Determining appropriate corrective actions

In any root cause investigation of a product or quality system nonconformance, the ability to determine the appropriate corrective actions can mean the difference between an effective CAPA that successfully addresses the issue and an ineffective CAPA that is doomed to be repeated. Too often, investigators, either in a rush to complete the investigation by its due date, or as a result of a lack of experience, may determine actions that are not appropriate in addressing the root cause of the nonconformance.

It is a given reality that root cause investigations must be completed in a timely manner and corrective and preventive actions must be implemented and verified in order to prevent recurrence of this event. However, compliance to the timeliness of an investigation and determining appropriate corrective actions do not have to be an “either / or” situation. It is possible to complete the investigation within the allotted time and identify appropriate corrective actions to prevent recurrence. Here’s how:

1- Develop an investigation plan at the onset of the investigation and ensure that each person with responsibilities are held accountable for meeting due dates. Why is this step important? Too often, investigations fail to meet its due date not due the complexity of the event, but rather, due to a lack of planning. Remember the old adage: “if you fail to plan, then you plan to fail.” This axiom holds true in the investigation world as well. The significance of an investigation plan is that it is a tool which aids in the tracking and planning of activities and it monitors actions toward completion. This visual aid, if you will, helps keep everyone on the same page and moving towards a unified goal.

2- Ensure that the action address the root cause of the nonconformance and not a symptom. This means that you must drill down to the core of the issue by brainstorming all probable causes and not simply stop at the first cause which “seems” most likely. Drilling down also means gathering input from other applicable SMEs or affected group members to ensure that brainstorming sessions are productive and that all possible scenarios have been evaluated.

3- Verify that the actions are effective in producing the anticipated outcome. On many occasions I have seen investigators come up with proposed actions that either do not address the root cause or are not executable for a variety of reasons. The act of verification may entail communicating with other impacted departments to determine whether the proposed solution may be implemented by the other group. I like to call this “a dry run”. The time to figure out whether an action will work is not during the roll out or implementation phase. A bit of pre-planning can spare you months of aggravation and possibly, another instance of a reportable nonconformance.