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?
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).
Here are some questions to guide the understanding of effort, responsibility and other aspects to be considered in measuring the effectiveness of a CAPA.
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.
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.
Will the measurement results be entered into the CAPA form manually? Or will they be tracked using an electronic system?
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.
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.
The analysis will have to be carried out by quality control, which will then determine whether the CAPA can be closed.
The results of the analysis should be communicated by the CAPA plan owners, usually by sharing monthly figures.
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.
PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.
It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.
The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes