The Global Harmonization Task Force (GHTF) is a voluntary international organization that supports harmonization of medical device regulations around the world. GHTF has five study groups, who issue guidance documents. Study Group 3 (SG3) covers issues related to Quality Systems.
The new guidance, Quality Management Systems – Medical Device – Guidance on Corrective Action and Preventive Action and Related QMS Processes id dated Nov. 2010 and is the final version of the document.
The document doesn’t use the acronym “CAPA” since “the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.”
The guidance partitions the corrective action and preventive action processes into four phases: Planning, Measurement and Analysis, Improvement, and Input to Management. The guidance illustrates each phase and the linkages with an overview diagram. In addition, the guidance each phase and it constituent processes.
In Phase I, Planning, the manufacturer specifies the processes and resources needed to meet the objectives. This phase plans for measurements and analysis and establishes data sources.
Phase II conducts measurement, monitoring, and analysis to determine conformity and nonconformity.
Phase III, the Improvement phase helps mitigate or eliminate the cause of a detected or potential nonconformity. This phase uses a six step process:
- Identify Root Cause
- Identify Actions
- Verification of Identified Actions
- Implement Actions
- Determine Effectiveness of Implemented Actions
Phase IV reports to Management. The Management Review helps management ensure the overall QMS is effective.