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.
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.
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.
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.
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.
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.
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.
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
Vol. 47, No. 4
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