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.