Guide for Corrective and Preventive Actions

Corrective and preventative actions are some of the common terms in the food industry. They present no matter what food safety certification or regulations a food manufacturer needs to follow.

What are the differences between Corrective Actions and Preventative Actions?

Corrective actions are necessary when an outbreak or contamination occurs, and they help remove contaminated food from the market while investigations into the cause are ongoing. Corrective action procedures also include monitoring for new outbreaks, issuing recalls where necessary, and educating customers about potential dangers.

We can take preventative actions at any point in the production process to reduce the risk of an outbreak occurring in the first place. These measures may include standardizing recipe formulations, conducting regular inspections of facilities, testing ingredients for purity and quality, and following best food handling and storage practices. Food-borne illnesses are a major public health concern. They can cause serious and sometimes fatal infections, especially in those most vulnerable–such as young children, the elderly, and people with weakened immune systems.

The corrective and preventive actions process helps prevent future harm caused by the deviation. Corrective actions help you get back on track quickly so you can resume full operations as soon as possible, while preventive action protects your organization from potential deviations in the first place. You can minimize disruption and maximize efficiency while complying with legal obligations by implementing corrective and preventative actions early in the process.

While corrective and preventative actions are very important to ensure we eliminate problems in the day-to-day food operations, we often see that this process are not being taken seriously. In fact, the CAPA process is one of the processes that are often done inaccurately. 

Let us illustrate this further. Most of the corrective action steps indicated in the corrective action section of the procedure are, in fact, “correction” or “immediate fix”. They are very useful procedures and the best way to help our production staff or team know what to do to resolve the issues. The subsequent steps are typically hidden. That means we are fixing a problem that we didn’t know what caused them and in this situation, the likelihood of applying the wrong fix became very high.

Are you actually solving your food safety and operational problems?

The answer became an apparent “NO!” So, how do we fix food safety problems correctly and address the root cause?

In this blog, we will focus on two simple key root cause analysis methods to determine the actual cause so we can fix the right problem.

Basic steps for correcting deviations

This blog describes the five steps a food safety manager should take to correct deviations: understanding the situation, conducting root cause analysis, implementing corrective actions, implementing preventative actions, and applying the concept of plan-do-check-act, followed by record keeping.

In other words,

The best guidance for corrective and preventive actions.

Step 1: Understanding the situation

To effectively implement corrective or preventive actions, it is important first to understand why they were needed in the first place.

Food safety deviations can mean any of the following:
-Noncompliance with applicable regulations
-Incorrect processing methods or practices
-Improper packaging

– Food adulteration is a deviation from food quality that includes intentionally adding substances to make the food product appear, smell, taste, or feel better than they are.

Occasionally, deviations can arise from simple human error; however, if we take no action following initial detection, mistakes can snowball into much larger issues over time without anyone realizing it until it’s too late.

It’s key not only to identify where deviations occurred but also to understand why they occurred so we can take the appropriate steps next time as quickly as possible without causing more harm than good.

Step 2: Conduct Root Cause Analysis

Once the situation is fully understood, it’s time to begin an analysis of the root cause. This is a process where all possible causes of the deviation are looked into and eliminated until only one remains. After this point, corrective actions can be implemented as needed without further delay. Often identifying and eliminating root causes can be difficult, but it’s essential to prevent future occurrences from happening in the first place.

Find out the actual root cause analysis.

A deviation from the norm indicates something is wrong and should be examined to identify the cause. This process of examination, also known as root cause analysis, is critical to managing risk within your business.

The goal of exhaustive root cause analysis is not only to find the specific problem but also to understand how it could have occurred again in future instances. This difficult task can be made much easier with the help of root cause analysis tools. Understanding how each element works together creates a foundation on which corrective action can be swiftly undertaken if needed.

This blog will discuss two key root cause analysis methods: the 5 Why Methods and Fishbone Diagram.

5 Whys Method

5 Why is a useful approach because it allows you to quickly and easily identify the root cause of an issue. By asking questions such as “Why did this happen?” and “What could have caused this?”, you can quickly determine the source of an issue. This information can help you correct the problem before it becomes more serious or leads to a full-blown audit failure.

5 Why analysis is popular is because it’s simple to use and can be completed in a short amount of time. This approach will help you gather information from all levels of your organization — from top executives down to frontline employees — which will make the troubleshooting process easier overall.

The Fishbone Diagram

The Fishbone Diagram is another key root cause analysis method that uses a tree structure to identify causes and effects.

A fishbone diagram is a visual tool used to describe how causes lead to effects. It can be helpful when understanding why something happened or figuring out how best to address an issue. The following steps outline how to create and use a fishbone diagram:

1. Decide what you want to investigate. In this example, we’re exploring why our food safety processes are not followed

2. Identify the sources of potential problems (the “fishbones”). These could be anything that might be impacting our results, such as inadequate training, unclear training, lack of monitoring on our part, stubborn employees, or broken equipment. Typically, we will group them under different categories such as human, processes, equipment, training, etc.

3. Connect the bones by drawing lines between them (or using arrows if they are connected points). This will help you see where each source of the problem contributes and which areas need more attention.

4. Evaluate the results and make changes where necessary. For example, if we find that a common category that is causing problems, we will ensure we take correction, corrective and preventive actions.

By doing this, you can more easily find the source of the problem and make better decisions about how to fix it.

Step 3: Implement Corrective Actions

Once root cause analysis has been completed, it’s time to implement corrective actions. These could include anything from fixing faulty equipment or procedures to training employees on how they should properly do their jobs.

Corrective actions for food safety deviations may include one or more of the following:

1. Correcting procedures and protocols to ensure compliance with regulatory requirements. This could involve modifying your operations manual, developing new processes, training employees on those processes, etc.
2. Investigating and correcting your food safety management system (FSMS) errors. n FSMS should be designed to document food safety activities and must track all steps from purchasing goods to shipping products outbound to customers. It also needs to accurately reflect actual outcomes achieved by your organization’s policies and procedures related to food safety. Incorrect information in an FSMS could lead you down the wrong path when investigating potential violations.

3. Taking corrective action based on results of laboratory tests conducted as part of routine monitoring programs. A failed test might not necessarily indicate that there has been an adverse effect on product quality. Still, it does provide valuable evidence about areas where improvement is needed ­­ ie, testing methods need refinement or workflows need modification. Properly analyzing such data offers critical insights into how best to protect consumer health while maintaining production efficiency

Corrective actions must be taken as soon as possible so that everything returns back to normal quickly and without any further issues arising down the road.

Step 4: Implement Preventative Actions

In addition to implementing corrective actions when necessary, preventive measures also need to be taken into account when deviations occur so they have not become recurring problems over time.

This could involve anything from proper training, good hygiene practices, frequent monitoring, and regular testing of systems or processes up until actual incidents take place, et cetera.

Proper training helps employees understand their roles in fulfilling customer orders safely and correctly observing all sanitation requirements.

Good hygiene practices include cleaning work surfaces and properly washing hands before touching any food.

Frequent monitoring allows for early detection of deviations so we can take corrective action quickly to maintain product quality and protect customers.

By taking these steps beforehand, you  will have already identified potential problems before they become big

Step 5: Apply the concept of Plan-Do-Check-Act (PDCA) along with the CAPA process

Root cause analysis (RCA) is a management tool that can be used to identify the causes of problems and take corrective actions. RCA is often used in conjunction with PDCA, which stands for plan, do, check, act. The steps of RCA are: plan, determine what caused the problem or issue, do something to address the cause(s), and check whether the problem has been fixed.

Applying RCA to root cause analysis can help you find and fix underlying issues that may have led to a problem. By identifying the source of an issue early on, you can prevent it from becoming more serious. Additionally, by taking corrective action based on your findings during RCA, you can ensure that your systems are functioning as they should.

Step 6: Record Findings

You must ensure the process of the corrective and preventative actions is documented on the Corrective and Preventative Actions Report or Non-Conformance Report. For smaller deviations, you could also document the corrections in their original report.

Be sure to know where you have documented them. Remember, if you do not have the evidence, you did not correct the deviations.

As a food professional or business owner involved in day-to-day food safety management, you must understand how to properly conduct a root cause analysis and apply the right corrections, & corrective and preventative actions that would work for your team. You can prevent corrective or preventative actions from becoming temporary fixes by incorporating the Plan-Do-Check-Act cycle (PDCA cycle).

P/s: If you like to understand what deviation is, the differences between audit and inspection, the differences between audit deviation and inspection deviation, and how to correct audit deviation or how to prevent rejection of your audit corrective actions, check out our blog on Steps to Correct Audit Deviation.

You can also read more about how to apply the PDCA cycle in the food industry here.

Did you enjoy this guide for corrective and preventive actions or learn something new? Let me know in the comments.