The 10 Phases Of An Effective CAPA.
Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system. Oftentimes, organizations do not fully document the CAPA phases and confuse verification of implementation and verification of implantation activities. This article will look at some of the regulations governing CAPAs and discuss the elements of 10 phases of a CAPA investigation that will help organizations ensure their CAPA processes are destined to succeed.
Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.
The organization shall document a procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken.
Records of the results of any investigation and of action taken shall be maintained.
Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.
The organization shall document a procedure to describe requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate.
Records of the results of any investigations and of action taken shall be maintained.