Corrective Action Ashima Wadhwa CAPA Quality System More

Corrective Action Ashima Wadhwa

CAPA Quality System – More than Just Corrective Action • A CAPA Quality System (CAPA is an acronym for ‘Corrective and Preventive Action’, or ‘Corrective Action, Preventive Action’) is absolutely essential in some format for a complete quality management program. In fact, in at least one quality management system, Good Manufacturing Practices (GMP), it is a requirement and a fundamental tenet of the program.

Need of CAPA • The corrective action, preventive action program is the means by which unforeseen issues are addressed, remedied, and eliminated from ever happening again. A CAPA quality system is a required part of ISO compliance, and is a vital part of TQM practices if a company ever expects to reach its goal of zero defects.

Steps For Corrective Action • Identifying the requirements for Corrective Action • Determining the action to be taken • Implementing the corrective Action • Periodic review of action taken

Identifying the requirements for Corrective Action • The first and foremost step is to identifying the requirements for corrective action. The main reason could be : • Defects • Complaints from customer • Non-conformances • Security Issues etc

Determining the action to be taken • • • The actions must ensure : Removal of defect Satisfaction of customer Conformances to objectives Improved quality No side effects to other modules

Implementing the corrective Action • Once the corrective action or preventive action (CAPA) is created and assigned, the objective is : • Create actions that can be assigned to appropriate staff • Manage follow-up items • Track action assignment due dates and overdue items • Change in all related documents

Periodic review of action taken • In a true capa system, there is a formalized process to “close the loop” to make sure all of the corrective and preventive actions were completed, that they perform as they were intended to perform, and the organization can be assured that it will never have to deal with this same issue again. This program is an easy program to automate, and there are many software and IT firms that have introduced closed-loop CAPA software programs. It starts with the actions, expected completion dates, and champions being entered into a system-wide database. • So it is essential to do periodic review of action taken.

Traceability • Traceability, in general terms can be referred to as “Completeness of the information about every step in a process chain”. It is an essential paradigm in contexts of objects like ‘Measurement’, ‘Logistics’, ‘Materials’ and last but not least ‘Software’ to name a few.

Traceability • One of the essential practices to ensure quality standards is Traceability, which in this context can be defined as “The ability to describe and follow the life of a requirement, in both a forward and backward direction”

Why Traceability is required in Software? • In software engineering, the testing performs the verification of software using different types of information available in the project. A number of activities are based on the results of testing. This dependence means that there must be some kind of traceability between items involved. In other words, it must be possible to follow from the software implementation to testing information and from the testing information to the next iteration of implementation.

Why Traceability is required in Software? • Traceability is a standard which plays a vital role in assuring the quality of the product. Most of the software projects fail due to communication gap i. e. Gap between the requirements (expected product) and final product (actual product), traceability acts as a bridge between these gaps.

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