The firm should have methods and procedures to input product or quality problems into the CAPA subsystem. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action. Determine if appropriate sources of product and quality problems have been identified. Such data includes information regarding product and quality problems (and potential problems) that may require corrective and/or preventive action.Ģ. Once you have gained a knowledge of the firm's corrective and preventive action procedure, begin with determining if the firm has a system for the identification and input of quality data into the CAPA subsystem. All procedures should have been implemented. The CAPA procedure should include procedures for how the firm will meet the requirements for all elements of the CAPA subsystem. NOTE: Corrective action taken to address an existing product or quality problem should include action to:Ĭorrect the existing product nonconformity or quality problems and Prevent the recurrence of the problem. It is important to gain a working knowledge of the firm's corrective and preventive action procedure before beginning the evaluation of this subsystem. If necessary, have management provide definitions and interpretation of words or terms such as "nonconforming product", "quality audit", "correction", "prevention", "timely", and others.
![capas tropico 1 capas tropico 1](http://heartshara.weebly.com/uploads/1/2/3/7/123714636/875644185.jpg)
Review the firm's corrective and preventive action procedure. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented. One of the most important quality system elements is the corrective and preventive action subsystem.ġ. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.Verify that corrective and preventive actions for product and quality problems were implemented and documented.Confirm that corrective and preventive actions do not adversely affect the finished device. Determine if corrective and preventive actions were effective and verified or validated prior to implementation.Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.Verify that there is control for preventing distribution of nonconforming product. Determine if failure investigations are conducted to determine root cause (where possible). Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigation procedures are followed.
![capas tropico 1 capas tropico 1](https://i2.wp.com/xboxmania.com.br/wp-content/uploads/tropico-6-dlc-lobbyistico-capa.jpg)
Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.
![capas tropico 1 capas tropico 1](https://www.mytrendyphone.pt/images/iPhone-5-5S-SE-Designer-Cover-TPU-Tropic-28052019-01-p.jpg)
Verify that the data received by the CAPA system are complete, accurate and timely.
![capas tropico 1 capas tropico 1](http://p.calameoassets.com/150811002909-0d8b668abdebbbfc89c95a2ef756e781/p14.jpg)
Challenge the quality data information system.Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action. Determine if sources of product and quality information that may show unfavorable trends have been identified.Determine if appropriate sources of product and quality problems have been identified.Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.