A risk assessment should be performed as part of the CAPA quality process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
Q: How much data do I need to support opening a corrective and preventive actions (CAPA)?
A: This is an interesting question because it raises the issue of whether a company is overusing or underusing the CAPA system. One data point is enough to open a CAPA depending on whether that data point is a significant occurrence. On the other hand, multiple similar deviations may be overlooked because they are deemed minor with little impact on operations. The most effective way to determine whether you should open a CAPA is to perform a risk assessment of the data.
Preventive Action
A single significant deviation, such as putting the wrong label on the product, should justify opening a CAPA. This type of production error carries a high risk. If the mislabeled product is released with the incorrect label, it creates a serious risk to patient safety. The CAPA is necessary because it enables users to determine preventative action needed to ensure the issue doesn’t recur.
CAPA Manufacturing
In addition, the CAPA will prompt the company to review data across manufacturing lines and manufacturing facilities so the corrective solution to prevent recurrence can be implemented across the company. An example of a CAPA manufacturing data point that does not necessarily need a CAPA opened might be a field complaint of a bottle of tablets that contained 99 instead of 100 tablets.
CAPA Audit
This occurrence should be investigated, but because it is low risk and more of an inconvenience to the patient, it may not require a CAPA. Opening a CAPA audit for this one event could be considered overusing the CAPA system.
CAPA Quality Assurance
However, if the complaint department tracks these data and finds a significant upward trend of short count bottles over a short period of time, a CAPA may be warranted. Underusing the CAPA system is also a concern. Not opening a CAPA when faced with data that suggests there is multiple occurrences of the same/similar deviation prevents the company from continuously improving processes.
CAPA Deviation
Let’s suppose that in reviewing deviations you notice that a few manufacturing employees have multiple deviations for the same minor issue in the same batch record over a short period of time. Assume the deviation has been determined to be human error and only retraining of the operators was performed.
CAPA Action
In this scenario, it would be prudent to open a CAPA for several reasons. First, human error is rarely the cause of a deviation. Second, obviously the retraining to prevent the error is not effective because the error keeps occurring. Third, the data is telling you about effectiveness issues with your process for investigating deviations & how it is implemented.
Quality System
Data generated from quality systems (QMS) is often used to prevent an event from occurring. For example, a preventive action is used to correct potential problems, and try to address them before they happen. In the example above, you can review other batch records to determine if the operator deviations have the potential to reoccur. Finally, you can implement appropriate QMS corrections to those batch records once other product batch records are reviewed.
Conclusion
There is no hard and fast rule on how much data you need to open a CAPA. It could be one data point or several data points. The best tools to use to determine whether a CAPA is needed is a risk assessment of the data and common sense.
About the Article
Pharmaceutical Technology
Vol. 47, No. 4
Page: 50
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
Background
A global health care company received an FDA Warning Letter for quality issues with its manufacturing facility. As the organization began working through the issues identified in the Warning Letter, it became clear, even with good quality systems, improved operational execution was needed to sustain successful results. The operational improvements were focused in areas such as shop floor discipline / execution, facility housekeeping and maintenance, managerial focus on all levels and, most of all, assessing and attacking specific operational shortfalls within all the operational groups.
RCA helped the organization recognize data quality gaps, develop action plans, and create tracking mechanisms to monitor operational progress of the Quality initiatives. RCA raised the bar on operational discipline and feedback.
RCA Approach
The manufacturing facility engaged Regulatory Compliance Associates® Inc. (RCA) to develop and implement a plan for operational improvements to support the evolving quality management system. This assessment and subsequent improvements involved needed support from the somewhat skeptical operations management group. RCA and the local operations management team worked jointly to assess the plant and identify gap areas needing improvement to support the quality initiatives.
RCA assisted the facility to develop and implement a tracking system to monitor operational tasks, ongoing process improvements and ways to enforce accountability of key personnel. This tracking included key performance metrics for the following areas: training compliance, floor audit performance, batch record error improvement, document timeliness and line clearance performance. Recognizing that the operations management team was inexperienced, RCA engaged and mentored the key operations floor managers as they began implementing improvements and tracking progress.
Result
Besides crafting and implementing the operations improvement plan, RCA assisted the company to instill a culture of operational excellence and individual accountability with an inexperienced team. RCA helped the organization recognize gaps, develop action plans and create a tracking mechanism to monitor operational progress. Not only did these actions clearly improve quality and compliance, but they provided financial returns such as a deviation and inspection cost reductions as well as increased available line time which more than covered the cost of RCA’s third party support. Most importantly, the management team learned the importance of communication across all departments and at all levels to achieve success. Ultimately, the facility’s commitment will contribute to an environment of sustainability long after the RCA consultants have left.