Quality Risk Management (QRM): Core Principles, Processes, and Objectives

quality risk management guide

In any industry, there are always risks that can affect the quality of products or services. These risks might come from different sources, such as human error, machinery failure, or environmental factors. Quality Risk Management (QRM) is the process of identifying, assessing, and controlling these risks to ensure that products meet the required standards. This article explores quality risk management - its core principles, process, and objectives. It also uncovers ways on how to integrate the QRM into industrial processes and operations.


What is QRM?

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating, and reviewing risks that can affect the quality of products or services. The concept of QRM is drawn from ICH Q9, a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline provides a structured approach to managing quality risks in the pharmaceutical industry, but its principles can be applied to other industries as well.

Quality Risk Management vs. Quality Management

Quality risk management and quality management are two often misconceived concepts. Quality Risk Management (QRM) focuses on identifying and managing risks that can impact product quality. It is about predicting what could go wrong and taking steps to prevent it. QRM is proactive, aiming to prevent problems before they occur.

On the other hand, Quality Management (QM) is a broader concept that includes all activities aimed at ensuring products meet certain quality standards. This includes quality control (checking products for defects) and quality assurance (ensuring processes are designed to produce quality products). Quality management ensures that products consistently meet requirements and that the production process is efficient and effective.

Quality risk management is a subset of quality management. However, QRM is specifically focused on risk reduction by managing the risks on the standards set forth by quality management. QRM supports quality management by ensuring the rigidity parameters used for quality control and quality assurance.

Principles of Quality Risk Management

The QRM methodology developed from the ICH Q9 is founded on two primary principles. This serves as the guide for the quality risk management process and ensures the QRM effectively and successfully conducts risk assessments.

The first of the two quality risk management principles emphasizes the need for a scientific approach in the evaluation of risks to adequately create links and correlations between risk factors. This principle states that decisions regarding quality risks should be based on solid scientific knowledge and evidence in order to make rational and justifiable decisions.

  • Scientific Basis: Using scientific data ensures that the risk assessments are accurate and reliable. This reduces guesswork and improves the confidence in the decisions made.
  • Patient Protection: The ultimate goal of QRM is to ensure that products are safe for use. In the pharmaceutical industry where the concept was drawn from, this means protecting patients from harmful effects. In other industries, it means ensuring the end-users receive a safe and effective product.
  • Improved Decision-Making: Processes and operations are designed based on scientific evidence, leading to more effective and efficient production methods.
  • Enhanced Safety: By prioritizing patient or customer safety, companies can avoid costly recalls and legal issues, maintaining their reputation and customer trust.

The second quality risk management principle suggests that the amount of effort and detail put into managing risk should match the seriousness of the risk. Not all risks are equal; some might have a minor impact, while others could be very serious. The resources allocated to managing these risks should reflect their potential impact.

  • Resource Allocation: It is inefficient to spend the same amount of time and money on minor risks as on major ones. By matching the effort to the level of risk, companies can use their resources more effectively.
  • Documentation: Proper documentation ensures transparency and traceability. For high-risk areas, detailed documentation helps in tracking the decisions made and the rationale behind them.
  • Efficiency: By focusing resources on higher-risk areas, companies can streamline their operations and reduce unnecessary workload.
  • Prioritization: Helps in prioritizing tasks and projects, ensuring that critical issues are addressed promptly while minor issues do not consume excessive resources.


Why Is Risk Management Important?

Quality Risk Management (QRM) is essential for any organization that wants to ensure the safety and effectiveness of its products. Managing risks is not just about avoiding problems, but also about improving processes and making better decisions. QRM helps organizations identify potential issues before they become major problems, allowing them to take proactive measures for risk reduction.

For example, a case study in pharmaceutical manufacturing showed how implementing QRM helped manage contamination risks. By using QRM tools like Failure Modes and Effects Analysis (FMEA), the company identified potential contamination sources, implemented control measures, and significantly reduced contamination incidents. This proactive approach not only improved product quality but also saved costs associated with recalls and rework​.

The same case study found that the integration of QRM in food manufacturing through Hazard Analysis and Critical Control Points (HACCP) has been instrumental in ensuring food safety. A study showed that companies employing HACCP principles experienced a 50% decrease in foodborne illnesses, demonstrating the effectiveness of systematic risk management in protecting consumer health and maintaining product quality.

Statistics from a study on the automotive industry reveal that using QRM methods such as FMEA reduced defects by 30% and improved production efficiency by 20%. This was achieved by identifying potential failure points early in the design phase and addressing them before they could affect the final product.

Overall, QRM's structured approach to identifying, assessing, and controlling risks helps organizations prevent quality issues, comply with regulatory requirements, and maintain high standards in their manufacturing processes. This not only enhances product safety and efficacy but also boosts operational efficiency and reduces costs associated with quality failures.


Quality Risk Management Process: Step-by-Step Guide

Managing quality risks involves several steps to ensure that all potential risks are identified, assessed, controlled, communicated, and reviewed. This process helps in maintaining high-quality standards and ensuring the safety of products.

The QRM framework outlines how quality risks are identified and addressed. Although this model is primarily developed for pharmaceutical manufacturing, it can also be used and applied to different manufacturing systems. The QRM follows a general flow that allows manufacturers to make empirical decisions based on gathered data. This model also provides opportunities to return to previous steps to seek more information, adjust the model on a case-to-case basis, or ultimately terminate the risk management process if deemed necessary.

It is important to take note that decision-makers in the quality risk management process should take responsibility for coordinating and collaborating with other concerned teams and departments, as well as the QRM process is clearly defined, applied, and reviewed with the resources made readily available.

quality risk management process

Risk Assessment

The first step in risk assessment is identifying potential risks. This involves analyzing every part of the production process to find areas where problems could arise. Techniques like brainstorming sessions, checklists, and process mapping can be used. Once quality risks are identified and listed, they are evaluated based on how likely each risk is to occur and how severe its impact would be on product quality to gauge its risk-based priority.

Risk Control

After evaluating the risks, the next step is to develop strategies to control them. This might involve changing processes, improving training for employees, or using higher-quality materials. The goal is to reduce the likelihood of the risk occurring or minimize its impact if it does occur. The implementation of control measures involves communicating the changes to all relevant stakeholders and ensuring that they understand their roles in implementing the controls and verifying that these measures are working as intended.

Risk Communication

A key component of the quality risk management process is to keep everyone within the organization informed about the risks and the measures taken to control them. This ensures that everyone understands their role in managing quality risks. Aside from that, risk communication extends to external stakeholders to ensure awareness and assure that steps are being taken to mitigate them.

Risk Review

Continuous monitoring of the risks and the effectiveness of the control measures is essential. This helps in identifying any new risks that may arise and ensuring that the control measures remain effective. Regular evaluation of the risk management process helps in identifying areas for improvement and, based on the evaluation, the risk management process should be updated as needed.

Quality and Risk Management Tools and Methods

Various tools are used in QRM to help identify, assess, and manage risks effectively. These tools provide structured methods to ensure thorough analysis and consistent decision-making.

QRM Software

QRM software is designed to streamline and enhance the quality risk management process. These software solutions offer several features:

  • Risk Identification and Assessment: QRM software helps in systematically identifying and assessing risks. It can collect and analyze data from various sources to identify potential quality risks.
  • Automated Workflows: Many QRM software solutions offer automated workflows that guide users through the risk management process. This ensures that all necessary steps are followed and documented.
  • Real-Time Monitoring: These tools allow for real-time monitoring of risks and control measures. This means that any new risks can be quickly identified and addressed.
  • Data Analysis and Reporting: QRM software often includes powerful data analysis tools that can generate detailed reports. These reports can help in understanding trends and making informed decisions.
  • Compliance Management: QRM software helps ensure compliance with regulatory requirements by providing templates and guidelines for documentation and reporting.
  • Collaboration Tools: These solutions often include features that facilitate collaboration among team members. This can be especially useful in large organizations where different departments need to work together on risk management.

Quality Risk Management Methods

There is a wide variety of methods used to identify and manage risks in different settings. Here’s a brief overview of the most common QRM methods used across different industries.

FMEA (Failure Modes and Effects Analysis)

FMEA is used to identify potential failure modes in a system, product, or process and to assess their impact. It involves listing all potential failure modes, their causes, and effects, and then ranking them based on their severity, occurrence, and detection. This method helps in prioritizing the most critical failure modes and implementing corrective actions to mitigate them.

FMECA (Failure Modes, Effects, and Criticality Analysis)

FMECA is an extension of FMEA that includes a criticality analysis to prioritize failure modes based on their risk. Similar to FMEA, but with an added step of criticality assessment to determine the likelihood of occurrence and the impact of failure modes. This particular strategy provides a more detailed analysis of risks and helps in focusing efforts on the most critical areas.

FTA (Fault Tree Analysis)

FTA is used to identify the root causes of system failures by creating a fault tree diagram. It involves starting with a top-level failure event and systematically identifying the underlying causes using logic gates. The FTA helps in visualizing the relationships between different causes of failure and identifying the most effective corrective actions.

HACCP (Hazard Analysis and Critical Control Points)

HACCP is used primarily in the food industry to identify and control potential hazards in the production process. This includes identifying critical control points (CCPs) where hazards can be prevented, eliminated, or reduced to acceptable levels and is designed to ensure food safety by systematically controlling hazards throughout the production process.

HAZOP (Hazard and Operability Study)

HAZOP is used to identify and evaluate potential hazards and operability problems in processes. It involves a structured and systematic examination of a process design to identify deviations from normal operation and their causes. HAZOP aids in identifying potential safety and operational issues early in the design phase and implementing measures to address them.

The Risk Matrix

quality risk management risk matrix

A Risk Matrix is a visual tool used in QRM to assess and prioritize risks. It helps in understanding the severity of risks and in making decisions about how to manage them. It consists of two axes - one for the likelihood (or probability) of a risk occurring and one for the impact (or severity) of the risk. These axes are usually divided into categories such as low, medium, and high.

Risks are plotted on the matrix based on their likelihood and impact. For example, a risk that is highly likely to occur and has a severe impact would be placed in the top-right corner of the matrix. For better visualization, risk matrices often use color coding to highlight the level of risk. Commonly, green indicates low risk, yellow indicates medium risk, and red indicates high risk.



What is the relationship between risk and quality?

Risk and quality are closely related because managing risks helps ensure the quality of products or services. Identifying and controlling potential risks prevents issues that could negatively affect quality.

What are examples of quality risks?

Examples of quality risks include contamination in pharmaceuticals, defective materials in manufacturing, equipment malfunctions, human errors in production, and inadequate storage conditions.

What is the purpose of quality risk management?

The purpose of quality risk management is to identify, assess, and control risks that could affect product quality. This proactive approach ensures products are safe, effective, and meet regulatory standards to safeguard consumer health.

What is the ICH Q9 update?

The ICH Q9 update refers to the revisions made to the original ICH Q9 guideline on Quality Risk Management. The update aims to provide clearer guidance for pharmaceutical quality, incorporate recent advancements, and enhance the overall risk management process.

Is ICH Q9 mandatory?

ICH Q9 is not mandatory by itself, but it is widely adopted by regulatory authorities. Following ICH Q9 guidelines helps organizations comply with regulatory requirements and industry best practices.


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The material provided in this article is for general information purposes only. It is not intended to replace professional/legal advice or substitute government regulations, industry standards, or other requirements specific to any business/activity. While we made sure to provide accurate and reliable information, we make no representation that the details or sources are up-to-date, complete or remain available. Readers should consult with an industrial safety expert, qualified professional, or attorney for any specific concerns and questions.


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Author: Herbert Post

Born in the Philadelphia area and raised in Houston by a family who was predominately employed in heavy manufacturing. Herb took a liking to factory processes and later safety compliance where he has spent the last 13 years facilitating best practices and teaching updated regulations. He is married with two children and a St Bernard named Jose. Herb is a self-described compliance geek. When he isn’t studying safety reports and regulatory interpretations he enjoys racquetball and watching his favorite football team, the Dallas Cowboys.