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

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

The Perfect Artwork Request / Briefing

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Depicts a dartboard with red darts on it
Photo by afif-kusuma-RjqCk9MqhNg

What is an Artwork Request/Briefing?

An Artwork Request is the start of the journey for a design agency. It contains the description of work that needs to be done on a design so that it meets all the necessary requirements to be ready to print and produce. This is applicable to both new designs and edits, and covers the process until it has gotten the sign off from all necessary departments and external parties.

Your design agency/studio needs a good request so that they can translate those requirements into a good artwork version.

Why is a perfect artwork request/briefing important?

  • It guarantees that you, as a client, get what you are expecting from your designs
  • It will reduce the number of back-and-forth iterations to complete the project
  • It assures that the chance of error is kept to a minimum
  • It makes turnaround times faster

Sounds simple. But in reality, it is not always so.

Why is that?

The reality is that many of the people making change requests do not create their information themselves, but they receive it from a third party (or sometimes even fourth). Frequently in a different language.

Furthermore, the level of understanding and knowledge about design/printing specifics of everybody involved in the artwork process varies a lot: across organisations, across different roles, across countries. It is literally impossible to expect that every single person involved knows the same, and that they are good at translating that information into an actionable instruction.

When that happens, and not enough/clear information is provided, it is very easy to fall into a trend that leads to extra time to ask questions and get answers, and to obtain and provide the right details (measurements, keylines, logos, images…).

What is then the perfect request?

The perfect request is one that describes the changes required in a way that makes the outcome anticipated clear and agreed on by both the requestor and the executor, but also other parties that may need to get involved later (e.g. manufacturer).

The perfect request should cover 5 main areas:

  1. Product guidelines – becoming familiar with the client’s guidelines is a pre. All designs must follow these, so they become a hidden requirement after the first iterations with a customer, but nonetheless, a very important item to request at the beginning or refer to.
  2. (Manufacturing) technical requirements – any printer/manufacturer requirements are important to understand so that the artworks are not sent back for adjustments at the last step of the process.
  3. Key data – including the text, changes to this, and graphics that the artwork needs to include and any earlier mockups or open artworks that may exist.
  4. Keylines – attach these always to a request, as using a wrong one will require big changes to your artwork versions.
  5. Format specifications – dimensions and other details about the artwork.

Obtaining this information may require interaction between different departments. It may be best to ask the experts on each area to pitch in to your request so that you get the right information in one go. Also important to have one system where to collate it all, rather than letting it fly through emails and attachments. But we can talk about that another time!

The important thing is to establish a great collaboration between your design agency and your quality and/or regulatory teams. They, together, need to manage the workflow process in a way that brings an artwork from request to execution with the least amount of changes and time to market.

And this collaboration starts with defining what is for your company a perfect starting point, using the above criteria, and what information needs to be provided and by whom at the start of the process.

Do you already know what YOUR perfect request looks like?

Share with us your perfect briefings via: marketing@twonas.com!

Zuriñe García
Marketing