APL: Finding the balance between risk and efficiency

APL at a glance: APL is one of Europe’s largest manufacturers of extemporaneous medicines and a leading contract manufacturer within Life Science. They have four locations spread throughout Sweden with a total of approximately 500 employees.  

The Challenge

Jan Ernberg, CEO of APL, is a leader who believes that quality and compliance are a fundamental part of the business. After joining the company in early 2019, Jan had identified major challenges, from not being efficient enough in their ways of working, to not sufficiently applying a risk-based approach in their QMS. However, his challenge was that he lacked the data he needed to prove his intuition and to create a plan to improve the situation. To meet this challenge, APL engaged Epista Life Science to help find the optimal balance between risk and efficiency.  According to Inger Bergman, Head of Quality Assurance at APL, “We saw the benefit of input from outside our organization. From someone with a deep knowledge of best practices who could give us an impartial overview and guide us in making the right decisions going forward. I was new to my job – having just started in the position a few months earlier – when the CEO approached me. Like our CEO, I also knew there were areas we could improve upon, but I didn’t have concrete data. So – Epista’s help was exactly what we needed to improve in those areas. It gave me  the energy to push compliance to the top of our agenda and make it more relevant than it has been before  in APL. And with many thanks to our CEO, who was firmly backing me up.”

The Solution

Epista used a proprietary methodology called CIRC (Continuously Improving Regulatory Compliance) to help APL find the optimal balance between risk and efficiency. “The CIRC method really spoke to us at APL. The results of the project became very clear and easy to understand, with an overview pictured in one diagram. This helped us communicate the reasons for change to the rest of team – so important.

They could easily see the inefficiency and waste created by our complicated work processes. While one can argue with a gut-feeling, no one can argue with concrete data,” says Inger. Among all the potential areas for improvement, the project focused on Quality Assurance processes. With four sites spread throughout Sweden, getting input from all relevant parties was a challenge. But Inger knew it would be worth the effort: “The QMS is for the whole company, so it was fundamental that everyone be involved."

And the efforts paid off. Epista interviewed department representatives in QA, QC, IT, Material Management, Development, and Production and analyzed the in-scope processes. Finally, they presented an action-oriented roadmap for improvement and optimization of quality processes, aligned with APL’s overall company objectives. Inger continues: “We have limited resources and have to use them wisely. Epista helped us figure out the specific initiatives for the biggest bang for our efforts – quickly”.

‍The Results

About the benefits of the project, Inger shares: “The CIRC report detailed the significant financial benefits we would achieve with investments in the right computer systems. Without going into details – money will be saved in the long run".

We have limited resources and have to use them wisely. Epista helped us figure out the specific initiatives for the biggest bang for our efforts – quickly. - Inger Bergman

More Results

There’s another big benefit that Inger adds to the business case. Following the CIRC roadmap gives people more value from the time that they work. The time gained from increasing efficiency is being put to good use. Employees use their valuable skills to contribute in more worthwhile ways to the company. This has helped to improve business results and company morale.

The report highlighted three main areas for improvement with specific actions underlying each of the headlines.

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Recommendations for APL to improve quality and efficiency

Project 1

• Improvements of the QMS & QMS processes

Project 2

• Implement a new and improved document handling system

Project 3

• Implement a new and improved system for deviations, CAPAs, and change management

Inger says: “To energize the organization and boost the start, we started with the low hanging fruits, but there is still a lot to do in order to execute all of the report's recommendations”.  Here are just a few of a very long list of concrete actions to quickly take to improve both quality and efficiency!

• Train all employees in the quality system
• Implement change control board and update change control system to the newest version, so the data can be used for KPIs
• Introduce business intelligence for deviations and complaints
• Clean up op two levels of SOPs - the ones that define the rest of the levels

Looking Ahead

Going forward, APL's compliance strategy will consist, in large parts, of recommendations from Epista's CIRC report with the addition of other activities that we have since identified. They are finalizing the budget for more IT investments in their EDMS and Change Management systems, and believe they’ll have everything in place in the next two to three years. Inger concludes: “As I was newly appointed to my role as Head of Quality Assurance when we started the CIRC project, I appreciated Epista’s contribution. It  was crucial  to define and implement a quality and compliance strategy to support the success and growth of APL”.

Epista's help gave me the energy to push compliance to the top of our agenda and make it more relevant than it has been before  in APL. - Inger Bergman, Head of Quality Assurance