How does your lab view nonconforming work? The attitudes toward nonconforming work can vary depending on the lab’s environment, regulatory standards, and culture. Nonconforming work can be a driving force for progress and lead to exciting developments in your laboratory. No lab framework is perfect and having a robust system to address nonconforming work can drive your lab to excellence with continuous improvement.
Providing a safe environment for identifying non-conforming work, implementing an easy-to-use system for logging nonconformities, and having a well-defined CAPA process can significantly enhance your laboratory's quality system and drive its success.
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Recently, I've implemented a practice where I ask my team to log any deviations from expectations in our nonconformance log whenever they occur. This is a log with a running tally of what nonconforming work has occurred. It tracks the date, who identified it, what this issue was, the immediate fix, and a quick risk assessment identifier. This process has become a norm in our lab culture and has increased our capability to trend issues, be proactive, and improve our systems.
Nonconforming work is going to occur in labs. Maintaining a calm and composed attitude will help you as a leader to proactively address issues and focus on driving continuous improvement throughout the process.
Before we dive into the implementation details, let’s clarify some key terminology:
Nonconforming (NC) work: This refers to any work that does not meet the standards of the lab's quality system.
Corrective action (CA): This is a response to address and rectify NC work.
Preventive action (PA): This is a proactive measure taken to prevent NC work from occurring in the future.
To effectively implement this process into your operation, you should focus on four key areas: user-friendly tools, clearly defined risk assessments, collaborative root cause analysis, and ongoing monitoring and reevaluation.
User-friendly tools
Develop a user-friendly log to capture NC work in real time. The simpler it is to use, the more likely your team will consistently use it. While there are specialized programs for managing NC work and corrective actions, our lab uses an Excel log. If you have shared file storage like SharePoint, provide a link on the main page. The easier it is to access, the more likely your team will keep it updated.
Along with a real-time log, using a well-defined CAPA response template helps the team address and resolve issues more efficiently. I designed a user-friendly template using fillable forms and SharePoint to streamline and monitor the progress of CAPA. This fillable form contains areas that document: immediate fix, root causes analysis, potential corrective actions, implemented corrective actions, monitoring, and follow-up review. With SharePoint, you can receive automatic notifications for new entries and easily track progress.
Clearly defined risk assessments
Each operation is unique, so it’s important to establish clear guidelines for when a formally documented corrective action request (CAR) is needed. For example, assess the risk associated with NC work by evaluating its frequency and impact:
High Impact/High Frequency: Considered high risk.
High Impact/Low Frequency or Low Impact/High Frequency: Considered medium risk.
Low Impact/Low Frequency: Considered low risk.
This approach helps determine the appropriate level of response required.
For high-risk NC issues, a CAR should always be initiated and completed. For medium-risk NC issues, discuss the situation with the team to assess its impact. The team should then collaborate on completing the CAR.
Graph 1
Visual aids can assist the team in adhering to established standards. For instance, the graph 1 supports independent risk assessment. If team members have any uncertainties, make yourself available to guide them through the assessment process.
Collaborative root cause analysis
Root cause analysis is a crucial process for uncovering the underlying causes of NC work. While corrective actions are important, without investigating the root cause, the issue is likely to recur. Root cause analysis can be challenging, but working collaboratively as a team can enhance its effectiveness. There are several methods for performing root cause analysis, such as the “5 Whys” and the Fishbone Diagram, among others. Be prepared for the possibility that multiple potential root causes may be identified.
The 5 Whys technique involves repeatedly asking "why" until the fundamental cause is identified. This process may require anywhere from two to 10 iterations. Start with the initial problem and continue asking "why" to delve deeper.
Once the potential root cause is identified, brainstorm corrective actions with your team to address the issue. The more involved your team is in developing the solution, the more likely they will support and implement the corrective action effectively. Educate your team on the CAPA process; although it can seem complex, a well-informed team is more likely to contribute positively and assist in its execution.
Ongoing monitoring and reevaluation
The CAR is complete, the corrective action has been implemented, and it’s time to return to normal lab operations, right? Not quite.
Monitoring the effectiveness of the corrective action is just as crucial as identifying the root cause and implementing the solution. If the corrective action does not resolve the issue, the team needs to reassess and apply a different corrective measure. To ensure you don’t overlook this step, set calendar reminders for three and six months to review the situation. Ask key questions: Did the corrective action resolve the problem? Has the issue recurred? Do we need to reconsider our solution?
Don't let CAPA efforts end with the closeout. Tracking and analyzing trends in NC work is vital. An issue initially categorized as low risk can quickly escalate to medium or high risk if it persists.
This also presents an excellent opportunity to implement preventive actions if trends reveal potential issues.
CAPA is essential for the success of laboratory operations. NC work will inevitably occur, and how the lab responds can significantly impact its long-term success. As a leader, emphasizing the importance of CAPA sets a strong foundation for your team. Implementing user-friendly tools, clear risk assessments, collaborative root cause analysis, and continuous monitoring and reevaluation fosters a highly effective laboratory system. This approach not only ensures high-quality results but also promotes a team-oriented environment that maintains and improves the system in place.
