Date: November, 2020 | Category: Quality | Author: Seth Richtsmeier

From a business perspective, it makes sense to avoid waste whenever possible. Print waste in particular costs companies time and money, since any mistakes made during a print run will have to be corrected with additional resources. It’s more than just material waste — there’s also employee labor that must be factored in.

The True Costs of Excess Print Waste in Production

According to studies from Gartner, 50 percent of business waste is composed of paper products, with the average office worker going through 10,000 sheets of paper per year. These numbers alone are staggering and don’t even account for other print products such as boxes and packaging.

There are also other costs associated with printing, including ink, warehousing space, and postage. These additional fees can add up to 30 times the purchasing price of the paper itself – a significant expenditure.

Beyond the financial implications, there’s also the environmental impact of waste. With 40 percent of the world’s timber being cut down for paper production, brands and consumers alike should look for ways to limit excess scrap.

4 Steps to Minimize Print Production Waste

To reduce the amount of print and packaging waste created, there are several steps companies can take. Here are a few key recommendations.

1. 1. Start with Employee Training

   A common factor when it comes to waste is human error. From typos to incorrect colors and fonts to formatting issues, there are many ways things can go wrong. “Mistakes caused by human error can definitely turn into possible reprints and extra platemaking” says John Reinhardt, Marketing Director of Prairie State Group, a leading packaging company in Franklin Park, IL.
   
   As soon as a new employee joins the team, they should receive adequate training to ensure they know what’s acceptable, how to spot errors, and how to correct those errors. Training should continue on a regular basis to ensure that everyone is aware of best practices.
   
   

2. 2. Review Pre-Press Files with Care

   Before sending projects off to print, run through the files a few times to catch any errors. It’s often best to have more than a single person check for mistakes, as it’s easy for a writer or designer to skip over their own errors.
   
   Catching typos and formatting issues early on saves time, money, and resources. Always have at least two sets of eyes review each file before sending off any major print job. It may help to have a checklist available with things to look out for, including updated logos, correct color swatches, common spelling mistakes, and anything else that may be looked over otherwise.
   
   

3. 3. Automated Quality Control

   There’s a reason it’s called human error – we’re all human and we all make mistakes. While it’s helpful to have multiple people review a print file, there’s always the chance of a problem slipping through the cracks. With automated quality control, the proofing process is easier, more efficient, and more accurate.
   
   Using digital inspections to compare proof documents against original files, conversion errors, and printing defects can be quickly detected and addressed. Users can review inspection reports and approve files for a full print run once ready. This early detection can prevent large-scale misprints, which saves the company from having to toss out entire batches. Again, this saves print materials, ink, coatings, and other costs associated with print waste. It also reduces the company’s environmental footprint (more on that below).
   
   

4. 4. Inventory Management

   While printing materials with errors is wasteful, storage issues that can damage products can be just as detrimental. All paper-based products should be stored in cool, dry environments to prevent mildew. It’s also suggested that these products be protected from threats such as fire, water, and contaminants.
   
   These recommendations should be applied to raw materials as well as finished print products, which can be even more costly to replace due to ink and other coating costs.
   
   

Minimizing Environmental Impact

In addition to taking control of the waste stream by minimizing mistakes, companies should also consider the environmental implications of their practices. When choosing packaging materials, prioritize recyclable paper products. This may involve choosing different coatings and ink to ensure the package can be recycled with other paper and cardboard materials.

There are also several packaging materials that don’t involve paper at all. Corn- and mushroom-based packaging are gaining traction as eco-friendly options. A seaweed-based material called agar is in the early stages of development as a viable packaging alternative as well. Keep an open mind about new products and consider how they can fit into your packaging stream.

Avoid Print Waste with Quality Control

Ultimately, the best way to reduce waste is to invest in your quality control. Eliminating the risk of misprints and formatting issues will save countless reams of paper and other materials. Automated quality control systems are a necessity for waste prevention. As Sales Manager Dave Mickiewicz from General Converting Inc. says “With [automated quality control], sheets can be quickly inspected to check for smashes, hickeys, content errors. It has definitely helped eliminate lost time and wasted materials”. 

To learn how your company can benefit from significant returns by automating your quality control process, check out GlobalVision’s guide Shifting Gears from Manual to Automated Quality Control.

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Date: May, 2020 | Category: quality| Author: Luisa Berger

Developing pharmaceutical packaging can feel as complicated and lengthy of a process as developing the product itself.

If left without logical structure, this process quickly becomes vulnerable to inconsistencies and human limitations that can slow down workflows, cause unnecessary reworks, and put companies at risk of a recall. The good news: implementing standardized processes and leveraging automation can protect companies from these vulnerabilities and accelerate their existing workflows. 

Pharmaceutical Artwork Management: A Non-Linear Process

The creation of a pharmaceutical label or package would seem to be a relatively linear process as the information moves from regulatory departments and core data sheets to designers and layouts and finally to printers and finished materials.

Yet, this relatively straightforward sequence quickly erodes with the countless revision and approval cycles that are introduced as a result of new upstream data or information, regional requirements, regulatory feedback, and many other influencing factors. The development and review of each of these stages can already be a lengthy process, making any additional errors or inconsistencies introduced along these workflows a potential bottleneck or implication further downstream. 

Ideally, at every new version or hand-off, a comprehensive review and comparison of the current version to the previously approved one would take place. The goal is to ensure that by verifying content accuracy and correcting errors and inconsistencies at each stage, the entire process can be streamlined for more efficient and effective work, rather than frequent, easily avoidable reworks.

While, in theory, it sounds great to thoroughly inspect every project and every version like this, in reality, these reviews can take hours, even days when manually checking content that can range from less than 12 words to over 120 pages. Enter automation. 

Automation for Packaging Artwork Management 

Automated inspection technologies are to these processes what a calculator is to engineering: a tool that quickly, reliably, and with precision performs functions that humans can do, but with significantly more time and greater room for error.

Automation acts as an aid, not a replacement, for human participation. Rather, by allowing computers to do what they do best, teams are actually able to apply their attention and efforts to those actions that, alongside these automated processes, keep projects moving forward and time-to-market speeding up. 

From original source documents and manuscripts to design layouts and graphics to physical proofs and finished materials, automation can quickly and consistently verify the diverse components and elements that make up these projects. With text verification tools, you can ensure that your copy was properly transcribed or conserved across versions and formats, fool-proofing that no errors or inconsistencies slipped through review.

Graphics errors, like missing logos, inaccurate graph drawings, or color inconsistencies, can be instantly highlighted using pixel overlay technologies. Even verification processes that already benefit from some innovation and standardization, like barcode and braille authentication and translation, can be further optimized using automation for faster, more informative results. Automated solutions like these are readily available tools that can be easily leveraged to transform productivity and optimize outputs.  

Bridging the Gaps in Artwork Management 

While these tools and capabilities can transform traditional processes and manual verification methods, when integrated into existing product lifecycle management (PLM) systems, these solutions can bridge the existing quality gaps both internally, within and across departments, and externally with vendors. 

In today’s context, most pharmaceutical and life science companies utilize software and digital management systems for organizing projects, document management, and other workflows. By seamlessly integrating into these existing platforms, these routine quality checks become an easily accessible and implementable procedure for verifying each contribution that benefits the efficiency and collaboration of everyone participating in that workflow. 

Given that companies in this space outsource those functions that are not within their necessary expertise, whether marketing, printing, or other vendor services, quality standards must also apply to this level. When both company and vendor employ the same quality control tools, there is a common language and agreed-upon standard that both parties are committed to upholding and remaining accountable to. 

Beyond Workflows

While these tools are optimizing the artwork development and review process for faster, more streamlined projects, these integrations also allow businesses to collect relevant data on areas of their workflows, like the number of revisions, common errors, vendor performance, and other relevant metrics. Ultimately, these insights can help inform further strategies and business efforts for optimization and improvement in these areas and beyond. 

Unlike desktop-only or shared, physical verification tools, cloud-based solutions allow teams to work independently and securely wherever they can access an internet browser. Whether integrating with existing systems or opting for a cloud-based solution, companies can ensure that their team’s ability to access their quality control tools and uphold standards is disruption-proof.

With more companies supporting working remotely, or external conditions limiting access to workplaces or tools, these easily accessible solutions allow teams to continue thriving and delivering flawless results, regardless of the circumstances. 

The artwork management and creation process is an extensive undertaking that involves wide-ranging collaborative efforts across and beyond pharmaceutical companies. By implementing coherent processes and leveraging automated solutions, these non-linear workflows can become more streamlined for faster outputs and fewer errors slipping through the cracks.

Curious about what effects this kind of automation could have on your own workflow? Book a process consultation with one of our representatives to explore how automation could work for you.

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Date: August, 2019 | Category: quality | Author: Ryan Szporer

“Just” backing up data isn’t enough to keep data intact anymore. While it’s a necessary step and a good start at that, a backup means little if there aren’t adequate safeguards in place to protect the integrity of the data that might have to be recovered. Even if back-ups themselves are a safeguard, they must be seen as an asset in their own right. After all, it’s estimated 100 mb of company data is worth $1 million on average. Half the firms that cannot recover lost data in 10 days cannot recover themselves.

It just makes good strategic sense to have a backup plan in the most literal sense as a result. Here are the top five strategies to keep data intact, for the sake of keeping your data integrity intact:

1. Know What to Back Up

It’s not only files that must be backed up but programs, including Operating System software as well. After all, if a newer version of a program has been released, it may not be able to read your data.

The fix simply requires that an image, or a carbon copy of all critical information including programs and their data saved into a single file, be backed up. That way no synchronization issues arise, preventing you from using the data even if you may have successfully recovered it. It would be like having the keys to the wrong car. Only this car can’t be hot-wired to run.

There is an admitted caveat: If you upgrade your hardware, the image may no longer be compatible itself. So, an alternative solution would be to just stay up to date with your program versions and continue to back up data as you normally would (i.e., thoroughly).

2. Encrypt Your Back-Ups

It almost goes without saying in this day and age, information must be kept secure for its data integrity to stay intact. One way to avoid confidential information from being compromised is to encrypt it into code, which is of course standard practice. It’s a standard practice for a reason though, namely its effectiveness. As a result, it’s significant enough in importance to rank on this list.

3. Make Regular Back-Ups

You can’t simply back up data before an upgrade. Ideally scheduled for when there is low network activity to prevent slowdown, back-ups should be made every day, with daily snapshots taken as well to monitor performance. Furthermore, at least two weeks of daily backups should be kept at any one time, as it represents a manageable time frame in case a file does get lost or corrupted.

Meanwhile, once-a-month back-ups should be preserved for one year, while annual back-ups should be kept for seven years in case a governmental request is made. In each case, consideration should also be made with regard to how much space is available, with old backups deleted to make room for new ones.

4. Store Your Back-Ups Properly

It goes beyond storing your backups in environmentally controlled facilities, even if that’s admittedly a good practice. You would also want to store your backups off-site, separately from the original data. Every good plan has redundancies built in and a backup/ data recovery plan is no different.

The reasoning is simple, as they represent contingencies in case of disaster. Imagine a worst-case scenario in which a literal natural disaster strikes. You would want as large of a chance as being able to pick up right where you left off as soon as possible. You don’t want to lose your backups and the original data all in one fell swoop. That would truly be a disaster.

5. Validate the Recovery Procedure

Validation can take many forms. With regard to the GlobalVision Quality Control Platform, for example, Installation, Operational, and Performance Qualification procedures serve to verify the application works as it should.

As the definition of validation suggests, it “provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” In the case of backups, the process in question is the recovery procedure. The back-ups themselves are the product.

Verifying the viability of the backup data is critical. Test runs ensure that, in a worst-case scenario like the one outlined in Point No. 4, the data and operations can be picked up in a reasonable amount of time, even if off-site. Restoring back-ups on a regular basis helps validate the recovery procedure. Restoring back-ups to an alternative server before so doing is actually the best practice as it validates the ability of the data to be recovered. Seeing as the data would have just been validated in a new environment, it also provides you with a backup you can be sure is viable, should you ever need to use it. Knock on wood.

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Date: June, 2019 | Category: Quality | Author: Ryan Szporer

Consistency is a trademark of both validation and data integrity. In fact, without validation and the consistency for which it strives, forget data integrity. It’s like there is no data at all.

What Is Validation?

To be clear, validation is defined as, “evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” The “consistently” is key. There is no good use for a system that cannot do what it promises every single time.

Think along the lines of a phone that only dials the right number four out of five times. Eighty percent is a good mark on a test, but not so much in case of an emergency when you need to call 9-1-1 and you get the local pizza place instead. That’s in large part why system validation is so thorough, with Installation, Operational, and Performance Qualification processes entering into the equation.

For its part, data must be consistent throughout its entire lifecycle for it to have integrity. It plays into the need for data to also be accurate, which is one of the Food and Drug Administration’s expectations for Good Manufacturing Practices. Altogether, data is expected to be “Attributable,” “Legible,” “Contemporaneous,” “Original,” and, of course, “Accurate,” or “ALCOA” for short.

Data itself can be validated too. For example, to achieve compliance with the FDA (21 CFR Part 11, specifically) in pharma and life sciences, companies must ensure integrity is maintained with regard to drug safety data as it is collected, stored, and transmitted. This is done through preliminary planning, risk identification, and testing. After the fact, everything is regularly verified as working as expected, while regular audits and reports are made to improve processes after the fact.

What Must Be Validated?

In essence, while validation is an admittedly and justifiably complex process, it boils down to that same simple premise: It all has to be verified as working as expected. Anything less and the resulting data can’t be trusted. It would be useless and just as good as if it were non-existent.

Now, confusion may admittedly arise over what exactly is being validated. In a word almost “everything.” For example, in pharma, every piece of equipment that touches or impacts the development of a drug during the manufacturing process must be validated.

While equipment validation is nothing specific to pharma and is important in other industries, IT systems and processes also qualify as requiring validation here. Even proofreading software like GlobalVision, which helps to verify packaging as being accurate but may not actually come into physical contact with the product itself, would fall into this category.

Audit trails and the like within applications are generally designed to keep excellent records. And, if they are validated as being reliable without fail, it’s safe to operate under the assumption the data they keep is as well. And, as mentioned earlier, the data must be validated too.

Data Integrity vs. Data Validation

Data integrity and data validation are two separate concepts, but they effectively have the same end goal. Data validation covers the testing and processes that lead to data complying with regulations put in place by the FDA (for example). Data integrity is what you get once it has been deemed to be secure as a result, along with several other qualifications.

In other words, much like data security is a basic tenet of data integrity and not vice versa, the same goes for data validation. If your data has been validated and/or you have proper security precautions in place, the threat of a breach or malicious attack has been mitigated. There has been no such breach with regard to data that has integrity. It has to be kept that way.

It’s similar to how a ship’s hull has integrity until it hits an iceberg. Steps are taken to avoid contact or keep water from breaching. Since there are measures in place and the ship is afloat, to begin with, it means the ship is secure. Meanwhile, validation determines how effective those measures are. If they aren’t any consistency, the ship shouldn’t have even made it out of the shipyard.

In that sense, the ship is like any other manufactured product. Only its best possible, viable version should be made available. Validation helps ensure that is the case. Consistently.

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Date: April, 2019 | Category: Quality | Author: Mike Malz

Regardless of the industry, all companies have the same goal in mind: to provide high-quality products to keep customers loyal and attract new ones. To accomplish this, each product must go through a strict proofreading process to ensure the accuracy of all labeling and packaging.

This can be time-consuming. As a result, some early adopters have switched to proofreading software due to time constraints. In fact, sticking with human proofreaders has proven to be a potentially costly mistake, one that may even lead to expensive recalls.

Avoid Manual Errors

Although they do their best, human proofreaders are not able to catch all errors that can be found on a label. In a North Carolina State University article about errors in food manufacturing, 25% to 50% of recalls were due to human error. There are many reasons why these errors were missed; For one, a proofreader could have been tired or simply unfocused.

With new technologies continuously introduced into every aspect of our lives, people can be distracted by an email alert or text message. When an error is detected in packaging, companies must issue a recall on their product, costing them thousands of dollars and leaving them with a ton of unsellable inventory. Fortunately, there are measures to ensure each packaging component is error-free. These measures can be combined into a single solution: an automated proofreading platform.

Proofreading That Checks Every Word

Human brains are trained to skip words. So, no matter how fluent they are in a language, they can overlook one that’s misspelled. Most people use spell-checking software such as the spellcheck feature in Microsoft Word or maybe even an online solution like Grammarly. These tools help catch those mistakes, but they do have flaws. For example, some English words are spelled differently, such as “color” and “colour.” One solution would be proofreading software that automatically detects errors in a loaded file.

Catch Discrepancies in Color

Despite evidence to the contrary, some may argue human proofreaders do catch misspelled words. Nevertheless, color differences are a different kind of animal. It’s important that the labels of packaging have a consistent color pattern. This helps promote brand awareness and identity. If the color has faded or the hue is slightly different, the product will come off as rushed. Color-detection software is one way to identify any issues before the file gets sent to the printing press.

A+ Barcode Grading

Every company wants to send out Grade “A” barcodes and nothing less, as recalls can be issued if they will not scan. And, yet, despite the very real need, human proofreaders are unable to tell if a barcode will scan properly when it reaches the customer. Leveraging technology is the only option here, and it makes sense to opt for the best solution possible. Having a process in place to digitally check barcodes saves you time and money. This is especially true when it comes to consumer goods.

Checking Labels Even After Printing

There is still a chance some errors or color differences will slip through the cracks even after the job is done and the labels are printed. The best way to review your printed files is by reverifying them, using proofreading software. This way the user can find any differences and decide to reprint if necessary.

It’s important to make sure that, even when the final label is produced, it remains error-free. It would be infinitely preferable to find errors in labels immediately after they’ve been printed instead of having a customer find them while in line at a store.

Making sure your products are high-quality extends to the packaging. Errors are not only costly but embarrassing. People are far from infallible, and companies that rely on human proofreaders risk having their products recalled and losing customers.

Making the switch to automated proofreading, like with GlobalVision, can save you time and money by sparing your firm from having to issue recalls. Businesses should consider spending a little more money now on solutions that help maintain their reputation and brand integrity. It’s not about short-term gains, but rather the long game, in which everyone is a winner.

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