Man working on compliance with a laptop

Date: January, 2019 | Categoryquality Author: Ryan Szporer


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 Software Development Lifecycle 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 Software Development Lifecycle (SDLC), data integrity is a requirement that must not be ignored. That goes for GlobalVision’s 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 them 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 the 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 is 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 the 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.

Capitalized letter, checklist, chart and calculator

Date: January, 2019 | CategoryQuality Author: Ryan Szporer


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 a 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, trials 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 to the auditors. Automated trails that are easily searchable make smooth audits more of a reality.

Trails are theoretically included in the 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

Date: November, 2018 | CategoryProofreading 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 Drug Labeling 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 a 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 the 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 the 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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Cartoon of the quality management system for ISO regulation

Date: August, 2018 | CategoryQuality 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 a Quality Management System

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 Quality Management System

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!


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Automated Quality Control

Quality inspection system

Man working on quality inspection with a laptop

Date: July, 2018 | CategoryQuality 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.


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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.

Quality Management: A Step-by-Step Process

Date: March, 2018 | CategoryQuality 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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See how some of the world’s top pharma companies have cracked the efficiency code with automation

Researcher working with machine on a cartoon background

Date: January, 2018 | CategoryQuality Author: Ryan Szporer


There are some constants that cannot be ignored, even between two radically different products.

If you were to take those two products and examine them, there is no denying there would be a long list of properties that vary greatly between the two. We’re talking shape, size, purpose, etc. In a way, they cannot be compared. Nevertheless, whatever the industry, products tend to follow similar development lifecycles. From the point at which a light bulb goes off in someone’s head up to the release of the product to the market, set stages are followed. One such stage, testing, is as universal as it gets in principle.

It’s then that the IQ, OQ, and PQ enter the picture.

For the uninitiated, the “Q” stays the same with regard to each of the above acronyms. They stand for Installation, Operational, and Performance Qualification and each impacts the product development process and quality control in its own way, but as steps, one after another.

As an illustration, consider the pharmaceutical industry. Each piece of equipment or system that enters into a drug’s “chain of custody” must be tested as being qualified for use. “Validated” is another way to put it, with validation 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.”

It’s an exhaustive process with many ins and outs, starting with the IQ.

Installation Qualification (IQ)

The IQ, or Installation Qualification, ensures, as its name suggests, that a product is properly installed.

Physical products like instruments or tools may call for properly allocated floor space, correct operating conditions, and that there is physically no damage to the unit in question. In the case of software, this means verifying items like whether the folder structures are intact and that the minimum system requirements are met. Checks may also include the memory of the workstation on which the software is being installed, the operating system, software libraries, and that all required files to run the application are accounted for.

“Minimum requirements” is perhaps a good way to put it in general. Whether it’s hardware or a piece of software that’s being tested, the Food and Drug Administration’s IQ definition applies. It states the objective is to document that the “system has the necessary prerequisite conditions to function as expected.”

After ensuring that the system in question can run, the focus shifts to how it runs.

Operational Qualification (OQ)

The OQ, or Operational Qualification, is next up. It is traditionally started out once the IQ has been run through, acting as a pre-requisite for technical acceptance of the software, equipment, or facility. In this capacity, the OQ tests that the functionality of a product is as desired. It acts as a review of start-up, operational, maintenance, safety, and cleaning procedures where applicable.

Each critical button/ function is tested to make sure it does what it should. This holds true for both software and hardware and includes everything from the smallest of details on displays to the exact range of temperature fluctuations, etc.

What’s critical is that every piece of equipment and software operates within the stated limits. Ultimately, that’s the point of the OQ. Once each is proven to be, it’s time to test those limits.

Performance Qualification (PQ)

The final step in the qualification process, the PQ, or Performance Qualification, is meant to ensure the product stacks up against real-world conditions, albeit in simulated scenarios. Whereas the OQ verified functionality, the PQ is results-oriented. Tests tend to have expected results attached to them, meaning they have to be consistently reproducible.

The detailed test plan itself is created from the product development lifecycle. Both the Functional Requirements Specification (FRS; document detailing the requirements that are expected to be performed) and Detailed Design Specification (DDS; document detailing how those operations are performed) factor in. System and unit testing (testing done at the modular level) are also taken into consideration.

The goal here, aside from making sure everything works, is to make sure the system is able to be validated. After all, the validation document serves as proof that the system works as expected when it is being installed at a customer site. That documentation is something the customer holds onto if ever an issue or audit arises sometime down the line.

At their cores, the IQ, OQ, and PQ are sub-sections of validation, simply parts of a larger process. The whole is greater than the sum of its parts, though.

GlobalVision as a Test Case Scenario

Take, for instance, GlobalVision, which develops automated quality control software (and various hardware accompaniments like scanners) for packaging components and product collateral. While its own quality control process is as thorough as you would expect and of course includes internal validation, let’s re-examine the pharma example from earlier.

GlobalVision offers validation execution services with industries like pharma in mind. Pharma is renowned for its stringent requirements revolving around standard documentation and GlobalVision has decades of experience within that space, among others, and caters to the top 10 pharma companies in the world.

As mentioned earlier, each piece of equipment or system that “touches” a product during its development has to be validated. Packaging proofreading software falls into that category. The pharmaceutical company in question could theoretically validate an application on its own. However, GlobalVision doesn’t just supply its own validation documents, extensively developed through its decades of experience working with companies in the industry. GlobalVision offers to execute them onsite, thereby further saving the company time and resources better devoted elsewhere.

In this case, validation execution is a value-added service tacked on to the product itself, the software. Software is somewhat of a particular case as multiple versions of a program are generally released, with each version theoretically an upgrade relative to the last, either through fixes or the addition of new features designed to address issues that had been encountered.

It further proves just how critical testing is to the success of a product, and how it’s ongoing. It’s essentially one lifecycle that never ends, further bridging the gap between different industries. Testing and the success it endeavors to achieve are their common ground.

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What to do when you find spelling errors in your print job

Date: October, 2017 | CategoryProofreading Author: Reuben Malz


 

Errors in packaging components arise all the time and are part of the game. They are unavoidable, but, what is a surprise to most people, is that spelling mistakes are the most common.

The largest investment in error avoidance includes expensive inline web inspection systems, cameras, scanners, and most of all, countless hours of manual proofreading time to painstakingly inspect the job. Almost no investment dollars are ever invested to ensure the text copy is free of spelling mistakes. As well, there is hardly any manual proofreading time spent on spellchecking.

Spelling Mistakes in Print Jobs

Man doing package inspection manually

If this wasn’t bad enough, just ask whose responsibility it is.

The customer may be contracting out the development of the copy, and assume spellchecking is done at that time. Internally, no one will be raising their hand.

Why? Because there are so many companies and their professionals in the downstream supply chain, that surely spellchecking must be done by someone.

The truth is, spellchecking is an orphan in most organizations. This actually should not be surprising at all for the obvious reasons.

  • It is a detailed, painstaking, and boring task
  • Many technical words are complex and long in characters
  • Foreign languages pose a significant barrier
  • No one is willing to pay for it
  • If there is a spelling mistake, we simply blame the printer.
  • We live with the error and hope it doesn’t happen again
  • The printer offers a discount to remedy the situation

This is why spelling mistakes plague so many printed packaging materials.


Misconception #1 – Spelling errors, is part one in a five-part series about the misconceptions in packaging quality control. Visit our blog next week for Misconception #2 – The Printer’s Proof.


Learn More about the Importance of Spellchecking in Technical Writing

What does GlobalVision do?

GlobalVision’s mission is to build software that standardizes quality approvals for product packaging and critical content. Our goal is to eliminate errors and automate inspections so companies can release products with confidence. Helping Businesses Bring Confidence to Quality Control. Learn more about GlobalVision.

What is GlobalVision Quality Control?

Automate Quality Inspections for Fast and Consistent Results. Speed up the proofreading process while improving the accuracy of your work by running digital checks with GlobalVision’s automated quality control tools. Learn more about Automated Quality Control.

 

Cartoon pamphlet, bottles, barcode and jar

Date: September, 2017 | CategoryQuality Author: Marvin Magasura


Business owners and manufacturers know that flawed packages carry a negative message for their brands. An imperfect package is an imperfect business, especially living in a world with customers that have lofty expectations. A simple crooked label can transform people’s views of your brand and possibly change their purchasing decision forever.

Companies around the world place great value on packaging inspection. These quality control regimes must be set in motion in order to spot and reject printing errors, wrinkled labels, or crooked caps before they see the light of day.

Given the fast-paced packaging and manufacturing environment we live in, file comparison software is the ultimate tool that will quickly pay for itself by decreasing your business’ labor costs while also reducing liability due to complete recalls. More importantly, they are unflagging, communicative solutions that can adapt immediately to changing inspection parameters.

What makes file comparison software so effective is the technology and algorithms that allow them to “see” products and inspect them for flaws – all done at high-speed, with near-perfect accuracy. The brain of this solution is the analytic software in charge of processing what the software captures, and comparing it to the stored “ideal”  file. 

Today’s file comparison technology and other automated systems are so advanced that these solutions can quickly and accurately tally every item, contrast them with ideal images, point to printing errors, and verify barcodes in a matter of seconds.

However, one of the biggest benefits provided by these systems is user isolation. Users don’t need to understand its complex algorithms in order to use them. Through their HMI (human-machine interface), users just have to choose their inspection target, set the parameters, and press “Go”.

Building a strong brand identity through packaging

File Comparison Software for Complete Packaging Inspection

Besides letting you inspect packaging and products more easily, modern file comparison software can also proof and verify barcodes, alphanumeric codes, and data matrix images.

If you need it, these systems will also check the quality of incoming materials and ensure all steps and processes are done correctly. They can even take care of the quality of your pallet loads before shipping them to a customer. Therefore, because of this complete integration, your whole packaging line will be optimized.

In addition to the increase in inspection accuracy, which will boost your presence in the market, file comparison software can communicate with your business’s computer system and update your production, inventory, and maintenance records. It also provides reports on the total flaws detected. So, if these are higher than your threshold, it will shut down your entire production line until you make the necessary adjustments.

Of course, this level of efficiency in packaging automation varies depending on your needs and the amount of money you wish to invest. The market is filled with different systems that offer a wide arrange of features, from the described above to mere label inspections or barcode reading from the run sheet of the day. The best part is that the majority of them are quite adaptive; You can accommodate them to new products that require different parameters and adjustments. 

Key Advantages

User-Friendly

Most, once installed, are very easy to use and require minimal maintenance.

Tech Support

Reputable file comparison software providers usually offer training programs for operators and ensure technical support in case anything goes wrong.

Market Diversity

The current file comparison software market provides a wide range of alternatives, meaning you can choose whichever best fits your needs.

Adaptability

Less-sophisticated solutions do not offer the ability to automate inspection changeovers, but modern high-tech systems can. So, if you run a diverse packaging line with a large variety of products, you can rest assured that you won’t be losing time doing manual changes every time a new product comes along.

The Cost of File Comparison Software

Like any new technology, especially when it comes to file comparison software, a certain initial investment is required. The actual amount depends on many elements, the main one being system complexity. File comparison technology ranges from a simple cloud-based application to physical scanners that use lights, cameras, lenses, and many other parts like servo motors and conveyors that allow for system adjustment to different targets, shapes, and sizes.

However, keep in mind that with any new investment, the words “cost” and “value” don’t mean the same thing. Focusing only on the financial expense of these systems will skew your assessment. Any prospective buyer of a file comparison software needs to weigh in a variety of factors:

● What are the system’s benefits/ features?
● Will I have to rearrange my entire production line?
● Does the software allow for simple in-house modifications in case any new product has to be checked?
● Do I get technical support from the manufacturer?

Add everything up and you’ll get the rough amount you need to spend. Now it’s time to include the prospective savings into the equation:

● Will I have to reduce the number of inspectors and operators?
● If so, will I reassign them to other areas?
● How much will automated packaging inspection boost my productivity?

And, most importantly, but often ignored:

● What will be my company’s financial value be if I get rid of customer complaints and complete recalls due to packaging mislabeling?

One word of advice before you make any decision: Erase any preconceived ideas from your mind. High technology is no longer a luxury that only big companies can obtain. File comparison software has evolved and the market is full of different choices, making packaging automation a gold standard and sophisticated practice available for small and medium companies alike.

Return on Investment for File Comparison Software

Due to the market’s wide diversification, prospective buyers now have a lot to evaluate. Every company considering crossing over to file comparison software should contemplate the implementation costs and possible completeness of their power supply along with its capability to adapt to new products and materials.

In addition, these systems typically provide quick ROIs, mostly because you’ll cut down on staff for manual inspection, not to mention all the savings related to fewer product recalls and fines from delivering flawed products.

Cutting down on staff is a tangible action. Therefore, you’ll get immediate results on your ROI. Decreasing fines and complete recalls are a lot harder to estimate accurately because the incidence of these events usually varies depending on the company, though. As a result, they usually are not considered at all when calculating the ROI for file comparison software. In spite of this, always keep in mind that, in the long run, these intangible forces can positively enhance your brand’s reputation and boost your profits.

illustration showing laptop with process of folders

The Future of File Comparison Software

In the future, file comparison software will probably advance in several areas.  Current trends are drifting towards cost-efficient solutions suitable for all types of companies, but especially for packaging inspection. Advances will include, among others, a boost in system flexibility, an increase in smart technology, and greater software and hardware alternatives.

Just a few years ago we saw how smart cameras began to challenge PC-based vision systems by getting rid of the need for a separate processor. Although they’ve been available for over 20 years, they only just recently became small and affordable enough to justify an investment.

The quality of image sensors is getting better every year too. So, camera manufacturers are spending less time dealing with these types of defects and more on image processing. With the rise of complementary metal-oxide-semiconductors (CMOS), image sensors are also getting smaller, leaving room for developing further processing features, like color-processing, digital zoom, image enhancement, rotation, and much more.

With such high levels of integration and processing capacity, this all-in-one technology was once an emerging trend but now has started to dominate in the market. We are likely to witness more evolution of smart technology in the years to come.

When it comes to the packaging industry, advances in user-friendliness are likely to simplify the setup and usage of these systems even more. Ease of use will no longer imply a point-and-click graphical user interface, but a comprehensive approach with access to all features.

Less training will be needed and people with very different skill sets will be working with these machines, eliminating the need for time-consuming and pricey training programs.

Although prospective users might want to wait for what the future holds, the current file comparison technology developments mentioned throughout this article imply that the future is now. It’s an exciting time, and one for manufacturers and packaging companies to jump on board with packaging inspection automation.

File Comparision Software for Packaging

GlobalVision also has a wide range of packaging scanners available to suit different packaging line needs. They include non-contact scanners for wet-ink press sheets to cylindrical scanners for cans, jars, bottles, and any other type of cylindrical container.

Above all else, GlobalVision offers its Print Inspection tool, which allows for file comparison of printed packaging vs. approved digital artwork. This tool is the perfect solution to avoid reprints and reworks of any kind, due to printing errors like blemishes, smudges, and unwanted marks in general.

Learn More about Quality Management System

Get our guide to learn more about how to stay FDA-compliant with regulatory labeling obligations

Learn how some of the world’s top pharma companies have cracked the efficiency code with automation