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.

Four Simple Steps

In my last blog I discussed the importance of drilling down to the root cause in any nonconformance investigation and how to distinguish between a root cause and a contributing cause. In today’s blog, I will discuss four simple phases in the investigation process to follow once you have identified your root cause that will ensure a thorough investigation and effective corrective and preventive actions.

1. Plan
Once the root cause of the nonconformance has been identified via a thorough investigation, a plan must be identified that will effectively eliminate the root cause for this event. This plan must take into account all of the outcomes from the investigation; i.e., “what broke down?” or “what failed to occur?” The plan must evaluate each of the areas of noncompliance and with input from appropriate subject matter experts, identify a strategy by which each of the identified deficiencies will be remediated.

2. Verify / Validate
Once the plan has been developed, it must be verified / validated to ensure that the action(s) as identified will in fact correct the issue. This step is essential because it provides you with critical information early in the process that will alert you of potential gaps/flaws in your proposed plan. This may include gaps related to lack of resources, ambiguous interpretation / wording, or unrealistic expectations, to name a few. This early notification step allows you to make necessary modifications to a proposed plan that may not be executable as initially projected.

3. Implement
Once the plan has been finalized and approved, the actions have been verified / validated, it is now time to implement the changes. With implementation comes proper documentation to ensure that all affected parties have been appropriately notified, the necessary trainings have occurred, and there is evidence to show that the training is effective.

4. Monitor
This final phase of the process is not only a critical one but also one that is often overlooked by many well meaning quality investigators. The monitoring phase is important because it allows you to see (in real time) how effective your actions have been. Many people falsely conclude that because an activity/ action have been “validated” then it must be effective. This is clearly not the case. Validation is simply “confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled.” Unfortunately, once that validated activity enters the production environment, deviations may occur resulting in the reporting of a nonconformance.

Investigating Cause – Drilling down to the root cause

In any nonconformance investigation, identifying the root cause is an integral part of the process. Identifying the root cause enables one to:

*Implement effective corrective actions
*Accurately trend data for process monitoring
*Implement effective preventive actions
* Develop effective strategies for continuous improvement

With so many different benefits of identifying the root cause of a nonconformance, it is imperative that the investigator does his/her due diligence to ensure that appropriate measures are taken.

One of the biggest challenges that various pharmaceutical / medical device companies face is that oftentimes, investigations stop at the first, immediate cause and fails to drill down further to address the systemic underlying cause(s). Or, their investigation may identify several contributing causes but fails to identify the root cause of a nonconformance. How can you tell the difference between a contributing cause and a root cause? Experience, Experience, Experience!

Experience is a critical factor in any comprehensive root cause investigation of an identified nonconformance. The key to differentiating between a contributing cause and a root cause lies with:

1. Experienced Investigators—they are an integral part of the process in that they are able to bring rational, sound judgment to the table. They have intimate knowledge of what works, what does not work and what requires improvement. They are not prone to “shoot at the hip” and stop the investigation after they have answered the first “why” an event occurred.

2. Experienced Mentors—coupled with an experienced investigator, experienced mentors are crucial in bringing unbiased, thorough, and systematic approach to a nonconformance investigation. They help the experienced investigator drill down even further into their process and to identify potential gaps and areas for process improvement.

3. Experienced Quality Oversight—The Quality dept. must give final approval of any nonconformance investigation and this individual must possess the necessary education, knowledge and experience in order to effectively carry out this quality function. Quality is the final reviewer of the investigation and as such, an experienced Quality reviewer will bring to the table a fresh viewpoint that ensures the comprehensiveness of the investigation.