulfilling specific requirements as established by an authority, law, rule, custom, etc.; a guiding principle.” Speaking to matters of interoperability and the reigning in of potential monopolistic business and antitrust practices, we are emboldened to look at those doctrines within which companies operate when bringing products to market. Unlike many other technologies, RFID (Radio Frequency Identification) is not a plug ‘n’ play or an off-the-shelf commoditized technology. It is, however, a fairly simple concept designed to address fairly complex challenges, such as combating drug-counterfeiting and black-marketing.

Widespread adoption of RFID has been hobbled to some degree by the slow, but methodical march toward standard development in terms of item-level application; particularly in the pharmaceutical space. In this case, adoption is acting like a double-edge sword. It can be a driver, as well as a detractor. The pharmaceutical community is smacking its lips at the prospect of tightening the lid on supply-chain security, and it is hoping to step through the looking glass into a future that holds promise for a safer and more profitable industry environment.

In the June issue of packagePRINTING magazine, we told a story of Oscar, a French bulldog who was injected with four RFID tags. (The use of RFID for the identification of companion animals, referred to as micro-chipping, is a very mature application whereby small glass-encapsulated tags are implanted as sub-dermal tracking/identification devices containing preprogrammed memory encoding. This technique offers a means for enabling accurate identification of the animal.)

Oscar received his first RFID tracking device as a pup in Australia. When the first tag was inserted, all assurances were given that it was compliant to Australian standards. Later, when Oscar’s family relocated to Europe, he received a second transponder, making the pooch compliant with the European Union “Pet Passport Program” mandate. But a local French vet was unable to read either tag, so Oscar received a third tag governed by the French standard. Oscar will receive a fourth implant when he relocates to the United States.

Standards are sometimes more complex than their name suggests. Just because something is referred to as a “standard” doesn’t necessarily confer interoperability. Often manufacturers design their own proprietary functions into what will be sold as a standard-compliant product, and as a consequence, compatibility with other manufacturers’ products is not guaranteed.

The micro-chipping of pets and other companion animals is an example of one RFID application which is struggling to implement a globally recognized standard. With the emerging international opportunity of applying RFID to the tracking and tracing of cases and pallets (Logistic Supply Chain applications), and even more critically, tracking products at item level where billions of tags will eventually be deployed, it is clear that standards do require careful scrutiny and meticulous attention.

Standardization is a complex subject. There are myriad standards groups (international, national, and industrial), generally denoted by acronyms, like IATA, CEN, ETSI, ANSI, AIAG and ISO. This alphabet soup is further complicated by an apparently random numbering of standards. Understanding RFID standardization requires some measure of structure and simplification. Among the numerous standards groups are two key bodies driving the RFID standardization process: EPCglobal and ISO.

EPCglobal Inc. is an industry standards group comprising end-user companies and technology suppliers. As a joint venture between GS1 and the Uniform Code Council (UCC), EPCglobal Inc.’s objective is to drive the global adoption and implementation of the Electronic Product Code (EPC) network across industry sectors. The EPC network will enable total asset visibility within industry and retail logistics supply chains. RFID is seen as a key facilitating technology for the EPC network and is one focus of the standardization activities of the organization.

The International Organization for Standardization (ISO) is, as its name suggests, an international standards body. It is the world’s largest developer of standards, a non-governmental organization that works with representatives from 147 countries to define standards for technology. For more than eight years, ISO has been developing standards for RFID.

In the past, these two organizations have operated somewhat independently on standards development, often with divergent approaches. However, more encouraging is that in the last 12-months there has been growing collaboration between these organizations. This is evidenced by the following: The International Standards Organization has incorporated EPCglobal’s UHF Generation 2 air interface protocol into its ISO/IEC 18000-6 Amendment 1 as Type C on UHF RFID.

In its July 11, 2006 press release, EPCglobal’s president, Chris Adcock was quoted as saying, “This is a significant milestone because it provides recognition of the work that the EPCglobal community is doing to build user-driven technical standards to advance the adoption of EPC/RFID technologies in supply chains throughout the world.”

“The publication of this Amendment to ISO/IEC 18000-6 gives the EPCglobal UHF Gen2 specification global approval and makes it available to an even wider range of applications. This was the first of hopefully many opportunities for EPCglobal and ISO to cooperate,” said Steve Halliday, chairman of the ISO sub-group responsible for the standard. Halliday is also president of High Tech Aid, an organization specializing in standards and education.

Beyond standards organizations, there are four main types or standards categories relevant to RFID:

Technology Standards ISO18000, EPC Class 1 and Generation 2 address the technological features such as the air interface communications format and data exchange protocols, which must be in agreement in order to assure compatibility or interoperability in systems produced by different manufacturers or systems providers.

Application Standards ISO10374.2, ISO17365, ISO17364 deal with agreements on the ways in which technology or systems are used, (in particular, applications that ensure consistent usage in a specified manner). Many devices only require technology standards. However, open-systems application standards using data carriers must ensure that data created at a source should be understandable by any recipients. Application standards often set parameters and associated values, which constrain the associated technology standard in terms of performance or other features. The application standard may incorporate the data standard or refer to an external data standard.

Data Standards: ISO15963, ISO15961, ISO15962. EPC Tag Data Specification Version 1.1 deals with the agreements on the way data content on RFID tags is structured for compatibility and interoperability requirements.

Conformance Standards ISO18046 and ISO18047 address agreements that specify the manner in which systems are to perform in order to be acceptable relative to particular performance or operational criteria.

Of these categories. technology and compliance standards are most relevant to the selection of RFID readers and tags. The technology standards strive for compatibility and interoperability, and the conformance standards specify those tests that may be conducted to ensure that manufacturers are applying the technology standards.

Much media coverage has been centered on the EPC technology standards; initially, EPC class 0 and EPC class 1, generation 1 specifications, (neither suitable for global implementation); and more recently, EPC Generation 2, which has been designed for international use. Overtime however, it is likely that there will be increasing visibility of the ISO 18000 standard, which was published well before the EPC Gen 2 specification and is the most comprehensive RFID technology standard available today.

Even within ISO 18000 there are choices to be made. The standard specifies RFID reader and tag communication protocols for five different RFID operating frequencies including 135 KHz, 13.56 MHz (HF), 2.45GHz, 860-960MHz (UHF), and 433MHz. Each frequency offers different characteristics and benefits based on the laws of physics governing the frequency bands. The frequencies offer differing read ranges, size of tags, robustness against environmental interference, and reliability of operation in close proximity to other tags or in random tag orientations. Two RFID frequencies are emerging as the dominant players, HF and UHF; HF for item-level tagging and UHF for case and pallet tagging. HF is covered by ISO 18000, Part 3 and UHF is covered by ISO 18000, part 6.

Today, EPCglobal is continuing to drive the standards process by forming two new standards development working groups; one focused on creating an EPCglobal Generation 2 standard for HF (high frequency) brands for addressing the needs of healthcare sector applications. The two specific groups being formed are the HF Air Interface Working Group and the UHF (ultra high frequency) Air Interface Working Group. The HF Working Group will focus on extending the logic and technology into HF that is today, part and parcel of the existing UHF Gen2 standard.

The UHF Working Group will be examining the potential for extensions to the current Gen2 UHF protocol for adding security features that are needed for item-level tagging. The item-level joint requirement group’s already established scenarios and requirements will provide the basis by which both groups will be operating. As a neutral organization founded on a frequency-agnostic vision, EPCglobal’s aim is to create an environment that ensures common data structures and command sets that enable ease and simplification of implementation.

Following work by the EPCglobal Healthcare and Life Sciences Business Action Group (HLS BAG), Mike Rose, vice president of RFID/EPC and Johnson & Johnson, said, “Our focus has always been on the needs of end users and helping them make business processes better, faster, less expensive, and more secure using EPC. High frequency performs well in certain pharmaceutical applications so it makes sense to extend the global reach of Gen2 to HF.” Rose is co-chair of the HLS BAG and a member of the EPCglobal Board of Governors.

While the organization provides oversight for conformance testing and interoperability of standards-based products, the process by which product development is actually approached is in and of itself, a logic-based approach that really embraces the authoritative stakeholders within the wider RFID industry. In short, it is the global solution providers that provide the steerage for actual product development.

In the final analysis, when viewing standards we gain a healthy respect for the tireless efforts required to keep pace with the ebb and flow of technology. We also come to understand that it’s a continual work in progress that is never in an inert state. Standards evolve as technology evolves and improves. Quoting from an article by IDtechEx, “[EPC] Gen 2 is, however, a bloated design compared to the concept of a simple read-only tag. However, it is a necessary one to bridge regional differences and provide a robust solution for the limited RFID infrastructure in place today. RFID is an evolving technology and no doubt at some point generation 3 will become the focus.”

So, it is already envisaged that a ­generation 3 standard will arrive. Standards evolution is not restricted to RFID. It is inherent to the very nature of technology where innovation leads to better ways of doing things. Adopting a “wait and see” approach for final global standardization in any technology sector will mean that you will be watching your competitors pass you by while you are still sitting on the fence, awaiting the elusive final global standard.

The best and logical strategy is to recognize that RFID standards will continue to evolve, and therefore adopt RFID infrastructure solutions which are flexible and adaptable to air-interface communication protocol changes, (i.e., multi-protocol readers). There are encouraging signs of convergence to truly global RFID standards and global regulatory harmonization. Deployments of RFID products and solutions are increasingly based on ISO standards rather than proprietary offers, cementing the broad adoption of RFID technology around the world.

A word on RFID frequencies

Steve Halliday was quoted in a recent issue of SCAN: Data Capture Report, (a management and marketing newsletter of automatic data capture), as saying: “I suspect most people have heard that RFID systems can come in UHF and HF frequencies, but do they know what those frequencies are, and do they know that there are other frequencies available as well?”

Halliday went on to describe a telephone conversation he had with an RFID supplier, which prompted him to ponder the various uses for RFID: “That really got me thinking about the range of RFID that we have available to us and the fact that one size does not fit all in this industry.”

“All of these frequencies are used for passive tag systems, and each has its advantages and disadvantages as far as capabilities and costs go,” continued Halliday.

Of course there are battery-powered active tag systems (most commonly operating in 303, 418, and 433 MHz), as well as 2.4 GHz that we refer to as Wi-Fi (see chart on p. 15). But, in terms of the pharmaceutical supply chain and for the sake of clarity within life sciences applications addressing supply chain asset tracking, tracing and authentication, as well as real or near real-time inventory management, we are focusing on passive RFID technology.

In the absence of a “one-size-fits-all” solution, when viewing RFID pharmaceutical applications, a variety of probing and challenging questions have surfaced relative to frequency and each should be closely examined on a case-by-case basis:

• Which frequency works best around liquids?

• Which frequency works best around metal and can also use metallic properties to enhance performance?

• Which frequency offers the highest and most dependable level of RAS (Reliable, Accurate, and Secure) features

• Which frequency’s physics (such as heat) make it most suitable for use with biologics?

• Which frequency offers the smallest and most flexible tag form factors?

• Which frequency delivers Six-Sigma (99.9997%) efficacy?

• Can economies of scale make HF tags just as attractive as less expensive UHF tags?

• Which frequency is best suited for item-level tracking?

• Which frequency is best suited for case and pallet applications?

• Will we eventually have a single frequency or will we see two standards?

The item-level frequency debate

In the absence of clearly defined standards we will continue to see “spin” relative to the frequency issue, and we will continue to see flourishing debates. In viewing the pharmaceutical supply chain security matter, the guiding question is what will the pharmaceutical community decree? Will Six Sigma (with 99.9997 percent efficacy) be an absolute requirement? Or, will 94-99.65 percent functionality be acceptable? One need only do the math to understand what seemingly innocuous failure rates can really equate to in terms of larger volume. In a case of 48, 4.2 Sigma has a failure rate of 17 percent, or one failure every six cases. Six Sigma, on the otherhand, has a failure rate of less than or equal to two percent, or one failure for every 6,127 cases.

About the author
Ken Reich, director of global marketing and public relations, TAGSYS, has more than 25-years of international experience. He has worked closely with engineers and scientists on launching and advancing technologies such as RFID, semiconductors, electronics, optical instruments, and power system innovations. Holding an MBA in Marketing and a BA in Communications & Journalism, Reich has published major works focusing on integrated marketing strategies and tactics in the global B2B marketplace.