Our subject matter experts Jessica Kjellberg and Katarina Stojanovic share their experience and insights in the field.
What is a quality system and why is it important?
A quality system serves as a framework to ensure that products and services meet high quality standards and are safe for use.
"Whether it's GMP, Medtech, research or suppliers to GMP operations, the purpose of the quality system is to create a structured process for how work is carried out," says Jessica Kjellberg.
The structure of quality systems can vary depending on the size of the company and its activities, but the basic building blocks are often the same.
"Organization description, non-conformity management and change management are some of the key elements of multi-standard frameworks, such as ISO 9001 and ISO 13485," she further explains.
How to find the right level for your quality system?
For new entrants in the life sciences, it can be difficult to determine how comprehensive their quality system should be.
"It's important not to take on too much from the start, but at the same time not to scale down so much that quality suffers," says Katarina Stojanovic.
One way to navigate this balance is to start with the most critical parts of the standard or regulation and build out the system incrementally. A good strategy is to draw up an overall structure for the quality system, identify which main processes need to be in place and then develop detailed sub-processes as the business grows.
"It is more important to start with a simple process with more free text than to have an extensive process that nobody understands or follows", Jessica points out.
How to manage change in processes?
Once a quality system is in Location , it will likely need to change and adapt over time.
"Creating or changing large processes takes time and often requires cross-functional work. It is therefore important to plan for a gradual implementation and not to try to make too big changes at once," says Katarina.
When changing processes, it may sometimes be necessary to manage historical documents or to adapt adjacent processes. In this case, Jessica recommends documenting a clear timeline for implementation and prioritizing the most critical parts first.
Audits and inspections - how to prepare
Regular audits and inspections are carried out to ensure that the quality system is working and that activities comply with the applicable regulations.
"An audit can be carried out by customers, regulatory bodies or internally within the company," Katarina explains.
Internal audits are important tools for identifying areas for improvement and preparing for external audits.During an external audit, auditors review documentation and processes, often focusing on specific areas.
"Before the inspection, it is good to prepare by going through the documents and instructions that may be relevant and preparing examples of how the processes are applied in practice," says Jessica.
She continues:
"It is also wise to avoid speculating or providing unnecessary information that could lead to more questions."
What happens during a regulatory inspection?
Regulatory authorities, such as the Medical Products Agency, and notified bodies carry out inspections to ensure that companies comply with applicable regulations. These inspections can be extensive and involve detailed reviews of documentation and processes.
"You should answer questions factually and concisely, ask for clarification if you don't understand the question, and if necessary, ask to come back with additional information," Jessica advises.
If a non-conformity is identified, it may lead to a requirement for action, and in some cases, deficiencies may result in warnings or sanctions. Having a clear strategy for how non-conformities are managed and changes implemented is therefore crucial.
Summary and key lessons learned
Establishing and maintaining a quality system is a continuous process.
"Start simple and adapt the scope to your company's needs. Use internal audits as a tool to ensure compliance and identify areas for improvement," Jessica concludes.
How can your company optimize its quality system and better prepare for inspections?
Reflecting on this question can be a first step towards more effective and robust quality management.
Learn more about how your company can ensure quality & compliance with internal audits.