Effective CAPA (correction action, preventive action) management is more than just an important regulatory requirement. It is a good business practice that brings many benefits. A strong CAPA program can reduce liability, improve customer satisfaction, prevent major financial losses and strengthen a company’s reputation. In addition, CAPA is an integral part of an Enterprise Compliance and Quality Management (ECQM) strategy. The ability to quickly identify and address deficiencies and zero in on the sources of potential problems and prevent them, drives a company’s continual improvement efforts and helps it achieve operational excellence both in product and process. And that translates to increased performance and greater revenue.
To achieve the maximum benefits from CAPA compliance, CAPA must be part of an integrated Enterprise Compliance and Quality Management system that collects data on existing and potential problems, investigates and analyzes the data, digs down to the root cause, addresses the issue, institutes specific procedures to avoid similar problems in the future and documents the entire process. CAPA is most effective when it is part of the culture of a company, pervading every organizational level and department.
1. Disparate systems
Even if CAPA compliance is included in a company’s standard operating procedures, it is difficult to achieve with the systems that most companies have in place. Different programs that don’t interface with each other, homegrown systems that lack universal application and even manual pen-and-paper processes inhibit the flow of information, delaying the resolution of quality issues and clouding the compliance picture.
2. Lax documentation
Without centralized control, the documentation chain required by regulatory agencies is often broken. Procedures are not always well documented and required steps are not always completed. And, if companies do not document their own CAPA procedures and fixes, regulatory agencies like the FDA will not know that CAPA requirements have been fulfilled.
3. Communication barriers between cultures and specialties
Employees of the same organization don’t always speak the same language, literally. Many complex manufacturers are multinational with different languages spoken among their employee population. In addition, the terms that an engineer would use to describe a quality issue may be different from what a compliance officer or marketing manager would use.
4. Lack of training
For as much specialized training as some receive, it is rare for the majority of employees across a company to be trained in compliance issues. As a result, employees don’t always know, understand or embrace their role and responsibility when it comes to quality management.
5. Disconnect among business units or product lines
It is common to find that CAPA management is seen as a job for the quality department only, not a concern in which the production, R&D, marketing or other departments should be involved.
6. Non-collection of trending data or data not readily available to appropriate personnel
Unless an integrated ECQM system is in place, most departments track and trend their own data on their own systems, making it hard for management to see the whole compliance picture across the company in real time. Without this vision, key personnel cannot predict and prevent possible deficiencies and meet CAPA regulations.
7. Seeking a quick fix versus seeking to correct the root cause
Companies tend to address product and material issues without reaching below the surface to identify and address potential process or quality concerns. The result is that they focus on product problems and ignore systemic issues that might lead them to correct a root problem. Getting to the root of the problem is a key CAPA priority.
It is important to remember that CAPA compliance is a large process involving many aspects of an organization. True CAPA conformity, being able to quickly identify and correct problems while putting practices in place to prevent future issues, requires the integration and flow of information freely across a company’s various departments and locations.
This is an edited excerpt of “Integrated Quality Systems: Simplify CAPA Management, Mitigate Risk and Maintain a High Level of Compliance.” To read the full paper visit http://www.cincom.com/lrc.