Guide To Quality Risk Management: Everything You Need to Know

Guide To Quality Risk Management Everything You Need to Know

To maintain quality standards and protect the reputation of your products, it is important to implement a quality risk management plan. In addition, quality risk management is essential to ensure that your products meet customer expectations and regulatory requirements.

There are many different quality risk management tools and techniques that you can use to assess and control quality risks. But what exactly is quality risk management, and why should you integrate it into your business?

This guide will teach you everything you need to know about quality risk management: what it is, why it’s important, and how to get started. We’ll also discuss how to assess and control quality risks. 


What is Quality Risk Management?

Quality risk management (QRM) is a systematic, proactive process for identifying, assessing, and managing quality risks. It is a key element of quality assurance and quality control. It’s especially critical in pharmaceutical industries, where quality standards are high, and the consequences of failure can be serious.

Quality risk management aims to ensure that products meet quality standards and customer expectations while minimizing the risks of poor quality. Quality risk management can be applied to all quality aspects, including product design, development, manufacturing, distribution, and post-market surveillance.


Why is Quality Risk Management Important?

Quality risk management is important because it helps to ensure that products meet quality standards and customer expectations. By identifying and assessing quality risks early on, you can take steps to prevent or mitigate them. This can save your company time and money and protect your reputation in the marketplace.


Principles of Quality Risk Management

Quality risk management has two primary principles, according to the International Council on Harmonisation (ICH):

Quality risk management and evaluation should have scientific basis, such as data and research. It should focus on the protection of consumer safety and welfare.

The higher the risk level, the stronger the QRM process. The level of documentation, formality, and effort should be equal to the current risk level.”


Quality Risk Management Process

Executing a quality risk management plan involves five steps:


Step 1: Before the Start of the QRM Process

Choose a leader and quality risk management team. This team should include representatives from all relevant departments, such as quality assurance, quality control, regulatory affairs, and product development. Here’s an example of a potential QRM team:

  • Quality Manager (Leader)
  • Business Developer
  • Operations Manager
  • Lead engineer
  • Sales and marketing head
  • Operations Manager
  • Manufacturing director
  • Clinical expert
  • Senior data analyst
  • Corporate lawyer


Step 2: Risk Assessment

Define the problem by asking what might go wrong.

  • Risk identification: Identify possible hazards related to the problem.
  • Risk analysis: Estimate risks associated with the identified hazards. For each risk defined, identify the chance of them occurring and the severity of the consequences.
  • Risk evaluation: Based on the risk analysis, evaluate each identified risk using a risk matrix based on your needs.
  • Set rules for defining the overall risk level: If more than half of the risks are high, then the overall risk level will also be high.


The risk assessment output will either be a qualitative description or a numeric value that expresses the overall risk level posed by the problem.


Step 3: Risk Control Selection

After the risk assessment is complete, it’s time to select risk control options. There are four main types of risk controls:

  • Elimination: Remove the hazard or problem completely. For example, if a machine is causing product defects, you could replace the machine with a new one.
  • Substitution: Change the hazard or problem for something else that is less hazardous or poses less of a risk. For example, if you’re using a dangerous chemical on workers, you could switch to a less harmful chemical.
  • Engineering controls: Change the way the hazard or problem is used or designed to be less hazardous or pose less risk. For example, if you’re using a machine that is dangerous to workers, you could add safety guards or redesign the machine to make it safer.
  • Administrative controls: Change how people work so they are less exposed to hazards or problems. For example, if you’re using a dangerous machine on workers, you could provide training on how to use the machine safely.


The output of the risk control selection will be a list of controls that can be implemented to mitigate the identified risks.


Step 4: Risk Control Implementation

Once the risk control options have been selected, they need to be implemented. This step will involve developing a plan for how the controls will be implemented, who will be responsible for them, and when they will be implemented.

The output of the risk control implementation step will be a plan for how the selected controls will be implemented.


Step 5: Risk Communication and Review

Once your team implements the risk control, establish a monitoring system to review and check its effectiveness. It’s important to review the risk management continuously, especially when:

  • There’s new research, knowledge, experience, or data on specific risks;
  • Some instances may impact the original decision; and
  • Changes in the factors that influence the overall risk level.


Risk communication involves sharing information about risks and risk management with stakeholders. This step is important to ensure that everyone understands the risks and controls to mitigate those risks.

The output of the risk communication and review step will be an understanding of the risks involved and the controls that have been put in place to mitigate those risks by all stakeholders.



If you want to implement a quality risk management system in your organization, DATAMYTE can help. Our Digital Clipboard lets you create a quality risk management workflow that can be used to identify, assess, and control quality risks. Our software also includes quality risk management tools, such as a quality risk matrix, that can evaluate and control quality risks.

The DataMyte Digital Clipboard is a workflow automation software that offers an easy-to-use drag-and-drop interface that lets you create quality risk management workflows quickly and easily. You can add, remove, replace, edit, and view quality risks in your workflow with just a few clicks. Plus, our additional tools make it easy to evaluate and control quality risks.

With the DataMyte Digital Clipboard, you have a solution to quality risk management that is easy to use and helps you get the job done right. So why wait? Get started today by booking a demo with us!



With a quality risk management system in place, you’ll be able to control quality risks quickly and easily. Use what you’ve learned in this guide to create the ideal management system for your business and industry! And if you need help, DATAMYTE is here to help. Get started now!



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