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A Guide to Conducting Root Cause Analysis in Manufacturing

Posted on September 18, 2020 by Shamonique Schrick
Shamonique Schrick

Root Cause Analysis

While it remains important in any aspect of manufacturing, root cause analysis in the food, beverage, and CPG industries is critical for safety, compliance, and performance reasons. Oftentimes, problems arise which do not have an obvious explanation. In these instances, further investigation is necessary to arrive at the root cause. 

While many manufacturing and processing companies already have some form of root cause analysis practices in place, they are typically inefficient. Plus, they limit opportunities to pursue continuous improvement. By implementing technology, you can accelerate your root cause analysis (RCA) process and improve performance and compliance while doing so. We’ll explore how below; but first, let’s take a look at how leaders in the food, beverage and CPG industries have recently shifted their attention to RCA.

The FDA’s Emphasis on Root Cause Analysis in the Food and CPG Industries

In July 2020, the FDA announced its New Era of Smarter Food Safety Blueprint. Its purpose was to encourage food and beverage companies to adopt technology to create a safer, more traceable food system that would also keep pace with changes in the global food supply chain. The agency doesn’t simply emphasize technology, however; they also recommend adopting simpler, more efficient approaches and practices, one of which is root cause analysis for food manufacturing.

Specifically, In Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response, the Blueprint recommends strengthening root cause analyses and using predictive analytics. This is precisely where tools like SafetyChain can be leveraged. The Blueprint calls for food companies to:

  • Strengthen root cause analysis procedures – coordinating with federal, state, local, tribal, and territorial partners – to ensure rapid deployment as soon as an outbreak is traced to a specific site.
  • Standardize criteria and format for producing reports on root cause analyses of outbreaks and determine the most expedited process for disseminating information and required actions to prevent a recurrence.
  • Enhance communication tools, for quickly and transparently relaying the outcomes of root cause analyses, both internally and externally, in a timely manner.

Technology like SafetyChain can offer a standardized RCA practice, which can help develop a framework for disseminating investigation results and lessons learned, both internally and externally.

What Is the Main Purpose of the Root Cause Analysis?

The ASQ Quality Glossary defines RCA as:

“The method of identifying the cause of a problem, solving it, and preventing it from occurring again; uncovering the correct and accurate reason(s) why something is happening or has already occurred.”

In food and beverage manufacturing, issues don’t just affect the company and its customers; they can also have a profound impact on public health and safety. RCA is therefore critical for not only identifying what went wrong when an issue such as a foodborne illness occurs, but also for preventing the same issue from happening again.

Examples of issues warranting a root cause analysis in the food industry include:

  •       An outbreak
  •       An event that could have caused microbiological, chemical, or physical contamination
  •       A processing failure
  •       A food safety system failure

The objective of the investigation is to identify the underlying factors, which can ultimately be prevented or controlled to reduce the risk of recurrence. This can be achieved by assembling an investigation team that will identify actual root causes of the problem — not just the contributing factors. This is an important distinction: root causes versus contributing factors.

Root Cause

This is the underlying reason that resulted in a breakdown of the system. If it weren’t for the root cause, the event would not have occurred, or would have been of significantly lower impact.

Contributing Factors

These are the physical, biological, behavioral, or attitudinal factors that directly or indirectly resulted in an outbreak or other incident.

Therefore, a contributing factor is what went wrong, while a root cause is why it happened.

Without addressing the root cause and only focusing on the contributing factors, food companies find themselves in a repetitive cycle of short-term corrections, which fail to actually address the heart of the issue. As a result, the issue persists. Conversely, when the root cause is identified and addressed, the company can prevent the problem instead of simply mitigating its effects.

What Are the Benefits of Using Root Cause Analysis in Food Manufacturing?

Preventing outbreaks and other food safety and quality concerns is the core purpose of root cause analysis in food and beverage, and the key goal emphasized by the FDA. Yet, RCA goes beyond compliance and allows your company to:

  • Identify inefficiencies which can affect production costs and quality issues
  • Reveal additional vulnerabilities in systems used to implement corrective actions
  • Take a systems-based approach, thereby allowing employees to anticipate risk and promote a proactive (versus reactive) food safety culture.

By uncovering inefficiencies and vulnerabilities, you’ll be able to make your systems and processes more infallible. This can also foster a food safety culture of prevention instead of response. With a greater focus on prevention, you’ll also be able to avoid financial loss and brand damage.

Which Tools Are Used for Root Cause Analysis?

There is no single, “one-size-fits-all” approach for completing an RCA, and many tools and methods are commonly used. Deciding which RCA methodology to use may be a matter of personal preference or company policy. Most importantly, the type of issue or nonconformity being investigated should be considered. Oftentimes, different tools are better-suited for different situations; for example, the size or complexity of an incident may warrant a specific approach.

Some of the most common tools for RCA are:

  •       The 5 whys
  •       The fishbone diagram (Ishikawa diagram)
  •       Pareto charts
  •       Scatter plot diagrams
  •       Failure mode and effects analysis (FMEA)
  •       The DMAIC process
  •       Fault tree analysis

SafetyChain can support all of these approaches and enhances your RCA process by making it faster, more efficient, and more thorough.

Where Traditional Root Cause Analysis Falls Short for Food, Beverage & CPG Companies

Many companies still use manual processes, such as permanent markers and sticky notes, to perform RCA. Yet, this approach is often drawn-out and ineffective. This clunky process can use up to three different systems (a whiteboard, Excel, and incident management system, for instance), taking time and attention away from the core problem. More importantly, it limits what you can do with the information you uncover, along with what you learn from it.

SafetyChain, on the other hand, manages the process of RCA from start to finish. It uses a systems-based approach to reveal insights your teams will actually use to pursue continuous improvement.

How Do You Write a Root Cause Analysis?

Regardless of which specific method you use, each RCA should begin with the same basic process:

  1.     Record the nonconformity or problem statement.
  2.     Include when the problem occurred and when it was discovered.
  3.     Identify implicated products or processes.
  4.     Complete any immediate corrective actions as needed.

The problem statement should be identified and agreed upon by the group of selected individuals who will complete the RCA. Include people who have in-depth knowledge of the process.

From there, you can determine which of the tools you’ll use to investigate the root cause. Below are two of the most common approaches to consider.

How Do You Use 5 Whys?

The 5 whys analysis is a simple, straightforward questioning process designed to drill down into the details of a problem or solution and peel back the layers of “symptoms.” To use it, simply keep asking “why?” until a root cause or root causes are identified.

Bear in mind that the root cause may take fewer than five whys to identify. Or, it could take more questioning to uncover the precise root cause. Don’t focus on the number; instead, aim to get to the true root cause instead of stopping at its symptoms.

SafetyChain supports this approach with forms that ask, “Why did this problem occur?” until the root cause is identified. From there, you can provide a solution to the problem which can be shared as a real-time notification. The system’s task scheduler can also ensure the appropriate parties receive alerts and reminders to address the issue. The system provides an analysis over time, so you can track key metrics on an ongoing basis.

How Do You Use the Fishbone Analysis?

The fishbone analysis is well-suited for more complex issues, but can be combined with the 5 whys process. If you’re uncertain of the problem statement, use this approach. 

For instance, you might have a product that tested positive for salmonella, which could be originating from your ingredients, equipment, or a personnel issue. A fishbone analysis lets you examine several different possibilities. Various causes are grouped into categories, and the causes cascade from the main categories until the diagram resembles a fishbone appearance. The generic categories for the fishbone diagram include:

  •       Materials
  •       Methods
  •       Measurements
  •       Machines
  •       Environment
  •       Personnel

You can then use the 5 whys to drill down further.

The SafetyChain platform supports the fishbone analysis by prompting users to describe the problem, then consider potential sources of issues related to materials, methods, measurements, and so forth.

Using Software for Root Cause Analysis

Oftentimes, food and beverage companies collect data for their RCA but fail to use it to its full potential. Documents get filed away, and insights therefore become useless. When you use software, however, you can achieve both instant and long-term visibility. You can then look into trends, which will allow you to make strategic decisions and develop infallible systems.

While RCA requires time and expertise, it’s a worthwhile activity for food and beverage companies. Performing routine RCA is an integral aspect of building a strong food safety culture focused on prevention. When RCA is coupled with robust technology, it goes beyond simple data collection to retrieve real-time and ongoing insights into trends that can help you improve performance, optimize safety and quality initiatives, and maintain compliance.  

To learn about ways to strengthen root cause analysis with software, check out our post on OEE Calculation for Root Cause Analysis or take a deeper dive with SafetyChain's OEE eGuide.

 

Topics: Productivity