How Validation Leads to Data Consistency and Integrity

Monitor with data integrity checklist

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 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 with 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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3 Ways Error-Detection Software Ensures Data Integrity

Error detection of quality control software ensuring data integrity
 

There are many ways to ensure data integrity. As automation becomes increasingly prevalent in the 21st century, software, especially on the back-end, is as important as ever. Not only does it serve as the driving force behind technology in all of its incarnations, it can also act as a fail-safe. As the term implies, “error-detection software” is one viable way to catch and stop errors that risk corrupting data in their tracks.

How to ensure data integrity? 

This is how to Ensures Data Integrity:

1. Enhances Security

While data security is different than data integrity, the two go hand in hand. Like data quality, data security is a single facet of data integrity (but not vice versa). Nevertheless, without the proper degree of security, data can become compromised due to breaches, among other threats. In other words, for data to have integrity, it must first be secure.

As a result, error-detection software can be considered a key component of any complement of tools designed and implemented to enhance the security of data. Errors are simply outliers or anomalies, which are defined as observations that lie outside of norms. Error-detection software can build baselines of systems, their users, and the data they create, leading to the easy detection of behavioral deviations, whether there is malicious intent or not.

2. Reduces Human Error

There’s an inherent risk whenever you rely on human resources. There are some things a machine will likely never be able to do as well, but analyzing data is not one of them. It’s similar to the situation with manual proofreading, where, the longer the process is, the less likely errors are to get caught. Fatigue sets in eventually and the effectiveness of proofreaders declines over time.

In much the same way, the automated analysis of unstructured data saves time, thereby improving the overall efficiency of the process. Employees wouldn’t be replaced, either. There would still be a need to oversee the analysis. The right error-detection software would all the while keep all relevant parties apprised of how the data behaves. As described in Point 1 above, that’s critical.

3. Prevents Issues from Recurring

It isn’t just the errors software might catch, but the ones in the future that would otherwise slip through the cracks. Consider digital proofreading software as an example. A form of error-detection software, GlobalVision features an audit trail for compliance with FDA 21 CFR Part 11.

So, the platform doesn’t just go over the document pixel by pixel or character by character to detect graphics and text differences (among other types). The application tracks parameter changes and log-ins, so data becomes “attributable” (which is one of the five principles of data integrity). The others are “Legible,” “Contemporaneous,” “Original,” and “Accurate” (spelling ALCOA).

The end result? Detected differences between master and sample files from the printer can be tied to individual departments and testers. The exact origin of any error can be easily discovered and addressed. Similar errors can be prevented in the future. In that way, the number of potential mistakes gets dwindled down. Proper company quality standards get corrected and set moving forward.

As another example, a Corrective And Preventive Action (CAPA) system prevents the recurrence of product and quality problems. In manufacturing, it can become a vicious cycle of sorts. If high-quality products aren’t routinely manufactured, there is pressure to falsify data so that it passes. That leads to a lack of data integrity. So, it can be argued, a lack of data integrity is a sign of a lack of quality.

In contrast, verifying all possible data sources for the root cause of errors keeps the chances of them recurring low. From a data integrity perspective, that means fewer lapses. Product quality and customer satisfaction, whatever the industry in question, can only improve as a result.

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Manual Proofreading Errors: How to Stop Label Recalls in Your Supply Chain

Cartoon computer work on the digital inspection fast and efficient comparing to manual work

Regardless of the industry, all companies have the same goal in mind: 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 the potentially costly mistake… one that may even lead to expensive recalls.

Too Many 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.

Check 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.

Every Shade of Color Matters

Despite evidence to the contrary, some may argue human proofreaders do catch misspelled words. Nevertheless, color differences are a different 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 who 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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Data Integrity Remains Key to Any Successful Software Development Lifecycle

Man working on compliance with a laptop

In spite of the term Software Development Lifecycle (SDLC), there aren’t concrete steps to follow when coding. Each case is somewhat different, even if there is one universal truth: Certain standards apply across the board. Data integrity is one such standard.

The Ultimate SDLC Goal

It may not be the ultimate goal, as that would be releasing a functional piece of software. However, as a key consideration of any successful SDLC, data integrity is a requirement that must not be ignored. That goes for GlobalVision proofreading software, which follows an SDLC approach, too.

The term “data” is relatively straightforward: information collected and potentially used by the application. “Integrity” is, of course, the end result achieved through the process of keeping that data uncorrupted and unchanged. It goes hand in hand with the concept of data security, which is sought after through the act of taking the necessary measures to protect it.

For example, individual lifecycles have proper security precautions built into and controls added at each step. One precaution would be the act of defining early on the sensitivity of the data a given system will require. As James E. Purcell writes in his paper, “Defining and Understanding Security in the Software Development Life Cycle”, this enables the security needs of the firm to be considered come the time for decisions to be made later on in the process. Failure to do so leads to potentially unforeseen consequences and add-ons and patches after the fact. Almost by definition, those should be last resorts.

The Software Development Process

Taking the development process one meticulous step at a time is a way to avoid them. As alluded to earlier, there are a variety that can be followed, but, generally speaking, as a list, it looks like the one below:

Analyze and Plan, which should include preliminary risk assessment. Relevant regulations that will come into play should be looked at and a plan of action as to how to address them should be devised. This should be reflected in the resulting software-requirement-specification document that comes out of these two phases.

Design, where whatever needs to be in the software gets included in the design-specification document. Depending on the system being designed and compliance considerations, it may end up including failsafes with regard to the database, so it is easily backed up and restored. Furthermore, as a security precaution to protect against data being stolen or corrupted, encryption, if applicable, is identified as a necessity at this stage.

Build the Software, presumably using secure code to eliminate any potential vulnerabilities that may surface.

Test, with regard to all aspects of the software in a thorough, structured fashion. Testing is as universal as it gets and becomes a focal point of a product’s development regardless of the industry. When it comes to software though, aspects like code quality and security testing are just two of many that should be considered here, ideally by a dedicated quality-assurance team.

Unit testing, where the smallest testable parts of an application are verified for bugs and vulnerabilities independently, is also a popular pre-emptive strike against breaches but can be automated. Meanwhile, black-box testing, which places the application under the microscope of a tester who does not look at its internal workings (as if it were in a black box), seeks to test a variety of things, including external database access and the software for data-structure errors.

Deploy or Release, finally. That’s assuming all tests have passed and any security shortcomings that had been documented during the testing phase have been resolved. As part of the final quality checks of the software, further security testing may actually be done.

Maintain and Evaluate, which translates to updating the software via security upgrades and improvements whenever necessary. It turns out, sometimes there are good reasons behind those Apple IPhone updates.

Dispose, as, even in obsolescence, software must be handled with discretion. If software is in the midst of being replaced, caution must be exercised to ensure any sensitive data is archived securely or disposed of in its entirety.

After all, any SDLC seeks to create software that is useful to the organization. Logically, software that can be superseded by a newer version has outlived that usefulness. By the same token, an application without the appropriate level of security is relatively useless, to begin with.

The Importance of Data Integrity

As a result data integrity becomes increasingly paramount, depending on the industry in which the software will be used. Expensive changes may be called for at a later date by auditors, but that’s only if the organization in question is relatively lucky.

In a worst-case scenario, hackers could find a way in, compromising not just the integrity of the data but the brand equity of the company too. That could cut any software development cycle drastically short. It doesn’t have to be that way, as the above steps show.

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The Importance of an Audit Trail to Securing Data Integrity

Capitalized letter, checklist, chart and calculator

It’s easier to think of an audit trail as a collection of breadcrumbs leading out of the woods.

The Bright Side of Being Audited

Admittedly, the word “audit” gets a bad reputation. It’s usually associated with the unpleasant process of the same name that can be initiated by the U.S. Internal Revenue Service. In actuality, audits are an unavoidable part of life for many corporations in the sense that they can take place not once but multiple times of year. With an audit trail, they don’t have to be nearly as grueling as people have come to expect, though.

For the uninitiated, trails are the lists of transactions or events kept track of to help auditors and, in many ways, those being audited too. Of course, at its most fundamental level, a company’s audit trail does contain financial transactions. However, they can be chronological catalogs of so many more types of events. An audit is simply an investigation of accounts and records in general. They aren’t limited to those of the financial variety.

For example, audits can be key to achieving and maintaining regulatory compliance, which is in turn critical to operating in sectors like pharma. For a company that develops software intended to meet ISO compliance, perhaps for use within that same pharmaceutical industry, regular internal and external audits are to be expected.

External vs. Internal Audits

External audits can either be initiated by the relevant regulatory body (for certification purposes) or even a client that relies on the given software. Take a digital proofreading application for example.

Continuing within pharma, each piece of equipment that enters into a drug’s chain of custody has to be “validated” as meeting pre-determined specifications and attributes. Obviously, software qualifies as equipment in that context. It makes sense that a firm with as much at stake from a quality perspective as a pharmaceutical company would want to get assurances that a piece of equipment on which they rely comes as advertised as being compliant. It’s theoretically similar to how consumers depend on medication and accurate information on its packaging.

In contrast, an internal audit serves as an evaluation of the company’s effectiveness, from risk-management, governance, and process standpoints. As data integrity arguably touches on all three areas, its importance in a corporate environment cannot be understated. In fact, audits specifically aimed at examining data integrity are a real thing.

Benefiting from an Audit Trail

Regardless of the focus of an audit, trails are undeniably critical to their success. And success is what all parties should strive for, whether they’re doing the auditing or being audited. No one wins however unnecessarily hard one becomes to complete.

That’s one of the misconceptions regarding audit trails that is generally associated with the earlier IRS example. Obviously an audit isn’t exactly something to look forward to, but it can be made less of a headache if all required records have been kept and are easily accessible for the auditors. Automated trails that are easily searchable make smooth audits more of a reality.

Trails are theoretically included in software as one of many required technical controls that enable users to achieve compliance with 21 CFR Part 11 with the Food and Drug Administration (in the United States; equivalent to Annex 11 in the European Union). Compliance here ensures companies implement good business practices through reliable electronic records, which must be able to be accurately displayed and exported. Here, the audit trail serves to log what changes to application data were made, when, and by whom and be available for review.

Whoever ends up conducting that review, whether it’s an agency or the company itself, the auditor will no doubt thank you as the bigger picture begins to take shape. Identifying the individual trees is key to seeing the forest as a whole, though. Finding your way through can be hard, but an audit trail can clearly reveal the right path to take.

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Why Error-Free Packaging Labeling Is a Must

Why Error-Free Packaging, Labeling Is a Must

Date: November, 2018 | Category: Proofreading | Author: Ryan Szporer

Pristine, error-free packaging, and labeling undeniably look good, but it’s more than that.

It’s a necessity, regardless of the industry in question.

Of course, it conveys brand strength, but, more importantly, it’s about respecting regulations that were put in place for a reason.

Mislabeling Misadventures

The strength of those regulations (and the severity of the penalties for breaking them) depends on the country. For example, in the United States, the Fair Packaging and Labeling Act with the Uniform Packaging and Labeling Regulation (UPLR; and National Institute of Standards and Technology Handbook 130) require consumer commodities to clearly disclose packaging’s contents and manufacturer info. The goal is for customers to be able to make informed purchasing decisions through the comparison of accurate price and quantity information on packaging.

Additional regulations meanwhile outlaw deceptive packaging and labeling. At both the federal and state levels, false advertising and labeling laws exist, with offenders risking additional liability to any victims. Victims can include consumers who are harmed by the product or businesses further down the supply chain who unwittingly purchased the product. If, on the other hand, a party down the supply chain discovers the fraud but fails to take action, they could be responsible too.

The aforementioned laws are admittedly not all-encompassing. State laws can differ and the FPLA sometimes delegates regulatory and enforcement responsibilities to the agencies who oversee individual industries instead. For example, the Food and Drug Administration regulates packaging and labeling in the food & beverage, cosmetics, medical devices, and pharmaceuticals sectors.

Food and Drugs as a Case Study

Taking the food & beverage sector as an example, put simply, the packaging must contain what the label says it does. If the FDA has reason to believe packaging is inaccurate, that it falsely claims the product inside is 100% fruit juice for example, imports can be detained without physical examination. The product effectively gets prevented from being distributed (and sold).

When a manufacturer is the guilty party, the FDA may issue a warning. In the event the manufacturer does not comply and correct the issue, the FDA takes additional legal action to ensure the product gets removed from market, without it being permitted to return until the issue has been corrected. Criminal fines and even prosecution may result depending on the infraction.

Fines up to $500,000 for misdemeanors that result in death can be doled out. A misdemeanor, which would not require proven intent, can also result in up to one year in prison. A felony, which implies intent or a subsequent violation after the first, can lead to a maximum of three years instead.

In the case of the pharmaceutical industry, which is also under the purview of the FDA and whose customers depend on packaging for accurate dosage information, it’s easy to see why penalties need to be especially severe. A single misplaced period can have huge negative ramifications.

Performing Labeling and Packaging Inspections

A packaging or label error doesn’t have to be fraudulent to be costly. In fact, a great deal of mistakes are simply caused by human error. Market research indicates that 60% of product recalls are caused by workers. And it’s easy to see why. Typos can easily be created and then missed due to proofing fatigue during the artwork-creation and printing processes.

It only reinforces the need for failsafes, like a digital inspection platform, to improve upon the efficiency of a company’s quality control. Performing labeling and packaging inspections at each stage of the workflow reduces the risk of a recall and the number of required revision cycles, so products get to market faster, without any errors.

Inspections are going to be performed anyway, including potentially by the governing body in question itself. It only makes sense that a company would want to put its best foot forward in preparation. Having previously integrated robust quality systems is one key to success in such an instance. Not having to correct an error after the fact is another key to success in general.

There is obviously a difference between fraudulent practices and innocent errors that simply do not get caught in time. Unfortunately, they can each have severe consequences. What separates them from one another is how, instead of actively trying to skirt regulations, companies can actively try to prevent mistakes. It just takes a conscious effort to improve upon internal processes.

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What is a Quality Management System?

Cartoon of the quality management system for ISO regulation

Date: August, 2018 | Category: Quality | Author: Marvin Magasura

 
 
 
 

What is a Quality Management System? 

A quality management system (QMS) is a term that refers to a system in charge of documenting all processes, responsibilities, and procedures for achieving quality objectives and policies. A QMS allows companies to direct and coordinate their operations to meet both regulatory and customer requirements while also improving their efficiency and effectiveness on a regular basis.

ISO 9001:2015 is the international standard that specifies all the requirements needed to implement a quality management system. In fact, most people use the term QMS as a synonym for the ISO 9001 family even though the latter is only a document that describes the former.

The Importance of Implementing a QMS

Why is it so important to implement a quality management system into your quality processes? Quality management systems actually serve plenty of purposes, including:

  • Engaging staff
  • Lowering costs
  • Reducing wasted materials
  • Setting company-wide direction
  • Identifying and facilitating training opportunities
  • Improving processes

Benefits of Quality Management Systems

What are the advantages of using a Quality Management System?

Once implemented, quality management systems have the power to affect all aspects of your company’s performance. However, the design and implementation of a QMS will bring you two overarching benefits:

  1. Meeting the organization’s requirements ensures that your company complies with industry regulations and provisions of services and products in the most cost-effective way. In the end, this will create room for growth, expansion, and profit.
  2. Meeting customers’ needs will help to build trust in your company, in turn engaging even more customers, sales, and profits.

Other advantages include preventing errors, reducing costs, helping to communicate a willingness to produce consistent results, improving your company’s offerings, and ensuring all processes are completely controlled and defined.

 

 

Quality Management Standards

As we previously mentioned, the ISO 9001:2015 standard describes all the requirements that a company must meet to implement its own quality management system. By far ISO 9001:2015 is the most implemented and recognized QMS standard on the planet that counts for complete international acceptance.

However, there are plenty of other QMS standards available, such as the ISO 14000 family that deals with environmental management systems, the rest of the ISO 9000 family (including both ISO 9004 and ISO 9000), ISO/TS 16949 for QMS intended for automotive-related products, ISO 13485 for medical devices, and ISO 19011 for auditing management systems.

Requirements to Implement a QMS

All quality management systems must address a company’s unique set of needs; however, we can name a few general elements that all QMS have in common, such as:

  • The creation of a quality manual.
  • The existence of quality objectives and policies.
  • A set of procedures, records, and instructions about all internal processes, data management, quality analysis, improvement opportunities, and customer satisfaction.

Each aspect of a QMS is intended to serve a specific purpose that in the end will help to achieve the final goal: meeting both the organization’s and customer’s needs.

How to Implement a Quality Management System

Before establishing a QMS, you must consider several elements. To begin, make sure that your decision to implement a quality management system is a strategic choice only influenced by your needs, objectives, services, and products provided. Now that you’re clear about what to do, here are the basic steps to implement a QMS:

  • Design and Build: They deal with the structure of the QMS, along with the plan for implementation and all its processes.
  • Deploy: In this stage, you’ll need to break each process into multiple sub-processes. It also includes staff education and documentation, training tools, and metrics.
  • Control and Measure: These stages are accomplished by systematic, routine audits of your QMS.
  • Review and Improve: In this stage, you’ll deal with the results of the audits. The goal is to determine the efficiency and effectiveness of all your processes regarding your objectives.

Conclusion

A product’s quality can be measured in terms of durability, reliability, and performance. Quality is a crucial element that differentiates your company from its competitors. By implementing proper quality management systems, you are ensuring that all necessary changes in your processes are implemented, which eventually leads to superior quality products and, in the end, bigger profits.

Are you ready to streamline your workflows by implementing a quality management system? Learn more by requesting a demo of GlobalVision here or try our web-based proofreading software, Verify, for free!

Maintaining Data Integrity with GlobalVision Software

Read our whitepaper on how GlobalVision complies with data integrity requirements, such as:
electronic signatures, different access levels and security, and an audit trail with full traceability.

Related articles:

What is data integrity? 

Automated Quality Control

Quality inspection system

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What Is “Quality Inspection”?

Man working on quality inspection with a laptop

Date: July, 2018 | Category: Quality | Author: Marvin Magasura

Terms like “audit” and “inspection” are prevalent in any manufacturing business. The first one refers to analyzing manufacturing organizations and processes, whereas the second refers to any product-checking activity.

Generally, quality inspectors do this by following a pre-established list based on certain product specifications. In fact, any type of product can be inspected, starting with just the components used for the product to semi-finished ones and (most often) the finished product itself.

According to the ISO 2859 standard – which is derived from MIL-STD 105 E – quality inspection involves activities such as testing, gauging, examining, or measuring one or more product characteristics. However, inspection efforts end when the results are compared with specified requirements to determine whether the inspected characteristic achieves conformity.

Why Early Quality Inspections Are Better

This is a crucial concept for any product developer because in the manufacturing world, the sooner we identify and eliminate errors, the better.

It all follows the 1:10:100 ratio, but before jumping to that, let’s remember that there are only six paths on which we can deal with errors. First, they fall into three categories: development, production, and delivery. Then, once identified, all we can do is either prevent or correct them.

Identifying and correcting an error in production will likely cost you 10 times more
(in both time and money)

According to multiple studies, there is a 1:10:100 cost/time ratio between these three broad categories. In other words, identifying and correcting an error in production will likely cost you 10 times more (in both time and money) than it would in development. Following the same ratio, an error will then cost you 100 times more to fix if it actually reaches the consumers.

That’s why applying quality inspection only at the end of the production line is a very risky move that only a few major companies dare to take. Big, organized, and customer-oriented companies are now focusing on inspecting earlier to save resources.

The Importance of Quality Inspection in Print

Package under digital inspection using GlobalVision tool

Companies needing to print in bulk will find that having a quality inspection process in place is extremely beneficial. Print inspection systems can provide the assurance and quality control your company needs to minimize mistakes. They will also guarantee the delivery of consistent results that will enhance your brand’s image through error reduction.

In fact, the role of quality inspection systems becomes even more vital when dealing with offset commercial printers. Given that most printing presses operate at incredibly high speeds, irregularities in the final product are more than possible, if not mandatory. Quality inspection software in print – as opposed to manual inspection systems – provides the necessary accuracy to achieve consistent and flawless results on a regular basis.

Modern Print Inspection

Modern print inspection systems consist of advanced technology that links with your printing press or web rewinder to achieve exceptional results. It works by integrating vision systems (cameras), web viewers, and high-tech software that will catch any errors in time before they are printed in bulk.

Over the years, these quality inspection systems have been developing at a rapid pace. Nowadays, you can find multiple options online at very competitive prices. In fact, given that they require little to no maintenance, one of the key advantages of implementing these non-traditional tools is that you only need to make a one-time investment. Other benefits include ease of use and operation and the ability to have more control over your result.

Conclusion

Quality inspection is an essential part of every production line.

Those who don’t understand how valuable it is are not looking at the big picture. Money-wise, the cost of manufacturing a product extends far beyond the build cost, as it continues across its lifecycle, from support and delivery to warranty claims and – for some products – disposal.

It might seem like an unnecessary investment now but, with proper management, they can reduce future costs, relating to customer support, warranty returns, and rejected/returned items. They can even add value to your company, as you’ll count on a competitive defense tool that will eventually pour more money into your pockets.

SECURING THE BRAND PACKAGING WORKFLOW

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control and the different techniques and systems that can be used in the packaging workflow.

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You Can Always Get What You Want… in Packaging Quality Control

Gif image of different components in Packaging Quality Control
 

When it comes to packaging quality control, it’s not necessarily about catching every difference. It’s about catching every difference you want to.

An Inspection for Every Industry

When running inspections, it’s critical to compartmentalize each type of error, whether the type is text, print quality, color, spelling, etc. This is of particular importance to firms operating in industries where they might have different sets of priorities as far as packaging is concerned.

For example:

  • In pharma, companies are worried more about the accuracy of text than color.
  • In cosmetics, it’s just the opposite, where vibrant colors have to stand out.
  • For food & beverage firms, it’s much the same scenario, where branding is everything.
  • In tobacco, firms are especially on the look-out for print quality, seeking packaging that’s as pristine as possible, without ink splatter or random dots showing up.
Quote from customer story of GlobalVision

Companies in each industry can place more emphasis on text inspections whenever necessary (for example), maybe even going so far as to ignore the differences that don’t matter to them. This can be done by simply choosing to run whichever inspection types apply most. Alternatively, sensitivity in each type of inspection can also be configured to suit the needs of individual firms on a case-by-case basis. Small differences can be discarded. Larger ones will be detected.

Take the extreme as an example. A given digital proofreading system is sensitive to errors of all types and reports back all the differences simultaneously. Heightened sensitivity, which leads quality control applications to catch as many differences between a reference and printed component as possible, is an undeniable asset. But that’s only in the right context.

That’s beside the classic definition of sensitivity when proofreading, which would lead to specks of dust on a scanner getting picked up as false positives. Sensitivity to that degree can be adjusted accordingly. It’s instead in reference to an inability to display those differences separately. If they appear altogether, it can be overwhelming to those tasked with approving (or rejecting) the files. When everything is lit up like a Christmas tree it’s hard to isolate individual errors. You can’t tell the false positives you should ignore from the ones you can’t afford to miss.

Inspecting Packaging with Pinpoint Precision

Laptop showing GlobalVision text inspection softwares

In contrast, when different types of inspections (graphics, text, barcode, Braille, etc.) are run separately, reviewers can better focus. After running a single inspection, they can run another separately and verify each set of results one after the other.

When differences get detected, they can be traced back to a specific part of the file-creation process, enabling decision-makers to get more of a handle on how to correct the mistake and take steps to limit the chances of it reoccurring. Alternatively, using specific solutions like GlobalVision, all the necessary inspections can indeed be run simultaneously. The results of each inspection will nevertheless be distinct. In the PDF that’s generated, even in a combined report, each set of results appears individually, one after another. It’s just easier for reviewers.

While more inspections are being performed instead of just the one, the difference in time spent reviewing is relatively negligible. After all, depending on the volume and size of the packaging components being verified, each inspection can literally take as little as a few seconds.

Meanwhile, the ability to dissect the differences with surgical precision allows for a shorter process overall. You’re no longer wasting time wading through a virtual junkyard, having to watch each step you take. You’re instead focusing on points of interest that stand out, the most important differences/issues in your specific situation.

Effective proofreading, by its very definition, doesn’t take longer than it has to. But it has to be done right. Being done right can just mean different things, depending on the industry in question and the buying patterns of a given company’s consumers.

By selecting which inspections to run and configuring the sensitivity to best detect the errors/ differences/ issues that are the gravest concern, that company isn’t just protecting their own best interests. They’re also doing it as efficiently as possible to get to market faster… with packaging that’s been proofread accurately based on their specific needs.

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Quality Management: A Step-by-Step Process

Quality Management: A Step-by-Step Process

Date: March, 2018 | Category: Quality | Author: Kajetan Wyrzykowski

Most consumers hear the word “quality” when associated with packaging and immediately think of the final product on the shelves in stores. However, its meaning is much different in the packaging and labeling industry.

A lot goes on behind the scenes of the packaging process. For instance, a quality management system must be put in place for the best chance of the product being a success, but what exactly is quality management? It ensures your packaging process is planned from start to finish, that all information is accurate, and that you provide an exceptional customer experience. It’s harder than it sounds to put in place though, as quality management processes vary depending on the industry.

The perception may be that a quality management process is implemented at the design and packaging stage of a product. However, many companies have deployed quality management systems at every stage. As an illustration, consider just how many departments are involved in the creation of a product, from its early stages until the package is in the customer’s hands.

Quality Management Calls for Accurate Information

The quality management process typically starts with regulatory affairs and marketing. These departments take the data gathered from the manufacturers and strategically market the materials. Pharmaceutical companies must meanwhile impose strict guidelines on their products for health reasons.

This is where the quality process comes in. All information needs to be clear and correct. No one wants to recall a product because of a small labeling error. A way to ensure the accuracy of packaging is by using quality management software to review your files before they are sent to the design department.

Ensuring Your Quality Management Vision is Clear

Part of the quality management process involves precisely displaying your vision on your packaging. When planning the design and packaging of your product, it is essential to choose a supplier that understands your needs. Choose carefully though; You want to work with someone who will be able to bring your creativity to life.

For example, if you are looking to take risks and be innovative with your design, your supplier must be equally willing to take that risk with you. Both the company and the supplier must be on the same page, or collaborating can become a challenge.

Quality Management: From Digital to Print

Woman and man communicating about print inspection

For businesses looking to take that risk and re-launch their packaging, having a physical proof is imperative. A proof, or a printer’s proof, is a copy of the design. These are made to ensure that the printer is meeting their client’s needs by helping their vision come to life. You want to make sure that not only is your design translated into an artwork file, but that it looks just as good in tangible form.

When your clients receive the good, the packaging is the first thing they see. If your file has errors in it or isn’t color-consistent, go back to the drawing board. Work with graphic designers to come up with a design that is both practical and conveys your brand’s message. Proofreading software can also be used by designers to review files for artwork accuracy, by comparing proofs to the internally approved original.

Validation Of Your Packaging

After your product has been packaged, the next step is to put it through a series of tests. You want to make sure that package is of the highest quality and you provide a positive customer experience. Most companies perform the following analysis on their packaging: Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

IQ ensures that the sealing equipment is installed at the manufacturing facility. PQ tests the integrity and repeatability during the sealing process. Lastly, OQ makes sure companies perform durability, rub, and drop tests so the package will hold up and not fall apart during transportation by the time it reaches its destination.

Conclusion

Even when your product is sitting on the shelves of stores, it must provide a good first impression to potential buyers. A product that looks high-quality will grab consumers’ attention and earn their loyalty. In other words, it’s important that your packaging be error-free and created the way you had anticipated. If you decide not to design your packaging in-house, partnering with the right supplier is essential. You want to work with someone who is on the same page as you, especially if you’re looking to revamp your brand. Ensuring your packaging is of the highest quality is the ultimate goal, whether you’re in regulatory affairs or work on the design team.

Regardless of your position, you play a major role in quality management, which should ideally span multiple departments. Consumers who see the value in your product are likely to stay put. After all, a company is only as successful as its packaging.

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