Corrective and Preventive Actions (CAPA) are currently one of the major points of observation by the FDA.
The management of CAPAs is complex and difficulties do not always depend on staff shortages, but very often they are attributable to a problem in the structure and flow of the process. How often is it the case that not all actions are tracked, not all steps are documented or even data is lost in a cluttered system with excessively long implementation timeframes.
Furthermore, corrective action should be minimised as much as possible, as a consequence of deviations, non-conformities, etc., in favour of proactive approaches such as greater use of Quality Risk Management.
Being Proactive and Preventing is less expensive than being Reactive and Correcting!
In the following paragraphs, we will reference the regulations, explore tools and techniques to improve the approach to preventive and corrective actions, answer the most frequently asked questions about CAPAs and, finally, use an infographic to demonstrate how to simplify a CAPA process using a digital system.
There are several techniques and tools that can be used to improve the approach to corrective and preventive actions.
The RCA uses different models and tools such as:
Despite strong regulatory pressures, not all deviations, complaints, audit results or supplier defects should trigger a CAPA. Trend analysis and risk management can help avoid the “everything is a CAPA” syndrome.
Trend Analysis: Paying attention to trends helps us understand whether a non-compliance is an anomaly or not and whether it therefore needs a CAPA process or simply corrective action following a deviation, etc. Trends can also identify minor issues before they become more risky, perform preventive actions and help to better prioritise non-compliances for further investigation.
Quality Risk Management (QRM). Quality Risk Management is a process to mitigate or eliminate risk. It starts with an initial assessment phase, up to a final periodic review. QRM is an increasingly popular process in the upstream inspection phase of any process and helps to reduce the number of open CAPAs.
CAPAs (Corrective Actions, Preventive Actions) are a system of quality control measures designed to eliminate the causes of a deviation, non-compliance, defect or other undesirable situation in order to prevent its recurrence.
Through a CAPA process, a company not only develops an Action Plan, but also determines, implements and monitors the effectiveness of an identified solution. Basically, through this process, the company Quality Control system is able to “self-correct” and improve itself.
The purpose of corrective and preventive actions is to acquire information, analyse it and identifyand investigate problems with quality in the product so ast totake appropriate and effective actions to correct the problem and prevent its recurrence.
Key to this process will be the testing and validation of corrective and preventive actions, the communication of activities to be carried out to the responsible parties, the documentation of activities and the collection and sharing of relevant information for management review.
CAPAs are opened following and in the presence of certain inputs. Including:
Who opens the CAPA?
Usually the CAPA is linked to other “parent” processes such as Deviations, Complaints, etc., so the people who open CAPAs are those who have previously instigated another process. However, there are often committees within companies, which discuss the process and jointly decide who should be in charge of it. Quality Assurance is generally represented in the committees.
The reference regulations for the management of CAPAs are:
Although CAPAs are not specifically indicated in the cGMPs for pharmaceuticals (21 CFR 210 and 211), there are requirements that are parallel to the CAPA concept. It is clear that CAPA expectations have become a current GMP for pharmaceuticals.
21 CFR 211 (e.g. 21 CFR 211.160 and 211.192) contain requirements parallel to the CAPA requirements listed in the Medical Device Regulations (21 CFR 820) (1-2).
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