Food Safety Root Cause Analysis
What is an RCA (Root Cause Analysis)?
An RCA, or environmental assessment, is defined as a retrospective investigation method used to identify why an incident occurred. An incident can be an outbreak, an event that could have caused microbial, chemical, or physical contamination, a processing failure, or a food safety system failure. The goal of this type of investigation is to determine the factor(s) underlying the problem and identify actions that can be taken to eliminate the problem, prevent its recurrence, and ultimately reduce the risk of foodborne illness. To accomplish these goals, the investigation team should take the necessary steps to identify the actual root causes, or environmental antecedents, of the problem and not just the contributing factors.
What should be considered before conducting an RCA (Root Cause Analysis)?
A. How should the scale of an RCA be determined?
Stakeholders should develop a shared understanding of when to conduct an in-depth, resource-intensive RCA. Developing robust and evidence-based criteria for scoping an RCA before an incident occurs is important for transparent decision-making regarding whether a food safety system failure requires a large-scale RCA or a more abbreviated analysis. Criteria can include triggers to help staff recognize more serious or complex incidents with high public health significance that require additional resources and expertise to investigate and control.
B. Does your organization have sufficient capacity to perform an RCA or have plans and procedures in place for capacity development?
Ideally, the individuals who make up a root cause investigation team will have the opportunity to participate in appropriate training before the need to conduct an RCA arises. (See Appendix A for additional training resources.) Before initiating an investigation, assess the current capacity to conduct RCA for different types of food safety incidents and determine.
C. How long should the RCA take?
Expected length of the RCA depends on many factors, including priority and level of resources that will be dedicated. Initial assessment of the project timeline and periodic re-evaluation as the investigation progresses may be necessary to determine if projections are realistic. By setting expectations and objectives early, the investigation team can plan according to the amount of time allotted to conduct the analysis, based on available resources and schedules. However, enough time should be allowed to complete the investigation even if unexpected delays occur. Unavoidable delays should not stop the investigation team from releasing findings that may prevent incidents even before the root causes are identified.
How is an RCA (Root Cause Analysis) conducted?
A. What steps should be taken before performing an RCA?
Data gathering for RCA should begin as early as possible following the incident when critical evidence can be secured. The following steps are not part of the RCA but are important data-gathering steps that affect the quality of the analysis and are included here for awareness.
- Remove contaminated product from the marketplace.
- Form the investigation team.
B. What are the steps for conducting an RCA?
Specific steps and procedures for conducting an RCA may vary depending on the organization; different methods may be chosen to identify root causes. General steps are provided below as an overview for those new to the issue, to help with planning and resource allocation, and to ensure a consistent approach.
- Collect data and define the problem.
- Assess information and develop a hypothesis.
- Categorize evidence.
- Identify the root cause(s).
- Define preventive/corrective control strategies.
- Implement and validate a control plan.
- Review the process and develop a communication plan.
C. What tools are commonly used for conducting RCA?
- Brainstorming
- Five Whys
- Fishbone or Ishikawa diagram
- KNOT chart
- Fault tree analysis
D. How do you know when you have identified the root cause or causes?
When conducting an RCA, it is important to acknowledge that there typically is no single cause. Often, a combination of several root causes resulted in the event. In these cases, it may be difficult to identify all root causes and to be sure when all have been identified. However, a systematic, data-driven investigative approach may increase the likelihood that all root causes are recognized.
How should findings from an RCA be communicated?
Organizations should plan to release a report that outlines three to four key findings that can be disseminated not only internally, but also to outside stakeholders. Similar to FDA’s strategy of posting environmental assessments of foodborne illness outbreaks, a dedicated RCA webpage can be created that lists the results of all or a selected number of RCAs that have been performed. Notifications may also be set up through a subscription service when changes are made or more information is added to the webpage. Industry partners, government, consumers, and other stakeholders can subscribe to this page and circulate the page to other interested parties. RCA findings may also be released in academic and trade journals, through industry and advocacy groups, and by using social media to share lessons learned.
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