When food safety issues occur in food production facilities, some string of dominoes have fallen to cause them. The shapes and sizes of those domino trails vary by organization, but they are always there.
If this happened tomorrow, would you have a corrective and preventive action (CAPA) plan in place? Do you have the skills needed to conduct a root cause analysis?
These are vital questions for which to have answers when facing a possible issue with pathogens or other threats. There are many reasons to have a CAPA plan in place and to be able to effectively find root causes. Among them, to comply with the FDA, to have efficient lines of communication among departments, and to provide information for management to evaluate when making decisions.
But there are two primary reasons to ensure a CAPA plan is in place:
- To protect consumers
- To protect your company.
We’ve put together a guide to help you set the dominoes back in order, but first, let’s establish definitions for some of the key terms related to CAPA and root causes:
- Correction: an action to eliminate a detected nonconformity. (A correction can be made in conjunction with a corrective action, but the two may be distinct).
- Corrective action: action to eliminate the cause of a detected non-conformity or other undesirable situation.
- Preventive action: action to eliminate the cause of a potential non-conformity or other undesirable situation.
- Root cause analysis: solving problems by attempting to identify and correct the root causes of events, rather than simply addressing their symptoms.
Below, we’ve lined out five CAPA plan steps that can help lead your organization toward the development of an effective CAPA plan, as well as providing guidance for conducting a root causes analysis when food safety issues threaten your facility.
1. DEFINE THE ISSUE
Documentation is key. Describe the nature, magnitude, locations, timeline, events, results, activities and actions of the food safety threat.
2. MEASURE & PERFORM INVESTIGATION
Use a cross functional team to investigate, presuming nothing and keeping an open mind. Document, Document, Document.
3. ANALYZE THE FINDINGS (Investigate Root Cause)
The goal if this step is isolating WHY the issue occurs. Your investigation should yield enough information to establish a sequence of events, and to diagnose the contributing factors and/or the direct cause. In some cases, this step may require a simple repair of a physical issue (i.e. a pipe is leaking, so fix it!). More often, there will be multiple factors to consider.
From this analyzation, determine what to name as deliverables, who should be responsible, and when they will be due. This step may include employee training, and will require clear communication about the go forward plan.
4. IMPROVE (CORRECTIVE ACTIONS)
Execute the action plan without delay, monitoring progress and documenting findings. Make the records available for review. If a capital restriction is delaying progress, make sure to request (and document) the necessary funding to address the issue.
At some point, you will reach the verification phase, where you will determine if the action plan has been executed. If so, demonstrate that you have documented evidence to prove it. Additionally, identify early detection points in case of recurrence.
5. CONTROL AND CLOSE OUT
Ensure that each step in the process is defensible through documentation, and that each action taken was effective. Review the true root cause and communicate the early detection points so that future issues become preventable.