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FSPCA - Food Safety Preventive Controls Alliance

Friday, April 3, 2020

Pew - A Guide for Conducting a Food Safety Root Cause Analysis

Pew Charitable Trusts published a guide to conduct a root cause analysis.  This type of analysis would be used by a food operation to solve issues that lead to a recall or even a deviation from a CCP/preventive control parameter.  "The guide describes practices for effective RCA that, if used routinely, would help identify lessons learned from food safety failures and ultimately prevent foodborne illnesses. The guide provides approaches and rationales for how stakeholders can prepare for and conduct an RCA, report findings and conclusions, and apply lessons learned to prevent recurrence."

So it is a good reference source for corrective action procedures.

Pew Trusts
https://www.pewtrusts.org/en/research-and-analysis/reports/2020/03/a-guide-for-conducting-a-food-safety-root-cause-analysis
A Guide for Conducting a Food Safety Root Cause Analysis
Approaches for investigating contamination incidents and preventing recurrence
REPORT
March 24, 2020
Topics: Food & Drug Safety & U.S. Policy Projects: Safe Food Read time: 53 min
Excerpt

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.77

1 - Collect data and define the problem.

Describe the incident and collect as much information as possible about the incident and the events leading up to it to create an accurate picture. This step may also involve identification of persons at risk, the size and scope of the incident and its consequences, the mode of transmission and vehicle, the source of contamination using epidemiologic and laboratory data, and other data sources.78

2 - Assess information and develop a hypothesis.

Develop an initial hypothesis of what factor or factors ultimately led to the incident, with an understanding that this hypothesis may evolve over time. Then, identify the contributing factors to the incident. It is important to note that this is a preliminary hypothesis to guide the RCA. Even with it, the investigation should be able to proceed organically and be driven by the available data or evidence. Further control measures that help prevent additional illnesses may be implemented as needed at this phase of the investigation as stakeholders determine the potential for ongoing transmission.

3 - Categorize evidence.

Gather all available data and evidence and categorize them based on source, credibility, likelihood, or other relevant classifications. Categorize the contributing factors and determine which basic systems may have broken down and potentially caused the incident. This step may involve further data collection.

4 - Identify the root cause(s).

Identify the fundamental reason for the incident, carefully differentiating contributing factors from root causes, which, if corrected, should prevent recurrence of the incident. (See the following section for common tools used to organize and analyze data and evidence to determine root causes.)

5 - Define preventive/corrective control strategies.

These actions may include, for instance, updating operating procedures, enhancing monitoring systems, instituting a training program, or ensuring that regular safety checks are in place and regularly reviewed.

6 - Implement and validate a control plan.

Research the incident to find out if this type of food incident has occurred before within the current setting. Root cause analyses cannot proceed in a vacuum and must be informed by history to ensure that prior lessons learned are considered. If the problem recurs, it is necessary to return to step 1, redefine the problem, and collect more data.

7 - Review the process and develop a communication plan.

Identify lessons learned. Determine how such knowledge can be shared internally and, if appropriate, externally. Review the RCA process and evaluate whether it has the capacity to continuously improve the analysis process.

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