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Thursday, 1 May 2014

RFID standards

RFID Standards ManWhat are RFID standards?

RFID standards are guidelines or specifications for all RFID products. Standards provide guidelines about how RFID systems work, what frequencies they operate at, how data is transferred, and how communication works between the reader and the tag.

Why are RFID standards important?

RFID standards help ensure that RFID products are interoperable, regardless of the vendor or user. They also provide guidelines by which companies can develop complementary products, such as different types of tags, readers, software, and accessories. Additionally, standards help broaden markets and increase competition within the industry, which brings the prices of standardized RFID products down. RFID standards also help increase widespread confidence in the technology.


Who sets RFID standards?

Standards Organizations
Standards are developed and issued by industry-specific, national, regional, and global bodies. The more global the standard is, the more bodies are involved in its development. International organizations that issue RFID-related standards include EPCglobal (a GS1 venture), the International Electrotechnical Commission (IEC), the International Standards Organization (ISO), and the Joint Technical Committee (JTC 1), a committee formed by ISO and IEC. Regional regulatory entities that govern the use of RFID include the Federal Communication Commission (FCC), which is in charge of the United States, the European Telecommunications Standards Institute (ETSI), which operates in Europe. Other regions have their own regulatory entities.
Organizations that oversee RFID standards for specific industries include the Association of American Railroads (AAR), the Automotive Industry Standards Group (AIAG), the American Trucking Associations (ATA), and the International Air Transport Association (IATA). Additionally, the GS1 VICS Item Level RFID Initiative (VILRI) oversees standards around item-level tagging and the use of RFID technology throughout the retail supply chain.

Better weighing and dispensing technology is required in modern pharmaceutical companies


 Most pharmaceutical companies have made major inroads in applying advanced control technology to improve their manufacturing processes. However, these efforts often stop abruptly at weigh-and-dispense operations. The weighing and dispensing of pharmaceutical ingredients may seem mundane, but it's crucial. If a mistake is made at this traditionally manual point in the manufacturing process, no matter what happens later on, the entire batch may need to be thrown out or remade. Unfortunately, errors can occur when operators write information down or when other employees enter process data into a computer-based system, says Glenn Restivo, life sciences solution marketing manager at Rockwell Automation in Philadelphia. In most cases, a weigh-and-dispense error isn't picked up until after the fact. "By then," he says, "you have a wasted batch." In modernizing weigh-and-dispense operations, one goal is to drive errors out of the operation, and record data properly and accurately, Restivo says. Another goal is to use data more effectively. "Weigh-and-dispense has become an integral part of a plant's electronic batching record," observes Thomas Farenholtz, director of professional services at Honeywell Life Sciences in Herndon, Va., which offers the popular POMS manufacturing execution system (MES). "Many manufacturers today are seeking to use the data from the weigh-and-dispense operation and extend this automation toward the rest of the plant," he adds. Although new pharmaceutical plants are typically built with extensive automation and electronic controls, older plants that make established products or commodities still depend largely on manual or semi-manual data collection and record-keeping. "Most companies [use] off-line scales to prepare materials for a batch," says Janice Abel, director of pharmaceutical marketing at Invensys Production Solutions, Foxboro, Mass. "Electronic record-keeping tends to be [seen] as a want, and not a need," adds Robin Laub, account manager at Schneider Electric (Palatine, Ill.), "and record-keeping activity gets put off." Technological Lethargy Perceived cost savings often play a key part in this technological lethargy. As profit margins continue to be pressured, managers at leading drug firms are scrutinizing manufacturing costs as they never have before. A recent GlaxoSmithKline survey, for example, found that the 16 largest drug firms spent more than twice as much on manufacturing as they did on R&D. Some firms resist upgrading because such changes would necessitate a fresh review and approval from regulators. "When you want to make some changes to automate certain functions, you have to revalidate the entire control system," says Mark Liston, pharmaceutical business director at Scneider. Even the validation of the scales used for weighing materials can be problematic, says Steve Smith, applications support manager at Kistler Morse Co., a Bothell, Wash., manufacturer of weighing systems. "The cost to bring everything up to date may not be worth it to them, because they would have to revalidate the whole process." However, manual checking, testing, weighing and recordkeeping may end up costing far more than they save, opening the door for monumentally expensive, often preventable human errors. Consider the fact that 354 prescription drugs were recalled last year, a 50% increase from the previous year and more than double 1997's figure, according to the U.S. Food and Drug Administration (FDA). Recalls can cost manufacturers several millions of dollars. In addition, observers say, five to 10 percent of the medicine currently produced in the U.S. falls short of quality or other specifications and has to be thrown out or reprocessed. Even if companies aren't making weighing or dispensing errors, outmoded equipment can prevent them from utilizing data, or streamlining or automating processes. "Data collection goes hand in hand with analysis---the idea is to turn the data into knowledge to improve your process," says Steve Pulsifer, marketing development manager in the life sciences group at control systems manufacturer GE Fanuc in Northamptom, Mass. Caught between a Scylla of regulation and a Charybdis of rising manufacturing costs, more drug makers are starting to modernize their weighing and dispensing functions to reduce expenses and ensure better quality control. Instead of developing software in-house, many are evaluating control vendor platforms to improve the speed and accuracy of their weighing and dispensing functions. And many are implementing this automation in phases, says John Blanchard, director of research and principal analyst for the food, beverage, and life sciences industries with the ARC Advisory Group, a manufacturing technology research firm in Dedham, Mass. "These improvements make good business sense," says Jim Marshall, engineering team leader with Eli Lilly (Indianapolis). "Better data integrity helps the plant with uptime and to run better." FDA is providing added incentive for modernization as it revamps its manufacturing guidelines. "FDA is putting incentives in place so that pharmaceutical companies can improve the efficiency of their manufacturing operations," says Bob Lenich, business development director at Emerson Life Sciences in Austin, Texas. Weigh and dispense system begins with an operator getting a bill of materials for ingredients that make up a recipe for a batch to be manufactured. Each material must be gathered from a warehouse or other storage area. Then it must be verified as the proper material, carefully weighed, checked again, and finally readied for mixing in the recipe. Sometimes the mixing occurs immediately upon assembly of the various ingredients, and sometimes it occurs later on, with the materials being chosen, weighed, and removed to a staging area in advance. Traceability an Issue At each step, checks must be observed to ensure that the operator, the equipment, the materials, their weights---and even the scales they are weighed on---are up to snuff. All must be verified to conform with manufacturing specifications and regulatory requirements. Drug manufacturers also benefit from an all-electronic solution by having faster and more accurate data records for traceability purposes down the line. "The idea is to be able to go dock to dock with complete traceability" for a particular batch and the materials used to make it, says Daren Moffatt, pharmaceutical industry business manager for Invensys. For many companies, it would take days to get that information, adds his colleague Janice Abel. While an operator is required to handle most of the actual weighing and dispensing functions, the process automation surrounding the weigh-and-dispense routine can itself perform most, if not all, of the associated record-keeping. By moving this process to an electronic data recording system, manufacturers can eliminate the chance that an operator maintaining paper records may skip a step or erroneously duplicate a step in the process. Also, the need to collect data stored on paper records can be so time-consuming that some companies avoid analyzing the results, a decision that allows inefficiencies in the process to continue unchanged. "Invensys can capture that information at the source---at the weigh scales---and feed it back into the system electronically," says Richard Howells, vice president of marketing at Invensys Production Solutions, Newton, Mass. Invensys' Wonderware Factory Suite's Intrac component handles the weighing data. Last but not least, an effective process weighing control system or MES at this shop-floor level can be tied into the company's enterprise resource planning (ERP) system. By contrast, traditional methods used to convert paper records to computer data often are not cost-effective, requiring a clerical person to manually enter the data into a spreadsheet program for later uploading to the corporate materials management and inventory system. Electronic collection of the data associated with the weigh-and-dispense manual process goes a long way toward eliminating such errors, and by extension, waste in the manufacturing process. Electronic record-keeping ensures that operators are efficient, prevents errors, and provides a more careful check of quality at each juncture in the process. "Saving a batch because the operator was going to add the wrong material otherwise can save a company anywhere from $50,000 to $2 million,"says Lenich of Emerson, which integrates Decision Management International's software into its process automation system to offer a turnkey application for drug firms. Similarly, Rockwell's Restivo notes that his firm's RSBizWare eProcuredure MES system automates these manual procedures while both managing and documenting the process. Adds Lorenzo Majewski, product manager at Rockwell Automation headquarters in Milwaukee, the system also can be set up "to create instructions to operators to guide them through the operation." E-signatures Important One area where most manufacturers are finding significant benefits to be gained via automation is the electronic signature. Basically, instead of having the operator who selects the materials and weighs the amount of each that goes into a batch sign his or her name manually---long a requirement of the FDA--- the operator now can use a computer to perform the verification. "The operator is asked to identify himself at least with his user name and password before he is allowed to do the action he is supposed to do," explains Robert Fretz, head of corporate manufacturing execution systems at Hoffman LaRoche (Nutley, N.J.). This kind of electronic audit trail can also be a productivity tool, Fretz adds, because the traceability of a specific batch no longer requires manual searching for paper records. The Rockwell Automation system, for example, automatically enforces the electronic signature, both at operator log-in and sign-off according to the FDA's 21 CFR Part 11 standards. Integration a Concern An obvious area where pharmaceutical manufacturers are concerned is data integration. What with a compendium of different technologies to be dealt with on the plant floor, it's a wonder companies are willing to take on the sometimes monumental challenge of making every piece of hardware and software speak the same language---and smoothly. "There is a variation in the spectrum of vendors," Marshall of Eli Lilly explains. "A lot of vendors have very good standalone systems, but the difficulty is integrating them with other vendors' solutions."Fretz of Hoffman LaRoche agrees, adding, "The nightmare is that most of our systems are composed of components of different vendors. The dream is to integrate all these systems," he says. "Drug firms need to develop a strategy for integrating all these different control systems," suggests Schneider Electric's Liston. "This coordination issue is a significant burden for our customers in the pharmaceutical industry," he says. Very simply, one reason for the common lack of data coordination is that most process automation vendors tend to come into a plant, install their own system, and then leave, without concern for how well or how poorly it interacts with other existing hardware and software in the plant and at the company offices. As Liston points out, "Project management gets it on site and gets it running, but takes no responsibility to come in and fix everything and make everything work." Usually, these kinds of integration headaches become the purview of the pharmaceutical company's validation team, which must address data integration problems after the fact. Another related issue is changing old systems and old procedures to mesh with the new weighing and dispensing technology. "Basically all the procedures in place in a pharmaceutical manufacturing facility are in place to make it difficult to change anything," says Fred Doubleday, CTO of Decision Management International (Bradenton, Fla.). "It's always easier to implement automation into a new plant than an existing one." Still, weigh-and-dispense processes and systems are on the verge of significant modernization. "Now that the FDA has accepted electronic record-keeping, more manufacturers will start automating these processes," says Invensys' Howells. "Or they will be forced to do so from a competitive and regulatory standpoint.

Tuesday, 22 April 2014

GAMP Standards For Validation Of Automated Systems

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What’s GAMP?
The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by pharmaceutical industry professionals in the United Kingdom to address the industry’s need to improve comprehension and evolving expectations of regulatory agencies in Europe. The organization also sought to promote understanding of how computer systems validation should be conducted in the pharmaceutical industry.

In 1994, GAMP partnered with the International Society for Pharmaceutical Engineering (ISPE) to publish the first GAMP guidelines. GAMP quickly became influential throughout Europe as the quality of its work was recognized internationally. Over time, GAMP has become the acknowledged expert body for addressing issues of computer system validation.

GAMP's guidance approach defines a set of industry best practices to enable compliance to all current regulatory expectations. More than simply a strict compliance standard, GAMP is a guideline for life sciences companies to use for their own quality procedures. As a result, it can be tailored to a number of computer system types.

Computer system validation following GAMP guidelines requires users and suppliers to work in concert so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.” Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality product leaves the facility.

The GAMP framework addresses how systems are validated and documented, in other words “how one will validate and document the system.” Companies do not need to follow the same set of procedures and processes of a GAMP framework to achieve validation and qualification levels that satisfy inspectors. Instead, GAMP examines the systems development lifecycle (SDLC) – a conceptual model that lays out the deliverable documents required by GAMP – of an automated system to identify issues of validation, compliance and documentation.

In essence, GAMP asks:

* Do you know what you want to do?

* Have you broadly defined the function requirements?

* How will you do it?

Identifying the “how” is essential to the design and testing phases of validation. Once the design is tested, and if it works as intended, then you have satisfied not only the function requirements, but the overall requirements for system use. A regulatory body expects to see documentation of the process.
‘V’ for Validation

GAMP recommends an SDLC called the V-model (see graphic) because it is a commonly used design, but there are others that can be followed. The V-model shows how the three main qualification activities (installation, operation and performance) are linked back to the design process.

These main steps correspond to deliverables within a computerized validation framework. The left side of the V represents the specification stream – user requirements, functional specifications, hardware and software design, and module specifications. The right side of the V represents the system testing stream against the specifications. The bottom of the V indicates the code modules.
Specification Stream
With the V-model, the document that initiates the validation process is the user requirement specification (URS). The URS describes the equipment or system as it is intended to function, and it is typically written by the system user. The original version should contain the essential requirements and the desirable requirements. As part of the validation process, the organization checks the software system before launch. Clear documentation of a properly functioning system is typically found in the URS to detail what the system should do and what it could do.

Next, the URS is matched with the functional and design specifications, which often come from the system or software developer. The functional specifications describe the functions of the system and how it was built. In the V-model, the functional specifications correspond to the operational qualifications, as each of the parameters should be tested. A gap analysis is performed to identify areas where an internal requirement isn’t met. This allows recognition of risks and outlines approaches to correct the shortcomings. The design specifications define the production of the hardware, software and instrumentation and how the software meets the requirements of the functional specifications for proper function.
Testing Stream
Validation is applied to several aspects of a pharmaceutical manufacturing system. The objective is to produce “documented evidence, which provides a high degree of assurance that all parts of a system will consistently work correctly when brought on-line. Validation includes three core elements:

* Installation qualification (IQ) – confirms complete documentation, which includes checking purchase orders, proper hardware installation, and software verification according to the manufacturer’s specifications; both user and supplier share primary testing responsibility.

* Operational qualification (OQ) – confirms the system operations by testing the design requirements that are traced back to the function specifications, including software and hardware functions under normal load, and under realistic stress conditions to assess whether equipment and systems are working correctly; both user and supplier share primary testing responsibility.

* Performance qualification (PQ) – confirms that a system is capable of performing or controlling the activities of the process, while operating in a specific environment – namely, a series of checks by the user against the original requirement specifications of the system; responsibility falls solely on the user.

Though there isn’t a singular method for achieving and maintaining traceability, regulatory agencies have an essential level of expectation. Despite the lack of a standard procedure, the selected process and method used by a system for traceability should be documented and understood. The core principles of traceability link system requirements, design specifications and testing documents with the processes and supporting documentation. In other words, traceability should demonstrate that by testing the documents, one is able to verify the system requirements a nd the design specifications.

The linkage among requirements, design and testing may be identified by the following relationships:

* Multiple requirements may be checked by a single design specification and confirmed by a single test;

* Multiple design specifications may be coupled to a single requirement; and

* Multiple tests may be necessary to verify one requirement or one design specification.

Traceability may be achieved through:

* A requirements traceability matrix;

* Automated software tools; and

* Embedded references directly within documents.

Organizations use GAMP guidelines to achieve traceability by checking whether a system is:

* Appropriate in its size, complexity, impact and risk;

* Documented and approved in the validation planning stage; and

* Integral to the overall project life cycle and for the support and maintenance of the system.
Top Three Challenges
As a voluntary program, GAMP offers both challenges and benefits. The top three challenges in implementing GAMP are establishing procedural control, handling management and change control, and finding an acceptable standard among the existing variations.

Establishing procedural control is a challenge in using GAMP guidelines because new frameworks may be necessary to gauge the validity of systems. Most pharmaceutical companies have already established a baseline that adheres to standards and regulations that exist today, but they may not have a procedure to check the processes that are in place. This could cause resistance among software developers who may prefer not to work within the confines of specifications and procedures developed by others. Specifications and procedures developed by previous software developers may hinder ways to adjust computer systems, but varying interpretations of GAMP guidelines allow for multiple solutions.

Another hurdle is change control. In the development or modification of computer systems, companies with even the highest of standards can suffer setbacks along the SDLC. Sometimes minor tweaks by the software programmer, whether necessary or not, may cause breakdowns after validation changes have been implemented. Internal processes and procedures must be established to guard against these occurrences.

Whether utilizing another company’s specifications and procedures or your own, effective documentation management is fundamental for compliance. Any inaccuracies or missing information renders all other efforts moot. Moreover, implementing a formal document management application may be cost-prohibitive for some organizations. Some companies simply use what’s in the GAMP checklists to evaluate their systems. Today’s environment demands a thorough process to show validation.
Get GAMP
How do companies become GAMP-aware when it comes to dealing with the variability of process and procedures that exist in the industry? Some manufacturers that operate plants in numerous locations have established their own set of specifications and procedures to follow GAMP guidelines, and may add and drop some criteria to dictate the level of validation necessary to work with them. Suppliers reference GAMP because they’re following another company’s pre-established procedures. The customer can dictate changes to the supplier if they are necessary.

The ubiquitous pharmaceutical industry deals with not only domestic and international companies, but also a number of regulatory bodies as well. Inevitably, they’re facing some code of federal regulations along with GAMP, especially when a company wishes to export to the U.S., Europe and other parts of the world.

There are many companies that are capable of validating their systems to their specifications because they know they have to satisfy the FDA and have aligned their efforts accordingly. However, the FDA requirements are not prescriptive with step-by-step procedures, but are guidelines with an approximation of checks and balances. Some companies demonstrate validation by documenting the process to make a product consistent and repeatable to their own specifications. In some cases, companies simply follow what the customer wants. The lack of a rigid guideline should signal to companies that some give-and-take is necessary - whether satisfying customers or regulatory agencies.
What Do I Need?
If a life sciences company wishes to use GAMP guidelines to set up its validation systems, some of the elements may already be in place. Certain aspects, such as the maturity of the hardware or software, must be taken into consideration to check whether these elements are “industry proven.” To test the validity of elements in the system, the appropriate hardware, infrastructure and network must be in place. When beginning the testing environment, the test author should understand the testing environment in terms of:

* Correct hardware (peripherals and interfaces);

* Software (validated tools, software configuration);

* Data units (inputs, outputs, quality and quantity of data);

* Procedures (especially for user acceptance testing); and

* People (training and experience), (GAMP Good Practice Guide, pg. 69).

Suppliers can offer highly scalable automation architectures, which can be applied to a stand-alone one-server/one-user application, or to multiple users interfacing with multiple servers. This allows companies the ability to improve flexibility, reduce downtime and improve productivity. For example, a database system that wasn’t 21 CFR Part 11-compliant would require the company to make adjustments to the computer system to become compliant. This means the automation infrastructure must drive regulatory compliance to ensure that products meet guidelines. Likewise, OEMs are now looking at ways to provide the pro forma operational qualifications for all features in their equipment, so companies can test each of the features. Likewise, automation suppliers offer technology enhancements, as well as parts, small systems, total systems and integrated systems to help streamline the qualification process and reduce validation costs.

Typically, the costs of validating a larger system often represent between 20-25% of the total cost of the system qualification. Reducing the cost adds value to the bottom line and enables a system to go on-line faster. It makes sense to have procedures and systems in place to make validation easier.

GAMP helps companies address current issues of operational/manufacturing challenges through standardizing data, monitoring systems and validating the system.

The benefits of utilizing the GAMP approach for both users and suppliers include:

* Improved understanding of the subject with the introduction of common terminology;

* Reduced cost and time to achieve compliant systems;

* Reduced time and resources for revalidation or regression testing and remediation;

* Reduced cost of qualification;

* Enhanced compliance with regulatory expectations; and

* Established responsibility for all involved parties.

Products are available to help companies avoid revalidating an entire system when a new version emerges. Software tools focused on the life sciences industry that support cost-effective, risk-based manufacturing approaches allow companies to see what testing has been done to examine the functions within the system.

When the FDA introduced its current Good Manufacturing Practices (cGMP) for the 21st century initiative, companies shifted their approach to validation. Formerly, they only had to heed a set of rules that accounted for every piece of equipment that was used. Now they can take a risk-based approach to validation by addressing patient safety, efficacy and quality in the product considerations. In essence, this enables the industry to place its investments where it makes the most sense. The onus ultimately falls on manufacturers to accept greater responsibility to validate their systems having the attendant benefits of cost and time to market savings.

GAMP helps provide a quality product from the manufacturer, and helps to limit the pharmaceutical industry’s culpability by ensuring proper steps were placed to deliver a quality product through validated systems. By incorporating input from the full spectrum of stakeholders, fine tuning and further development of the process is geared towards benefiting the life sciences industry and the general consumer market.

The tools exist for companies to take the steps needed to reap the benefits of validation. Clearly, if you aren’t taking the necessary steps to compete, then your competitors are assuredly doing what they can to gain a market advantage. Understanding and early adoption of GAMP can increase a company’s competitive position, especially with the introduction/implementation of new technologies. By staying aware of technological innovations, companies are able to increase efficiency, minimize risks and reduce costs.

Monday, 21 April 2014

Track and trace to avoid quality control disasters

Remarkably, the vast majority of food processing facilities around Australia still rely on human beings to do the track and trace inspections
It is a critical aspect of quality assurance and food safety to identify a product at its origin and track and trace the forward movement through the entire process of the food supply chain, including food processing, filling, closure and packaging. To retrospectively identify where and when a problem may have occurred, and to date and time stamp the event, is a prerequisite.
The ability to automatically recognise defects up and down the supply chain has become an integral part of quality control in the food industry business and is a legal requirement in many processes.
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The problem is that human beings cannot, for the most part, keep pace with industry requirements for increased production speeds and increased product quality. Operators get tired, lose focus and make mistakes. This loss of concentration could result in them failing to detect potentially defective products; the criteria that they apply during inspections are inevitably subjective.
Machine vision (MV) is the technology to replace or complement manual inspections and measurements with digital cameras and image processing. The technology is used in a variety of different industries to automate the production processes, increase production speed and yield, and to improve product quality.
Typical applications of machine vision in the Australian market:
  • Code validation - confirming that all the codes on the product are readable.
  • Label inspection - ascertaining that the labels are placed correctly.
  • Label validation - validating that the correct label is affixed to the product.
  • Packaging integrity - ensuring that any recycled packaging material is adequate.
  • Filling monitoring - validating that the correct product and correct amount is filled.
  • Closure inspection - ensuring that lids and caps are positioned and tightened correctly.
  • Sealing validation - ensuring that foil covers and anti-tamper seals are present and correctly applied.

Code validation

Machine vision solutions for code inspection are used to verify code presence, position, formation and readability, and sometimes to also provide code reading and matching. Such systems can automatically identify and reject containers or packages with missing, incorrect or unreadable codes to ensure only properly coded items are produced.
Codes that can be validated are date codes, batch codes, barcodes and 2D data matrix codes, all ensuring that non-compliance can be traced and acted on.

Label inspection

High-speed labelling of products, of all types, shapes and sizes, can result in a wide variety of possible defects. These defects can lead to labelling errors that can be harmful to a brand or even present liability issues for a brand owner. Labels can be inspected for label presence, wrinkles, tears, skewed labels, double labels, flagged or missing labels, as well as incorrect label pairs (back and front) on containers and packages.
Overwrap alignment is another form of label inspection in which wraparound labels are checked for straightness and proper position. With appropriate MV system design, a 360° inspection on round bottles can be performed.

Label validation

The importance of correct labelling on a food product grows each day as scientists and doctors discover more food properties that need to be identified and displayed: peanut allergies, gluten-free, salt content - the list is extensive.
Machine vision technology for label inspection can be set up to help ensure correct labelling, and packages and containers with incorrect or defective labelling can then be automatically rejected in the production line.
Incorrect product labelling on the supermarket shelves could result in costly litigation, or worse.

Packaging integrity

Inspection of recycled packaging equipment can be easily achieved using MV technologies.
In beer bottling lines it is common practice that the beer crates are checked for wholeness, and if the crate has any damages, such as a hole in the bottom, it can be rejected before a bottle is inserted and falls through.
A further application has been implemented by a leading confectionery company in Melbourne that uses MV to check that the confectionery trays are clean for re-use before reintroduction into the manufacturing process of the next batch.

Filling monitoring

Ensuring that the correct product is filled into the correct container, and that the correct amount is filled, can be achieved using MV together with the code validation technologies.
This application is used by a global pet-food producer with process plants in Australia. Here the importance of correct filling is even higher due to the fact that much of the production is exported to Asian markets where brand reputation is paramount. Product recall, in this instance, can be very costly, both in terms of product waste and brand damage.

Closure validation

Obviously the integrity of closures and seals on bottles and other containers is important for the quality of the product and the safety of the consumer. MV systems can be used to visually check the closures and seals for integrity.
A simple application, albeit in a related industry, is using MV technology to check that the correct colour cap is placed on the correct home brand bleach bottle at a Queensland-based contract bottle filling company. And, more importantly, that the sealing is perfect - leaking bleach in the boot of a car could have some unpleasant consequences.
Checking the closure’s colour and dimensions verifies that the right closure has been applied to the container, while visually checking liner formation and placement ensures the product is properly sealed and protected from contamination and leakage. In the same way, tamper seals can be checked to make sure they are not broken.

Sealing inspection

There are many other applications where the integrity of the sealing process is paramount. The sealing of all wet food needs to be checked - any small flaw in the seal will result in the product possibly leaking contents, and the definite likelihood of the product spoiling. Additionally, tamper-proof seals can be checked for correct application prior to packaging and a photographic record kept of every product inspected.
We have reviewed a small selection of applications for the use of MV technology.  Further applications of machine vision in other markets include:
  • Checking product quality - bruises, cuts, damage to fruit and vegetables, cracked eggs.
  • Sorting fresh produce by size, colour and type - nuts, oranges, eggs, coffee.
  • Checking for defective bottles and hygiene inspection in the bottle-washing process.
  • Additional checks on bottle crates - logo inspection (correct crate for specified product), edge inspection to avoid sharp edges causing injury.
  • Fish filleting using MV in conjunction with robots.
MV technology is developing as a rapid rate, providing faster, smarter and more accurate measurements. This evolution ensures that the food industry can apply the technology to more complex track and trace applications thereby assuring an even higher degree of quality assurance and food safety.
As the food and beverage authorities tighten the regulations, MV solutions are the best way to ensure compliance.

Saturday, 19 April 2014

Automating Order Fulfillment with a New Generation of RFID

Back to the Future
If you’ve been following our 100 days of RFID campaign from the beginning, you’ve known that one of the reasons we’re doing this is to celebrate 10 years of RFID in conjunction with our upcoming anniversary.  But, today we’re getting in the time machine to celebrate 15 years of RFID.  Come along for the ride as we fire up the flux capacitor!
The year is 1995 and here’s what the RFID technology scene looked like: low frequency, which meant tags couldn’t be read from a great distance; proprietary technology, which meant customers had few options when upgrading; and higher costs, which meant trading off business benefits.
Well before ThingMagic was founded, Würth Oy, a Finland-based supplier of tools, fasteners and other industrial products, pioneered RFID’s use in order fulfillment.  This was a low frequency (LF) system based upon proprietary hardware that automated the picking process along a nearly one mile long conveyer line at its plant in Riihimaki. The point came, however, when Würth no longer could obtain parts for the proprietary hardware powering the system, so it turned to ThingMagic partner Vilant to replace it with one based upon UHF without any downtime to the picking line.
Vilant - Wurth OyThe closed-loop application features 40 stationary ThingMagic Astra readers that interrogate EPC Gen 2 passive ultrahigh-frequency (UHF) tags on roughly 1,000 plastic containers. The information collected via RFID is used to direct the conveyor belt system to send the containers to the proper picking stations. The key for Würth and Vilant was to make a slow and planned switchover so as not to incur any downtime, as over 70% of orders are fulfilled using this line, with over 40,000 RFID tracking events per day.
While Vilant successfully met Würth’s goal of moving its order fulfillment system to the next generation of RFID technology, it now can focus on taking advantage of what this generation provides them. In particular, the ease of maintenance and customizability of the system allows Vilant and Würth to innovate faster and easier. In addition, the greater performance of the system allows Würth to collect better data for quantifying how each picking station is used, maximizing the use of each station and eliminating bottlenecks.  Würth also is in position to eliminate paper from its picking process by presenting employees with electronic lists with locations for each item for even greater efficiencies.
Now that you know this company’s story, what RFID change do you think it’ll effect in the next 15 years? Or will it be closer to five years? We’re interested in your comments.

RFID-enabled Robots Create Efficiency in the Workplace

Robots have certainly undergone their share of transformation over the years – from the  stereotypical robot in “Lost in Space” to the child-friendly WALL-E – and I think Kevin Ashton, in a recent RFID Journal article, made a good point in arguing that robots have managed to shed creepy images, but have yet to make the complete transition to being human-like.
RobotsOne ongoing limitation is that robots have not been able to have a true dialogue with humans - like that between Luke Skywalker and C-3PO, who boasted to be fluent in "over six million forms of communication"! Can RFID bridge this communication gap?
A few years ago, researchers from the Georgia Institute of Technology and Duke University embarked on a project where they used ThingMagic readers with robots in a healthcare setting. With long-range read capability, the robot named EL-E can move freely while still being able to detect RFID tags in various locations, and a finger-mounted, short-range antenna enables her to interact with a tagged object, such as handing a stethoscope to a physician.  EL-E can also assist physically-impaired people, giving them the appropriate medicine bottle when they are unable to help themselves. We’ve blogged before about how improving the patient experience can also accelerate the patients’ recovery. A robotic right-hand-man could allow nurses and physicians to spend more time researching, talking to and engaging with their patients, and therefore being able to treat the individual.
Check out another robot from Georgia Tech's Healthcare Robotics Lab -  GATSBII - a PR2 robot from Willow Garage outfitted with patch antennas and a ThingMagic M5e reader, as seen on CNN’s The Big I show!

More recently, and right here in Boston, we are seeing more investment in robot technology with companies like Rethink Robotics looking for new ways to make our industries more efficient and cost-effective. Their flagship product, Baxter, is designed to fit seamlessly into a manufacturing environment to take certain types of work off the hands of employees. Because of the enhanced level of interaction between human and robot, the robot can perform risk-posing tasks such as climbing a tower to do repairs, or repetitive, assembly line work that could free up people to do more complex, value-added tasks. In doing so, people can become more productive and the business is more efficient. And we all know that greater efficiency is the key to success in today’s economy.
The video below demonstrates how Baxter interacts with humans.
With RFID tags becoming more ubiquitous , can this be the technology that breaks down that communication barrier between robots and people?
It may be a while before we can think of a robot like C-3PO as our wing-man, but with RFID we may be able to more naturally interact with the next generation of robots – not in Hollywood - but in the business arena.

Enterprise Asset Management with RFID

ARC Advisory Group recently published a report titled "RFID Enables Improvement for Mobility and Enterprise Asset Management", in which they cite a "rapid uptick" in end user plans to implement RFID solutions for enterprise asset management (EAM).  According to a survey of 65 companies, ARC reports that a growing number are planning to move away from using bar codes in favor of deploying RFID to help manage their corporate assets.  Of the survey respondents - representing more than 1,300 facilities - 12 percent indicated they were already using RFID, while 20 percent said they have budgeted to add RFID to their EAM systems this year.
RFID-enabled applications identified by ARC as being available to users to help improve their asset management and maintenance include inventory management, recording asset history, data acquisition for condition monitoring, and location tracking.  According to RFID Journal's coverage of this report, one application that stands out is the use of RFID for inventory management or tool tracking because of the durability of RFID tags compared to bar coded labels in industrial environments.
Enterprise asset management and tool tracking are applications that ThingMagic is very familiar with.  Tool Link, an innovative solution offered by Ford Motor Company and DeWALT, includes ThingMagic's rugged RFID readers and tags and is available in 2009 and 2010 model Ford pickups and vans.  ThingMagic is also partnered with Atlas RFID, supplying the RFID technology to power the Atlas RFID AMS (Asset Management System) - a comprehensive, automated asset data collection and management system that promotes the safety and security of personnel, tools and equipment. Further, Element ID, a provider of high performance RFID readers and specialty industrial automation equipment/systems, recently announced the integration of the ThingMagic M5e embedded RFID module into their UHF Series Appliances for tracking high value assets throughout a building, such as IT assets, or lab or hospital equipment.
The bottom line - Big gains in productivity are economically feasible TODAY by using low cost Passive RFID and complimentary visibility technologies.  No application is too challenging, so if you want to explore how to implement RFID to improve the management of your assets,