August 8, 2023

Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety.

There are also huge risks to companies themselves, who face steep legal and compliance costs as a result of workplace injuries.  

In fact, the U.S. Occupational Safety and Health Administration (OSHA) conducts thousands of unannounced inspections annually, while penalties continue to go up every year.  

All of this points to a heightened need for proactive management of workplace environmental, health and safety (EHS) incidents. In this article, we explore the most essential tools in the quality management system (QMS) for managing EHS incidents from start to finish, including: 

  • EHS incident tracking and reporting software 
  • Root cause analysis tools such as 5 Whys, 8D and failure mode and effects analysis (FMEA) 
  • Impact assessments for more effective risk management 
  • Corrective action tools and processes  


 Download a free case study to learn how one leading manufacturer created a customized process for root cause analysis and corrective action 


EHS Incident Tracking and Reporting Software 

It’s critical to be able to track and report on EHS incidents in your plant, so you can capture data for more effective problem-solving and document your response for compliance records.

With an EHS incident reporting solution, you can: 

  • Launch a corrective action as needed directly from within the solution, allowing you to track its resolution end-to-end  
  • Manage responsibilities, due dates, reviews and approvals in one place 
  • Add an impact assessment or launch root cause analysis processes (e.g., 8D or 5 Why) from the incident record 
  • Streamline collaboration on incident management tasks and root cause analysis investigations 
  • Export incident data to automatically populate the relevant OSHA 300 forms  

Root Cause Analysis Tools 

The next step after documenting the incident is to launch a root cause analysis. A robust QMS will include several tools for conducting your investigation, such as: 

  • 8D problem solving 
  • 5 Whys 
  • Failure mode and effects analysis (FMEA) 

Below we discuss each of these in more detail, including best practices on how and when to use the tools.

5 Whys  

The 5 Whys is one of the most common tools used in root cause analysis. This technique starts by asking why a problem occurred, repeating the question in succession to uncover deeper potential root causes.  

The 5 Whys is most commonly used for straightforward problems, compared with complex or repeat issues requiring in-depth investigation. It’s also a good starting point for brainstorming possible root causes, and may be used with other approaches such as 8D problem solving.

From a QMS perspective, you should be able to launch a 5 Why directly from the incident record. This helps document your response to the incident for compliance, analysis and collaboration purposes.

8D Problem Solving 

The 8D method is an in-depth, structured approach to problem solving, often used for problems that: 

  • Have recurred despite previous attempts to solve them, which points to inadequate root cause analysis or ineffective corrective action 
  • Are high-risk or otherwise complex
  • Don’t have a documented root cause and corrective action

 8D or the Eight Disciplines stands for the following eight steps: 

  • D0: Plan 
  • D1: Create the team 
  • D2: Define the problem 
  • D3: Contain the problem 
  • D4: Root cause analysis 
  • D5: Identify corrective actions 
  • D6: Implement corrective actions 
  • D7: Implement preventive actions 
  • D8: Recognize your team 

One best practice here is to add an effectiveness check six or eight months after the corrective action is complete. This helps you ensure that failures aren’t ongoing, and that you identified the correct root cause. 

Built-in 8D tools in the QMS can help streamline the process for manufacturers that frequently use this type of problem-solving. As a pre-configured process, it allows you to initiate an 8D from the incident record and automatically route it from one step to the next. The QMS also makes it simple to add periodic effectiveness checks, so you know you identified the right root cause and corrective action.

Failure Mode and Effects Analysis (FMEA) 

An FMEA is used to document potential failure points in a product or process. The FMEA allows you to score each failure point by severity, occurrence (likelihood) and detection to measure overall risk.  

While many people typically think of FMEA in the context of product development, it’s also useful for root cause analysis. That’s because an FMEA can:

  • Give you a list of potential failure points to start from in your investigation 
  • Help with brainstorming for 8D or 5 Whys investigations
  • Assist with evaluating the effectiveness of controls and whether they could be contributing to the issue

Within the QMS, you should be able to pull up any relevant FMEAs and link them to the incident record. With some simple configurations, the incident record itself should also allow you to drop in an FMEA to use in documenting your investigation. 

Impact Assessment 

Once you have determined an incident’s root cause, knowing how it might affect your business or process can help prioritize your actions. QMS risk management tools make this possible by allowing you to drop an impact assessment into the incident record as part of your documentation. 

The risk assessment should generate a risk score based on the three dimensions of risk: detection, likelihood (or occurrence), and severity. 

In other words, what’s the probability of catching the incident before reaching my customer? Is this incident likely to happen again? If so, what would be the potential outcome? By answering these questions to create a risk score, teams can make data-driven decisions around where to best prioritize their resources. 

Corrective Action 

After you’ve completed the investigation and impact assessment, the final step is to identify, implement and verify corrective actions. A QMS corrective action solution lends several advantages here, including the ability to: 

  • Track all corrective actions in one place to make sure problems aren’t overlooked 
  • Use queries to identify similar issues with solutions that worked previously (or instances where past corrective actions weren’t sufficient) 
  • Link EHS incidents to audit questions to verify issue containment and corrective action effectiveness 
  • Add charts and KPIs to your QMS dashboard to increase visibility of issues 
  • Generate complete records of the corrective action process, including who was involved, steps taken and post-incident monitoring 


Safety has a far-reaching impact in manufacturing organizations today, affecting team morale, productivity, compliance status and even brand value. 

A standardized, streamlined approach to EHS incident management is essential for protecting workers and avoiding compliance violations. QMS incident management and root cause analysis tools provide built-in structure and best practices, so you can solve problems better, faster and with greater confidence in your operations. 


Download a free brochure to learn about the AssurX EHS Incident Management Solution 

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.