How Reynders Reduced Quality Complaints by 60% and Boosted Work Instruction Efficiency by 50%

Reynders Label Printing has implemented Azumuta as a solution for digital work instructions and product traceability. Learn how this solution helped Reynders streamline their operations, increase efficiency, and maintain the highest levels of quality in their product line. 

50% More efficient Work Instructions

60%

Less Quality complaints

3

months of Implementation

Reynders logo
Company

Reynders Pharmaceutical Labels NV is part of Reynders Group and manufactures custom pharmaceutical labels for the top 10 pharmaceutical companies.

Headquarter

Reynders Pharmaceutical Labels NV is headquartered in Boechout, Antwerp

Employees

+550 employees in Reynders Group

INDUSTRY

Pharmaceutical industry

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Challenge

The Challenge

Context

Reynders Pharmaceutical Labels (RPL), part of the Reynders Label Printing Group, specializes in producing labels for clients who are market leaders in the pharmaceutical sector, including Pfizer, Janssen Pharmaceutica, Schering-Plough, Alcon-Couvreur, GlaxoSmithKline and Baxter. Reynders Pharmaceutical Labels has been operating in a separate production facility for 25 years in order to manufacture a wide range of standard and custom pharmaceutical label products. Whether for vials, syringes, tubes, injector pens, or bottles, Reynders Pharmaceutical Labels prints every single type of label, such as booklet labels or hanger labels, with clinical precision.

In Reynders’s mission statement, we can read: “ […] We make data-driven decisions and have automated plenty of processes to reach near-perfect quality control. […]”

For a long time, Reynders Pharmaceutical Labels has been passionate about acting on this mission, and the result is that the shop floor is now running highly digitized, where any-time follow-up is the cornerstone. We are, therefore, very proud that Azumuta fits this purpose and that we can be a significant part of their production cycle. The story between Azumuta and Reynders Pharmaceutical Labels started in 2020. At that time, RPL already had a robust framework for managing paper instructions but still struggled with the inflexible and time-consuming nature of maintaining non-digital work instructions. Aside from the desire to change this, they also wanted to gain more insights into how the execution of these work instructions went on the shop floor to create a well-informed feedback loop. Therefore, RPL was looking for a partner that would guide them to further digitize their work instructions and also provide.

The main challenges that led RPL to Azumuta can be grouped into three main pillars.

Time-Intensive Work Instruction Management & Flexibility 

Before the introduction of Azumuta, RPL already had a robust framework in place to make and approve the many specific paperwork instructions. However, due to the inflexible nature of paperwork instructions, the management of the instructions tended to cost a tremendous amount of time. Let’s discover the most time-intensive aspects and how Azumuta delivered a solution.

1. Work Instruction Management

In the pharmaceutical industry, the client often has very specific requirements. This translates into the need to be highly flexible on the shop floor, coupled with high accuracy and precision, typical for a high-mix, low-volume environment. As a result, there is a need for separate work instructions per client, product, and format,… These extreme amounts of variants on products due to customizations lead to an enormous amount of possible combinations of work instruction steps in the production cycle. Maintaining separate work instructions on paper for each of these combinations is a never-ending task and can, therefore, lead to a lot of stress for the responsible persons. As a result, It was not always possible to provide completely customized work instructions to the operator that would only state the specific steps that were needed for the production of a specific batch.

How Did Azumuta Help?

Due to Azumuta, RPL is now able to efficiently manage an enormous amount of product variations in a highly time-efficiënt manner via our easy-to-use variant functionality. Not only did RPL win a significant amount of time in managing their work instructions, but they also increased their precision in terms of what the operator sees on the shop floor. With this functionality, RPL can specifically push a work instruction completely configured to the specific product that needs to be produced (e.g., client, format, etc.).

In essence, RPL is now able to manage its enormous amount of product variations efficiently and effectively in Azumuta while also being more precise in what content the operator sees on the shop floor.

“As a customer in the pharmaceutical industry, managing the extreme amounts of variants on products due to customizations can be a daunting task. The never-ending task of maintaining separate work instructions for each combination can lead to a lot of stress for the responsible persons. Azumuta's easy-to-use variant functionality has been a game-changer for us, as it has enabled us to efficiently manage an enormous amount of product variations while increasing precision in what the operator sees on the shop floor.”

Koen Catteeu - Operations Manager
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2. Changes in Work Instructions

In a highly flexible environment where RPL is active, it is not a surprise that work instructions can change rather quickly. This is because the adjustment of work instructions can originate in three ways:

  1. RPL itself can decide to change its work instructions due to changes in the production process, additional safety measures, new materials, etc.
  2. The decision to produce a new variant of an existing product or introduce an entirely new product can lead to the need for new work instructions.
  3. Client demands and other parameters can change. In the pharmaceutical sector changes occur frequently, which results in high pressure on keeping the work instructions up-to-date.

The frequency of changes in work instructions was a significant challenge for RPL, as keeping track of all changes and making sure that every separate instruction was up to date was immensely time-consuming. For example, a small change in a certain instruction step meant that all instructions that used this step needed to be changed. For general steps, this could easily lead to the need to update work instruction documentation for more than 50 different workstations. In the dynamic environment in which RPL operates, mitigating this challenge was a key goal in order to increase agility by easily tracking and updating changes to instructions.

How Did Azumuta Help to Increase Work Instruction Flexibility?

At Azumuta, we strive to structure work instructions as efficiently as possible. The variant functionality, amongst others, allows us to provide an exceptional level of flexibility in terms of adapting work instructions. For example, changes to general steps that are used in several product variations now only need to be changed in one location, while in the past a small change could lead to the need for adjusting multiple work instructions. With Azumuta, short-term changes could now be made quickly, digitally, and become available to operators immediately. This agile way of working enables RPL to adapt very quickly to changes while still maintaining an exceptional level of quality, resulting in a competitive advantage.

3. Distribution of Work Instructions

In addition to the management of the work instructions, the distribution of these instructions to the shop floor also represented an important aspect that cost a lot of time for the production leaders. Before Azumuta, RPL had an effective system for this distribution but still, the production leaders felt that it took a lot of time to get the right paperwork instruction to the right location and to the right operator. Moreover, as previously mentioned, these instructions were not always specific, as it was not possible to provide completely custom work instructions for each product variation.

How Did Azumuta Help?

At Azumuta, we believe that the distribution of work instructions to the shop floor should be completely automated. Without any manual steps, we can push the correct work instruction, completely configured to the specific order, to the right operator at the applicable workstation. This decrease in complexity for the operator results in fewer errors and, eventually, an increase in productivity.

In conclusion, the introduction of Azumuta has significantly improved the work instruction management process for RPL in several ways. Firstly, the variant functionality has allowed for the efficient management of an enormous amount of product variations, while also being more precise in terms of the content that the operator sees on the shop floor. Secondly, the agile way of working has increased the flexibility in adapting to changes, resulting in a competitive advantage. Lastly, the distribution of work instructions has become fully automated, resulting in a decrease in complexity for the operator, fewer errors, and an increase in productivity.

Case study: Reynders

Quality Control

In the pharmaceutical sector, quality control is a highly important aspect of the production process. Before the introduction of Azumua, RPL already had adequate checkpoints during the production process that would make sure that the quality of the batch was up to standard. However, the challenge of paper-based quality checks was that operators were recording their observations on paper checklists, and these forms were later reviewed and analyzed by the quality control department before the final release of the order. This method is reactive, meaning that issues may not be identified until after they have occurred. It was, therefore, RPL’s goal to introduce a framework that would facilitate continuous quality control and feedback while the operator goes through the instruction steps. The end goal was to make sure mistakes were caught and rectified early on through real-time feedback, which decreased the possibility of a batch containing defective products.

How Did Azumuta Help?

First of all, as a first line of defense against quality issues, Azumuta is exceptionally strong in visualizing work instructions. This already decreases the possibility of errors, but at RPL, they wanted more assurance concerning quality control. To do so, we decided to integrate RPL’s ERP system with Azumuta so that client orders in the ERP system could be synced with Azumuta in real time with the correct context. In the ERP system, a lot of quality parameters are attached to a product order (e.g., type of varnish, the width of the label, label position, etc.). Via the integration, these quality parameters are sent to Azumuta, where we can eventually use them to provide automated and continuous quality control.

How do we use these quality parameters in practice? With Azumuta’s software, it is possible to collect critical quality data during the production process due to our Electronic Batch Record system. This system ensures that certain values/parameters of the batch can be captured during the production process, either by letting the operator fill in certain checks or, at certain steps, automatically read values from certain hardware tools (e.g., inclinometer, scale, …). In terms of the first option, while the operator goes through the steps during the production of the batch, the instruction steps are configured so that the operator needs to provide input on certain quality metrics of the batch. This can range from a simple OK/NOK to the input of certain specifications of the batch (e.g. position where the label is printed, type of used varnish, etc.).

Our platform captures this input, and then this data is compared in real time to the quality parameters that were received from the ERP system. This way, feedback or other actions can be taken in real time while the operator is going through the instruction steps. This is very powerful as RPL can now ensure continuous monitoring and feedback on operator input. This way, mistakes can be caught and rectified immediately, resulting in a decreased possibility of delivering batches of products with defects.

Pascal Vandecasteele fotografie Low Res 11 scaled

Quality Certificate

The quality certificate was not perceived as a real challenge at the time RPL was considering the software solution of Azumuta. However, one of the notable improvements that were implemented was the shift from a paper-based certificate of conformity (quality certificate) to a digital one. Initially, this transition was not part of the scope of the project, but it became evident that a digital certificate would be a significant improvement for RPL’s customers. This certificate of conformity needs to be sent to the client to prove the quality of the batch.

The move to a digital certificate of conformity was a natural progression from the digitization of quality control within the software. As operators performed their quality checks using the software, the data was captured digitally. It was then apparent that this data could be exported into a custom-made report and sent directly to the customer when the final release took place.

Before the introduction of Azumuta, the operator would manually fill in this certificate on paper during and after the production process to capture a list of quality metrics of the batch. One of the most significant drawbacks of a paper-based system are:

  • Increased risk of errors: Handwritten certificates of conformity are more prone to errors compared to digital records. The chances of making mistakes in manual data entry or calculation are higher, which can lead to incorrect information being recorded.
  • Time-Consuming: Filling out paper-based certificates of conformity is a time-consuming process that can take operators away from other important tasks. Moreover, manual record-keeping requires time and effort to organize, review, and retrieve documents when needed.
  • Limited accessibility: Handwritten certificates of conformity may not be easily accessible to all stakeholders who need to review or analyze the data. Physical documents may be limited in distribution and may need to be shared through physical copies or scanned copies, adding to delays and reducing accessibility.

The digital certificate of conformity offers several advantages over the paper-based approach. Firstly, it eliminates the need for manual data entry, reducing the likelihood of errors and saving time. Secondly, it is more convenient for customers to receive a digital certificate as it can be easily stored and accessed electronically. Thirdly, the digital certificate can be sent instantly, reducing lead times and improving the efficiency of the quality control process.

How Did Azumuta Help?

As previously explained, our Electronic Batch Record system gathers all captured data related to the production of the batch. With this in mind, together with RPL, Azumuta developed an export feature that allows the digital quality check data to be automatically translated into an exported PDF or Word report. This feature enables their customers to receive the certificate of conformity as a detailed and accurate report that highlights the results of the quality checks in an easy-to-read format. By exporting the report directly from the system, customers can receive the report as soon as the final release takes place in production, reducing lead times and improving the overall efficiency of the quality control process.

Moreover, by providing the export feature, we have eliminated the need for manual reporting and the possibility of data discrepancies. This ensures that RPL’s customers receive a reliable and consistent report every time. In addition to exporting the digital conformity reports to customers, the Azumuta software also offers an automatic storage feature on a GMP-compliant server (in case needed).

“With the introduction of Azumuta's software solution, RPL was able to digitize their quality control process, allowing operators to perform quality checks using the software and capture data digitally. This data could then be exported into a custom report and sent directly to the customer when the final release took place, eliminating the need for manual data entry and reducing the likelihood of errors.”

Koen Catteeu - Operations Manager
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Implementation

Implementation

With the above-mentioned challenges in mind, RPL searched for a partner to help them in achieving their goals. After evaluating various options and a demonstration, Azumuta was selected by Koen Catteeu, Mieke Sebrechts, and their team for this endeavor. In this section, we are briefly laying out how the implementation of Azumuta at RPL went.

First, the RPL team decided to translate their paper instructions to Azumuta format, which was the biggest chunk of work. After that, they tested the system for one client to get to know the Azumuta look and feel. After positive feedback, they decided to do the rollout for all other clients and products after two weeks. In the meantime, the connection between RPL’s ERP system and Azumuta was also established. This way, client orders in the ERP system could be synced to Azumuta in real time with the correct context (quality parameters, variants, etc.). As previously explained, this was needed in order to facilitate digital quality control.

Through good cooperation, RPL was able to implement the usage of Azumuta for the complete shopfloor after 3-4 months. According to Koen Catteeu, one of the key reasons for this fast and effective implementation was the fact that Azumuta is very user-friendly for persons who do not necessarily have a background in IT. This meant that persons who were close to the shop floor (e.g., production engineers) could lead this project, which resulted in the ability to work agile. Of course, there were several instances where they had to make quick changes during the implementation. This was, however, effectively responded to through support and collaboration between all involved parties.

According to Koen Catteeu, it was highly enjoyable to see how easy the switch went from paper to digital in terms of operator adoption. At first, the operator could always resort to paper copies of the work instructions that were displayed in Azumuta, but after a couple of weeks, these paper copies were rarely used anymore. Seeing that Azumuta’s essence lies with operator support, this was a great testimony of how understandable and easy to use our software solution is for the operator.

“Switching from paper to digital with Azumuta was a breeze. Our operators quickly adopted the new system and were able to perform tasks accurately and efficiently thanks to the clear visual aids and proactive quality control management. We were impressed with how user-friendly and easy to use the software solution was, even for those without an IT background. The implementation process was fast and effective, and any changes we needed to make were quickly responded to through collaboration and support from the Azumuta team..”

Koen Catteeu - Operations Manager

From the very beginning the operators were happy with the implemented solution. They understood that digital work instructions and proactive quality control management provide great benefits in a manufacturing environment where precision is crucial to ensure high-quality products. With digital work instructions, operators can easily access clear visual aids that provide context for each step, making it easier for them to perform tasks accurately and efficiently. In addition, the proactive quality control management system can detect when an operator provides an incorrect quality-related answer and immediately provide feedback and follow-up actions to ensure that the correct quality requirement is met. This not only helps to prevent errors and defects but also allows operators to learn from their mistakes and continuously improve their performance. As a result, operators are more satisfied with their work and feel confident in their ability to perform tasks correctly.

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Results

Results

After more than two years, we are proud to see how Azumuta is now deeply integrated into RPL’s shop floor. Here are a couple of key efficiencies that resulted from this implementation:

  • Decrease in the complexity of work instructions: the time spent on managing work instructions has decreased by 50% as Azumuta allows RPL to manage an enormous amount of product variations efficiently and effectively.
  • Azumuta provides an exceptional level of flexibility in terms of adapting work instructions. This allows RPL to adapt work instructions 60% quicker while still maintaining an exceptional level of quality.
  • Azumuta’s platform ensures a flexible and efficient structure for the distribution of work instructions, enabling RPL to provide specific work instructions to the operator that are completely configured to the specific product that needs to be produced. Besides that, the operator also receives real-time feedback on quality while going through the instructions. Overall, this ultimately resulted in a decrease in customer complaints related to human errors of 50-60%.
  • Azumuta enables real-time follow-up on the shop floor, providing RPL with insights into the execution of work instructions and creating a well-informed feedback loop from the shop floor.
  • The connection between Azumuta and the ERP system led to a sync between management and the shop floor, which led to better communication and fewer planning errors.
  • The digital quality certificate, which was previously filled in on paper, is now generated automatically via Azumuta, based on data that is gathered through the production cycle of the batch.

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