Standard Operating Procedures (SOPs) are a critical component of any organization’s quality management system. They provide clear, detailed instructions on how to perform specific tasks, ensuring consistency and accuracy in the performance of those tasks. However, keeping SOPs up to date and accurate can be a significant challenge for organizations.
SOPs are critical in the creation and update of packaging materials for Pharma, Food and Retail companies where a mistake introduced in the packaging can trigger a costly product recall.
Consistency
One of the major challenges is maintaining consistency in the SOPs. As an organization evolves and changes, it can be difficult to ensure that all SOPs reflect the current processes and procedures, specially when dealing with changing external stakeholders, such as printers, regulatory agencies and contract manufacturers. This can lead to confusion and errors, as employees may be following outdated or incorrect instructions, or even worse, ignoring them all together because they do not reflect the reality of their daily work. Additionally, as new employees are hired, or existing employees move to different roles within the organization, it can be difficult to ensure that everyone is following the same SOPs.
Accuracy
Another challenge is ensuring the accuracy of the SOPs. As processes and procedures change, it is important to update the SOPs to reflect those changes. However, it can be difficult to ensure that all changes are captured and that the SOPs are accurate and up to date. This can be especially challenging in large organizations where there may be multiple departments or teams responsible for different SOPs.
The Devil is in the details
The line between accurate representation of proceses and overly detailed instructions that are difficult to follow is sometimes thin. A third challenge relates to this line and the art of keeping the SOPs concise and easy to understand. SOPs should be clear, concise, and straight forward to follow. Overly complex and detailed SOPs can make it difficult for employees to understand and follow the instructions, leading to confusion and errors. Additionally, writing too many pages can be overwhelming and time-consuming for employees to read.
How can you address these challenges?
To address these challenges, organizations can establish a system for regularly reviewing and updating their SOPs. This can include assigning a specific individual or team responsible for maintaining the SOPs, and setting up a schedule for regular review and updates. Organizations can establish a clear process for capturing and documenting changes to the SOPs, and for ensuring that all employees are aware of and understand the most up-to-date SOPs. By adopting these strategies, they can ensure that their SOPs are accurate, up to date, and easy to understand, without falling into the trap of writing thousands of pages.
Digitalization of processes can be a difficult task. Here are some strategies to make it a bit easier. Photo: canva.com
Are you transforming your company processes into digital ones? These are a few things to consider when doing so to make sure your team is on board!
The digitalization of company processes can be a challenging transition for employees who have been doing the same thing for a long time. This is because it requires them to adapt to new technology and ways of working, which can be overwhelming and intimidating. Additionally, some employees may feel that their job is being replaced by a system, leading to fear of job loss and uncertainty about their future.
However, with the right strategies in place, companies can help their employees to embrace the digitalization process and make the transition as smooth as possible.
One strategy for helping employees to embrace digitalization is to provide them with training and resources. This can include training on the new technology and processes, as well as access to online resources such as tutorials and FAQs. Providing employees with a clear understanding of how the new technology works and how it will benefit them and the company can help to alleviate their fears and uncertainty. Additionally, providing employees with the opportunity to test out the new technology in a controlled environment can help to build their confidence and familiarity with it.
Another strategy is to involve employees in the transition process. This can include involving them in the selection and implementation of the new technology and processes. By giving employees a sense of ownership and control over the process, they are more likely to be invested in its success and feel more positive about the changes. By involving employees in the process, companies can also benefit from their expertise and knowledge of the current processes, which can help to identify potential issues and improve the efficiency of the new technology.
Communication is also key when it comes to helping employees to embrace digitalization. Keeping employees informed of the reasons for the change, the benefits it will bring and the progress made during the process, can help to reduce anxiety and uncertainty. Regular updates and opportunities for feedback can also help to address any concerns employees may have and ensure that the digitalisation process is as smooth as possible.
Finally, companies can also help their employees to embrace digitalization by providing them with career development opportunities. This can include training and development programs to help them acquire new skills and knowledge that will be relevant to the new technology and processes. This, in turn, can help to keep employees engaged and motivated, and provide a sense of purpose and direction during the transition.
We have helped many companies make the transition to our SaaS Artwork Management System, and have experience this reticence to change the old ways from employees. “We have always done it like this” is not really a reason to not move forward! Some companies deal with it better than others, but the above strategies are in the core of all successful implementations we have done where some resistance was shown by one or several members of the team.
We are proud to say that many of those change-adverse people who were not happy at that moment in time have turned to become our best advocates for the use of Twona.
User feedback is crucial when designing and programming a SaaS solution for large and complex corporate companies to manage their packaging design process. Without user feedback, the solution may not meet the specific needs and demands of the users, leading to dissatisfaction and a lack of adoption.
By gathering feedback from users throughout the design and development process, the solution can be tailored to their specific needs. This ensures that the software is user-friendly and easy to navigate, making the packaging design process more efficient and streamlined. User feedback also helps identify any potential issues or bugs that may have been missed during testing.
Incorporating user feedback into the design and development process also demonstrates that the company values the input of its users and is committed to providing a high-quality solution. This can lead to increased customer satisfaction and loyalty.
Additionally, user feedback can provide valuable insights into the industry and market trends, allowing the company to stay competitive and continuously improve the solution.
There is of course a fine line between listening to your users and building a custom application for each of them.
How to prevent this from happening? These are some ideas to make it work for everyone:
Making sure that any feedback you receive is properly tracked and reported – this way you can link similar ideas/requests and map them to your own product development timelines
Translating the feedback into clear requirements (SOPs) – without clear requirements, nothing can be built. Users need to be very specific when talking about their needs so that there is no possibility to get something lost in translation.
It is imperative that the need applies to a majority of your user base – if what a customer wants is not what another one needs, there is little room for an implementation that will affect all your users. While some features may not be used/needed by all, building something that will only apply to a handful of users defeats the purpose of increasing the quality of your software and will deteriorate your client satisfaction.
When all these three conditions apply, customer feedback can become a great tool to make sure you are designing and programming a SaaS solution that is built to last and that users identify and are comfortable working with.
At Twona we often incorporate feedback from our users into upcoming releases. It may take some time for things to appear in your screen – we work with an agile methodology, but until proper requirements are drafted and confirmation that the solution will be beneficial to most users, we may not proceed to put it in the planning; or after going thru the 3 steps above, realize that the request was not meeting but a customer needs and could not move forward; but in any case, we do take their input seriously and report each feedback input into our tracking system for discussion with the Product owner and engineer teams.
So if you are one of our clients, do not hesitate to let your Success Manager know about your ideas!
Releasing a new product at a specific time can be very important for the results,the time factor will always be something to consider. If we are dealing with a deviation that implies a withdrawal from the market, speeding up the changes will be even more critical and always with several departments involved.
The approvals of our packaging materials have been traditionally managed via email in two different ways:
Serial process: in sequence you ask for feedback to different stakeholders and when one material is approved the next step can begin consecutively.
Parallel process: we ask for feedback to different stakeholders in different departments at the same time.
Photo by Twona
When we talk about approvals there are usually at least 3 departments involved, for example regulatory affairs, marketing, quality or your technical colleagues. As many people we need feedback from,the more difficult the email process becomes.
It is not impossible, but it certainly takes a lot more effort to find, trace and control the process, not to mention the increased probability of errors and the delay it can cause.
How does your company manage approvals among departments? What about when there are external stakeholders involved in the process like a printer?
This is how we handle approvals within our artwork management software (AMS), Twona:
Photo by Twona
Select the file: we select in our system the file from which we need feedback from. The file with unique identifier associated with a single project:
Fill in the form: where we specify the permissions that you can see below, the subject, the recipients and we include our comments to give it context.
Receive email: stakeholders, within our organisation or external users, will receive an email to access the approval screen and give their feedback.
Review file (s): here we can leave comments in the text field or leave sticky notes in the file itself, we can also add files if necessary as well as give our approval or rejection eventually.
Control approvals: in Twona (AMS) there is a direct access in the upper menu to the approvals with the necessary indications to know the status of the process.
Photo by Twona
Once you work this way, there comes a time when you wonder how you were able to manage so many approvals without making mistakes.
Photo by Twona
This is how we manage the packaging materials together with the comparisons tool (X-RAY) and everything offered by the artwork management software, Twona, but that’s another story.
I wonder how you resolve this process today and I invite you to leave us your comments.
Do you miss any relevant information or step for your approvals?
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
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 inconsistencies. Time 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
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.
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.
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??
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.
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.
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.
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.
