Corrective Action Procedure --------------------------- .. impl:: Maintain a Corrective Action Procedure :links: R_APPB_76 Since Corrective Actions are directly mentioned in AppB, it's wise to have a very clear and direct procedure defining how it will be done. Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected. Corrective Actions are designed to assure that conditions adverse to quality are promptly identified and corrected. Such conditions may include: * Failures * Malfunctions * Deficiencies * Deviations * Defective material * Defective equipment * Nonconformances .. graphviz:: digraph G { Anyone [label="Anyone",color=green,shape=circle] Identify [label="Identify condition \nadverse to quality",shape=box]; Create [label="Create CAQ ticket",shape=box]; Notify; Classify [label="Classify significance"]; Significant [label="Significant condition\n adverse to quality?",shape=diamond] Cause [label="Determine the cause"]; Preclude [label="Do Corrective Actions \nto preclude repetition"]; Stop [label="Close ticket\n and stop",color=red,shape=circle]; Document [shape=house]; DCause [label="Document cause \nof condition",shape=note]; Action [label="Document actions\ntaken",shape=note]; Report [label="Report to \nappropriate management"]; Anyone -> Identify -> Create -> Notify -> Classify -> Significant; Significant -> Cause [label="Yes"]; Cause -> Preclude -> Document; Document -> {DCause, Action} -> Report -> Stop; Significant -> Stop [label="No"]; } In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.