Tips for Implementing a Root Cause Failure Analysis Program
October 1st, 2018 // 12:27 am @ jmpickett
Implementing a root cause failure analysis program at a pharmaceutical facility can be challenging, especially when failures do not affect the quality of the product. Including failures that are not related to quality in your root cause failure analysis program can bring much value to a drug company. There are three major factors for your program’s success:
- Having a very well defined process that offers a strong foundation and framework.
- Aligning your root cause failure analysis program with your current quality investigation processes to make it easier for the program to be introduced, and reduce resources needed.
- Communicate the RCFA program’s value to top leadership in the company.
It is recommended to implement the following six-step process in your root cause failure analysis program:
- Notification: This is a pre-determined collection of triggers that starts the RCFA investigation when there is a failure event that leads to a loss in the drug facility. Your RCFA program may investigate many types of major events. Most common events are related to equipment failures.
- Clarification: Collect the information that is needed to do an analysis of failures. When an RCFA is started, the facilitator should be assigned rapidly to collect evidence or information and data that is related to the event before the evidence is no longer apparent.
- Analysis: The team should use their tools for problem-solving to determine what the root causes are. Some investigations for will involve more complex root cause failure analysis than others. A fishbone analysis can be important for a simple failure, but a fault tree could be better for a more complex event. The tools used in a root cause analysis are like those that are used for a quality investigation.
- Corrective action evaluation: Your team will determine corrective actions for each root cause that is identified, and then determine if they are financially feasible. You should do a cost-benefit analysis to decide which corrective actions will give the most value to your company.
- Verification: Ensures that the company’s corrective actions are done properly, and validates the correction actions are implemented effectively. Before the program is implemented, corrective actions and analysis should be shown to a body in the company that can do both a critique and analysis of the program. This team should consist of senior leaders in the company, technical managers, and other relevant employees.
- Documentation: Final reporting of the results, document storage, communicating results of the program. Every investigation should have a final report. Aligning the style of the program with a current report style from your quality investigations will help your firm to have a common language for investigation.
Setting up a good process to look into nonquality problems at a drug site can be challenging because of the priorities that are given to FDA and other regulatory compliance issues that lead to FDA 483s and FDA warning letters. But you can reduce your risk, avoid expensive failures and boost manufacturing production by starting a root cause analysis program to investigate failures that are unrelated to quality.
