Integrating Risk Management as an Effective Approach to Root Cause Analysis - Optimize time and cost of product development by managing risk. - BioPharm International


Integrating Risk Management as an Effective Approach to Root Cause Analysis
Optimize time and cost of product development by managing risk.

BioPharm International
Volume 22, Issue 1


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.

Project Charter

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.

Project Scope

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

Table 1. A successful sequence for establishing process 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.

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.

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