Is your food or beverage manufacturer ready for new federal regulations that can bring added scrutiny to your corrective and preventative action (CAPA) system?
If not, your company could face increased Food and Drug Administration (FDA) scrutiny, including an FDA violation and additional inspections. The reason is a new rule as part of the Food Safety Modernization Act, which gives the FDA broader inspection powers. Companies the FDA deems as “high risk” can be subject to FDA inspection once in the next five years and then at least every three years thereafter.
Does your CAPA plan address FSMA regulations? The answer, as seen in the recent post, “The food manufacturer’s strategic guide to technology,” may mean making smart decisions about software tools for operations.
Let’s take a closer look at some best practices to use in your CAPA plan and what FDA inspectors are looking for to determine FSMA compliance.
Your CAPA plan provides an opportunity to identify and recommend solutions to potential problems. When an incident occurs, the CAPA provides the detailed solution and the steps necessary to implement. It’s a road map for companies to ensure consistent remediation and compliance with FSMA regulations.
The basic components of a robust CAPA plan include:
- Identification of the problem. The root problem needs to be clearly identified and articulated.
- Evaluation and review. It’s necessary to determine the scope of the problem, the implications of the problem for consumers and suppliers, and the severity of the consequences of the problem.
- Investigation. A plan to research the problem and its causes is paramount.
- Analysis. All potential causes of the problem should be explored. It is recommended that several different methodologies are used to ensure thorough analysis.
- Action plan. The list of probable causes is developed.
- Implementation. The action plan is put into motion.
- Review. Verify the mitigation was done properly and review the entire incident and CAPA process.
CAPA documentation and the FDA
Many food and beverage companies are still using word processing and spreadsheet programs to track their CAPA compliance. With the implementation of the FSMA, the FDA is looking for companies to have integrated, digital solutions that are less apt to have errors and inconsistent data.
FDA inspectors are expected to look at these 10 steps when conducting a CAPA assessment:
- Procedure definitions and documentation. Inspectors are expected to check that management has detailed definitions and interpretation of key phrases, such as “nonconforming product,” “prevention,” “timely” and “correction.”
- Consistent information collection and review. Customer complaints, returned products, quality records and audits, installation reports and litigation must all be cataloged.
- Data usage. FDA staff will look at your trending data, corrective actions, acceptance work and quality systems documentation to ensure you are interpreting data correctly.
- Data entry accuracy. Inspectors will spot check data sources to ensure accuracy, thoroughness, and timeliness.
- Data analysis. This assessment examines whether statistical and non-statistical methods are being used to identify recurring issues.
- Investigation procedures. Inspectors can ask about the procedures used to investigate an incident followed by a review of the records to determine if they match your description.
- Double-checking. Inspectors will look at corrective actions taken to determine if more could have been done.
- Verify documentation. Corrective actions will be spot-checked to ensure actions are documented correctly.
- Validation of actions. Your past actions will be assessed to determine their efficacy.
- Management roles. Inspectors will check to make sure problems and corrective actions are communicated properly to appropriate managers.
To ensure proper FSMA compliance and better communication and data integration, many food and beverage makers deploy an enterprise resource planning (ERP) solution. An ERP solution integrates key functions – finance, sales, management, operations, and distribution – to help companies make better decisions faster.
At NexTec, we help food and beverage makers find the ERP solution that fits their enterprise. We work with partners like Sage X3 to implement solutions that transform companies.
Sage X3 is a powerful ERP that integrates and automates. With NexTec add-ons designed specifically for the Sage X3 platform, companies can have an automated CAPA solution. Inspections no longer take days of prep time with the commitment of many resources. Instead, automated CAPA functionality means documentation can be generated in minutes.
To learn more about the power of Sage X3 and the role of an ERP in CAPA compliance, download our infographic – Don’t think CAPA is important? The FDA does.