Top 3 Compliance Risks Involving Packaging (and How to Prevent Them)

Photo by Meriç Dağlı

The packaging world shakes hands with a plethora of different industries; Pharmaceutical, Fast Moving Consumer Goods, Food & Beverage, Cosmetics, etc. Each industry has its own unique working environment, including unique hazards that come with each. But any industry that deals with packaging shares some overlapping risks. Here are the top three compliance risks for packaging, and one potential solution that can take them all on.

The Three Monsters:

1. Recalls

Anyone involved in the packaging world knows the dreaded word “recall.” Some have had the misfortune of dealing with this problem head on, and others have only heard through the grapevine about the steep consequences that must be faced when dealing with a recall.

A recall is peculiar in that one seemingly microscopic misprint can make the difference between a successfully launched product and millions of dollars worth of logistics rollback and untold damage to quality and reputation. The consequences of recalls have short term immediate impact as well as long term ramifications, such as sanctions.

2. Process Risks

A process risk, while often less blunt than a recall, can have more subtle and extended impact, which makes them more dangerous in that they are easier to overlook. Process risks involve a failure to follow established processes. In the packaging world, an example of this could be as simple as skipping a step in the validation process for the design of a new pamphlet.

Photo by UX Indonesia

process with postits
Photo by UX Indonesia

When process risks become habitual the potential for heavier risks (such as recalls) increases, productivity can decline, and the quality of output can suffer, overtime causing damage to the bottom lineand more importantly to the vital structures that keep companies afloat.

3. Illegal Practices

The risk of illegal practices is in many ways self explanatory. Everyone would like to believe that their company is immune to such risk, but illegal practices are not exclusively intentional. More often than not illegal practices take place unknowingly and are a result of the mismanagement of processes or resources.

In terms of packaging, unintentional illegal practices can take the shape of mislabelling, mismanagement, and nonobservance of legal requirements.

What causes these risks?

While there are varying factors that enhance the probability of the risks above, it is clear that the three risks share some common threads. Miscommunication is a likely cause in many errors attributed to recalls, process risks, or illegal mishaps, and can be an ill-fated result of disorganization with an individual or team, lack of transparency for the proper parties, or workflow inconsistenciesTime Pressure is another phenomenon that those involved in packaging design are intimately familiar with. The rush to get to the shelf can often mean that safekeeping processes are overlooked and corners are cut to decrease the amount of time it takes to start seeing a return on investment.

Photo by Kenny Eliason

Photo of a sand clock
Photo by Kenny Eliason

Completely eliminating these risks may not be possible, but companies can create some mitigation strategies to lower the probability of these occurrences.

One Solution to Rule Them All – Online Artwork Management Tools

While the root causes of compliance risks may seem intimidating at a glance, the good news is that these issues can be prevented with proper support. In today’s technological age there is a wide range of Artwork Management Systems (AMS) that boost communication efficiency and workflow organization through a plethora of verification, workflow management, and proofing tools. By using an AMS, companies are able to support the artwork design process by eliminating old manual processes and lengthy back and forth email exchanges with different parties.

But what really makes an AMS so interesting for organizations? You can find some of the well-known benefits below.

Organize communication and create one source of truth

  • Create one centralized artwork repository containing all versions, which is accessible at any time.
  • Eliminate back and forth email exchanges and communicate about the project within the project itself.
  • Allow for internal and external feedback and approvals, tracking status, comments and confirmations to be accessed in one single place.
  • Record full audit trails of what happens with the project from briefing to print.

Increase workflow visibility

  • Identify & eliminate bottlenecks in your workflow process, see where improvements are needed most.
  • Track KPIs & gain actionable insights, visualize your workflow and prevent process errors.

Streamline approvals

  • Share files of any size, no more inbox limits.
  • Request feedback approvals from internal and external stakeholders on the right version.
  • Return annotated files and attach new ones for changing purposes.
  • Visualize all approvals from one single place.

Give you the power of proofing

  • Gain a clear view of changes in packaging done through different versions (text & graphic) and reduce the need to inspect manually.
  • Red line overlapping documents and also x-ray side by-side comparisons.
  • Download proofing reports.
  • Comment directly on documents, where multi-user notes combine together.

Automate and integrate to eliminate redundant tasks

  • Set automatic notifications.
  • Integrate with other tools to speed up processes.

Do the reasons above sound like something that would make your process easier, and give you the peace of mind that your company requires? If the answer is yes, you may be a good fit for an AMS.

Photo by Twona

Compliance Risks are Nothing to Fear

Compliance risks are an ever present obstacle that anyone in the packaging industry must stay vigilant against. But that doesn’t mean that they are insurmountable. With proper workflow transparency and consistency, compliance risks are easily mitigated. If you’re ever in fear, you can depend on AMS and other solutions to save the day.

Published by Twona: Twona is a multi-faceted packaging specialist company with 20 years of experience in software solutions and packaging design. Twona’s flagship product Twona AMS has helped companies worldwide organize and streamline their packaging design process. You can start a free trial of Twona AMS today by clicking the following link , or request a demo now.

System Connectivity – inspiration to manage your Artworks

Photo by Stefano Bucciarelli

Nowadays we have tools that help us manage our Artworks. The two major ones being:

  • Artwork Manager – guarantees the correct identification of our Artworks, avoiding duplicity, and respecting fundamental rules for the industry (Good Manufacturing Practice (#GMP) , offers a unique identifier, traceability, archive of all files, … amongst others
  • Quality tool that allows us to review the final product through comparison. These comparisons can be at the graphical level between two artwork versions, or review of a text with the design, i.e. content check.

Both tools have evolved over time to improve and cover all possible use cases and maximize processes on a tool level. The next step would be to talk about #connectivity at a few levels:

Photo by Clint Adair
  • Connectivity with external parties – allow third parties (e.g providers, printing companies, clients) to interact with our tools. An example is an #approvals system where we ask for feedback about a specific Artwork. External users can approve/reject these and leave their comments and attach files, completing the review process.
  • Connectivity amongst the different tools we use, a.k.a #integration. This is controlled through automation platforms, from a wide range of programs, which we can make “talk to each other” to generate a specific action. The possibilities are countless, some examples of this potential are: automate your inbox; administer a project; Artchive and make security copies of work ; notifications and alerts; monitoring ; client support; reports, graphics and control panels; web design; accounting and invoicing;

If your current system is isolated from the external world, or you think integration of your applications is possible, this is the time to change your AMS and open your eyes to the sea of possibilities that integration platforms have to offer.

Rafael Cruz Núñez
Artwork Manager

Accessible cereals, leaflets, and more… for everyone

Photo by Tiard Schulz 
Photo of cereal bowl with strawberries and berries

A few years ago, the Kellogg Company started a trial in partnership with the RNIB in the UK, to use a special code in their packaging that, using NaviLens technology, would read out ingredients and other label information to clients.

This trials, from I could read, originated in the US and actually are spreading – thankfully – to other countries. In July 2021, it was announced that this technology would come to Europe, amongst others to The Netherlands and Spain. I have not seen it in the shops of any of these two countries yet even though it was announced for Q1- I will be sure to triple check the shops this week to confirm.

You may have noticed that I am not mentioning visually impaired and blind clients when talking about the Kellogg’s example. They are the key group the trial started for, and the heavy users of the technology currently.

However, Jamie S. published a post recently with a statement that I believe so true! When we talk about accessibility and accessible products/services, very often the collective it is aimed at is mentioned as we are making the product accesible to them. But aren’t we all benefiting from those improvements? From a lowered pavement that allows you to move the baby buggy with ease, to subtitles on videos to not activate audio at work, to GPS on your car to reach your destination, … we all use them daily!

And this is why, I linked a few more things together in my mind.

Not long ago, our colleague Rafael Cruz Núñez published an article about what seems like the future of leaflets in the pharmaceutical industry. The article mentions how printed leaflets inside a box are likely to become a thing of the past. However, these are really important for health reasons, so removing them altogether is risky.

Photo by Twona

Pharmaceutical packaging is subject to many regulations, one of them is to include braille on their boxes to make them accessible to a larger collective and avoid the risk of mixing up medicines. But what happens to the leaflet? This contains the critical information needed to administer the medicine, and understand side effects. Implementing such technology on pharmaceutical packaging would contribute to making medicines far more accessible than what they are now. But, to be honest, this would help you too, as I cannot be the only one whose leaflets disappear or get damaged after opening the box!!

So, after making public transport, museums, and now also food accessible for everyone, maybe it is a matter of time before we see these colourful NaviLens codes in medicine boxes too??

Zuriñe García
Marketing

Kaizen 改 (kai -change) 善 (zen- for the better)

Photo by Connor Ludy - Japanese signs on orange background
Photo by Conor Luddy

Kaizen is no new concept, it is quite an old concept well renowned in the industry, in relation to quality management.

Most sectors nowadays must adapt quickly to a changing environment, in a nearly organic manner. There is that resistance to change nearly inherent to human beings. Once we are used to something, and we are agile in a specific process, it takes a while for us to amold to a change that means learning a new technology, forgetting or unlearning the previous process.

Considering that a new adjustment or process would be beneficial, could it be that adding a new process would be what causes the initial friction?

Photo by Elisa Ventur

How many of the changes you experienced in the last year meant learning to use a new tool or software?

There are possibly workers that can manage their jobs with 2 or 3 tools, buy I would dare to say that most of us use at least 5 or 6. Is that too much? Without too many details, I can count: Task and team manager + internal communication tool + online cloud storage + CRM + ERP + Invoicing system ; Shared document editor + Wiki + Password manager + Video conferencing system + Email + Time tracker + Process automation and workflow management…

So, just working with half of these tools is quite a lot to use on a daily basis, each team would have their own tools to manage and control their processes in the best way possible. Does it mean that we have enough and we cannot absorb any more tool-related changes? I do not have an answer to that but I do not think that is the best approach to the matter. It is, however, the time to reflect on how the process can be simplified, which is why I am taking on the automation of processes or integrations.

Photo by Mathew Schwart

In that search for continuous improvement through change, it could be that we have become obsessed with wanting to use the best tool for everything – the most complete CRM, with a task manager and teams easy and usable; tools to communicate; intuitive invoicing system; and organized resources planning to link operations in different areas, ERP.

Do not get me wrong. Of course, we all want the best for our teams, and we want to provide the best in market tool for each process. But, sometimes, when we study processes from a top perspective, looking at the big picture, maybe the answer is in learning the connection between different tasks to create a sequence and automate as much as possible.

Is tool integration the new Kaizen of our time?

Rafael Cruz Núñez
Artwork Manager

Leaflet digitalization in the European Union?

Photo by Danielle Rice - map of europe
Photo by Danielle Rice

If you follow us, you would remember an earlier article about changes in the pharmaceutical industry in the last years, around tools and technology for document management.

Was it an exponential change in the industry ?

Some examples of these changes are:

  • A paper archive/database
  • Tracing in an spreadsheet
  • Control of changes on paper
  • Email or Fax as project manager
  • Visual Artwork review
Photo by EMA

These types of processes are now a thing of the past, and are being replaced by Artwork Management systems, and proofing tools that take change management to a totally new level.

The change has been enormous and more changes could be needed due to agreements between the European Medicines Agency (EMA) , management at Medicine agencies (HMA) and the European commission projects from 2018, aiming at a digital transformation in sanitary support in the European Union (see the draft here: EMA)

This transformation has implications that are beyond my knowledge, but some of the phases that it entails were:

  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 2018 – collaboration between EMA-HMA-EC identifying the needs for a future digitalization.
  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 28 november 2018 – EMA runs a workshop with patients/consumers, health professionals, interested parties in the industry, academics, NGOs and regulators. This returned the key principles of this process.
  • February to July 2019 – public consultation with over 500 comments.

After reviewing these comments in relation to the key principles defined, a pilot program emerged in January 2022, aimed at evaluating the impact of the removal of the paper leaflets in a small portion of medicines for human use, within hospitals.

These medicines should include in their primary packaging a non serialised Data Matrix code that, once captured, would allow direct access to the digital version of the leaflet from the information allocated in CIMA.

Photo by Rodion Kutsaev

The pilot duration will be at least 2 years, and it will be implemented progressively.

Would there really be a digitalization in health assistance in the European Union? I believe that after all the effort, this will become a reality. The only question is to what extent is the EU capable of coordinating for the big change of digital times.

And you, are you ready?

Rafael Cruz Núñez
Artwork Manager

Remote work is here… to stay?

Photo by Nelly Antoniadou - image of small scrabble like letters in black wooden pieces, saying Work from home
Photo by Nelly Antoniadou

Unfortunately, change sometimes comes hand in hand with a crisis, of different types. The last change in the working environment had as a catalyst a sanitary crisis.

Even though it is of course true that not all jobs can be performed remotely, a great percentage of these only require a computer connected to the internet. Although it did not go without difficulties, imagine how this pandemic would have looked like for us 20 years ago!

Would have you been able to do your job from home 20 years ago?

If you go back in time … do you remember the amount of paper that was used at the time, that needed to be archived… a large room with the photocopiers, maybe even a fax… using telephone for everything, and access to an intranet with servers in the same building?

I have been working from home for a while and I feel confident that I have all the documentation I need and that the servers we use are on the cloud. If you work with Artworks and think there is some room for improvement for your process or moving to more modern technologies, I invite you to have a look at us.

Photo by Chris Montgomery

There are many pros and cons about remote working depending on your activity and job environment . Working remotely you avoid unnecessary travel back and forth to your office, although it is true that sometimes that commute also helped “disconnect”. You remove distractions with chit chat and extra long breaks to talk to people. But the job is more isolated, and sometimes there are meetings where an email was enough (although that also happened in the “real” world).

In my view, there is still a process before the job environment adapts to this new paradigm, where there are many possibilities: mixed formats and phased approaches for new hires, etc.

Photo by Magnet-me-EOLgQ6jl

Similarly, it is important that regulation comes to place for those remote / home workers based on what this means for their economies: support for extra expenses (utilities for instance). If you are working from home and are new to this topic, make a search around legislation that has been approved/promoted in this respect .

This article is not a fear monger about what would happen if we are forced again to all work/stay at home; on the contrary, the article is a praise to the fast adaptation of many companies in a difficult situation, demonstrating how agile they could be to make sure they could work as usual in a changing world, from one day to the next.

Do you think remote work has come to stay?

Rafael Cruz Núñez
Artwork Manager

How we manage our marketing projects

Photo by Twona
Image of Twona AMS system showing artwork uploaded and options for artwork details, project, preview and communication with messages
Photo by Twona

A few months ago, we were contacted by the marketing team of one of our Pharmaceutical clients to check if our solution could help them process their work, collaborate, and get approvals in a simpler manner than what they currently do. Our response was that yes, of course it can! You know why we know it? Because we use it ourselves!

In my role as Marketing manager, we use Twona to process our design deliverables. Like in many other companies with a small department, we used to handle everything through Slack/Google Chat or email, and store the files in drive. Since our type of work is very similar to what our clients are using for packaging designs, we also needed a better way to discuss things that are not lost in a myriad of chat messages, approvals of the work, and an organized archive of all the versions and easy tracking of the final approved one.

Using the system has proven a much better way to manage all this process.

  • Everyone in the team has access to it, and can find the latest version of a logo, a linkedin graphic or a brochure. Our project structure and naming convention help with this, even if the file itself would be called something generic, it is easy to find it with the search functionality.
  • We created a simple project workflow that fits our needs as a small team. Now, I get an overview of all the open projects, which ones are for review, or need attention, and can manage and rearrange the priorities better.
  • There are clear deadlines and assignment of responsibilities.
  • When the team is low on work, they can easily take older, less priority projects without these being forgotten, and without losing time.
  • Everyone involved gets notifications when something comes their way, so either to take a look at the information before a briefing meeting/discussion, or to go review the uploaded designs.
  • All communication related to a project and all files linked to it are in one place, so if we want to go back to something, it is always available.
  • Creating new design requests based on earlier files is much faster now, without having to re-attach all files to an email or include links. Also we can hide attachments that are no longer relevant, avoiding risk of using the wrong information.
  • We have no limitation on what to store so also high resolution and raw files can be included, in case someone else needs to work on those later.
  • We are able to send files safely for review through the tool to external parties such as partners or printers, always knowing that we are choosing the right files.
  • As we can leave annotations in the files, or attach other documents, the designers know what to change, and anyone (this is our choice) can access the feedback, so if a person is sick, someone else can take up the work without much of an issue as all the files are there, and all the notes/changes requested are also included in one place.
  • We can review that all changes requested have been made, or that the printer has not introduced anything strange when sending the final print proof, by using the native comparison tool.

Moreover, the team is happy with using Twona AMS for our own marketing projects, and it was a quick and simple transition for us.

We have made small adjustments as we progressed and introduced different types of projects, to be able to put projects on hold, or make material available for our partners, amongst others.

If you are considering a more organized way to manage your communication and collaboration around marketing projects, check out Twona and see if it can be of help for your team too!

Zuriñe García
Marketing

Standardizing products in the pharmaceutical industry

patrick tomasso unsplash

Homogeneize/Standardize is the process to harmonize or confer homogeneity or unity to the elements of a set or an area. When it comes to our packaging, it has many other implications:

  • Identification & communication of attributes and visibility.
  • Item Distribution Strategy.
  • Increase in perceived value of the product.
  • Brand recognition.
  • Loyalty.

With the term defined and considering the high strategic importance of standardizing our packaging, we are going to focus on how to deal with the production of (standardize) materials.

What is the best way to guarantee that our team of designers produce homogeneous materials?

Without a doubt, it is the use of templates. These templates, which are expected to be a shared resource, must be unique and protected to avoid changes and therefore generate unwanted deviations.

It is important to develop as many templates as types of products are in our portfolio. These types or groups of products have similar content, form and distribution:

  • Blister box
  • Vertical box
  • Label
  • Leaflet
  • Blister

Using a Folding Box as an example, our template must contain: logos and corporate identity signs, road safety or photosensitivity icon, recycling symbol(s), dosage chart and a long etcetera depending on the complexity of our design.

In order to complete our template, we are currently still missing a fundamental element. It is of vital importance to have a mockup in our template so that designers can use the elements that compose it when building new products.

Back to our example of a Folding Box. In our mock-up there will be a set of elements in the front face such as the name of the product/component in the correct corporate font, size and formatting that would help the designer create the final material. Very important is to make sure that these elements are not to be specific and refer to a real product/component. These should contain a generic text, such to avoid human errors by not replacing the correct text from the Medicines Agency.

For example: Molecule Brand 00 xx xxxxxxx xxxxxx EFG – all these in the correct font and sizes/styling.

Austrian national library – unsplash

Besides reducing risk of mistakes, another benefit of using templates is to exponentially speed up the design process. The template is expected to already solve many questions when starting producing a material: What font should I use? Where are the logos and icons? What were these products like that I haven’t worked on lately?…

To finish with our recommendations to standardize your designs with the use of templates, it is important to highlight that a template is subject to real and common cases. What does this mean? The template should be simplified as much as possible so that its use is agile and efficient, therefore, they should not include exceptions or extreme cases when creating the template.

Our template must encompass the common elements of at least 90% of our materials, as well as our guide or procedure for a material that you can see in a previous article: Facing a Rebranding without stress.

Rafael Cruz Núñez
Artwork Manager

Stress-Free Packaging Rebranding

Photo by myriam-zilles-KltoLK6Mk-g-unsplash

Image of pills, different types, formats and colors.
Photo by myriam-zilles-KltoLK6Mk

As difficult as it may be to recognize it, we sometimes have a hard time adjusting to change. It is that adaptation process what seems like an uphill task.

For a pharmaceutical lab to be competitive, it needs to keep adjusting their processes; using new tools that make work more efficient, or renewing their brand image, for example. And that is the aspect we are going to focus on.

Rebranding and its feared companion: the new Guideline

A rebranding is a brand image change that affects a company’s products and packaging and which rules are collected in a document, named a guideline. Some of the changes that these entail are:

  • New corporate design.
  • New color ranges.
  • Fonts.
  • Icons, logos.

Finding the necessary information to adjust your designs in a document of 30, 60 or maybe even 150 pages, can be complex. Do you imagine working each day with such a lengthy document?

If you have never gone through a rebranding process, here is a shocker: no guideline, none at all, ever, has covered all possible cases. I mean exceptions, nearly impossible implementations, small formats like a label or adjusting those rules to a double molecule, with hidroclorotiazide, for instance.

How to handle a rebranding in an efficient manner?

When you first get introduced to a new guideline, a mix of feelings arise: it is both exciting and challenging at the same time. Before you start hyperventilating at the thought of how complicated it can become to check that or another details, make sure you do this: simplify the document into smaller sections, so you can solve each case separately, focusing on what is important.

The key is to divide the information in several areas, one way is for instance by type of product:

  • Folding Box
  • Leaflet
  • Labels

Whatever division you choose from, it should answer one question: “How do I design/ review a …” > For example, for a Folding box, as it is a very common product that has a rather high complexity.

The procedure to design a box from the guideline is then dissected into smaller pieces that compose it: front face/back face/secondary faces/closing sleeve…

Each section of the divided guidelines will obviously have to contain all its specific rules, and always have images/drawings of real examples. Make sure to also define margins, corporate elements, proportions, and colors, besides the actual content of that box face.

My recommendation is to leave exceptions or special cases to the end. Make sure that the section covers 90% of the cases and leave the 10% for the end of the section.

Similarly, from my experience, besides splitting up information into more agile documents, I would recommend creating templates for the most common cases. It is also very useful to generate checklists that contain the key elements that cannot be missed. Both of these will help you tremendously on the final review.

And you? What tricks do you use to make your rebranding projects simpler and less stressful?

If you are currently going through a rebranding process or it is in the planning, and you have any questions, do not hesitate to contact me. Good luck with that rebranding process!

Rafael Cruz Núñez
Artwork Manager

Improve your quality (of your work and your Artworks)

Photo by Twona
Depicts a the design of a wrapper of a chocolate tablet, turned 90 degrees clockwise, with red markings when there are changes from two versions of the artwork.
Photo by Twona

One of the areas where we have achieved more speed, and a reduction in the number of errors, is the quality area.

Does this sound familiar?

  • Three people are reviewing the content of a new leaflet.
  • One of them reads the text from the Medicines Agency mentioning the format (e.g bold, italics, indent…).
  • The two others visually review a printed Artwork.
  • The whole process takes at least 45 minutes.

Imagine the amount of deviations that a isual check can have, without mentioning the waste of personnel time!

This (real) experience happened a while ago, and nowadays, there are tools in the market that help with this review. Do you think the one you use is quick and efficient enough?

Here is where technology makes our life much easier, as we have comparison tools at all levels, the graphical and the content side, to check Artworks. We always use them internally, before our clients do their own checks, both by the designer who is producing the Artwork and by a colleague in the QA team. This is what we call the 4-eye principle.

Photo by alessio-lin–6LYjG0H32E

Twona X-RAY

Our experience? With the content comparison we are able to review a new text in 5 minutes. Similarly, reviewing changes that we received on an Artwork graphically becomes a much simpler task.

Twona X-RAY’s graphical comparison can visually recognize documents, automatically adjust them to overlap and make the revision process much more efficient Some critical examples for us have been comparing an Artwork with a press-proof that has a different orientation, in which some technical details, such as a Laetus code, has been inserted.

I would like to invite you to try our comparison tool, and calculate how much time and resources you could be saving on your daily Artwork control and review process.

If you still have paper piling up on your desk , going to the office is mandatory to be able to do your work or have the feeling that there are things that can be improved, do not hesitate to share with us your needs, and we can help you make that leap to succeed in a changing and more demanding future.

Rafael Cruz Núñez
Artwork Manager