Mastering CAPA for QA Managers Webinar

It’s important that you are able to identify control and it is the non-conformances, the corrective actions, and the preventive actions that are one of the crucial mechanisms of showing that you do have control over your program.

Finding Non-conformances

Finding non-nonconformance’s is very important to your business. Auditors don’t want to hear, “we don’t have non-conformances, we don’t write those things down, and nothing bad happens around here”. That doesn’t tell people that you’re doing a perfect job. That suggests that you don’t have control over your program. Every facility has something that is not right and a non-conformance needs to be written down. When we see non-conformances and corrective actions and preventive actions that is a good thing.

Differences Between a Correction and a Corrective Action

Correction

In our first example we look at a pre-operative inspection form and multiple types of non-conformances. If in pre-op I’ve observed that a table is not clean, I can write my correction directly into this form. If we re-clean the table and test it with ATP swabs and it passes, then it doesn’t necessarily mean that I need to do a corrective action or preventive action in this circumstance. If we saw it at pre-op we were able to take care of it before production started. If this was an event that maybe happened one time or the first time it’s ever happened, that is a correction we can live with.

Corrective Action

If it’s going to be something where this is a recurring issue then just having a correction every time it happens may not be acceptable. For example, if an employee was observed putting on a smock from his locker and that smock had stains on it and the employee could not identify when the smock was last cleaned that’s going to need quite a bit more investigation and here is where we have a non-conformance report. I’ve linked the pre-op inspection where I saw the problem to this non-conformance report with more detail and what I put in this description is to say that the employee has done this before.

We need to think through what the corrective action and preventive action is going to be because in this instance where I have an employee that is doing something they’re not supposed to do and it is a major food safety violation I would like to talk about what discipline looks like as far as far as a corrective action and in this instance I selected this scenario specifically to bring in how do we make a decision about disciplining an employee and how that fits into this larger corrective action.

As a corrective action we can retrain the employee, however I specifically mentioned in my description this was not the first time this has happened. This is a huge issue for us because not only is it a direct food safety violation but I’m concerned about the other employees what are they seeing and what does it mean to me as a QA manager am I being undermined for for these kinds of food safety issues and as we all know if you’ve interacted with employees who are not following the rules how they behave to a supervisor and what they do after the supervisor leaves is often very different. It is very dangerous to just say hey I’m going to retrain and we’ll call we’ll let bygones be bygones.

Disciplinary Actions and Corrective Action & Preventive Action (CAPA)

PrimusGFS is the one GFSI program that mandates that there are disciplinary actions. The other GFSI programs do not require disciplinary actions for corrective actions, including FSSC 22000, BRCGS, and SQF.The FDA doesn’t say you need to fire someone , however, if you choose to make that a corrective action or a preventive action that’sabout the most severe corrective action & preventive action (CAPA) you could do.

In the example with the employee putting on a dirty smock from his locker we could say the immediate correction was to place the smock in a dirty bin and to collect ATP allergen samples. In a couple of days, we have to go back and look at the ATP results. If you run products in the facility with and without allergens, then we would have to place the product on hold to ensure there was no cross contamination until the results of the ATP tests have come back. In this case you may choose to give the employee a written warning for not following your hygiene and PPE requirements.

In this example you can state for the preventive action that you are going to start doing locker checks every day for a week or a month. If we find no deviations we can come back off of that and reduce it so that in combination with scheduled training, that can be considered the corrective action and preventive action for this incident.

Documenting Corrective Action & Preventive Action (CAPA)

Our properly documented corrective action and non-conformance is something we should be proud of because we found
it and the fact that we found it at pre-op is a point of pride for us. It’s something we want to demonstrate we want to show.
We are going to put the pre-operative inspection and that non-conformance together along with the written notice to the employee. That’s all going to go together.

Be ready to present to an auditor the documentation of the non-conformance that includes:

• How it was found
• What you did about it immediately
• What the correction was shortly thereafter
• What the preventive steps are for the future

Corrective Action for Customer Complaints With Recall Considerations

Most facilities get customer complaints and do something about them. Even facilities that generally lag behind on writing down non-conformances, often address customer complaints. In this example, we want to talk about what it means when a customer complains and how we address this.

If you have a customer complaint form and you’re going to use a non-conformance report and you’re going to do a corrective action, then you’re going to have a bunch of documents. If you have a stream of documents that are together there really isn’t a right or wrong way to do this. Any time that you write down what happened and it is an official statement from the person who’s supposed to do it you do have a written observance of a non-conformance. If you describe what you did about it as a correction, corrective action, or preventive action, then we have the basis of what we need for this program.

In our example we have a customer complaint of pie that was shipped out and mislabeled. The fact that I have a customer complaint form and a non-conformance report is money-in-the-bank for presentation to an inspector or to an auditor. It is most important to create a written narrative of what happened.

In this example we have apple pie shipped to a customer and it has pecan pie labels. If you’ve shipped apple pie and it says pecan pie, then depending on how it’s discovered and when it’s discovered, if you’re in the United States, the Food and Drug Administration (FDA) or the state that you’re in may want a phone call about it. That potentially would be a recall situation.

In this scenario, you do have an allergen mislabel. Now, if you make that discovery before the product leaves the truck
and that truck comes right back, then it is possible the argument can be made to the government that this was not yet a recall situation.

If it was something that was discovered days later, then you are going to have to consider issuing a recall.

If people bought this pie, then you need to issue a full recall and you would need to make an announcement. In this example it was not brought off the truck and you realized the mistake quickly, the pies were brought back, and they were relabeled.

The corrective action here is relabeling of the pies. Now that you’ve relabeled the pies, they are now correct and that’s good, but you need to investigate what you need to do to prevent this from happening again. You are going to have to increase the frequency of label checks on the line and do a final check off.

If you are in a facility in which mislabeling has happened more than once then we’re going to have to start thinking about things about different colored labels, who gets to print and control labels when they are brought to the line, and what the line is between a
corrective action and preventive action.

For more free training on Corrective Action and Preventive Action (CAPA), watch our seven-episode CAPA series and download the free resources.

If you have questions & need customized food safety or quality management system support please contact us at: INFO@KELLERMANCONSULTING.COM or call (800) 535-1376.