By Abbie Llanes
You have just been audited, by a customer or by a third-party, and are now facing a Corrective Action Request (CAR). What is a Corrective Action Request? What do you do? Your first instinct should be to ask why.
Why?
Exactly!
When you understand what caused the problems, you can create long-term solutions to prevent them from happening again or negatively impacting other processes. Why—again—is this important? The bottom line is that every business is run on revenue, margins and overall profitability. Top management meetings are inundated by numbers. Certainly, your work is important on many levels, but underlying every other aspect of your work is your responsibility to help improve food safety and quality. A simple mistake means time and money is spent to rework or destroy product. CAPA (Corrective action and Preventive Actions) derived from 5 Whys or fishbone are tools that can be used to address a systemic issue, control processes, and ultimately help prevent a costly food safety or quality incident.
So, what should you do after you clearly defined why this corrective action was issued?
Investigate
Find out what caused the problem. Not just what happened, but what started the problem. In order to find the right solution, you must first identify the root cause of the issue.
The 5 Whys Method
The 5 Whys, a root cause analysis method, is just one tool that can be used to better understand the root cause of a problem. In this method, you ask “why” as many times as you can until the root cause is determined—not necessarily just five times.
The Fishbone Method
Another simple root cause analysis tool is called the Fishbone (Ishikawa) Diagram. In this methodology, factors are broken into categories. This is also known as the 6M: Manpower, Method, Machine, Materials, Measurements, and Mother Nature. These are commonly-used categories for manufacturing environments, and each likely cause is assigned to the appropriate category.
Manpower
To determine the root cause, start an investigation that includes the people involved in the process. Interview them, discuss the process together, and let them help you understand what may have led to the issue in the first place. It’s critical that the focus be on gaps in processes and systems, rather than individuals, as a problem is seldom isolated to an individual. Focusing on the individual also puts them on the defensive. If the lines of communication are not as open as we would like them to be, the employees are less likely to discuss what they need or why they do the things that they do for a procedure.
Method
Next look at the standard operating procedure and verify that what you say is indeed what you do. Variation, inconsistency or discrepancy in systems and practices play a very important role in the outcome of the process, as do the practices of employees who are directly involved in executing the technical aspects of the job. Resources are important to consider as well; if your team members are not provided with what’s needed to do their job properly, they will find ways to improvise.
The company values set by the leaders of the organization in terms of food safety and quality can also greatly influence the decision-making process of your team. We must ask our team to answer this: Is it more important to make product on time, which may need to be re-worked; or is it more important to make good product the first time around? To be fair this is a challenging question to grapple with. There are often internal pressures, such as the production department’s demand to meet the daily quota in accordance with the shipping schedule. These pressures can result in higher prices if output is given higher priority than food safety and quality. It won’t matter that you were able to meet your production schedule, if the product does not meet defined food safety and quality specifications, and ultimately customer expectations.
Machine, Materials, Measurements, and Mother Nature
The rest of the categories laid out in the fishbone format relate to issues other than personnel activities such as equipment, materials, product specifications, and the environment. Even the different seasons and changes in weather can play a role in how agricultural raw materials may impact process. The equipment used to measure product specifications can prove to be out of calibration and incorrect readings at times. That’s why it’s so important to calibrate at least annually by a third party and verify measuring devices daily or at frequencies deemed appropriate for product specifications. A lot of these things can go back to policies laid out in the prerequisite programs set in place by the facility. The development of PRPs (prerequisite programs) and effective execution of those program can a play a pivotal role.
The items noted above are just a few examples of what to look for when conducting your own investigation for determining root cause and developing corrective actions to prevent it from reoccurring.
After Root Cause – Fixing the Problem
Once a root cause is identified, make sure you find a solution that thoroughly addresses the issue. If you don’t, it is very possible the problem will happen again. CAPA investigators frequently identify non-conformity as a root cause, thus leading to develop an ineffective solution.
Example
Let’s say that there’s a specific area of the facility where you frequently find trash on the floor. The non-conformity is that the trash on the floor may pose a risk for pest harborage and provide unhygienic conditions for the facility that can lead to product cross contamination. If the ‘fix’ that the company applied was to train people to pick up the trash and dispose of it in a different location, and this non-conformity still continues to occur, then the solution did not permanently address the problem. It may have been just a correction.
The corrective action in this simple scenario may be to place an appropriate trash receptacle in this location or in the close proximity, assign responsible personnel as when to remove the trash and verify during the pre-op and throughout the day. It is important to know the difference between a correction and a corrective action, that way your CAPA responses will be more likely to be effective, and less likely to reoccur.
Final Thoughts
In developing CAPAs, there are two important things to document:
- Provide a summary of the root cause of the problem. The summary must identify the main cause(s) of the problem and should also lead to corrective actions which will prevent the problem from happening again.
- Provide evidence of the solution. Justify that the solution works by documenting pictures, revised documents or records, training records, etc. It is not only important to find the cause of the issue but to also prove that your team efficiently implemented a solution to prevent the non-conformance from recurring.
