A manufacturing and technology corrective and prevention action (CAPA) system is the overall coordinated methods used to investigate and correct quality issues to prevent recurrence. A functional CAPA system is an important requirement for ISO-certified general manufacturers and their suppliers and contractors.
Both ISO 9000 and ISO 14000 require corrective action tracking systems and remedial processes to correct nonconformances, prevent their recurrence, and improve overall product quality.
Watch Related Videos
Manufacturing and technology companies understand the importance of maintaining quality in their products. This requires incorporating a quality management system that addresses the quality control and quality assurance needs at various levels in the business. Assessment of quality can be difficult, especially when a company's infrastructure is divided in multiple tiers such as processes, people, departments, and business divisions, etc. The core focus of management is to find a way to measure quality and evaluate the company's actual standing in the market. Audits and customer feedback are two methods primarily used for gauging quality. With these methods, management is brought face to face with the various issues that affect the overall health of the quality management system. It is essential to resolve these issues and prevent their recurrence, which is why companies are taking advantage of manufacturing and technology CAPA software systems.
There are many manufacturing and technology CAPA software systems available on the market. These software systems are able to meet the general demands of companies but many don't really cater to specific business requirements. The MasterControl manufacturing and technology CAPA software system is carefully designed to provide companies with a flawless CAPA program that performs according to established quality management requirements. MasterControl's manufacturing and technology CAPA software system is completely web-based and structured according to ISO 14000 and 9000 principles. The remainder of this article addresses how MasterControl manufacturing and technology CAPA software is completely compliant with these regulations.
CAPA is a concept widely used for improving any company's quality processes. CAPA is an integral part of the quality management system, which is why the documentation of different issues - including the customer complaints, non-conformances found through audits, or bugs that surface during quality control testing - is crucial. Good manufacturing practices (GMP) allow manufacturing and technology companies to base their manufacturing process lifecycle in accordance to a set of rules that help bring quality to the forefront. MasterControl manufacturing and technology software is aligned with the GMP and provides companies with the facility of building a thorough repository of all CAPA issues and their solutions. The software makes it possible for users to systematically investigate non-conformances and their root causes. Since each step of the CAPA is documented, management is able to readily analyze all dimensions of a problem and quickly find solutions.
MasterControl manufacturing and technology CAPA software is fully complaint to the ISO 9000 standards that mainly address the good quality management practices. Companies want to incorporate a cost-effective CAPA program, which is why they usually opt for paper-based or hybrid CAPA systems. However, these systems lack the infrastructure to maintain CAPA documentation connectivity and reliability, which is the basis for a sound CAPA program. It becomes extremely difficult to bring various users together for documenting issues and discussing possible solutions. Even the simplest of operations such as searching and retrieving documents can take unusually long. With MasterControl manufacturing and technology CAPA software, the management is provided with a secure online repository which also makes the review and approval of documents a relatively easier task.
Another basic requirement of a CAPA program is has the capacity to be automatically triggered as soon as an issue is identified. The MasterControl manufacturing and technology CAPA system is completely automated. With its advanced tracking forms, the data collection process requires minimum human intervention and input. Our manufacturing and technology CAPA software system seamlessly integrates with other MasterControl applications including the MasterControl Training module which provides management with the facility of efficiently training employees on the changes made in processes so that the executed standard operating procedures are compliant with ISO 9000 regulations.
The ISO 14000 family addresses different aspects of environmental management. ISO 14000 stresses the importance of incorporating an effective environmental management system. If the products manufactured may be potentially hazardous to the environment it is imperative to test them and their impact on the environment. Products are classified as safe to use when it can be demonstrated that they do not direct any harm to the environment.
MasterControl manufacturing and technology CAPA software helps identify and control the impact of a company's activities and its products or services on the environment. MasterControl software provides a systematic approach in implementing CAPAs, which makes it easier to set the objectives and demonstrate how they are achieved.
MasterControl manufacturing and technology CAPA systems also provide companies with an elaborate analytical and reporting console for performance evaluations and analysis. As per the ISO 14000 regulations, MasterControl manufacturing and technology CAPA software provides a holistic approach to processes within the system so that there is transparent communication between people and connected processes throughout the enterprise. Connectivity between processes ensures that the data can be collected without anything falling through the cracks. Data collection from various sources is an important step in resolving a CAPA which is taken care of through MasterControl's manufacturing and technology CAPA system. As such, the software has been proven to be compliant with ISO 14000 standards.
To learn more about our manufacturing and technology CAPA Software contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.