CAPA FAQs

Why Is CAPA So Important for My Organization's Quality Management System?

An automated corrective action and preventive action (CAPA) system is crucial to ensure organizations are addressing quality events and solutions in an efficient manner throughout the supply chain. Employees must be able to identify events and issues, investigate why those events occurred, propose a CAPA plan that effectively solves the root cause, and be able to track and manage any tasks and workflows pertaining to the CAPA process to ensure the problem is solved.

Additionally, having CAPA processes in place as part of your quality management system is required by a number of regulations and industry standards, including GMP, ISO 9001 and 14001,TSCA, REACH, and other international standards. Failure to comply with these regulations and standards could have far-reaching consequences that could include anything from fines and penalties, to loss of business from customers looking for organizations with a proven quality management system.

How Does Sparta Systems Enable Organizations to Improve upon their CAPA Processes?

Sparta Systems’ CAPA solution allows organizations to take a holistic approach to their CAPA systems. By holistic, we mean that users can log and manage quality issues from any source, and the automated workflow engine puts those records through the appropriate steps to ensure a 100% closed-loop system. By taking a holistic approach to CAPA, organizations can better mitigate any risks of lost information and reduce waste through system consolidation and better collaboration across the supply chain.

Is Sparta Systems’ CAPA Solution a Good Fit for an Organization in My Industry?

Most likely, yes. Sparta Systems does not take a one size fits all approach to CAPA. Rather, we take a highly configurable approach that can be implemented with many other IT systems to address higher order organizational operations. It is used by organizations in a number of different industries, including those in the food and beverage industry, pharmaceutical companies, medical device organizations, and more.

How Can Sparta Systems’ CAPA Solution Ensure that Tasks Are Completed on Time and By the Right People?

One of the most important aspects of a successful CAPA system is traceability. Quality managers must know who is responsible for what and when that task will be done. Our CAPA solution ensures visibility across the organization, so all users can see what task is assigned to whom and what its due date is on one interactive dashboard. This not only increases accountability, but it also improves collaboration.

The systems’ 24/7 Business Rules Engine also generates automated emails when due dates approach. By having visibility and accountability in place through a central dashboard and integrated reporting, users across the organization can stay on the same page to ensure CAPA investigations and other tasks are completed.  Additionally, if problems do arise, other departments are automatically notified, so they can plan accordingly.  See below for managing Due Dates and their extensions.

Can Sparta Systems’ CAPA Solution Help Manage Due Dates and Extensions?

The configurability of the system allows flexibility in the design to meet your specific business needs.  In particular, it’s important to have the right business rules that are enforced by a system to control Due Dates, and your users’ ability to change and extend them.  This is becoming increasingly important as companies seek to improve efficiencies and metrics that are calculated from a system.  Therefore it’s important to be assured that key data points aren’t altered without controls.  Through managing an extension request and retaining the original due dates, you’ll always be assured to have clear and accurate information for your processes.

What is a Corrective Action?

A corrective action is the activity or activities performed to correct a quality incident that happened and keeps it from recurring.

What is a Preventive Action?

A preventive action is put in place as a continuous improvement to prevent the same or similar problem from happening at any location within the organization that may have the same or similar processes in place. This allows organizations to reduce the amount of time and resources “fighting fires”, and focus on proactively making products better

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