Barcodes Comes to Healthcare …… Finally!

Category : Uncategorized

I know.  Some find it hard to believe that healthcare does not already use barcode. Thankfully,  now , like your local supermarket did in the 1970’s, healthcare has finally embraced the use of globally standardized barcodes.  This major change comes just in time to help improve patient safety, combat counterfeit drugs and reduce healthcare costs.

The move was prompted by the FDA [i]and coordinated with other governments regulators around the world. The first clue the consumer will see is called the UDI (Universal Device Identifier). It will appear on several million healthcare items and can take various forms in barcode or even be in RFID (radio tags) as well.

Unlike our retail barcodes, which only have a product identification encoded, UDI’s can contain a product ID as well as the specific batch number, serial number, expiration date, etc. for the package.  All are important for safe use, tracking and to help in the event of a recall.

Compliance – Quality – Content

Those of us that use the self-checkout lane at the market know that some barcodes can be hard to scan or even un-scannable. These scanning problems are caused by out of spec barcodes.  This is, of course unacceptable in healthcare[ii].  The UDI must be accurate and readable by all the various scanner types expected to be used.  To make that happen, manufacturers are required by regulation to meet standards[iii] for print quality, size and content.  Like other manufacturing quality characteristics, records are kept for review by internal and external QA personnel.  Regulators around the world issue warning letters to manufacturers and many of those relate to the labels.  Barcode and barcode quality is new and complex for many manufacturers. However, it is the binding technology between the physical and digital worlds we live in and vital that it be done right. It may be best to get some outside help.

Is 100% inspection required?

The answer to this question depends on a few things. The most frequently used printing technology for on demand variable barcode printing is called thermal transfer.  When used correctly, this digital printing technology is up to the task.  Other printing technologies may be somewhat trickier to use. Manufacturers will evaluate their current printing capability with SQC (Statistical Quality Control)[iv] to determine if it can be used without inspecting every label individually.  In either case, Good Manufacturing Practices require that the printing process be used according to set procedures. [v]

So, the answer then is usually a qualified NO – 100% inspection is not usually required unless the printing technology is not capable or inconsistent or if you can’t follow procedures for dependable use.

In healthcare, barcodes can contain multiple fields of information.  There are additional rules associated with how that data is formatted and its contents.  That is an additional inspection that would be wise to perform since a barcode that is not formatted correctly is as bad as one that can’t be read at all.

Where Are We Now

Manufacturers have already started to mark their products.  Hospitals are already starting to make plans for changing over to the UDI system.  It will take a bit of time to build up the database (1.3 million as of 2/1/17) and the quality of marks and content and add the new processes at the hospitals.  But this important change will bring a significant positive impact to our healthcare system for many years to come.

Contact us for more information.

[i] FDA Announcement and Objectives http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/

 

[ii] FDA Quality Systems http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

 

[iii] Excerpt from GS1 Specifications – a FDA UDI issuing authority

Symbol(s) specified (*) X-dimension mm (inches) (**) Minimum symbol height for given X mm (inches) Quiet Zone Minimum quality specification
  Minimum Target Maximum For

minimum

Xdimension

For target Xdimension For maximum X-dimension Left                          Right  
GS1- 128 0.250

(0.00984″

)

0.495

(0.0195″)

0.495

(0.0195″)

12.70

(0.500″)

12.70

(0.500″)

12.70

(0.500″)

10X 10X 1.5/06/660
GS1

DataMatrix

(ECC 200)

(***)

0.380

(0.0150″)

0.380

(0.0150″)

0.495

(0.0195″)

Height is determined by X-dimension and data that is encoded 1X on all four sides 1.5/08/660

Note that minimum quality is shown as ISO grade/aperture/wavelength

 

[iv] Using verifiers to get  SQC information – SCANALYST 3

[v] GMP – How to use thermal transfer printing correctly to comply with labeling requirements


GMP – How to use thermal transfer printing correctly to comply with labeling requirements

Category : Uncategorized

Why you should care

In the last few years compliance with supply chain specifications and barcode print quality standards has jumped into the spotlight.  Companies are now aware of the importance as they seek additional productivity and they enter new markets and support new applications. Almost all markets now have their barcodes under quality compliance requirements.  The reason is quite simple, it is just too expensive to handle products that can’t be scanned.  Product that can’t be scanned as it passes through the supply chain becomes very expensive and a problem for both sender and receiver.  The good news is that you do not have to cause problems, you can verify that your quality is good and protect yourself from penalties and lost customers.

How to do it

This deals with variable data type printing where the information in the barcode can change from label to label, day to day etc. The most often used printer for variable data label printing is thermal transfer.

Start with a good printer.  The options are really wide.  From a battery powered portable, to a desktop or to a heavy duty industrial grade, from a few hundred to a few thousand dollars. You generally get what you pay for and it really unwise to use one of the low-cost printers for a high-volume task that requires quality.

Add a good label design that has all of the elements required and has been verified to confirm that the barcode is an ISO grade 4 (or at least a 3) using a baarcode verifier. Thermal transfer printers can produce high quality and it is a good idea to start out at the best possible grade. The verifier will show what quality parameter is weakest so you can adjust your design accordingly. Good label design software will make this a bit easier.

Use good proven supplies such as labels and ribbons.  Test barcode quality using your supplies and if good (ISO 4 or 3) and they stand up to expectations (no smear, tearing, etc.) then stick with those supplies.  There really are big differences between supplies. If you have to change supplies, test the new supplies on your printer using a barcode verifier before committing to a problem.

Line up good support for your printing process.  This is important.  Make sure  everyone knows that you are expected to produce minimum print quality grades (usually 2 or higher) to be in compliance.  They may be able to help you achieve the best grade or at least test the grade before returning the repaired printer to service.

Set up procedures for the users to follow that will help insure compliance.  These might include verifying quality before and after a run of labels or after a shift change, daily, etc.   Testing after changing ribbon or label rolls and after cleaning and maintenance is important because this is when most problems start.

Make it easy to do a good job.  The only way to be sure you are printing barcodes that are in compliance is by using a barcode verifier. Make sure you have provided the printer operators with convenient tools to do a good job.

 


Using verifiers to get SQC information – SCANALYST 3

Category : Uncategorized

Statistical analysis methods are used to determine if a products quality parameters are acceptable. If you are marking your products with a barcode then the quality of that barcode is measurable and well defined in the ISO standards. All barcodes are described technically in ISO documents. The descriptions include how to encode, decode and inspect for quality.  The quality inspection for all follows a template established in 1990 that evaluates and grades a barcode based on important quality parameters. A barcode verifier is used to measure these parameters. They are mathematically calculated from measuring a ‘scan profile’[i] of the barcode. A scan profiles grade is the lowest parameter grade for that profile. Ten scan profiles are taken for each barcode tested and their average is the overall grade for that barcode.  That is the grade typically specified in industry standards for ‘Minimum Acceptable Print Quality Grade’.  The common minimum is 1.5 or higher. You do not want to produce barcodes below that grade level because it will most likely make it difficult to scan with some scanners.

So then, how do barcode producers make sure they are not violating the standards?  There are 2 ways:

  1. 100% inspection – usually only necessary when the printing process is not performing within acceptable ‘control’
  2. Use Statistical Process Control Methods (SPC or SQC) to establish that the printing process is within tight control and then, periodic sampling and related production procedures

To determine which is best for you, the first step is to determine if your printer is capable of maintaining a tight control of the barcode quality parameters.  To do that you can verify a set of sample barcodes using an ISO verifier.  These will show detail on the measurements for the quality parameters.  Record the details for each parameter[ii] including the % shown as well at the numerical grade.

Plot the percentages for each parameter in a
chart. The shape of the chart will typically show a bell shaped curve from which you will be able to see how
well a particular quality parameter is maintained.

Some printing processes have difficulty, but fortunately, one of the most widely used types is quite capable.  Thermal transfer printers can produce grade 4 (the best) very consistently if used correctly. Start with a good label design (where the barcode is Grade 4), use labels and ribbons that have been tested for use on your printer and finally, verify print quality before and after each run/lot/shift/day to ensure you are still in compliance.  The same is true for printers that have been serviced or if you are changing suppliers of labels or ribbons. These periodic inspections should be part of your published production procedures and a detailed record should be kept.  The initial printer capability study, the periodic inspections and the published production procedures form your GMP for barcode printing.

If you have any questions, please give us a call or send an email.

 

[i] A scan profile is a record of the reflectance values measured along a line across the width of a barcode.

 

[ii] If you are using SCANALYST you will find all of the parameter detail in the database


A Second Chance to Make a Good First Impression

Category : Uncategorized

Most Class 3 and Class 2 medical device manufacturers have now completed the UDI submission process for listing their products in the GUDID, the FDA’s catalog of medical devices.

This marks the beginning of a big change in the medical device industry.  There are now over a million medical devices listed in the database.  There are expectations that this new standardization will help improve care, reduce costs, speed development and approvals, etc.  After waiting and thinking about it for a few years, there is now a small army of medical professionals working on the details of how to apply this important tool to improve their work.

This is a chhand-shakeance to make a new first impression.

Imagine the opportunity!  A $200 BILLION market making a transformative change, looking for those suppliers that will be the leaders in the future.  These leaders will have recognized the opportunity and embraced the change.  They see a chance to improve communications and want to get much closer to their market and their customers. They see a chance to collaborate and improve performance. They can see the inevitability of this being their payment method as well. They know the importance of getting a good start and doing it right.

They also see that now is the time to tune up their internal processes and prepare for the road ahead.

Problem

One aspect that plays the key role in the system and is quite visible but, ironically, is often overlooked is compliance with the UDI product identification standards.  They are extensive, dry and technical for sure.  They are often misunderstood, less often ambiguous but almost always seem complex. However, they are the tool that will get us from here to there.  On the way toward use, you can expect your products to be scanned more often than ever, by a much broader range of scanners, within automated conveyor and robotics systems, and finally by an impatient customer.  Without compliance to the product identification standards there will be no rewards, just problems. Products that do not comply will become visible to the community and those responsible will pay the price in lost credibility, lost customers and possibly worse.  The risks are high, but fortunately these problems are avoidable.  The ‘getting the right product in the package’ and ‘the right text on the package’ are pretty straightforward because anyone can see them with their eyes if they look. Let’s jump to the really difficult bits, the machine-readable identitydm-and-128 that people cannot check with their eyes and do not intuitively understand, the barcode and/or the RFID.

Solution

There are 3 main elements to checking the UDI barcodes:

  • Print Quality-ISO – This is a check to insure your barcodes can actually be read by the end users. You can’t test and grade a barcode by using a simple scanner. You need an instrument called a verifier. This will grade your barcode on a scale of 4 to 0 (good to no-good). The minimum grade for UDI is 2. This grade will allow your barcodes to be read by all in the distribution of your products and in the final
    use transaction as the UDI is scanned into the patients EHR and the CMS documents. There are different barcode sizes for different applications. One that is too small for the application will not be scannable.   This check is not optional.
  • Data Content/Format – The UDI is a multifield identifier. It can carry a lot of data about the product. To communicate that data accurately (or at all) there are content and format rules to follow.   Product ID, lot number, serial number, expiry date, plus another hundred or so fields are possible. Each field has a set of rules and may have some hidden unprintable characters.  It can get tricky and a mistake means that the barcode is useless, even if it did scan. Obviously, this check is not optional either.
  • FDA Guidelines – Keep in mind that UDI is a program expected to take a few years. Along the way there will most likely to be a few things learned. Opportunities and challenges resulting in minor tweaks to the program. For instance, a recent guideline talks about the necessary order of the AI’s in the barcode data stream. Some guidelines are indicated as optional but may be quite important to your customers.  It can be worthwhile to follow the guideline even if it is optional or at least to check with your customers.

Important to do it right

There are now 6 BILLION barcode scans per day and growing. It is also important to remember that the smartsmartphone-scanningphone is now used as a scanning tool by billions of people around the world. That means your products barcodes and the associated data are readily available to a whole new, very large, group of people.  As you know, when you see a barcode, you expect to be able to scan it.  If you can’t scan it, you know something is wrong and you will get suspicious.  Counterfeit or ?  You will need good print quality to let them scan it at all and need good content and format to provide them with the information they may be looking for.

The same is true in the healthcare provider community. A nurse’s primary responsibility is to deliver patient care.  They have no tolerance for a poorly done barcodes, incorrect barcodes or multiple barcodes on the product. Those extra ones on your package may be needed in your production or in another geographic market but they sure add to confusion at the point of use. Nurses need barcodes that simply work. They do not want to scan a few times until they get the right distance and angle.  They do not want to scan multiple barcodes until they finally get the right one. They just do not have the time to do someone else’s quality control.

Compliance is very important if you want to take advantage of this opportunity to create a great first impression. We can help you.   For more information about this or to see our systems, please contact us. www.scanalyst.com

Finally, if you are a supplier of printers, supplies or maintenance to a medical device manufacturer then this is a second chance for you to make a good first impression as well.  If you are interested in stepping up to meet the challenge of this or other mission critical barcode applications, please contact us.

To see more about tools for compliance, please check out  http://www.scanalyst.com/how-to-buy-a-barcode-verifier-in-2016/


Recalls and traceability

Category : Uncategorized

There have been a lot of product recalls in a wide variety of industries over the past decade.  The Samsung recall is a bit different. It is huge and it can really, really hurt someone. Yet, on the surface you would think that it would have been made to be at least quite limited if not avoidable.

Just look at the numbers, a few hundred incidents with millions in use. Now look at the potential causes, battery chemistry and battery construction.  This may turn out to be a problem caused by more than one factor but it does seem that traceability of batches of batteries to the phones they were installed in would have saved Samsung a few billion dollars and their reputation.

Could this happen to you?  Time to review what’s happening in your supply chain?

http://www.wsj.com/articles/samsung-recall-puts-supply-chain-oversight-in-spotlight-1476224149

 


Another example of why healthcare needs a strong barcode culture

Category : Uncategorized

Recently a hospital patient in Massachusetts had one of his kidneys surgically removed. The surgery and the loss of a kidney was a mistake and was not necessary.  The patients’ records had been confused with another patients records and the result was the surgery and the unnecessary loss of a kidney.

The regulators are putting the facts together on how this happened.  Clearly, there was a lot of human error involved.  All of the checks and double checks did not seem to work. Sometimes you just have to accept that we are all human and that we do make mistakes. However, you have faith that the system will catch the mistakes before any damage is done.  In this case, and many others, the error was missed, the system did not work and the damage was done.

This incident, and probably many others, could have been prevented by building healthcare procedures that use standardized barcode printing and scanning.   Patients ID, CT scan results, lab results, medications, medical devices should all carry easy to scan data that can be used by computerized healthcare delivery systems to prevent this type of error.  These modern methods are proven and now have to become part of our healthcare systems.  I encourage the regulators to consider the fact that appropriate use of barcode and computer technology would have prevented this and other adverse events in healthcare.

http://www.telegram.com/news/20161013/faulty-id-methods-led-to-surgical-error-at-st-vincent-hospitalblogUDIhelp


Best Practices – in-process labeling

Category : Uncategorized

Best Practices for barcode verification of in-process labeling – some tips

1. If you have a printing system that you can confirm is in good working order and producing ISO grade 2 or better (using an full-ISO verifier)

2. And that you can confirm this particular printing system is ‘in control’ – meaning that there is a small and predictable variation not effecting outcomes (determined using an full-ISO verifier)

Then you can include procedures in the process that:

1. Has the operator produce and test a sample label (using an full-ISO verifier) before the run starts – record the detail to a database for proof and reference later – include the batch or lot info as well as the time/date, operator ID and printer ID.

2. After confirming acceptable results in the test above, run the batch of labels while having the operator observe the system to see if there are issues during the run. Periodic confirming tests with the verifier are recommended. Again, the test results should be recorded in the database (some verifiers can do this automatically). In addition, a visual guide such as a horizontal line somewhere on the label can give the operator a clue if the printhead has burnt out or if it needs to be cleaned.  Be aware that the operators visual inspection is not a substitute for the test with a verifier.

3. At the completion of the run, perform a final inspection with the verifier of the last barcode produced.  Again , the results must be recorded.

 

If you do not have a verifier and need one or would like to know more about them, here is a handy guide to sort through it all and get you on track for success. http://www.scanalyst.com/how-to-buy-a-barcode-verifier-in-2016/


Blog – How to Buy a Barcode Verifier in 2016

Category : Uncategorized

How to Buy a Barcode Verifier in 2016

Barcode verification is famous for being complex.  Some of the newer verifiers have done a good job in making it easier and we have tried to make choosing one for your needs easier as well.  This article is intended as a guide to help simplify that decision for you and your company.  We bring out some of the considerations and features that are important today so you can identify your needs and then do some shopping. This covers full ISO verifiers only.  For information regarding on-line or partial ISO verifiers, please contact us.

If you are in one of the many businesses that are already familiar with barcode verification and use it in your practices and processes, then you might skip over the “Why you should use one and How it works”.  Otherwise, if you need a refresher you can go to the end for the “Why and How”

Buying Guide

Picking the right tool for the job

tool tall

Which verifier is right for you?  Well, it depends.  Here are a few important questions.

What type of barcodes do you want to verify? Does your company print Linear barcodes, 2D barcodes or both? There is a definite move toward 2D barcodes that can carry more information.  You may only print linear codes today but tomorrow you (probably?) will have to print 2D barcodes as well. In addition, there is also a move toward serialization and traceability that is increasing the installations of Direct Parts Marking 2D barcodes. These are printed with lasers, inkjets or dot peen directly on the product surface.  Buy what you need but look forward a bit so you don’t have to replace equipment in a few months.

Barcode Types Linear 2D and linear DPM All

 

What size is the barcode you need to verify?  Width and height for barcodes vary quite a bit but this is important because it will determine what Field of View (FOV) you require on the verifier you purchase.  Linear barcodes typically require the largest FOV, 6.5” for GS1.  It would be unusual for a requirement larger than that but if you have one just let us know.  You might be surprised how small an area some verifiers check.  They may have been designed for small 2D barcodes and will not be able to check some of the larger linear codes you make. To get a wider FOV, they require you to purchase extra camera modules.  The extra expense comes with extra complexity and work for the user. Shop for a verifier that does all of your verification requirements so you do not have to purchase extra modules or a second verifier with a wider FOV later. Camera based verifiers that have an adjustable focus allow you to adjust the field of view. You can close in on smaller barcodes and back away to check the larger ones.  This has the added benefit of getting the camera resolution working most effectively for you regardless of barcode size. Most companies will be producing (and eventually verifiying) both large linear and small 2D barcodes.

Field of View Small –

2D and UPC

1.75”

Medium –

Big UPC

4”

Larger –

6.5” plus quiet Zones

Infinite –

Camera based with focus and FOV  adjustable

 

Where are you going to use the verifier to verify barcode?  To meet your customer needs for barcode quality, verification can no longer be some little-known function performed in a laboratory somewhere.  You will be checking more frequently and taking the verifier to the processes that make your products or perhaps to a customer warehouse.  There are verifiers that are light and easy to use portably, unencumbered by dead batteries or the need for a power cord.  This could be a significant consideration as you expand and manage your quality.

Portability Not portable > > Small and light, rugged, no power plug required

 

Are you in an industry group that has barcode standards that you must follow? Retail, Food, Healthcare, Manufacturing (auto, etc.), DoD, Electronics all have added requirements beyond barcode print quality. Almost all segments are increasing their use of and reliance on barcode for new industry efforts toward reduced costs, improved productivity, traceability, etc. GS1 has a comprehensive standardized communication layer that uses a barcode as a multiple field data record defining the product and its characteristics.

This is an important consideration because the industry standards are extensive, can be complex, will lead to error if not checked and compliance is expected.  If the barcode content is not formatted correctly, the customer cannot use it. Kaput!  The interpretation of the barcode content relative to the application standards is probably the second most important consideration for a verifier buyer. Your current verifier most likely does little checking in this area but most of the newer verifiers do.

Industry standards Not available Not included > Available and included

 

Is the barcode printed on a label, on packaging or on the product itself? Is the barcoded surface flat?  Is the package sealed or overwrapped after? When a barcode is printed on a curved package it cannot be verified using a flat-bed type (fixed focus, contact) verifier.  The same is true of packaging with folded panels. One of the panels contains the barcode. If you check the packaging unfolded it may pass but once you fold it to enclose the product you may not have adequate quiet zones as an example.  It is always best to verify your products barcode just as your customer’s scanner would see it.

Verifying the package as it appears to the customer’s scanner may reveal and help eliminate a lot of problems.  This is referred to as In Situ inspection

In Situ inspection? No – flat bed scanning > > Yes – non contact scanning

 

Are you in a regulated industry like healthcare or make products with risks if they cannot be scanned?  If so you will probably require record keeping. Regulatory agencies expect to see detailed records as proof of your inspection practice. Anything less than detailed dated records are considered to be ‘just a rumor’. If you have multiple inspection locations or printers, then you may want all inspection records kept in a central database. That will facilitate GRC applications.

Record keeping of inspection details is important to those responsible for continuous improvement of their processes and as an aid in purchasing new printing systems and supplies that can comply.  Engineers refer to this as Statistical Process Control (SPC).  It may reveal a way to save a lot of capital.

Records No, by hand or just printed paper tape > > Full database with user defined fields

 

Are you using standard applications for email, spreadsheets, etc.? You will find it easier and more effective to send out the detailed inspection information directly from the verification software rather than having to take a picture of the barcode then scan in the verification report.  Also, if the database containing the inspections can be looked at and manipulated through common applications such as a word processor or spreadsheet application, the data is more useful and therefore more valuable.                                                                                                                                       

Integration – Emailing and spreadsheet analysis no > > Embedded email client and an open database

 

Do you collaborate with others to solve problems fast and effectively? It is the best way to get things done and that is especially true with barcode verification.  The addition of detailed parameter reports, scan profiles and especially images of the barcode area are key to getting everyone involved on the same page quickly and working toward a solution.

Collaboration tools No – manual > > Full image of barcode area and detailed report

 

Do you feel that you may need upgrades in the future? Perhaps today you are only using linear barcodes but you want to have the door open to using 2D barcodes in the future.  Will your verifier be able to be upgraded when you need the extra capability?

Upgradeable No > > Yes

 

What about training and support? Very important. Like many, you may have been printing barcodes for decades and you now find a need to build up your company’s competency in barcode verification. No matter how good a verifier system is, it is always good to be able to get help from a knowledgeable person who has your back.

Training and support No > > Yes

 

Could this become the company standard? You might look at a verifier you are considering and ask ‘Could it become the company standard?’  , ‘Will this model do 90-95% of everything we do?’.  Finding a company standard provides big long term and short term advantages such as training and support as well as reducing initial costs and operating costs.    

Company Standard No > > Yes

 

And of course, cost! The important thing is to identify what you really need and then do your shopping. You can expect to pay $3000 to $14,000 for a barcode verifier, with most falling into the $4000-$7000 price range with varying capabilities. There are certainly discounts available.  Remember what they say, ‘It is bad to pay too much but may be far worse to pay too little.’

Cost > > > Suits your needs and is a Great value

                                                                                                                                                                                                               

Summary

Well, I hope you can see how verification fits into your business and how some of the considerations above could be important in your decision making. With the added difficulty of complying with complicated industry standards and the need to maintain records for regulators as well as the new barcode types, it is a good time to full review. All you have to do now is to prioritize what is important for you and do a bit of research to find the best candidates.  Some of the comparisons may have already been done for you. If you would like you may contact us via mail@ais-co.com or 614 431 3300

 

Verifier Feature

Possibilities

                                 >      Good            >     Better              >           Best

Types of barcodes it Verifies .. Linear  And 2d DPM All
Field of View Small Medium Larger Large and adjustable
Portability Not portable > > Small and light, rugged, no power plug required
Industry standards Not available Not included > Available and included
In situ inspection? No – flat bed scanning > > Yes – non contact scanning
Records No, difficult or just paper > > Full database with user defined fields
integration – Emailing and spreadsheet analysis no > > Embedded email client and compatible database
Collaboration tools No – manual > > Full image of barcode area and detailed report
Upgradeable No > > Yes
Training and support No > > Yes
Company Standard No > > Yes
Cost > > > Great value

 

 

The following is reference materials.

The Why and how of barcode verification

Why should I buy one?  The answer to that question will help you decide on what type to purchase.  Barcode print quality verifiers were first designed in the 1990’s to implement ISO standards for inspection and grading.  It is an inspection method used to predict how well your barcodes can scan.

The early versions were a bit difficult to use and were relegated to the techie tool chest. Through the years, barcode became the key to improved productivity and data collection, the language of business. With the gradual maturing and growth of barcode standards from GS1, DoD, AIAG and other associations, barcode print quality verification became mandatory and verifiers became easier to use and equipped with more features to manage compliance. Today, the only reason to not verify is if you do not need the barcode to be read!  Verification is the only way to determine if and how well your barcodes can be read by others. Some will make the mistake of assuming that if they can scan it with their scanner then their customers scanner can as well. Not true. See Scanning vs. Verification below.

Today it is very important to get barcodes ‘right’ because barcode is relied on as a primary method for accurate information. It is very good so everyone expects that barcodes can be scanned and they are building infrastructure on that assumption.  An automated warehouse conveyor system with an unattended scanner used to receive your product; a robotic or manual picker scanning your product to select it for an outgoing order; a shipper using a hand held to scan labels and create a manifest; a nurse scanning a pharmaceutical barcode with a cell phone to insure it is right before it is given to a patient; all have an expectation that the barcode can be easily read and that the data it contains is correct. To see how well your company fits into your customers’ future take a look at verification grades.

ANSI Grade (ISO)

Significance

Comment

A (3.5 or better) This should scan on the first pass almost instantaneously. The best place to be. You have room for common variation due to production or handling.
B (2.5 – 3.5) Will most likely read after 1 or 2 scans Minimum for most heavily automated manufacturers. Recommended as a target grade for automated conveyor scanning or robotics.
C (1.5 – 2.5) The minimum quality usually specified – may take a few scans to get a read Minimum for most standards organizations such as GS1, DoD or AIAG
D (0.5 – 1.5) Because of low contrast, ITF-14 bar codes printed on to fiberboard are allowed a D Grade May cause difficulty with some scanning hardware. Some may think it is a ‘scanning problem’ but it really is a ‘printing problem’
F (0 – .5) Fail – do not use Although it may scan sometimes on some scanners at some distances at some angles in some lighting, it cannot be relied on to scan and should not be used.

Even if you have not heard any complaints it is possible that you are causing problems for customers and they just haven’t figured it out yet. Most customers spend time and money to improve their supply chain execution. When they find weak links they issue a warning, a chargeback or drop them as a supplier.  Customers consider the barcode as part of your product but if they are having difficult with your barcodes, it is almost like you do not have a barcode at all.  Do you think it is possible to sell a product without a barcode today? Barcode quality is essential for the efficient distribution of your product and for its correct and safe use.  And now for most, it is now mandatory.

How does verification work?

The inspection methods used for barcode verification are contained in the various ISO specifications covering barcode types.  ISO/IEC 15426-1 (CEN/ANSI in the USA) covers linear barcodes. This specifies that to verify a barcode you read a narrow path through the bar code and convert reflected light into a Scan Reflectance Profile: bars are represented by troughs and spaces are represented by peaks.
prof5

You do this 10 times for each barcode symbol. Barcode verifier software analyzes the information in the scanblogprintingbarcode profile to measure and grade parameters that affect the barcodes quality (ability to be scanned).  Parameters such as Edge Contrast, Modulation (MOD), Minimum Reflectance (Rmin), Maximum Element Reflectance, Non-Uniformity (ERN), Element Reflectance Non-Uniformity (ERN max), etc. are graded for each of the 10 scan profiles.  The lowest parameter grade is the grade for that profile and the average of the 10 profile grades is the overall symbol grade. (Don’t worry, this is all done in the software for you!) The resulting overall grade is predictive analysis of how well that barcode can be scanned.  These basic inspection methods have been practiced successfully since the 1990’s.  It is a technically sound method and works effectively in practice.

 

Scanning vs. Verification

There are many different types of barcode readers.  Lasers, CCD’s, Pens, contact and non-contact, imagers, line scanners and of course cameras similar to your cell phone camera. Behind each of these readers there is a variety of software used to interpret what the reader has seen.  Multiply those two variables then again by the number of different manufacturers and their different models over the years and you will begin to see the scope of scanning today. There are literally thousands of different scanner types and configurations in use.  Ideally, you want all of those scanners (customers really) to be able to scan your barcodes.

If you ‘test’ your barcode quality with your scanner, the only thing you will have learned is that your scanner can read it.  You will not know if your quality objective has been met, that your customers will find it easy to scan your barcodes and that you are in compliance with standards.

The standards are established, mature, well known and globally supported.  Verifying and being in compliance provides the security of knowing that any customer in any location using any scanner will be able to use your barcodes as you intended.

 

 

 


blog – OMNI-CHANNEL

Category : Uncategorized

Barcode Verification and Omni-Channel Shopping

It is no secret that a lot of retail sales are moving toward online sites. It seems like we will eventually strike some balance between sales thru physical stores and sales thru their online counterparts.  Omni-channel shopping is one of the variants where a customer will order a product online from a retailer and pick it up at their local store from that stores inventory.  This offers shoppers the convenience of online shopping and the added convenience of almost instant access to the product they want.

Although there has been an increasing call from retailers for vendors to improve their compliance with barcode standards, the move toward Omni-channel shopping really ups the ante. The reason is very simple.  The retailers store inventory has to be near perfect to allow them to confidently offer it for sale online.  Just imagine how a customer would feel if they purchased an item online, went to the store to pick it up and found that they did not have it.  The retailer would most likely lose the sale and the customer.

So then, what does it take to be successful?  At least one of the ‘must do’ items is to tighten up your companies use of barcodes for transactional information.  If you are finding that:

  • Some barcodes cannot be scanned and manual key entry is required
  • Some barcodes are difficult to scan and it takes a few seconds of trying before you get it
  • Some barcodes contain the wrong information

Then you most likely have a vendor compliance problem which will impede your Omni-channel execution.

What to do? Barcode verification is the key. It is a predictive analytic tool that will grade a barcodes ability to be scanned.  This means that barcode problems are not inevitable. They can be prevented.

It turns out that almost 90% of ‘scanning’ problems are actually printing problems.  If you attack the real problem (printing poor quality barcodes) by requiring vendors to use barcode verification, you will resolve the problem.  This is best done in a proactive approach.  Some of the elements could include:

  • Write your purchase contracts to include a statement requiring ‘compliance with industry standards’ and point to the appropriate document (retail is GS1). Quality is now mandatory. Most standards require a Grade C or better. This quality level will provide barcodes that can easily be scanned on automated conveyor systems and by even inexpensive hand held scanners. They will read in a ‘snap’, virtually instantaneously.
  • When a new vendor is being set up, ask for a representative label sample. Verify the barcode on that sample is in compliance both for quality and content.  The new vendor should be easily able to produce a Grade A or B label for this initial sample. Keep that verification record on file for future reference. It may help when an issue arises.
  • Verify the ‘problem’ barcodes that you are already aware of. These are the very worst of the group and probably represent just the tip of the iceberg but they have to be taken care of.  You will find that these barcodes do not follow the standards and could be in the Grade F area.
  • Set up a reoccurring inspection where a random sampling of barcodes is verified, even if they have not been causing any apparent problems. You will most likely find that many are in the F or D range. There may not be any reported problems in this group but you are not getting the quality specified to keep your systems operating efficiently. Scanners on conveyors will not be able to read the low grade codes on the first pass which may mean they have to be handled manually. Cashiers and warehouse pickers using hand held scanners may take a few extra seconds to find the right distance and angle to read a barcode, if it reads at all.  These are real costs!  Let all your vendors know that you are checking and remind them of your need for quality …. And their responsibility.

ANSI Grade (ISO)

Significance

A (3.5 or better) This should scan on the first pass almost instantaneously.
B (2.5 – 3.5) Will most likely read after 1 or 2 scans
C (1.5 – 2.5) The minimum quality usually specified – may take a few scans to get a read
D (0.5 – 1.5) Because of low contrast, ITF-14 bar codes printed on to fiberboard are allowed a D Grade
F (0 – .5) Fail – do not use

 

Even if you are not involved with Omni-channel shopping, it is always good to be above the fray. There are enough challenges in retail without adding ‘bad data’.  That one can be fatal.


Blog – Our History in Barcode Verification

Category : Uncategorized

Barcode Verification

AIS’s Involvement

Mid 1970’s – We helped with the “golden turkeys” problem in random weights.  This may have been one of the very first barcode quality issues.

1980’s – Resolved various barcode print quality issues for clients in 1980’s with various printing technologies – inkjet, dot matrix, impact hammer/drum, thermal and thermal transfer

1990 ANSI specs are finally released.  This was long awaited since there were known problems and no published verification standards.  There were actually several competing (and really different!) barcode verifiers on the market already.

1992 – SCANALYST prototype constructed – This prototype, which laid the groundwork for future generations of SCANALYST, was designed to work with Quick Check and RJS Verifier hardware.  The system was designed with retail and manufacturing sectors in mind and provided users with barcode standards training as well as provided onboard barcode standards training and database reporting tool

1993 – SCANALYST becomes a Windows application – With the operating system move came a new highly graphical user interface and an extensive new HELP system.

2003 – AIS reached over 1,500 SCANALYST users all around the world.  SCANALYST was being distributed by verifier manufacturers as wells as resellers.  In total, there were 5 versions available; SCANALYST, SCANALYST Xchange, SCANALYST Lite, SCANAuditor and QCViewer.

2005 – 2D Barcode ISO TAG participation – This was at a time when there were a lot of 2D barcode specs being reviewer.  This included QR code.

 2010 – Partnering with Ohio University’s AIDC center, AIS helped develop the “2D Judge” for inspecting NIST Traceable Calibration Conformance Cards.  The ‘one of kind’ system is the ultimate barcode verifier with extremely high precision.   It is currently being used to produce all of the 2D barcode calibration cards.

2012 – For the first time SCANALYST is integrated into an on-line DPM grading system.  The system marked the large aluminum casting using dot peen and then verified the 2D barcode quality prior to shipping.  This system was developed, designed, built and delivered by AIS.  To date, several million parts in this mission critical manufacturing process have been marked and verified with a very high success rate.

2014 – SCANALYST 3 is released – Sitting on a whole new platform and a completely re-engineered set of hardware, SCANALYST 3 was delivered into a select manufacturing segments.

2015 – Full line of the SCANALYST 3 gets released into all markets.  The line includes SCANALYST 3, SCANALYST 3 – 2D, SCANALYST 3 – Linear and SCANALYST 3 – DPM.

FUTURE – New versions will be released in 2016…………stay tuned!

 


We look forward to being the answer to your barcode needs