Agile and process-orientated quality management: a contradiction in terms?

Quality management systems often have a reputation for being cumbersome and bureaucratic. Especially in the medical technology industry, where ISO 13485 and MDR impose strict documentation requirements, rigid Q processes can become a stumbling block. But it doesn't have to be that way! In this article, we will show you how you can use agile and process-orientated practices and a lean process design to make your quality management system more efficient while maintaining compliance.

The medical technology industry is a dynamic sector that can be characterised by rapid technological advances and innovative developments. At the same time, it is subject to strict regulations due to its high ethical and social responsibility. High quality standards are therefore essential to ensure the safety and efficacy of medical devices, and a robust and efficient quality management system (QMS) forms the foundation for meeting these high standards. It ensures that products and services meet the highest quality requirements, that the safety and efficacy of medical devices is guaranteed and that all regulatory requirements are met.

Despite the theoretical advantages of a quality management system (QMS), small and medium-sized enterprises (SMEs) often face considerable challenges in practice. Statements such as:

"The quality management system is slow", "When I ask QM, I have to fill out three forms before I get an answer. I'd rather not even ask" or "We've always done it this way" are not the exception, but the rule.

From my own experience, I know that pragmatic approaches to solutions are often met with surprise: A former colleague from my time in industry said, "You're not typical Q at all." This shows that pragmatism and quality management do not go together in the eyes of many.

It also makes it clear that quality management not only has a bad reputation within the company, but often no longer fulfils its actual purpose or is misunderstood.

But why is this the case?

The challenges of quality management in medical technology: A look at SMEs!

The medical technology industry in Germany is primarily characterised by SMEs. This means that the high documentation requirements of ISO 13485 and the MDR (Medical Device Regulation (EU) 2017/745) have to be managed by small teams with limited resources. As a result, the quality management systems (QMS) of these companies are often historically grown, paper-based, inert and unpopular with employees.

In addition, companies that are certified according to ISO 13485 have often organised their QMS in fixed processes with many interfaces. This means that there is at least one rigid process for each standard chapter that must always be followed exactly. This often leads to long processing times, a lack of decisions and undocumented activities.

The following exemplary process shows the complexity and inertia of such a system:

A company is dissatisfied with a raw material supplier. A member of the purchasing department identifies a potential new supplier and submits a change request. This is printed out, completed, signed by the employee and then countersigned again by the head of department. The request is then handed over to the quality management representative (QMB). The QMB assigns a number, enters the application in a table, searches for the evaluation form, prints it out and forwards the documents to the Head of Research and Development and the Person Responsible for Regulatory Compliance (PRRC) for review. They review and approve the application one after the other. The documents are returned to the QMB for final approval and the measures are defined.

The application passes through the Purchasing, Research and Development, Quality Management and Regulatory Affairs departments. The applicant is ultimately given responsibility for implementation and is now faced with a project that is almost impossible to manage, as the measures that the other departments have to implement seem too abstract. In addition, she is given an unloved position in which she has to monitor the activities of the college.

In the worst case, this process can take several weeks. There are many reasons for this:

• The application may have to be reissued, as paper documents are often lost between departments.
• Changes are prioritised differently in different departments.
• During the definition or implementation of measures, it is sometimes discovered that further, time-consuming measures are necessary.
• It turns out that the necessary resources cannot be made available, so the change is cancelled.
• Sometimes it is discovered too late that relevant departments have not been involved, which makes implementation difficult. For example, the new material cannot be processed because production was not involved at an early stage.

Agility, process-orientation and efficiency in quality management - a new approach!

The above example clearly shows how rigid processes can significantly slow down decision-making processes. Despite their rigidity, however, they guarantee consistently high product quality. In dynamic areas such as development, product changes or complaints, however, flexible and agile processes are indispensable.

Corporate goals and regulatory requirements: A balancing act!

The main objective of quality management should be to achieve the company's objectives as well as to fulfil customer requirements and reconcile this with the fulfilment of regulatory requirements. The term "customer" encompasses not only healthcare facilities, users and patients, but also the organisation's employees. Satisfied internal and external customers are the key to a smooth and effective working environment.

In order to achieve these goals, existing processes must be critically reviewed and adapted to the requirements of internal customers. It is important to choose the right methods, minimise interfaces and implement agile teams. These teams should be authorised to make independent decisions. The Quality Management Representative (QMB) and the Person Responsible for Regulatory Compliance (PRRC) are integrated as required, whereby their decision-making powers remain strictly limited to the requirements of ISO 13485 and MDR.

Digitalisation and agility: a perfect match!

In contrast to rigid, hierarchical and sequential processes, an agile QMS enables a flexible and rapid response capability. The previous example could proceed as follows: The employee from Purchasing would enter their change idea digitally in a request and sign it digitally. The request would then also be made available digitally to the QMB.

In an agile scenario, the involvement of departmental management would not be necessary, as change requests would no longer have to be evaluated sequentially by different positions. Instead, agile teams would be established that have decision-making powers and others that ensure implementation or monitor the change.

This collaborative approach means that changes are evaluated and implemented more efficiently and quickly. Individual positions in each department no longer need to be monitored and priorities are set as a decision-making team, which ensures consistency across all departments. Changes and emergencies can be responded to quickly, uniformly and collaboratively.

Furthermore, consistent digitalisation supports this agile approach considerably. It is important to carefully assess the requirements for digitalisation and select the appropriate software solutions. Although not every company has the resources to purchase a CAQ (computer-aided quality) system, this does not rule out digitalisation. Common tools such as filling out forms in PDFs, mapping processes in comprehensible flowcharts or using the MS environment's action tools can be used to support digitisation in any company.

TentaConsult as your partner for agile and process-orientated quality management!

The medical technology industry is caught between innovative developments and strict regulatory requirements. In order to survive in this challenging environment, the use of a flexible and pragmatic quality management system is of crucial importance. Such a system not only helps to increase efficiency and acceptance of QM systems, but also guarantees the quality and safety of medical technology products.

TentaConsult supports you in critically scrutinising your QM systems, optimising them and making them more agile. We help you to select the appropriate methods for each process and to optimise the QMS to the specific needs of your company. This includes identifying and evaluating the relevant regulatory requirements and adapting processes to these requirements to ensure smooth and efficient product development or change. By working closely with us, you ensure that your quality management not only meets regulatory requirements, but also becomes a competitive advantage by strengthening your company's innovative power and market position.

Do you require help or further information?

Please do not hesitate to contact us!