CAPA EXAM
action plan - answer-create a list of required tasks
analysis - answer-perform a thorough assessment
CAPA processes - answer-used particularly in food processing, medical device
development and manufacturing, and pharmaceuticals
Corrective action - answer-elimination of the cause of an existing noncorformity or
undesirable situation in order to prevent reoccurance
corrective action - answer-enact corrective actions over a slightly longer time period
to prevent reoccurence
corrective action - answer-involves the identification, documentation, and
elimination of the root cause
corrective action - answer-taken under more intense consideration than corrections
evaluation - answer-appraise the magnitude and impact of the problem
FDA 21 CFR 820 - answer-quality system regulation that requires corrective and
preventive procedures to be documented in medical device manufacturing facilities
identification
evaluation
investigation
analysis
action plan
implementation - answer-procedure
identification - answer-define the problem
implementation - answer-execute the action plan
investigation - answer-make a plan to research the problem
preventive action - answer-fully incorporates the notion that preventive comes first
and eliminates problems, and thereby, the need for corrective action
preventive action - answer-identification and elimination of the cause of potential
nonconformities in order to prevent occurence
preventive action - answer-now considered a part of good planning and risk
management
proactive - answer-preventive
action plan - answer-create a list of required tasks
analysis - answer-perform a thorough assessment
CAPA processes - answer-used particularly in food processing, medical device
development and manufacturing, and pharmaceuticals
Corrective action - answer-elimination of the cause of an existing noncorformity or
undesirable situation in order to prevent reoccurance
corrective action - answer-enact corrective actions over a slightly longer time period
to prevent reoccurence
corrective action - answer-involves the identification, documentation, and
elimination of the root cause
corrective action - answer-taken under more intense consideration than corrections
evaluation - answer-appraise the magnitude and impact of the problem
FDA 21 CFR 820 - answer-quality system regulation that requires corrective and
preventive procedures to be documented in medical device manufacturing facilities
identification
evaluation
investigation
analysis
action plan
implementation - answer-procedure
identification - answer-define the problem
implementation - answer-execute the action plan
investigation - answer-make a plan to research the problem
preventive action - answer-fully incorporates the notion that preventive comes first
and eliminates problems, and thereby, the need for corrective action
preventive action - answer-identification and elimination of the cause of potential
nonconformities in order to prevent occurence
preventive action - answer-now considered a part of good planning and risk
management
proactive - answer-preventive
