The difference between effective and ineffective quality event management systems often comes down to knowing whether to implement corrective and preventive actions (CAPA).
Any company that launches a CAPA for every quality issue that occurs, regardless of the magnitude of the impact, will quickly find its quality event management system inundated with paperwork and without the resources to adequately respond. If data from each quality event — such as inputs from customer complaints, nonconformity reports, management reviews, audit findings, out of specifications (OOS), deviations and so forth — is deemed to be worthy of a CAPA, “death by CAPA” inevitably occurs.
Ken Peterson, a widely regarded expert consultant who specializes in CAPA, risk assessment and quality event management systems, has made it his life’s mission to help companies avoid death by CAPA. For decades he has lent his quality event management expertise to a long list of successful global companies like Pfizer, Abbott Laboratories, Kodak, IBM and leading quality event management software provider MasterControl.
Peterson outlines the best practices for quality event management systems that he’s refined over decades in a free three-part webinar series sponsored by MasterControl. In the first installment of the series, Peterson offers useful five risk assessment guidelines that can help companies navigate the handling of quality events.
5 Quality Event Management Tips
- Assess each issue for impact and frequency.
- In each assessment, be specific in examining the “Five W’s” (“What,” “Where,” “When,” “Weight,” and “Who”) that pertain to the issue in question.
- Give each issue an impact and frequency score (i.e., negligible, minor, important or critical impact and rare, frequent or occasional occurrence). To be effective, a quality event management system needs a viable entry point, or “risk gateway,” in order to prevent death by CAPA. Impact and frequency are the two main factors that should determine access to this gateway.
- Based on impact and frequency scoring, determine which issues should be input to the CAPA system.
- Register conclusively pertinent issues into the CAPA system.
Using the Five W technique, organizations can gauge the magnitude and specifics of quality events in order to better resolve them. A quality event management system’s reliability in leading to resolutions, according to Peterson, hinges upon its users’ ability to ask and answer the right questions. Adequately answering each of the Five W questions will streamline the organization’s process of getting to the heart of troublesome issues and determining the risks those problems pose.
The Criticality of Analyzing Cause
Peterson stresses the importance of using cause analysis when investigating quality events. Determining a root cause entails asking key questions such as:
- Is the problem with a process or piece of equipment?
- Is it an issue with products or services?
- Could the quality event management system itself be at fault?
These types of questions should provoke further investigation. If the problem appears to be of unknown origin, a tangible cause must be determined.
Knowing When to Make the Right Choice
Choosing the wrong process — or even the right process at the wrong time — can cause further and more severe problems down the road, according to Peterson. In the webinar series, he goes into detail about the following problem-solving methods and explains how there are pros and cons to each, depending on the situation:
- Trial and error.
- Relying on experts and experience.
- Comparative analysis (i.e., what is known about the problem and what the problem definitively is not).
After the appropriate problem-solving technique has been identified and applied to the quality issue at hand, Peterson recommends that organizations pursue the following five sequential steps to investigate cause — if possible, by leveraging a robust quality event management software solution:
- Problem: First, establish a concise problem statement.
- Investigate: Determine the “is” information (i.e., what the exact problem is and is not).
- Compare: Experiment with comparative analysis to explore other similar or related areas where the problem could be occurring but is not.
- Clues: Collect and analyze the clues that have been gathered through the comparative analysis to form hypotheses about what might be causing the problem.
- Cause: Apply critical thinking to determine the likely causes that are suggested by the clues.
Once you think the most likely cause of the problem has been identified, Peterson warns, it must match up with the data in your quality event management system to be considered the true root cause. If the presumed cause you’ve identified doesn’t explain the data, it can’t be correct and the investigation must continue.
Learn More About Quality Event Management Systems
This is just a broad overview of the in-depth observations about effective quality event management systems that are shared in the three webinars. You can start learning more about investigations into the causes of your quality events and discover new methods for improving quality event management systems by viewing the first webinar in the series here.
James Jardine is a marketing content writer at MasterControl, Inc., a leading provider of cloud-based quality and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
Originally published at https://www.mastercontrol.com.