CAPA Plan Submission for Growers

Guidelines for the submission of a Corrective Action and Preventative Action (CAPA) Plan for Growers 

The MCA, Office of Laboratory Services (MCA-OLS) will track the following conditions and a licensee will be required to submit a CAPA if any of the four conditions are met: 

• An overall product testing passing rate of 85% or less for two consecutive months;  
• An overall average total of 80,000 CFU/g or greater for the month for Total Aerobic Microbial Counts (TAMC) and/or Total Yeast and Mold Counts (TYMC), excluding retest values and R&D testing; 
• A total of 10 or more batches (lots) failed for TAMC and/or TYMC for the month, excluding retest values and R&D testing; or 
• Two or more test failures for pesticides, mycotoxins, and heavy metals within a 60 day period. 

The MCA-OLS will notify a licensee if any of the four conditions are met. Then the licensee must submit to MCA-OLS a CAPA plan within 15 business days after the notification which includes the following details: 

• An investigation determining the root cause of the contamination;
• A detailed plan outlining steps to effectively reduce the high failure rate and/or CFU/g counts; 
• If applicable, updated and implemented standard operating procedures to ensure passing samples in the future; and 
  • In addition, the MCA may require a processor to: 
  • Conduct further investigation; and • Implement additional procedures to prevent future contamination. 

From the date the CAPA plan is approved, the MCA-OLS will monitor the licensee’s adherence and the effectiveness of the implemented CAPA plan for a period of six months. MCA-OLS will provide a report and letter regarding the effectiveness of the CAPA plan at the end of the six month period. 

Please direct any questions regarding this guidance to the MCA-OLS at [email protected].