Diverse strategies, techniques and tools for conducting an organized and systematic Root Cause Analysis (RCA) have been used sporadically for decades across the fresh produce supply chain. Now, per the FDA Blueprint for the Future: New Era of Smarter Food Safety, there is a push to “collaborate with federal, state, industry, consumer, and academic stakeholders to advance, standardize, and socialize root cause analysis protocols for food safety.” In this week’s Virtual Town Hall PMA produce safety specialist Trevor Suslow, Ph.D. was joined by Dr. Michelle Danyluk, Professor at University of Florida and Dr. Kurt Nolte, Produce Safety Network investigator, Food and Drug Administration – CFSAN to discuss the often-complex process of an outbreak root cause investigation or industry-initiated RCA and to provide everyday strategies and tools which are more generally applicable to the produce industry.
Root Cause Analysis Process
To start off the session, Dr. Suslow provided a brief overview of the process of conducting a Root Cause Analysis:
- Define the problem and questions.
- Align the predicting factors: often, the key here is to ask, “what was different this time?”
- Generate hypotheses based on the differences between this situation and past ones.
- The difference may be a weather event or other unanticipated risk factor.
- Challenge the hypotheses within the RCA.
- Resolve, verify and evolve both the RCA process and food safety systems.
All practical and everyday approaches to an outbreak have a systematic RCA process at the foundation. Once the problem has been clearly defined, there are steps, rooted in RCA that help define next steps and actions to take:
- Assemble a team: establish a timeline and define resources.
- Select tools: keep in mind that one approach will rarely be adequate in solving the problem.
- Assemble the data: find connections; look behind the curtain, ask the right questions and question the right people.
- Align the facts: what do the facts and experience indicate?
- Defend the hypothesis: Do the facts fit? Does it explain the problem?
- Define the actions: Regroup and restart as indicated. Get help as warranted.
In planning for industry awareness-building and skills training for a RCA, Dr. Suslow outlined the activities in progress under the Western Growers-Joint RCA Work Group, additional plans underway within the FDA, AFDO and university Cooperative Extension, as well as other resources.
A Regulatory View
As a representative from one of the many resources on RCA outlined by Dr. Suslow, Dr. Nolte provided a regulatory perspective of the On-Farm Investigation and points to draw upon to improve an industry-based RCA process. In their 2020 Action Plan to help advance the safety of Leafy Greens the FDA outlined three key focus areas:
- Knowledge Gaps
The FDA takes outbreaks of any kind extremely seriously, and as a result of every incident they continuously try to improve and prepare for the next one. RCAs are part of that action plan and focus particularly on the response focus area in looking at on-farm investigations and finding ways to improve them.
Recognizing the importance of finding ways to improve on-farm investigations Dr. Nolte outlined five preliminary and onsite considerations for growers to make when conducting an on-farm assessment:
- Discuss: budget, schedule commitment, rigor, limitation, and type of assessment.
- Assemble appropriate individuals and team(s) that will be objective in approaching both the investigation and hypotheses development.
- Define the problem, purpose and scope of the investigation and develop a plan.
- Use all available tools to record and collect all objective evidence.
- Evaluate existing evidence and contributing factors to understand the process, events and facts.
When asked whether the absence of training was a barrier for the industry, Dr. Nolte noted that the absence of training and application of knowledge is a gap we can close. Growers have enormous amounts of responsibility on their shoulders, which may leave little time to develop the skillset to look at a problem and explore it fully. Our industry could benefit from a roadmap for growers to follow that is easier to manage and promotes full implementation of strategies.
An Industry Perspective
Following Dr. Nolte’s explanation of the regulatory view of a RCA, Dr. Danyluk was able to provide an industry perspective. Dr. Danyluk walked participants through two examples of RCAs that she has been part of and provided the key learnings for running a RCA that came out of those experiences.
- When testing samples there is a need to pull a lot of samples to get a true telling of whether the pathogen might be there. Out of 490 samples, only 7% were positive, which was not an unusual finding.
- Where you pull samples from is important when tracking the true source. Depending on what you are testing for the pathogen could be 95-96% less likely to be found in a manure pile than at the animal production facility or field, for example.
- Depending on the target gene, differences exist in the prevalence and efficiencies of detection among the same type of sample from different locations and over time.
- When collecting samples be sure to be unbiased. For instance, if your hypothesis says that the pathogen came from the field, equal amounts of samples must come from the field and manure piles, rather than just the field.
Whether on the regulatory or industry side foodborne illness outbreaks carry serious consequences and must be handled appropriately. A RCA is the foundation to an investigation and can help you not only better respond, but also prepare for the next time an outbreak occurs.