No. FDA guideline CFR 820.20 calls out management’s responsibility as it relates to CAPA. Management responsibilities include:
- Establishment of a QA policy and objectives and for ensuring commitment to them.
- Establishment of an appropriate organization structure to support the stated quality objectives.
- Provide everyone who can affect quality with both the responsibility and the authority necessary to ensure that quality objectives are met.
- Ensure that adequate resources are available to support quality objectives.
- Appointing a member of management to have authority over and responsibility for quality.
