Conducting Root Cause Analysis.
Conducting Root Cause Analysis.
Conducting Root Cause Analysis.
July 7, 2021
Contributors to this Guide
Acknowledgments
Disclaimer: This document is for information purposes only. It does not provide technical, medical or legal advice. The
use of this guide, receipt of information contained on this guide, or the transmission of information from or to this guide
does not constitute an attorney-client or any other relationship. The information in this guide is not intended to be a
substitute for professional technical advice. Always seek the advice of a qualified expert with any questions you may
have regarding your specific situation. Any legal information herein is not intended to be a substitute for professional
legal advice. If you need legal advice for your specific situation, you should consult a licensed attorney in your area.
This document also includes feedback from other industry stakeholders from Cornell University,
the U.S. Food and Drug Administration, and a fresh produce industry focus group.
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Table of Contents A “How-To” Guide for the Produce Industry
5-WHYs Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Fault Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
1. To determine the underlying reason or reasons that caused the unexpected event or incident.
2. To identify the actions needed to eliminate the problem, and to determine if there were multiple co-
dependent factors or inter-related issues.
• Exactly what was the specific incident, such as a positive pathogen detection, recall or outbreak,
deviation from SOP / GAP, expected result, or protocol?
• Establish a timeline: What is the timing? What is the sequence of events that led to the incident?
• What is the scope of the problem – i.e., what elements of your operation are involved? Who was
involved and should be interviewed?
• What factors may have contributed to the problem? What was different this time compared to past
instances when this did not occur?
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Samples – collect samples that are relevant to and representative of the circumstances.
People – it is important to question the right people and ask the right questions. This is very
hard to describe as it is generally situation- and operation-specific.
Paper and electronic record review – Ensure workers’ verbal recounts match what is
documented. Look for evidence of what did or could not have happened and not assume what
was meant to happen, did happen.
Remember that it is common for people to forget and, at times, to fail to recall failures or to coverup
failures to notice or act. The “soft skills” of creating trust and confidence in those being questioned is
generally hard to teach. Sincerely seeking the cause and the right corrective actions, rather than blame,
generally sets a productive tone for those being questioned, which allows the team to more effectively
work through this part of RCA discovery.
Remember to pursue all leads: Don’t assume anything and keep a mindset of looking “behind the
curtain”.
Example 1: The RCA team will interview personnel involved in taking water samples (operational
factors), conducting environmental assessments of the growing environment (external factors), and
setting up and maintaining the irrigation system (physical factors). Team members will gather relevant
contemporary weather data (historical data may be helpful as well) for the preceding and concurrent
days the samples were collected.
Example 2: The RCA team will first interview personnel in charge of the harvesting crew the day of
harvest (operational factors) and then interview harvest workers according to the information gathered
from the harvest supervisors. Another team member will review equipment inventory records logged
for the day of harvest (physical factors).
• Look for connections – Failures are rarely caused by one factor or a singular circumstance.
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
• Explain how the incident/event happened; determine and implement corrective actions.
• Do the facts presented fit the event/incident/situation? Do they explain the problem?
• Develop and implement corrective action(s) to correct the problem if it still exists; if there are
multiple contributing factors, there may also be multiple corrective actions. Some correction
actions and lasting preventive controls may involve or require an external party.
It’s important to note that, in some cases, a root cause is not determined for various reasons. This does
not mean the RCA is not successful, and there should be no expectation to name a cause if evidence
does not support it. Even in cases where a resolution cannot be determined, the RCA process provides
opportunity to learn more about procedures and processes, reinforces the necessity of preventive
practices already in place, and may expose non-causative, unanticipated issues that need to be
addressed.
Example 1: The RCA team discusses their findings regarding potential causes and contributing factors
for the elevated generic E. coli levels. Based on a preponderance of evidence, the team determines
the root cause of the transient high generic E. coli levels in the irrigation water was a manure stack
located upslope from the canal several weeks prior to sampling and subsequently spread on alfalfa
fields adjacent to the canal. Weather data showed substantial rainfall on numerous occasions while the
manure stack was present. For this example, since the high E. coli levels were transient and the manure
stack was no longer present, corrective actions may include building better communications with
neighboring farms and re-training of farm labor to improve notification of observations to foreman/
supervisors.
Example 2: The RCA team discusses their findings regarding potential causes and contributing factors
for the misplaced harvesting tool. Based on a preponderance of evidence, the team determined there
were dual root causes:
1. A newly hired harvest worker who was not properly trained in harvest tools SOPs due to time
constraints. She failed to follow SOP for equipment storage during toilet usage (i.e., put it in the
designated bucket/holding receptacle). Near the end of harvest, the worker went to the toilet
and left her knife in the harvested product carton she had just finished harvesting (another SOP
violation).
2. Inaccurately conducted equipment inventory – While the new worker was using the toilet, a
coworker put her carton on the finished product stack without noticing the knife. When she
immerged from the toilet, she joined the others getting into the bus forgetting about her missing
knife. In the meantime, the field operations manager took an inventory of the harvest equipment
and failed to notice the missing knife.
• Ask yourself – “now what’s next?” Are there any follow-up tasks after RCA is complete?
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Table A1. Common tools / methods used in conducting RCA (See illustrated examples of these resources
following the table.)
Fishbone A graphic tool created to Identifying potential Does not lend itself well
Diagram (also explore factors contributing contributing factors. to depicting complex
called Cause to an “effect” such as an interrelationships among
& Effect or unexpected and often multiple contributing factors
Ishikawa) undesirable incident or event.
5-WHYs Asks “why” 5 times or as Simple linear technique Not conducive for solving
many as necessary to get a for simple, uncomplicated or gaining a better
clear explanation for why an incidents understanding of complex
incident occurred issues such as positive
pathogen test results for pre-
harvest crops
Fault tree A systemic description Analyzing failures in a Can be too binary (e.g.,
depicting potential pathways packing or processing Yes or No) for nuanced
between cause and effect. system. circumstances; relies on
Often used for equipment symbolic shapes that may
failures be difficult to remember for
those not trained in its use.
Process maps, A technique to represent Helpful for understanding Requires detailed knowledge
flowcharts a process by organizing what went wrong in a of a process
information in a graphical system or process e.g.,
manner or sequential packing or processing
diagram. incident
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Fishbone Diagram
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Problem / Defect
Answer what caused Answer why the problem Answer why the problem
the specific situation wasn't detected wasn't detected
1st WHY?
2nd WHY?
3rd WHY?
4th WHY?
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Fault Tree
AND
OR OR
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Cross-Functional Flowchart
Customer Sales Contracts Legal Fulfillment
Standardized YES
terms?
Agent
approves order.
Attorney marks it
OK,
returns to agent.
Pick order,
NO YES log shipment.
NO
Attorney marks it
Agent
NO,
cancels order.
returns to agent.
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Problem Definition – Preharvest pathogen detection on tender greens expands from single to multiple fields in
short succession.
1. A preharvest sample (25 g) 7 days before harvest tests positive for Salmonella.
• 32 hours later, secondary samples from 1 of 5 one-acre blocks test positive for Salmonella and STEC.
2. Contiguous five-acre block tests positive for STEC preharvest overlapping with STEC, Salmonella and STEC +
Salmonella positives on finished product from the initial harvested four-acre block.
3. Non-contiguous five-acre block more than 0.25 mile from the initial positive block, tests positive preharvest
for both STEC and Salmonella. Testing overlapped with harvest/re-sampling decision-making around second
block results.
• Re-sampling second and third scheduled harvest blocks results in 3 of 10 STEC and Salmonella
positives.
• Raw product from both harvest blocks were tested with a diversity of positive results observed in 4
of 10 samples.
4. Twelve days after the initial positive test results, a fourth field preharvest sampled in 5 one-acre units (125 g)
is negative for STEC and Salmonella. This field was approximately 1.5 mi from the initial field.
• However, finished product testing in larger mass units (175 g) revealed a mix of STEC, Salmonella,
and STEC + Salmonella positives. Samples representing 6 of 24 pallets had positive outcomes.
Initial Review for Contributing Factors – Field Operations Team and Food Safety Manager Assemble
• Initial review of field, raw harvest, and finished product outcomes and spatial distribution was confusing with
no discernable connections between fields, equipment, or inputs.
• All fields were managed by conventional practices with overhead irrigation and last irrigation was 10 days
before the scheduled harvest.
• All water is sourced from irrigation district canals directly or from a series of secondary laterals except for one
field which used more remote well water during a heavy demand period.
• After three rounds of internal review with field operations and review of audit checklists, no unifying risk-
based or contributing factors emerged.
• Positive tests were experienced within the same large ranch but with different crop types over the following
weeks.
• Owners and senior management gathered a broader internal team and brought in the contracted crop
management consultant firm and harvest contractors.
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
• Monthly water tests did not reveal any non-compliant results for generic E. coli.
• Compost (dairy manure and chicken litter sources were included in the feedstock) was applied to some but
not all ranch blocks the preceding early summer more than 60 days before pre-irrigation and seeding. The
noncontiguous ranch blocks, in rotation to receive this compost, did have one large lot field-side deposited,
approximately 15 tons (~3 tons/ac), at each location for spreading and incorporation, and remaining in
dump piles for up to three weeks. One COA was supplied for all the delivered commercial compost.
• Adjacent land features and use activities were largely agricultural and no clear presumptive risks or new use
aspects were apparent.
• No single harvest contractor or harvest equipment could account for all field lots testing positive.
• All crop management foliar sprays were specified, by company SOP, to be filled with municipal water sourced
at the company equipment yard or from a nurse water tank truck also filled with this municipal water source.
• Monitoring records included observations of birds and bird droppings, coyote prints and scat, and dog
prints, but judged as low numbers and limited intrusion; nothing at all unusual.
• No fields were impacted to any notable level by insect pressure or plant disease.
• Cross-contamination from internal closed-loop collapsible harvest totes was discussed, but no clear inter-
field use pattern emerged.
• More records were reviewed, and details were discussed and debated but the group did not arrive at a
consensus hypothesis or plausible root cause.
• Management approved testing residual sump pump water and conducting swabs of the irrigation mainline,
pipes and emitters associated with positive lots.
• Interviews were conducted with the labor contractor engaged to conduct field sanitation.
• Swabs of harvest machines and harvest totes was considered but deferred as no cross-connections of use
could explain the spatial and temporal distribution of positives and negatives.
• Jumping a few steps and several meetings ahead… field observations at the two earliest contiguous blocks
with positive lots revealed clear evidence of irrigation lateral canal clearance which, though observed by field
operations during the events and in initial RCA field inspections following the positives, was not mentioned
in the initial hypothesis generation exercise.
• Positive results, mostly for Salmonella but some STEC, were obtained from the PTO sump, mainline, and
sprinkler sections… once a presumptive root-cause was agreed on by the team and advisor, it was decided
not to culture or sub-type the molecular positives as it was too costly.
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
• A decision was made to use this crew to rake the extensive macroalgae from the lateral canals and areas of
the PTO sump.
• This maintenance effort was conducted during irrigation events at both blocks which released algae
fragments, subsequently found to harbor Salmonella and STEC, disturbed sediments likely to harbor both
pathogens into the water flow, and this water passed from these sumps after each irrigation set to lateral
connections conveying water to other ranch blocks.
• It was further determined that algal extract formulations with growth boosting microbes and supporting
nutrients were included in the fertigation program. These were added to the program by the crop consultant
but not communicated to the management level in a way that provoked recall during hypothesis generation
exercises. However, it was not likely to have raised a question within RCA until noted by an external advisor.
• It was further determined during pointed interviews that some foliar application tanks were periodically
filled at the PTO sump equipment when the water tanker was not immediately available. These tractor-
mounted sprayers were moved widely around the ranch operations, but records were incomplete, and recall
was questionable in relation to positive and negative ranch lots.
• Though the RCA was terminated at this point, a consensus view was that algae removal and sediment
agitation resulted in contamination of the crop during irrigation and established these pathogens at higher-
than-normal levels in a persistent manner in the irrigation sumps and pipes.
• The addition of the injected biostimulant formulation was not determined to be a confirmed root cause
contributor but recommended follow-on research confirmed that both Salmonella and E. coli O157:H7 would
grow in algal extracts and fish emulsion in canal water at the environmental temperatures and was especially
likely in the spray lines and irrigation pipes.
Final Assessments
Though not possible to unequivocally prove cause and effect, it was reasonable to determine via the RCA
process that canal disturbance during active irrigation was the key contributing factor in the widely dispersed
contamination. This likely contributed to the complex and inconsistent lot-to-lot positives and was compounded
when this same surface water was used in some foliar spray equipment potentially contaminating it.
• The patterns of positives were never fully resolved but management felt they had carried out the RCA far
enough to implement several programmatic changes in training, communication, record-keeping, and
revised SOPs with frequent spot verification.
• Clear instructions for notification and detailed communication of any repair or management issues were
implemented to include the food safety manager.
• Numerous uncertainties surrounded the possible contribution of the compost to Salmonella introduction
into the water distribution system as the material in the initial field was place immediately across from the
lateral. However, based on the COA, and no additional testing, it was impossible to rule-in or definitively rule-
out.
Secondarily, the observations of variable pathogen test outcomes particularly between pre-harvest testing and
finished product tests raised questions regarding the need to modify the sampling plans and detection platforms.
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Conducting Root Cause Analysis A “How-To” Guide for the Produce Industry
Resources
A Guide for Conducting a Food Safety Root Cause Analysis | The Pew Charitable Trusts (pewtrusts.org)
Process maps and flowcharts: Process Flowchart - Draw Process Flow Diagrams by Starting with Business
Process Mapping Software | Process Flowchart Symbols | Process flow diagram | workflow diagram
(conceptdraw.com)
References
Appels K, Kooijmans R. How Root Cause Analysis is done - Food Safety Experts (foodsafety-experts.com),
January 10, 2017.
Belisario D. What is a Fault Tree Analysis (FTA)? - The Beginner's Guide (edrawsoft.com), January 27, 2021.
BRC Global Standard, Understanding Root Cause Analysis (template.net), June 1, 2012.
Rooney JJ, Vanden Heuvel LN. 2004. Root cause analysis for beginners. Quality Progress, July 2004. https://www.
abs-group.com/content/documents/rca_for_begineers.pdf
Vorley G. 2008. Mini guide to root cause analysis, Quality Management & Training, Microsoft Word - Green RCA
mini guide v5 small.doc (root-cause-analysis.co.uk)
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