CAPA, also known as Corrective and Preventive Action, is a way to establish and keep a company’s compliance in a holistic and sustainable way. Just a few measures can sometimes eliminate unforeseen situations caused by non-conformities. CAPA as a concept falls under several ISO business standards and Good Manufacturing Practices and is a common paradigm for the pharmaceutical industry.
The fundamental idea of CAPA is to get down to the root causes of specific problems and the risks associated with them. The completion of this process includes preventive actions so that a particular problem does not reoccur in the future. Companies can create a risk-based CAPA process and comply with the latest ISO standards.
Follow the arivis processes and steps towards a risk-based CAPA process and establish your compliance in a holistic way!
There are many inputs to CAPA that are the crux of the Quality Management System (QMS). This is because it helps you solve any problem. It’s important to know that authorities expect these inputs to be varied and not just from a single source. For this reason, the CAPA process is considered the core of the Quality Management System and also indicates how effective the QMS is in general. If an internal audit is an input, you should be aware of your peers and what they use as inputs. This internal benchmarking helps you in understanding patterns of issues that have occurred somewhere in the organization.
Shared process knowledge assists you in understanding your own CAPA. This is when corporate culture turns into collaborative success, which enables your organization to implement preventive actions even before an actual problem occurs. The 5D platform is entirely data-driven and quality processes with implemented arivis5D Compliance give you the necessary predictive models for your smart decisions. This helps not only in internal audits but also helps to survive inspections effectively.
Creating well-designed forms seems like a no-brainer, but the reality is that it takes a long time to eliminate technical bugs and create something that is logical and chronological in nature. Designing a great CAPA form helps to improve the effectiveness of your CAPA process.
Beyond that you will reduce usage errors and improve the efficacy of the whole process. The forms ensure completeness and should include all the mandatory elements for a robust CAPA, but also can have individual configurations for your organization.
Learning from solved issues in the past is a must. Further analysis of process-related quality problems lets you change views in a predictive mode before they compromise the compliance of your organization. Any of these, of course, might have undergone the process and required corrective actions. Organizations actually should not just sit on data but should turn into predictive mode by regularly analyzing their quality patterns. A retrospective analysis should include data and information from all inspection findings, complaints, issue tracing, and quality records.
They are used for getting metrics for data analysis and are commonly used for the containment method. Factors such as depth and frequency of inspection need to be risk-based decisions.
This is a proactive approach that determines how capable our organization is in terms of inspection readiness. Once you use data from the process validation, you can utilize patterns to determine a risk-based approach of further management.