Digitalization and smart manufacturing projects and initiatives can come under a number of different headings. One of the most common is paper-to-glass, where legacy, paper-based processes are digitalized and, where possible, automated.
Paper-to-glass projects deliver significant improvements measured against a range of KPIs. They can also help establish a foundation for further digital transformation projects and modernization initiatives.
This digital transformation case study outlines how the SL Controls team transitioned essential compliance processes in a life sciences facility from paper to glass. The new digitalized, automated, and semi-automated SOPs (standard operating procedures) transformed operations, eliminated errors, and delivered substantial efficiency savings.
The Project
The client in this case study is a multinational medical device company. We were brought into one of its facilities to digitalize and automate processes to drive efficiencies and improve productivity, compliance, oversight, data-based decision-making, OEE, operational agility, data integrity, and competitiveness.
Our client operates a batch production process on an automated filling and packaging line at the facility that is the subject of this case study. The production element of the line was efficient as filling and packaging processes were automated and largely digitalized.
This was not the case with compliance processes. While there was an element of digital record-keeping, essential compliance and quality workflows and SOPs were paper-based and manual. This included:
- Line clearance
- Changeover verification
- Cleaning execution
- Regular maintenance execution
These paper-based and manual processes meant the manufacturing facility could not operate at its full potential. Daily challenges included:
- Human error – staff were required to manually record data on paper before transferring it to a range of different systems, most of which were not connected or integrated. This exposed the company to the risk of human error and the knock-on impacts on batch release timescales, quality control processes, compliance, and data integrity.
- Data integrity issues – data integrity wasn’t just impacted by human error, as even accurate data could be recorded in different formats. There was also a lack of standardization in the organization’s systems.
- Inefficient use of resources – the paper-based processes in use by the organization meant resources were not used efficiently. Operations teams had to spend time on non-value-adding tasks, such as manually recording data on paper and then entering that data into digital systems. Human errors and data integrity issues led to batches being put on hold, resulting in resources having to spend additional time conducting investigations.
- Lack of oversight – the paper-based and digital data that was available could not be relied on to be complete, up-to-date, and correct, reducing oversight.
- Batch release delays – the overall impact of the company’s paper-based, manual systems resulted in unnecessary batch release delays. This had inevitable consequences for the overall performance, profitability, and competitiveness of the facility.
The last point in the list above is worth expanding on further, as batch release delays did not just occur when problems such as human error arose. To a greater or lesser degree, every batch release process took longer than necessary because of the lack of automation and the use of paper-based systems.
What We Did
The solution we developed for the client utilized the Ignition platform, with its modern and highly customizable SCADA and related features. Ignition also has excellent integration capabilities making it ideal for this project as we were working with existing equipment.
Using Ignition, we automated the legacy SOPs for all quality, cleaning, and maintenance procedures that are part of the batch workflow. This included leveraging the available equipment data on the line to automatically confirm equipment status and readiness. These digitized workflows are executed on mobile tablets running the developed application.
The Results
Accelerated Batch Release
Batch release on the production line was accelerated by an average of one hour per shift through a reduction of non-value-adding tasks, a reduction in human error, and the removal of data integrity risks.
Risk Reduction
The new system removed paper-based risks of completeness and quality control.
21 CFR Part 11 Compliance
The new solution fully complies with 21 CFR Part 11, and the system is fully validated.
Quicker Decision-Making
Operators, supervisors, and managers have access to real-time data, improving oversight, speeding up decision-making, and enabling data-based decision-making.
Improved OEE
Digitalizing 20+ processes accelerated batch release and raised the bar for equipment OEE (overall equipment effectiveness).
Scalability
We implemented the Ignition platform so it could be efficiently and effectively expanded across other systems, processes, equipment, and production lines both within the facility and in other facilities operated by the client.
John Downey, Portfolio Operations Manager at SL Controls, said: “The part of this project that is the focus of this case study concentrates on batch release and related compliance and operational processes on a filling and packaging line in a regulated facility. However, it also clearly demonstrates the power of not only the Ignition platform but also the concept of transitioning legacy processes from paper to glass.
“Our client has advanced technologies in a number of areas, particularly production processes. Compliance and quality processes had fallen behind in the digitalization push, so remained paper-based, manual, resource-intensive, and prone to error.
“The transition from paper to glass was smooth using the Ignition platform and the solution our engineers developed. Ignition is more widely used across the facility, but the benefits of this specific part of the project were significant, immediate, and measurable.”
Don Pearson, Chief Strategy Officer at Ignition by Inductive Automation, said: “We have worked with the SL Controls team on a number of Ignition implementations over recent months and years, and we are delighted they are one of our Premier Integrator partners.
“There are multiple applications for the Ignition platform in the life sciences sector, including in the essential areas of quality control and regulatory compliance. Digitalizing these processes through Ignition is possible even when using legacy equipment, and this project shows the results that can be achieved.
“We are proud this medical device facility now uses Ignition for a range of operational and compliance purposes, and we look forward to further expansion of the Ignition platform in the future. Well done to the SL Controls team for another successful Ignition implementation.”