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Difference Between Risk Management and Deviation Management!

Author – Bivor Shrestha (Director of Product & Services at Qualityze Inc)
01 Aug 2023
Risk management vs deviation management

Qualityze Podcast : Risk Management vs. Deviation Management: How Are They Different?

Have you got what it takes to take control of your business’s risks and deviations?

Risk and deviation management is crucial for any business that wants to operate efficiently and effectively. With our software, you can quickly identify and assess risks, track, and monitor deviations, and take action to mitigate their impact on your business.

Don’t let risks and deviations hold you back- take control today with right approach, right tools, and right people by your side!

Difference Between Risk Management and Deviation Management

Risk management & deviation management are two closely related but distinct concepts in the field of quality management.

Risk management is a systematic approach to identifying, assessing, and mitigating or eliminating potential risks to an organization’s operations, assets, and people. By managing risks, an organization can minimize the likelihood and impact of negative events, such as accidents, losses, or delays, that could threaten the organization’s ability to achieve its objectives. Risk management is proactive, meaning it aims to prevent problems before they arise.

Deviation management, on the other hand, is the process of identifying, assessing, and addressing deviations or non-conformities that have already occurred. A deviation is a departure from a specified process or standard that is intended to ensure quality or compliance. The goal of deviation management is to understand the cause of the deviation, determine its impact, and take appropriate corrective and preventive action to prevent similar deviations from occurring in the future. Deviation management is reactive, meaning it addresses problems that have already happened.

Related Article: Looking beyond the horizon: A practical approach to Deviation Management

Both risk management and deviation management are important aspects of quality management and have the ultimate goal of ensuring that products and services meet or exceed the requirements of customers and regulatory bodies. But while risk management aims to prevent deviations from occurring, deviation management aims to identify and correct deviations that have occurred.

A good practice in the Quality management system, mainly for Quality Management in Manufacturing Industry, is having both risk and deviation management in place, as it helps to identify and mitigate the risks in the process and correct the deviations that may happen in the process, which would help to improve the process and quality of the products and services.

A tabular comparison between risk management and deviation management is a useful way to understand the key differences between the two concepts. Here is an example:

Risk Management Deviation Management
Proactive approach Reactive approach
Identifies and manages potential hazards and threats Identifies and addresses deviations from established procedures
Focuses on preventing negative outcomes Focuses on correcting negative outcomes
Includes assessment and mitigation of risks Includes investigation and corrective actions
Example: implementing safety protocols on a construction site Example: Investigating and correcting deviations in a pharmaceutical manufacturing process

As you can see from the table, risk management is a proactive approach that focuses on identifying and managing potential hazards and threats, while deviation management is a reactive approach that focuses on identifying and addressing deviations from established procedures. Both are important for ensuring the safety, quality, and compliance of operations, but they have different objectives and are implemented at different stages of a process.

Some Examples of Risk and Deviation Management in Different Industries

There are many examples of risk and deviation management in various industries; here are a few:

  • In the financial industry, risk management involves identifying and assessing potential financial risks, such as market, credit, and operational risks. This includes developing and implementing strategies to mitigate or eliminate those risks, such as diversifying investments, implementing risk management systems, and implementing compliance policies and procedures.
  • In the construction industry, risk management involves identifying and assessing potential hazards on construction sites, such as falls, equipment failure, and weather-related incidents. This includes implementing safety protocols, such as fall protection systems and safety training, to reduce the likelihood of incidents occurring.You can also integrate other modules for that you can go through Quality Management Software for Construction Industry for more information.
  • In the food industry, deviation management involves identifying and investigating deviations from food safety and quality standards. This includes implementing procedures for detecting and preventing food contamination, conducting regular inspections, and implementing corrective actions to address any issues.
  • In the Pharmaceutical industry, risk management is a crucial step in the drug development process, identifying and evaluating potential risks associated with new drugs and taking steps to mitigate those risks. Deviation management, on the other hand, would be used to address any deviations that occur during the manufacturing of those drugs, such as deviations in the production process or the use of unapproved ingredients.
  • In the aviation industry, risk management includes identifying hazards and potential threats that could impact the safety of flights, such as weather conditions, mechanical issues, and human error. In contrast, deviation management includes identifying, investigating, and taking corrective actions for any deviations from established procedures and protocols, such as deviations from standard operating procedures.

These are just a few examples, but risk management and deviation management are used in many different industries and a variety of different contexts. The important thing is that they’re in the place to minimize potential risks and maintain compliance with safety, quality, and regulatory standards. You can also get Qualityze Field Safety & Recall Management Software to manage the Safety of the Product.

Is it a good idea to use software to manage risks and deviations?

The software can be a valuable tool for managing risks and deviations, as it can help to automate and streamline specific processes, making them more efficient and less prone to errors. For example, risk management software can identify potential risks, evaluate their likelihood, and impact, and track the progress of mitigation efforts. Likewise, deviation management software can record and track deviations from standard procedures, identify the causes of these deviations, and implement corrective actions to prevent them from happening in the future.

Nevertheless, software alone is not a panacea for managing risks and deviations. Using it properly requires a combination of risk management & deviation management techniques, such as regular risk assessments, training and education programs, and a culture of continuous improvement.

Additionally, it’s essential to have the right software that fits the organization’s needs and goals, that has the features and functionality to effectively manage risks and deviations, and also be sure that the software can integrate with other systems and processes that already exist in the organization, such as EQMS Software, ERP and so on.

Also, the software implementation and deployment are not one-time events; they must be continuously monitored and evaluated to ensure that it is being used effectively and aligned with the organization’s overall risk management and deviation management strategy.

Why choose Qualityze Risk Management and Deviation Management Software to your rescue?

If you are looking for reliable Risk Management or Deviation Management software, then Qualityze is the right choice.

Qualityze Risk Management & Deviation Management Software is designed to help businesses of all sizes effectively manage potential risks and deviations. Some of the key reasons to choose Qualityze include the following:

  1. Comprehensive risk and deviation management: Qualityze offers a complete solution for managing potential risks and deviations, including tools for assessment, tracking, and mitigation.
  2. User-friendly and intuitive interface: Qualityze’s software is easy to use, allowing businesses to manage risks and deviations quickly and efficiently.
  3. Scalability: Qualityze can be customized to meet the specific needs of a business and can quickly adapt as the company grows and evolves.
  4. Advanced reporting and analytics: Qualityze provide businesses with detailed reports and analytics, helping them to understand their risk and deviation profile and identify areas for improvement.
  5. Strong collaboration capabilities: Qualityze enables businesses to collaborate with team members and stakeholders, helping to develop a collaborative approach to risk and deviation management efforts.
  6. Secure and compliant: Qualityze ensures data security and compliance with various regulatory requirements
  7. Flexibility: Qualityze offer greater flexibility to the users, which enables the users to easily access information, collaborate, and take actions from anywhere.

Overall, Qualityze Risk Management and Deviation Management Software provide a comprehensive, user-friendly solution that can help businesses effectively manage potential risks and deviations, ultimately protecting their operations and bottom line.

Quick Read: Risk Assessment Vs Risk Management: How Are they Different?

In Conclusion

Qualityze Risk Management & Deviation Management Software help organizations of all sizes effectively manage potential risks and deviations. Its comprehensive features and user-friendly interface make it an ideal solution for organizations looking to take control of their risk and deviation management efforts.

If you have questions about Qualityze or would like to schedule a software demo, our customer success team is ready and happy to assist. Reach out to them by email at or by phone at 1-877-207-8616, and we’ll be glad to answer any questions you may have and help you get started with Qualityze EQMS Suite.



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