By Danielle DeLucy, ASA Training & Quality Consulting
In the highly regulated life sciences industry, serious quality issues can and do occur. Once an investigation team convenes and performs a thorough root cause analysis (RCA), the focus then turns to remedying the issue. Perhaps the most commonly used method to fix quality issues — and ensure they don’t rear their ugly heads again — is to create thorough corrective and preventative action (CAPA) plans. These plans take each root cause that was investigated and spell out specific steps to address them.
However, before you can consider the issue corrected, the CAPA needs to be verified as effective and complete, per international regulations and standards. For example, step 3.2.2 of ICH Q10 states: “CAPA should be used and the effectiveness of the actions should be evaluated.” Thus, quality units must perform effectiveness checks on their CAPA plans — measuring and determining that the corrective action has (or has not) eliminated the problem.
There are main three reasons for taking CAPA plans through effectiveness checks:
Verifying the effectiveness of a CAPA closes the loop between identifying a problem and completing the actions to solve a problem.
Choosing The Appropriate Measurement
Determining the best verification approach for the wide range of problems that could occur can often be challenging. Both qualitative and quantitative methods can be used to measure success of a CAPA. Qualitative methods explain and gain insight and understanding of an issue through intensive collection of narrative data, generate a hypothesis to be tested. Quantitative methods explain, predict, and/or control phenomena through focused collection of numerical data and hypothesis testing.
Some firms struggle to use quantitative methods in performing effectiveness checks, because certain aspects of CAPAs can be harder to measure than others. However, you can measure just about anything. For example, you can measure entry errors for operators who are deviating from good documentation practices by identifying areas where quality records are reviewed and documentation errors are measured. You can measure by operator, by type of documentation (e.g., lab record, batch record, or cleaning log), by month, etc.
Another example is the measurement of transcription errors made when copying information from sample ID labels to laboratory notebooks. Say an investigative team determines that the labels made on the current label printer are frequently unreadable and suggests a CAPA plan that includes replacing the current label printer with one that produces legible labels. A proper effectiveness check would include returning to the area within a week to determine if the new printer is operating correctly and the labels can be read. In addition, the team could also monitor the number of errors made during the week and compare the rate with the number of errors made prior to solution being implemented.
To help determine the most appropriate measurement for your effectiveness check, answer some/all of these questions:
Once these questions have been answered, you can move on to developing ways to verify your CAPA effectiveness.
Methods For Verifying Effectiveness
There are many highly effective tools and principles you can use to make your effectiveness checks successful. Here are a few common approaches:
When To Schedule Effectiveness Checks
Another vital piece to ensuring a robust and properly managed CAPA effectiveness verification is establishing the appropriate timeframes to perform the checks. When settling on a due date, it is important to allow enough time for the corrective action to take effect, while also maintaining a sense of urgency around ensuring that the issue is fixed and will not recur.
Some deviations or problems only require a simple procedure update, retraining of staff, or recalibration of a piece of equipment. However, in many cases, CAPAs are opened to address more difficult issues, such as changing the facility layout, altering gowning practices, increasing sample sizes, or implementing a new piece of equipment. In these cases, it is best practice to set up several effectiveness checks over a period of time. Perhaps the first check can be done rather quickly after the CAPA plan has been approved, but others will be spread out over months.
CAPA effectiveness checks are a surefire way to track, trend, and remediate deviations that occur during manufacturing and laboratory testing. By developing solid corrective action plans and appropriately timed effectiveness checks, firms can begin the process of remediating issues that could cause deviations. Having a strong quality unit in place to perform these checks is the key to ensuring that these effectiveness checks are conducted in a timely fashion and are improving the process. When done right, these checks demonstrate your firm’s commitment to quality and compliance.
About The Author:
Danielle DeLucy is owner of ASA Training and Consulting, LLC, which provides pharmaceutical- and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, she spent 15 years in the industry serving in numerous quality management roles. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters or consent decrees, and those wishing to improve compliance, establish more robust quality systems.