Blog – The Bridge Is Out

The Bridge Is Out

And Your Barcode Infrastructure is?

I recently read about a bridge in California that was washed out.  The loss of this bridge meant an additional 200 mile a day commute for many was used by 20,000 people each day.  Believe it or not, this made me think about barcode.

When we start the day we make some assumptions that the core things we rely on will be there for us; heat, food, electricity, transportation, communications, jobs, etc.  Today, almost everyone in the world is positively impacted by another infrastructure that they do not think about, barcode.  It is everywhere. It is very important. It is how things work.  In many ways it is like that bridge, a link from one side to the other, the physical side to the digital side.  It is how we know what is going on. It allows us to exercise control and manage activities. Like the bridge, if we lose it we will really feel it.

Two observations

It works very well, thank you.

Forty years and 5-6 billion scans per day!  Most of that has been in retail food stores around the world.  It has been credited with the significant changes in the food industry during that time and is now set to make the food chain safer in the future.  Actually, many of the programs to improve healthcare, retail and manufacturing rely on using barcode.

It either works well or it doesn’t work at all or somewhere in between

Yes, I meant what I said.  The only thing that is completely black and white about barcode systems is the bars themselves.  In reality, there is a lot of grey area.  Think about this; why is it that some items scan very easily with one quick swipe across the scanner while others require a few tries with slow and careful positioning.  In fact, most barcode systems are working in the grey area. Performance could be worse but it could be a lot better too.  This costs some extra time for each of those billions of scans.  It also means that some of the questionable barcodes cannot be scanned at all.

So what?

We use barcodes so much because it is inexpensive, fast and, most important, accurate.  It allows us to avoid manual key entry which is very inaccurate and unacceptable for even a backup method.  In the coming years, as barcodes are used to improve our food and drug supply chains, there will be a need to scan barcoded serial #’s at multiple points along the supply chain to maintain the traceability of these items.  At these points the scans will be performed using simple hand held scanners.  The people using those scanners will have a hard time with the questionable barcodes and this means trouble for the manufacturer.  Their products will be worthless if they cannot be scanned and tracked.  For consumer safety and regulatory compliance, they will not be allowed to continue on to the consumer.  Manufacturers will have to up their barcode game to stay in business.  Barcode will go from something that we did not think about to become an important item on the management dashboard.  They will have to be aware of and manage what they are doing to prevent the loss of a customer or a consumer.

Here are a few things they might ask:

• Are you now in compliance with your industry specifications for barcode size, quality, position, etc.?  Ask for the details of how you stack up against the specs.  ‘We don’t know of any problems’ is not the answer you are looking for.
• Is there a system in place to catch the out of spec packaging or labeling materials before they get out the door and cause big problems?  Does it work?
• If you purchase packaging materials with barcodes, does your contract specify that the barcodes must be inspected by the manufacturer and be in compliance with industry standards and specifications?  Are you getting such assurances from your packaging suppliers?  In writing?

Blog – If you are printing barcodes…

If you are printing barcodes…..

We all see barcodes being scanned almost every day. It has become part of our daily lives. When we see a barcode we automatically assume that it can be scanned, and in fact most can. However, there are many that are ‘bad barcodes’ out there. Do any belong to you?

What is the definition of a bad barcode?

It cannot be scanned by the customer or consumer with their scanner

• Low ISO print quality grade

This is the best way to determine if your barcode is going to work. It is a multifaceted test that can predict a barcode’s scannability with the variety of scanning technologies now in use around the world.

• Inadequate quiet zones

This is the ‘white’ area around a barcode that the scanner uses to set its reference point for the background. The quiet zones are very necessary but very often overlooked.

• Over wrap

A great barcode cannot be scanned if you have placed ‘lines’ of overwrap through it.

• Around an edge

When a barcode wraps around an edge of a package or around the circumference of a cylinder it looks like a partial code or a distorted code to the scanner. These are impossible to decode safely.

• It does not have valid data

Encoded data does not match expected data or include expected fields. Some of today’s principle barcode applications are well defined and have only had minor changes over the years. This is changing as the technology is seen as a tool to meet challenging (and changing) business and social needs.

• The encoded data is not formatted for the application

A Multi-field barcode is not following rules defined in the application. There are many linear and 2D barcodes that contain more than one field of data. Part number, lot number use before date, are just a few of the over 200 possible fields you could find in one barcode. Formatting these barcodes properly adds a level of complexity that can be challenging. An improperly formatted code is about as bad as a completely un-scannable barcode. In some situations it may even be worse.

• The barcode’s bars or cells are too small to be read by the scanner

Linear barcodes X dimension (narrow bar) or 2D barcode cell size is less than the application specifies

• It is not tall enough to be read easily

Linear barcodes height is less than the application specifies

• Just not in compliance with the applicable specs

The nuances of the principle barcode application specifications are too big a subject to cover in this small article. Many would say that the specs have enough complexity and breadth (> 400 pages!) that it really is a job for a computer system rather than a person. The reality is that this is a complex technical task and that a person cannot determine if their company is in compliance without the tools to do the job.

What are the most common mistakes made in printing barcodes?

Not checking your work

Compliance with standards is no longer optional in today’s world. The barcode is used to track, charge, dispense and use, prevent from misuse, prevent from counterfeit, create transactions, etc. It is data, very accurate, very inexpensive, very timely and very valuable. It is part of your product and a reflection on your quality. It is part of the value you put into your products. It expected to work and it is expected that you checked it before putting it out into use.

Using a scanner to check

This is the classic – WWe scanned it here and it worked!”. Consider this: there are at least 6 basic scanning technology types, several hundred sub-types and several thousand brands/models in use here and around the world. Your scanner is just one of those, so if you are checking your quality with a scanner and sleeping at night, stop that. The only way to be safe is to verify your barcodes using a barcode verifier. If you manage a barcode printing function then you should be able to state what quality level you are producing (ISO or ANSI) and produce records to support it.

Blog – Are You Getting Ready For UDI or DQSA?

Are You Getting Ready For UDI or DQSA?

(FDA Universal Data Identifier and Drug Quality Security Act)

These programs are going to be a great help in meeting healthcare industry challenges and for patient safety. It represents the start of a significant step up in the broad use of information technology in healthcare. The data will be primarily created from AIDC transactions as products are moved from manufacturing through distribution and on to the consumers. The data are expected to be very accurate and timely and yet inexpensive. In fact the data needs to be all that for success. That is why global barcode standards with expected quality levels are specified. To work in these markets you will need to comply with the standard. Unlike many other industry segments, healthcare companies will have to actively comply to stay out of trouble in the market and keep their reputation and clients.

As an AIDC specialist with experience in optimizing barcode based supply chains, I can share with you that you have a real job to do lying ahead.

These breakthrough programs are important, complex and, of course, mandatory. You have to prepare to do it if you want to be allowed to stay in business at all and you need to do it right over the long term to maintain credibility in the market and to stay in business as well. So if you haven’t already, read the documentation available, get the team together and lay out the steps you must take to achieve compliance and then maintain compliance.

Here are a few ways we can help.

This paper is intended to fill an often overlooked void in the planning, preparation and execution of UDI compliance. The fact that it is overlooked is understandable. The healthcare industry generally and the medical device community in particular do not have the experience necessary to pick up on this nuance. In summary, you are working to comply with FDA regulations that use GS1 or HIBCC barcode standards. Both of these standards call for barcode print quality to meet or exceed ANSI Grade C. This specified level of quality will result in all or most scanners around the world being able to accurately and readily decode the data in the barcode. This is a critical aspect of the regulations; the barcodes have to be correct and scanned accurately and efficiently for the system to work. You can expect that if you do not get it right someone will find out. Fortunately, the barcode print quality test methods are non-destructive and predictive. Barcode verification is a great tool to help you do it right.

So then, how does this barcode content and quality aspect interact with your planning? Actually, they come together in several important ways from beginning onward past the planning, through execution and into the ongoing maintenance of your compliance program. Let’s look at a few phases.

Discovery – Where are we now and what work has to be done? – The Initial Audit

Here is a rhetorical question – “Do you know specifically, by product, where you stand? What data is now on the package, what needs to be on the package, what the current barcode contains, what it will have to contain, the average ANSI print quality grade of the package/label printer, whether it can handle serialization or if it has to, etc. ?”

The answer usually is “Not exactly”. Many companies are made up of multiple businesses, in multiple locations, with many different products that may have been in active distribution for many years. In addition, each product may be marketed into several different countries and each country may have their own regulatory and language requirements. There may not be a core data repository of all this product information up to date and conveniently available to answer this question. That is what you will need to start. This may be a significant task!

If you would like to see one approach to this data collection, check this out.

Choosing the right type of barcode

After finding out what data has to be in the barcode you will be better able to determine what barcode symbology to use. There are 2 types available, linear barcode and 2D barcode. The linear code is called Code 128 and the 2D code is called Datamatrix. Typical product marking examples may look like this:

Linear

Or 2D

Both examples contain the same amount of information. You can see that it took 2 linear barcodes to encode the same amount shown in the one 2D barcode. The 2D code takes up less space on the package, is safer (more redundant) than the linear and is easier to scan (any angle). In distribution, the linear codes require 2 scans by the operator and intelligent software to group and record the data correctly. The direction is definitely toward using 2D barcodes. Although 2D offers significant advantage over linear, both are available for use. Many in the barcode community believe that 2D will eventually be the defacto standard and suggest that while doing all the work for UDI might be a good time to make the switch.

The multi-field barcodes used in UDI can be tricky to master. There may be several fields in one barcode. These fields are encoded and decoded following rules in the standards and often involve using ‘unprintable’ characters that can make the task both difficult and hazardous. To see one tool used to help check this out. This GS1 Application Compliance Analysis is a tool to insure that the data in the barcode is formatted correctly and can be processed when scanned. It is complex and cannot be done readily and reliably by a person without the tools. An error here is as bad as a barcode that can’t be scanned! It is definitely something you will want to integrate into your testing.

What new equipment and processes are required?

The terms ‘variable data printing’ and ‘on demand’ printing may be new to some reading this. Essentially, it means that your printing process can readily change the printed data as you change from one lot to the next, one serial # to the next, etc. Digital printing equipment such as thermal transfer printing is one technology capable of doing this however wet ink processes using plates usually are not. If you need to purchase new equipment then some pre-purchase questions should be asked. They include:

The obvious things like speed, size of print, barcodes on board or loaded, dependability, consistency of print quality, ease of maintenance, rugged or susceptible to damage, support, initial cost, cost of supplies, etc.

Not so obvious questions would include – can you clear all previous data by command, can it produce your label design with ANSI print quality of Grade C or better consistently, can it do that with linear and 2D, if you are going to use linear code are you going to print ‘ladder’ style (not recommended due to variable quality) or ‘picket fence’, is the mark able to withstand the abrasion, exposure and time while passing through distribution, does the system require proprietary software?, if it does require proprietary software then what is your backup plan just in case,

You will need to print a prototype label configured for your products with all fields positioned and sized both in character size and field length. You may need a few different prototypes if your product labeling is varied. A few caveats: If you use a digital printing system and try to verify the barcode quality of the image rather than the finished printed packaging you will not have a true indication of what your customers and inspectors see. You should only verify finished packaging. Don’t forget that there is an area around the barcode that cannot be used for print. It is a reserved area called the ‘quiet zone’. Its size varies with code types.

Look for a future paper on ‘100% Inspection vs. SPC and Process Controls’

More prototypes and a final audit

At this point you should have seen enough samples from the various printing systems to have narrowed the choices down to just one or two and can make some final decisions.

While you are picking hardware and testing to insure it can handle both required content and quality, someone should be getting the sources for the required label data and laying out the process of getting the data into the printer command language with a user interface or, if applicable, into the label generation program. A second data project involves getting the fields of data required for the GUDID database. This is not the same data used to print a products labels but does relate to that specific product.

Now it is time to produce a final (hopefully) prototype label for each product. Test these fully for quality and content and circulate them to the members of the UDI team for comment and approval. Again, here is an example of how this could be done.

Ready for submission

At the risk of making it sound much easier than it probably is, now just submit it (After checking everything again of course). Lets assume that your submission is accepted. You have your license to go to market and now the market knows what to expect from you. Showtime, it’s now time for you to deliver.

Ready for implementation

During the development of your plan you will have discovered rules to follow, the process steps and their order, security and permission issues, test procedures, etc. essentially everything you need to safely get started. It is the first cut of the manual for how to make it all work.

Ongoing compliance maintenance

Congratulations on getting the submission accepted. This gives you license to start producing and selling into the UDI regulated market. Don’t relax just yet, however. You will have to continue to work within the rules to keep that license. Some of the steps in your process manual would have referred to required testing. For instance, barcode quality and data content should be checked on the initial label or 2 of every run. With thermal printing, it is also wise to check again when a ribbon is changed or a new label roll is inserted. Each of these checks should be recorded in a database with a timestamp and details. The timestamp helps you to insure the checks are actually completed and the detail helps improve the process. Click here to see an example of a system that gets this done. Your procedures will have to be adjusted periodically to react to weaknesses you discover and handle with countermeasures.

Watch here for an article on ‘Thermal Printing Best Practices’

Ongoing compliance maintenance

Over the years ahead, changes and additions to your product line will have you going back over these steps. It is not a onetime event, it is now a step in your product development lifecycle.

To all the UDI and DQSA implementers and consultants out there, please feel free to contact us for more information or to make suggestions.