Continuous improvement is a requirement of SQF and all food safety quality management systems. When demonstrating process improvements, the CAPA process is followed. This is a diagnostic procedure aimed at identifying the root cause(s) of system non-conformities. The objective of a CAPA investigation is the development and implementation of an action plan designed to prevent problem recurrence or future non-conformities. Below are tips on improving your CAPA procedures.
Follow a formal process to conduct CAPA
Scheduling a formal team meeting is the best approach to conducting proper CAPA investigations. A cross-functional team should follow a specific method (Fish bone diagram or 5 Why’s) to ensure that all root causes are identified. It is critical to collect the right data and make the right observations to perform the investigation.
Make your CAPA process time-sensitive
A sense of urgency is important when addressing non-conformities. If left uncorrected, process deviations may lead to increased food safety or quality risks. It is good practice to adopt a similar corrective action timeline to the one prescribed during third-party audits. Under SQF, 30 days is the allowable timeline for the correction of minor and major non-conformances. Should the corrective action plan implementation take longer than 30 days, an extension may be granted with justification (e.g., capital investments). In the interim, a suitable corrective action must be implemented to correct deviations.
The importance of data trending to determine the root cause of a problem
The review of system non-conformities, such as CCP or equipment failures, pest-sighting trends and other GMP-related non-conformities, must be considered when performing Root Cause Analysis (RCA). The review of valid data trends (over 3 or 6 months) can pinpoint potential isolated problems or systemic issues. Trending can provide insights as to when a process changed and started to deviate from requirements.
Provide adequate CAPA training
The team should be familiar with the CAPA process and tools. While formal training is not required, it is good to provide initial training and annual refreshers to the CAPA team. The process will be more robust if the team leader receives formal training and applies her/his new knowledge. Examples of formal CAPA training courses can be found at these links:
Visual CAPA tools may be used by the team to guide the RCA. A fishbone diagram, also called a cause and effect diagram or Ishikawa diagram, is such a tool. While helpful, it must be used properly. The 6 sources of process variations are just a starting point and should not be considered actual root causes. Failure to dig deeper will result in identifying the symptoms of a problem rather than the real reasons for the process deviation.
Understanding the types of actions under CAPA: corrections and corrective actions
Applying a fix (a correction) doesn’t always resolve the underlying cause of a problem. Corrective actions, on the other hand, are designed to prevent problem recurrence and target the right root cause(s). For instance, if a food-contact surface is found to be contaminated with a food-grade lubricant, a correction may be to clean the surface. A CAPA investigation may identify potential root causes: an employee may have over-greased the equipment or the equipment design may be responsible for the oil spill. When the correct root cause is identified and validated, the corrective action leads to the disappearance of the issue. In this case, employees may be instructed to follow a procedure when greasing machines. Alternatively, a change to the equipment design may solve the problem permanently.
When to use Preventive Actions
Preventive Actions are used when the food safety or quality management system is mature. In this context, employees have mastered processes and are no longer reactive. CAPA becomes a pro-active way of preventing future non-conformities. A means to determining if preventive actions should be implemented is to review process trends and recognize “near-misses”. When trained employees identify a situation where product or food contact surfaces could have been compromised, a preventive action can be determined using the Root Cause Analysis (RCA) process.
Ensure corrective actions are implemented
It is essential to verify that the corrective actions have been implemented successfully and according to plan. This is achieved by reviewing trends over a reasonable period of time (3 months) after corrective actions are implemented. The corrective action files are reviewed for completeness. The review ensures that all corrective actions have been implemented and that the fix didn’t create a new problem. The non-conformity has been addressed and the system operates within acceptable limits.
Reference: QP Quality Progress Magazine, September 2018