Establishing a Root Cause Failure Analysis Program at a Pharma Facility

Corrective actions are implemented to reduce future failures, but resources aren’t allocated to identify the root cause on a significant failure; This gap creates the opportunity to implement a RCFA program.

By Anil Agrawalla, CMRP, Life Cycle Engineering

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Your clean steam generator system stops and alarms. Production halts; operations quickly calls maintenance. Maintenance jumps into action and determines that the bearing seized in the feed water pump. A bearing order is expedited through procurement, maintenance efficiently makes the repair the next morning, and the production team runs tests before putting the system back into operation. Corrective actions are created to ensure that the bearing is stocked in the MRO storeroom, and to double frequency of the pump’s preventive maintenance. The senior leadership team is satisfied with the response and corrective actions, and praises the team for limiting the production delay to just 24 hours.

Does this scenario sound familiar? A critical piece of equipment fails and the facility scrambles to get the system back to operation. Corrective actions are implemented to reduce future failures, but are done without asking why the equipment failure occurred. Resources aren’t allocated to identify the root cause on a significant failure like this, yet resources are dedicated to other issues that don’t seem as important to the business. This gap creates the opportunity to implement a Root Cause Failure Analysis (RCFA) program.

Implementing an RCFA program at a pharmaceutical manufacturing site can be a large undertaking, especially for failures that don’t affect product quality. Site resources and priority are given to investigations for quality-related issues due to the strict nature of FDA and regulatory requirements for issues that can impact a patient’s health. Non-quality-related investigations can significantly impact business but often don’t get the same scrutiny as quality investigations. 

Including non-quality-related failures in a well-planned RCFA program can bring substantial value to the company. Three factors are key to program success when implementing an RCFA program in a pharmaceutical environment:

  • Having a well-defined process that provides a strong foundation / framework
  • Aligning the RCFA program with the existing quality investigation process to help ease the introduction to the site and reduce the resources required for implementation
  • Communicating the program value to senior leadership and the rest of the site to achieve site-wide adoption and ensure persistency.

A six-step RCFA process will provide the needed framework. Alignment with the existing quality investigations occur within each step. 

The notification step is a pre-defined set of triggers that initiate an RCFA investigation whenever a failure event results in significant loss to the facility. As a general note, an RCFA program can investigate any type of significant event. For the scope of this program, events are intended for equipment-related failures. Although the initial failure symptoms experienced are equipment-related, these failures may end up having root causes that are not directly attributed to the equipment.

The triggers used to initiate an RCFA investigation should encompass all aspects of the business including major safety incidents, environmental violations, product quality issues, high maintenance costs, and production downtime events. The triggers should look for single, significant failure events as well as smaller, repetitive failures that occur frequently. Though a single, smaller failure would normally not be investigated, the chronic and repetitive nature can lead to a significant cumulative cost to the company. The type of trigger and its trigger level need to be customized for each company. The triggers should be set so that the cost of the root cause investigation is less than the business cost experienced by the company.

The Quality, Safety, and Environmental departments may already have their own investigation triggers for failure events that have a quality or safety effect. Since the process, tools used, and goals of those investigations are similar to ones used in an RCFA program, a separate analysis is generally not needed. A maintenance or reliability employee trained in the site’s RCFA program should join the existing investigation process to help with identifying and mitigating the root causes. High maintenance repair costs and production downtime can have a significant financial impact, so both of these can be triggers for an investigation. Triggers for chronic events can include repetitive causes that are trended in the CMMS’s failure coding, or excessive stoppages noticed on the production floor during production runs. 

A process map of the Notification step, shown in the figure below, displays an example set of triggers. As the figure shows, there is a clear definition and level for each trigger, which reduces the ambiguity of when an RCFA should be triggered. The success factor for this first step of the RCFA program is to ensure that the rest of the facility is aware of the RCFA program and its triggers. All employees, from operators to directors, are responsible for identifying equipment failures that trigger an RCFA investigation and notifying the RCFA process owner.

A process map of the Notification step

Clarification entails the gathering of information necessary to analyze the failure events. Once an RCFA is triggered, an RCFA facilitator should be quickly assigned to gather any evidence or data related to the triggered event before the evidence disappears. The evidence can range from physical parts, data logs, manufacturing batch records, or interviews from employees involved in the event. It is critical for the RCFA facilitator to be skilled in investigation techniques, particularly those involving interviewing personnel. The facilitator should be able to gather factual event information without alienating the interviewees. These techniques are often taught through the Quality department for quality investigations, and can be utilized to train the RCFA facilitator.

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  • Great article, which of the six steps do you think have the biggest barrier to success? It seems that most management wants to close the issue and move on before implementing full RCFA. How do you take an organization that is barely winning (.502) and turning them into a champ?


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