In companies that are highly regulated, such as Life Science, problems that impact quality need to be supported by robust and well-structured processes so as to resolve their causes and avoid recurrence. One of the most common processes and methods is CAPA (Corrective Actions, Preventive Actions).

CAPAs are not only used because they are required by the regulations, guidelines and standards, but, if carried out correctly, they can help organisations to improve their processes and reduce waste, thereby increasing their competitive advantage.

A really important step in the CAPA process is checking its effectiveness once the preventive corrective actions have been implemented. This is to ensure that CAPA is an effective solution to the problem encountered and to reduce the risk of its recurrence or, as is often the case, to avoid it recurring some time later.

What aspects and questions should be considered when measuring the effectiveness of a CAPA? What methods and tools should be used?

1. Measuring the effectiveness of the CAPA: qualitative and quantitative data

To verify the effectiveness of a CAPA we need to measureit using both qualitative and quantitative data. With the former, people gain insight and understanding of a problem and its resolution through the collection of ‘narrative’ data, such as interviews or evaluations from experienced personnel. The latter explain, predict and/or check developments through targeted collection of numerical data and hypothesis tests.

Any aspect can be measured, what is important is identifying the target element(s) that determine the effectiveness of the implemented actions and achieving the final objective.

Let’s take a very simple example.

Our root cause that led to the creation of a CAPA, was a transcription error that occurred when copying information from the sample label to the laboratory records. The transcription error was caused by a printer malfunction that resulted in barely legible labels.

The CAPA included changing the printer as one of its tasks. Two elements to check its effectiveness could be: returning to the printer at set intervals and qualitatively assessing whether the labels are printed correctly (qualitative data) and quantifying the number of errors generated in a given period of time by comparing them with the number of errors generated with the previous printer (quantitative data).

2. Measuring the effectiveness of the CAPA: some questions to ask

Here are some questions to guide the understanding of effort, responsibility and other aspects to be considered in measuring the effectiveness of a CAPA.

• Who will do the measuring?

The task should be assigned to the person or team in the company who ensures that problems in the quality control system are solved according to the regulations.

• What will be measured?

The number of errors after implementing the CAPA measures compared to the number of previous errors. The number or type of deviations that occurred as a result of the CAPA measures. Etc.

• Where will the data be measured/tracked?

Will the measurement results be entered into the CAPA form manually? Or will they be tracked using an electronic system?

• When to take measurements?

The measuring time and frequency depends on the severity of the issue. For issues that could affect the patient’s health, measuring effectiveness should be immediate.

• How will the CAPA’s effectiveness be measured?

Will quantitative or qualitative data be measured? For example, if an SOP is revised, then staff performance or compliance with the new version of the procedure can be measured by monitoring the number of deviations from the various process steps described in the procedure.

• How will the measurements be analysed?

The analysis will have to be carried out by quality control, which will then determine whether the CAPA can be closed.

• Who will communicate the results to the Management Team?

The results of the analysis should be communicated by the CAPA plan owners, usually by sharing monthly figures.

Methods and tools to check the effectiveness of a CAPA

Periodic Checks – This method involves establishing a regular review of the process/change that was introduced through the CAPA.

Surprise internal audits – Audits can be useful for ensuring that operators, processes or equipment are following the measures laid down by the CAPA.

Sampling – Sampling is an effective tool for checking corrective measures related to environmental monitoring or laboratory testing.

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