Navigating Without a Map
An undefined or inconsistently employed CAPA system will result in a compliance gap that will be revealed during an inspection. Most CAPA 483s are due to either an inadequate process or inconsistent process adherence. More specifically:
- Failing to define escalation to CAPA
- Inadequate process or failing to follow the process
- Insufficient documentation
- Inadequately assessing effectiveness
Finding The Way
Establishing a CAPA system should start with understanding how the standards define CAPA.
Correction: An action to eliminate a detected nonconformity.
Corrective Action: An action to eliminate the cause of a detected nonconformity in order to prevent recurrence.
Preventative Action: An action to eliminate the cause of a potential nonconformity or other undesirable situation in order to prevent occurrence.
Some issues may actually result in a combination of actions but only corrective action and preventative action require an effectivity check. In this stage you must provide evidence that the issue was actually fixed and that the fix did not affect anything else.
One of the first steps must be to provide guidance on which nonconformances should be escalated to CAPA. In some cases, a company’s procedures may not define this and therefore the decision is left to the discretion of the user. This leads to too many issues finding their way into the CAPA system or too few never getting there at all. Too much traffic in the CAPA system bogs down the process and prevents issues that truly warrant a CAPA from expedient implementation.
A risk based approach can assist in removing subjectivity around the CAPA decision. Those issues that adversely impact the patient, the operator or the employee should be escalated to CAPA. The company may also consider the frequency of the issue in the overall assessment. Once you have decided to initiate CAPA, the record should contain the following basic elements:
- Clearly define the action taken. This should link back to the original problem statement noted in the nonconformance or the investigation. This helps to prevent scope creep. It can be very tempting to think that you can boil the ocean.
- The action should be aligned with the root cause. If you don’t address the correct issue, the CAPA may ultimately be ineffective.
- Create a plan and establish responsible parties to meet expected milestones. Gain agreement up front from all parties involved.
- Define the plan for the effectiveness check.
It should also be noted to periodically update the record to ensure adherence to the timeline and to assist in overcoming obstacles. You must consider the risk to product that any delays may cause. The FDA will be concerned if you take a long time to fix an issue. It implies that you are continuing to make and distribute potentially bad product. In the mean time, you must demonstrate that the issue was contained.
A Good GPS
Although some companies still have paper or rudimentary electronic systems, a dedicated quality event management system is the best bet. These tools provide defined templates to document records and provide easy access for data analysis and tracking and trending.
Whatever system is utilized, clear procedures, properly trained staff and a helpful tool will assist in arriving at the destination of compliance and safe and effective products.