The RCA roadmap borrows heavily from best practice methodologies for process development and characterization. It consists
of eight steps designed to identify the metrics for success, the sources of variation in the process, and their success remediation
steps, as follows:
1. Establish a project charter.
2. Understand the project scope.
3. Understand the process and product.
4. Understand the measurements.
5. Understand the performance.
6. Address the corrective action.
7. Monitor process stability.
8. Summarize the results.
The purpose of defining the project charter is to clearly establish the metrics for success for the project. We are often
simply told we have a failure or a problem and to fix it. Defining the specifics of the issue is essential to setting the
scope and direction of the investigation. Any structure may be used for this exercise, but the establishment of the charter
should be objective and include definitive metrics for the current process and the future desired metrics that would represent
a successful RCA exercise. If a product is failing or trending out of specification on stability, then a summary of the historical
performance of the product should be a starting point for comparison. The charter also should establish the priority for resolving
the RCA exercise. If there are regulatory, safety, or business implications driving the RCA, then a sponsor for the exercise
will be essential to gain the right organizational support for the investigation. Clearly identifying this individual and
gaining his or her buy-in for the effort is critical to a successful RCA. The project charter also focuses the team on the
primary goals and scope of the project and milestones for completion. Another measure of value may be to analyze the cost
of poor quality, both internal and external to the company. Understanding the cost exposure of dealing with deviations, failures,
and recalls contributes to the urgency and priority that should be assigned to the RCA in the organization.
Setting the project scope is a critical activity during the chartering process. RCA exercises too often get derailed by issues
that are not related to the fundamental problem or event. For example, if a tablet is failing potency on stability because
of the presence of escalating degradation products, do not worry about the content uniformity or tablet breakage issues that
production may be struggling with. Although there could be a relationship between these characteristics, it is better to let
the investigation and the data drive the conclusion rather than pursue all paths simultaneously.
Process and Product Understanding
Before any RCA exercise can begin, the investigating individual or team must have a baseline understanding of the process
or product and the steps and variables involved in the process. Although there is no absolute set of tools to use for this
exercise, a successful sequence for establishing process understanding is shown in Table 1.
Table 1. A successful sequence for establishing process understanding
Based on these analyses, a clear list of what we do and do not know should now be apparent. This should drive activity to
address the missing information. A fundamental truth for RCA activities is that we cannot effectively implement a corrective
action if we do not understand the drivers of variation in the process.