Root Cause Analysis In Quality Investigations

What is Root Cause Analysis in Quality Investigations?

Root Cause Analysis ProcessRoot Cause Analysis (RCA) within an organization’s quality Investigations process allows an investigator to determine the likely cause of a non-conformity. It is important that a company routinely evaluates the components of its quality systems, including RCA, and how it meets and exceeds life sciences compliance standards. 

While there are many ways to go about determining the root cause of non-conformance, three of the most common root cause analysis tools are: 

  • “5 Why” Analysis
  • Failure Mode, and Effects Analysis (FMEA)
  • Fish Bone/Ishikawa diagram

Contact a Dayspring Technology consultant at 844.437.7789 to discuss implementing these models into your quality system.

These tools can all be used in the root cause analysis of events such as audit findings, complaints, non-conformances, studies, and corrective actions. The severity of the non-conformance should determine the tools and length to which you investigate. There are no standards that define the investigational tools you are required to use for compliance, though control guidance for ISO 27001, 9001, and 13485 states that investigations shall include (root) causes, corrective actions, implementation of corrective actions, and the effectiveness of those actions to resolve the concern.  

Let’s take a close look at the analysis tools.

“5 Why” Root Cause Analysis

“5 Why” root cause analysis is a simple approach to investigating a non-conformance. Once you have identified the non-conformance (i.e. Product A did not meet the purity specification), start by asking the question, “why?” Repeat this questioning five times over to try and get to the root cause of the non-conformance that occurred. This is one of the least rigorous root cause analysis techniques as statistical analysis is not needed to come to an outcome. Although simple and straightforward, this RCA can have limitations. It can be non-reproducible or inconsistent and doesn’t consider multiple answers to each step.

Failure Mode and Effect Analysis

Failure Mode and Effect Analysis (FMEA) is commonly utilized when evaluating a new product, new process, or risk management.

Definitely the most thorough of the three, FMEAs can be extremely time-consuming, and require clear direction and exhaustive detail,” said Brenden Ferraro, Dayspring Technology consultant with extensive experience in Life Sciences Process Validation, Quality Assurance Non-Conformities/CAPAs, and process improvement. “FMEA takes a full overview of a process and breaks it down into elements where each element is evaluated for potential failure modes and their effects. “

Outlined by IEC 60812:2018, an FMEA starts by taking the subject process and dividing it into steps or elements. Once these elements are identified, a performance standard should be set. A performance standard should represent the level of performance essential to achieve the successful function of the process. 

Once a performance standard is set, potential failure modes should be identified. Failure mode detection methods and existing controls are then evaluated. Controls are design features or other existing provisions that have the ability to prevent or reduce the likelihood of failure. 

After evaluating the detection methods and controls, the effects of the failure modes are identified. These effects are the consequences that the failure could present to an end user or the process itself. Once identified, the causes of these effects are evaluated. The extent to which a cause is explored depends on failure consequences that have a more significant effect. The effects are evaluated for their severity and likelihood of occurrence. Once all of these are set in place, action items should be created, implemented, and documented. 

Bonefish Diagram ExampleIshikawa (Fishbone) diagrams

Another way to document root cause analysis is through Ishikawa (Fishbone) diagrams. Fishbone diagrams allow for a visual layout of factors that have the potential to cause documented non-conformity. Two ways to lay out a fishbone diagram are 4M &E or 5 W&H. 


4M&E covers the method, materials, manpower, machine, and environmental aspects that potentially affected the non-conformance in questioning. Each factor is evaluated for the potential effects it had on the non-conformance where appropriate actions are assigned. 


5W&H asks the questions of what, why, when, who, and which and then asks how that happened. The idea is for these questions to be open-ended. This allows for a more in-depth look at what caused the non-conformance. However, the questions alone cannot solve the problem. 

A setback for fishbone diagrams is they do not prioritize the causes that could influence the non-conformance. This potentially leads to time being spent on issues that are not relevant. It is also a technique that is also dependent on how well the session went. The amount of effort you put in will likely yield a similar result. 

Streamlining Quality Investigations

If your organization is struggling with effective quality investigations or a heavy backlog of quality issues and don’t know where to start, remember that there are numerous ways to effectively investigate events. The three models reviewed in this blog all yield an effective life sciences compliant investigation with multiple standards and regulatory requirements. 

If you would like to discuss these models further or implement them as part of your quality system, Dayspring Technology would be happy to learn more about your organization’s needs. Contact us today.

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