
In Quarter 3 2025, the Food and Drug Administration (FDA) saw a decline in product recall events, but the number of units recalled was high. The Q3 reported 25.17 million recalled products, which was 75.8% more than the 14.32 million of Q2. But industries like automotives, consumer products, or pharmaceuticals are not spared from this trend either.
Recalls are just one symptom. People, processes, systems, and external shifts can all erode operational efficiency and product quality, across any industry.
This means every business is at risk of incurring significant financial losses and, in some cases, reputational damage due to such recalls.
So what is the solution to this? Build a robust operational risk management framework that oversees production and mitigates threats that can disrupt business processes. In this article, we explore what operational risk management is, the key steps involved, and its benefits.
What is Operational Risk Management?
Operational risk management is the procedure of identifying, assessing, and mitigating threats that could disrupt the business processes. The risks to operations can arise from inadequate employee training, inefficient processes, outdated technology, or regulatory shifts.
Letting them go unattended will affect your productivity, cause you financial losses and might even lead to a complete shutdown of your business. Operational risk management helps you formulate policies, processes and controls to prevent and reduce the impact of these risks on your business.
What are the types of operational risks
Operational risks are categorized into 4 types.

1. People Risk
People risks are threats arising from the human resources employed by the organization. These can include a lack of training, human errors, operational misconduct, and high turnover.
2. System Risks
System risk includes machinery, equipment and IT infrastructure deployed in the business process. Outdated systems are often the cause of abrupt stops and damage to business operations.
3. Process Risks
Producing any good or service requires clear guidelines on business processes. Operational risks associated with the business process stem from poorly documented workflows and weak internal controls.
4. External Risks
Many external factors also affect business operations. These can include third-party misconduct, changes in regulatory requirements, geopolitical shifts, or natural disasters. Some of these risks can be mitigated through operational risk management, while others have to be accepted by the businesses.
Why Operational Risk Management is Important
Having flaws in your operations concerning quality processes, organization, health and safety, information security, and waste management is detrimental to your business. It affects your finances and reputation, and brings legal scrutiny to your business. The points below highlight why operational risk management is important.
1. Saves from Financial Losses
A compromise in product quality or a workplace accident injuring employees can cause significant financial losses when the company has to recall products from markets or pay compensation claims. Operational risk management helps protect against financial losses by allowing you to formulate controls that oversee these tasks.
2. Ensures Regulation Compliance
Organizational risk management encompasses compliance with legal requirements and industry standards, such as the OSHA Act, the Clean Water Act, ISO 9001, ISO 27001, etc. Non-compliance not only disrupts business operations but also exposes the company to legal liability.
3. Preserves Brand Image
Anything that disrupts business function, such as data breaches, poor product quality or workplace accidents, reflects poorly on your brand image among your customers and stakeholders. Having an effective operational risk management framework highlights your commitment towards building a workplace that can tackle these risks.
What is the Operational Risk Management Framework?
The operational risk management framework consists of the following steps:

1. Identify Risks
The first step is to examine operational workflows and identify risks that could affect operations. It entails assessing production methods and administrative procedures, gathering input from employees and stakeholders on potential risks, and conducting scenario analysis. All identified risks must be documented comprehensively.
2. Assess Impact and Likelihood
Once the risks have been identified, their impact on the operation and likelihood of occurrence should be assessed. Risks can be assessed using a risk matrix and heat maps. This helps you prioritize threats based on the business’s risk threshold and allocate mitigation resources accordingly.
3. Implement Mitigation Strategy
After identifying and assessing risks, you now have to plan a mitigation strategy based on your risk tolerance threshold. This would include:
- Avoidance: Eliminate the risk by discontinuing or redesigning the activity that causes it.
- Transfer: Shift the financial and operational liability of risk to third parties, either by buying insurance or outsourcing tasks.
- Reduction: Formulate control measures and processes that reduce the likelihood and impact of risks to the business.
- Acceptance: Some risks are integral to business operations. It is better to accept them and prepare to address them if they occur.
4. Monitor Continuously
Operational risk management is a continuous task. Business risk environments keep changing, and your mitigation strategy has to change accordingly. This highlights the need for you to conduct regular internal audits to identify emerging risks, assess the efficacy of current mitigation plans, and make operational risk management changes as needed.
What are the Benefits of Operational Risk Management?
A robust operational risk management framework goes a long way in avoiding threats that affect business processes and reaps the following benefits:
1. Enhanced Decision-Making
ORM requires management to identify and assess risks continuously. This creates space for decision-makers to evaluate their risk threshold, helping them make informed decisions about prioritizing threats requiring immediate attention and allocate resources accordingly.
2. Increased Productivity
Operational risk management ensures that risks that can disrupt business processes are addressed before they can escalate. This means continued business activity, thereby increasing workers' productivity.
3. Better Resource Allocation
Risks can be low, medium or high level. Each one requires a varying degree of attention and resources. Operational risk management ensures that all human and material resources are allocated appropriately to address risks.
Challenges in Operational Risk Management
Even though every business aims to build a resilient operational risk management framework, it still faces challenges that make it difficult to avoid operational risks. These are:
1. Failing to Detect New Risks
Monitoring risks and developing a mitigation strategy is an important aspect of operational risk management, yet many businesses fail to incorporate it in their ORM framework. This leaves them vulnerable to operational risks arising from introducing new processes and technologies, changes in regulatory requirements, or the ineffectiveness of current mitigation strategies.
2. Poor Risk Communication
To identify and mitigate operational risks, they first need to be clearly understood by all stakeholders, management and employees. But oftentimes, top management poorly communicates these risks to their employees and does not involve them in the ORM process, thus creating gaps in addressing them.
3. Relying on Outdated Manual Processes
Many organizations still rely on manual processes to manage operational risks. This limits their ability to identify and address risks in real time, which might escalate and disrupt business operations.
Best Practices for Operational Risk Management
As a continuous process, organizational risk management requires you to keep finding ways to improve it. Here are some best practices to help you with it.
1. Top Management Involvement
Management sets the temperament for how employees will perceive operational risks. Board members and team managers must show their involvement in addressing operational risks and encourage their employees to participate in mitigation efforts actively.
2. Create a Well-Defined ORM Framework
The process for identifying, assessing, mitigating and monitoring risks should be clearly defined and well documented. This ensures consistency in data, enabling organizations to gain actionable insights and formulate better risk management policies.
3. Allocate Roles and Responsibilities
As top management cannot oversee every operation, they should assign roles and responsibilities to employees to supervise risks and their mitigation efforts. This ensures accountability and creates audit trails.
4. Leverage ORM Software
Manually tracking and managing operational risk is error-prone. It hinders your ability to assess risks in real time, creating vulnerabilities in your processes. Leveraging software for operational risk management, such as Effivity, can automate the whole process of identifying, assessing, mitigating and monitoring risks. It keeps a real-time check on operations and helps you gain insight into key risk indicators.
Wrapping Up
Operational risk management is an essential process for continued business growth. People, systems, processes and external factors all hold the capability to disrupt production, thus affecting your bottom line. This is why top management should actively participate in formulating policies and controls to address operational risks. The best decision would be to incorporate software such as Effivity to automate operational risk management.
The Effivity operations management software provides a central hub for all operational information, ensuring it is communicated to every stakeholder and employee. It schedules regular audits to track risks and generates action plans to address new risks. With Effivity, you deploy a data-driven approach for operational risk mitigation and find opportunities for business growth.
Book a free trial with Effivity now and streamline your operational risk management!