Biomedical Engineering Reference
In-Depth Information
Figure 2.4
Remaining candidates for root cause
Figure 2.5
Constituent elements of packaging and labeling
Each constituent element is considered and eliminated from
consideration when it is determined that it could not have
been the root cause of the deviation.
When the investigation is complete, and a root cause or
probable root cause has been identifi ed, the project lead will
prepare a Final Investigation Report (FIR) to submit to
management for review and possible approval. The report
should include the sections displayed in Table 2.5.
As an executive summary of the FIR, the Investigation
Summary includes the sections displayed in Table 2.6.
Management will review the FIR, and decide on the
appropriate CAPA, including a reconsideration of previous
CAPAs as necessary.
