What are Corrective and Preventive Actions?

This quote means that we need to act upon findings and that it is not enough to only verify and document the gaps identified when conducting inspections, internal audits or receiving third party audits. It is required to manage the results, look for immediate corrections, long term solutions and most importantly, look for continuous improvement. To maintain a healthy and effective food safety and quality management system, it is required to reinforce verification activities 24/7. Corrective and Preventive Actions (CAPA) is about defining corrective actions and preventative actions.

The U.S. FDA communicates key concepts in line with the Food Safety Modernization Act (FSMA) rule (Reference 1). These concepts are defined below.

Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.
Corrective actions (CA): These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. That means, to remove the causes of existing non-conformities (NC) and avoid reoccurrences (reactive approach).

To understand CAPA in its entirety, we should add two more concepts.

CAR: Corrective Action Request, also used for Corrective Action Report to notify when, how and who identified the NC, who is assigned to, description of the NC, follow-up action and any other details required to understand this NC and if the solution was effective.
Preventive Action: Action to eliminate the cause of potential nonconformity or another undesirable potential situation. That means, avoiding issues happening for the first time, avoiding occurrence (proactive approach).

Every site is required to have its own CAPA procedure and a proper system to record what was identified. A common workflow or CAPA process includes the following steps (Reference 2).

1. Identification of the non-conformity
2. Categorization of its severity and priority
3. Correction or mitigation action or containment
4. Root cause analysis or investigation of its origin
5. Corrective action
6. Execution of the CA/Implementation
7. Verification of effectiveness
8. Closure

Ideally, the system should capture and manage quality assessment-related data. Corrective actions requests should be triggered directly from a non-conformance event, like a violation monitoring a critical control point, as well as from audit findings. In your report, allow the recording of additional information that could come out of root-cause investigations of issues. Attach information as evidence of its status like before and after pictures, reports, etc.

Create a system to monitor and control corrective and preventative actions created from results and observations. Below are some best practices.

• To avoid a long list of CARs, consolidate NC from different sources, for instance, regulatory inspections, internal audits, GMP inspections, external GFSI approved scheme and customer audits, grouping them in one reporting system.
• Improve the overall quality culture of your organization, allowing cross-functional teams to participate in the corrective action management process. Engage them in its categorization, root cause analysis, and solutions.
• Ensure you and your teams have a robust problem-solving process and knowledge of root cause analysis methodologies.

Several NC can come from the same root-cause; therefore, its solution would require only one corrective action, or vice versa. One NC would trigger several root causes; hence, several actions, quick fixes and more complex corrective actions.

Ensure monitoring of the entire CAPA process, as follows.

1. Assigning and owner to each CAR
2. Categorizing each NC according to its severity, for example, as “recommendations,” “minor,” “serious,” or “critical,” and its level of priority, as “high,” “medium,” or “low.”
3. Based on the level of severity, determining if a quick solution is required or following root-cause analysis methodologies to implement an effective corrective action.
4. Never leaving the CAR open, even if it requires large investment.
   • Always look for mitigation or temporary actions and ensure its ongoing follow up until you put the long-term solution in place.

Provide periodic reporting with the status of the corrections and/or corrective actions, as follows.

• Create a functional dashboard and analytics to allow charting and trending in addition to reporting.
• Use a “progress meter” to detail dates and statuses of actions as overdue, at risk, on track or completed. “Completed” means the team has already verified that the solution was effective to avoid reoccurrences.
• Track the percentage of open CARs and what further actions are required to take, including resources required as capital, people commitment, training, etc.

With the management of NC and your Corrective Action Plan in place, it is time to look for Preventive Actions. Identify key team members to periodically walk your site, verify your processes, documents, and records, get familiar with your food safety and quality management system, and follow a risk-based approach to identify possible scenarios of what could go wrong. Then, start putting in place preventive actions, to avoid occurrence of NC for the first time. This allows maintaining continuous improvement in your organization.

There are solutions that automatically capture NC and provide Analytics and Reporting capabilities with graphical dashboards to track each audit from initiation to closure. These solutions are accessible to the whole team, with escalation protocols, giving managers complete real-time visibility into the food safety and quality system and wide visibility into the status of CAPA activities.

Working with Adroit, as a preferred partner of Aptean, will allow you to track metrics with the food-oriented ERP system, Aptean Food & Beverage ERP, JustFood edition. Learn more on the implementation at our Aptean partnership webpage.

References:
1. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food
2. https://asqasktheexperts.com/category/capa/

Disclaimer: This information is to be used as guideline only. It is the responsibility of the readers to maintain strict compliance with all local, state and federal laws, rules, regulations and third-party standards.