What is Quality Risk Management (QRM)? A Complete Guide for 2025

Managing risks while maintaining stringent quality standards is a challenge faced by almost any industry. In today's fast-paced world, rapid technological advancements and increased cross-border trade have allowed several industries to make rapid advancements and transcend geographical boundaries.

Businesses must navigate more complex supply chains while adhering to strict regulatory demands. In this landscape, QRM (full form, Quality Risk Management) plays a central role in identifying and controlling risks associated with product quality, regulatory compliance, and customer satisfaction.

Quality risk management (QRM) is crucial for countless fields, such as manufacturing and processing, but it becomes especially necessary for sectors like pharmaceuticals and healthcare. QRM principles help enhance decision-making, reduce errors and disruptions, and improve trust with stakeholders and customers.

In this article, we take a comprehensive look at QRM’s full form, what it is, the QRM process, and why it is essential.

Quality Risk Management: What It Is and How It Began

Assessing and controlling risk has existed for centuries. However, it was only formally implemented in the pharmaceutical sector in the early 2000s. The International Council for Harmonization (ICH) introduced the holistic approach to quality risk management to the pharmaceutical industry in 2005 when it published its tripartite guidelines, Quality Risk Management, Q9.

Quality Risk Management (QRM) is a risk-based, systematic approach to quality management. It involves assessing, evaluating, controlling, and communicating any risks related to product quality, the manufacturing process, or customer safety. After identifying risks, QRM evaluates their potential impact and likelihood and plans measures to mitigate them. The effectiveness of the implemented controls is continuously monitored.

The quality risk management process can significantly affect the safety of patients and consumers in fields like pharmaceuticals and healthcare. Due to this reason, the QRM approach is primarily used in the biotechnology, medical devices, and pharmaceutical industries to ensure that products meet regulatory and quality standards.

The Principles of Quality Risk Management

Two agencies, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the European Commission (in its Goods Distribution Practice Guidelines for Medicinal Products (GDP), have outlined certain principles and examples for QRM.

The guidelines outlined by the ICH include:

• The evaluation of quality-related risks must be based on scientific data and research and focus on customer protection.
• The higher the level of risk, the stricter the QRM process must be. In other words, the formality and documentation should be proportionate to the level of risk.

Quality risk assessment goes beyond the manufacturing process alone. The European Commission highlighted a range of principles and examples that could affect product quality and safety. These include the environment and temperature, equipment calibration at regular intervals based on risk assessment, the scope of equipment qualification and process validation, operational principles, handling of returned medical products, and the risk assessment of transport and delivery routes.

What is the Quality Risk Management Process?

QRM is a systematic and well-structured process with multiple crucial steps. Each part helps identify, analyze, and mitigate potential risks.

1. Identifying Risks

The first step in the QRM process is identifying potential risks that could affect product quality or patient safety. These could include hazards, gaps in design, failure modes, and more.

Analyzing your organization's manufacturing process, product design, transportation, storage, and other aspects can help identify risks. Techniques like the FMEA (Failure Mode and Effects Analysis) are often used in this context.

2. Analyzing Risks

After identifying hazards, your organization must analyze them and determine their severity, likelihood of occurrence, and possible consequences. Factors to look for include the rate of occurrence, how detectable the risk is, and any potential impacts on customer safety, product quality, and compliance regulations.

QRM tools and techniques can then evaluate and prioritize risks. Risk matrices are popular tools and provide a visual representation of potential hazards. Companies can use these to categorize risks based on their severity and likelihood. Quantification methods can also assign numerical values to hazards, offering a more objective evaluation approach.

3. Risk Reduction or Acceptance

After evaluating risks, organizations have several options for dealing with them. The first is risk mitigation and reduction. These could include bridging gaps in design or processes, enhancing controls, adding additional employee training, or modifying procedures. These preventative measures and corrective actions reduce the likelihood of the risk's occurrence or impact.

However, certain risks may be acceptable in some cases. For example, the cost or effort needed to mitigate risks could outweigh the benefits. Accepting risks is based on clearly defined and stringent criteria only after rigorous analysis.

4. Monitoring, Documentation, and Communication

Quality risk management is a recurring process that must be continuously monitored and improved. Organizations must regularly review their procedures and designs and reassess their risk management techniques as they receive new data, expand or change their processes and products, and change compliance regulations. Any risk findings, activities, and decisions taken during the quality risk management process must be documented and communicated with regulatory authorities and stakeholders.

How Do You Document Quality Risk Management Assessments?

Documenting the quality risk assessment process is a good practice for your organization. It can help you clearly evaluate and manage risks associated with your business's systems, products, or procedures. When documenting your risk management procedures, it is essential to cover certain aspects. This includes the following factors:

• What the potential risks or hazards are
• What the consequences of these risks are, and the severity of the consequences
• How probable is it that the problem will occur

In Conclusion

Quality risk management (QRM) is more than a regulatory framework—it has become a necessity for the growth and success of businesses today. By systematically identifying, analyzing, and mitigating risks, QRM allows organizations to streamline operations, improve efficiency, and deliver consistent, high-quality products.

Risk management software also plays a considerable role in successful QRM. For example, Effivity's Quality Management System provides a Risk and Opportunity Module that allows organizations to document their risk assessments meticulously. This module captures the different types of risks and opportunities, defines the source of where the risk will occur, describes it in detail, defines its probability, impact, and probability, and more.

To learn more about how our Risk and Opportunity Management Software can help you in your QRM process, visit Effivity's website today!