Biomedical Engineering Reference
In-Depth Information
Table 2.5
Format of fi nal investigation report
1. Investigating area
2. Lead investigator
3. Investigation Summary (see Table 2.6 below)
4. Impact Assessment
5. Description of Deviation
6. Investigation Conclusions, including root cause
7. Recommended material disposition (if applicable)
8. Disposition Justifi cation (if applicable)
9. Proposed Corrective Action/Preventative Action
Table 2.6
Format of investigation summary
1. A chronology of events, date of occurrence, etc.
2. Immediate actions taken
3. Areas evaluated
4. Supporting documentation
5. Rationale for the exclusion of potential root causes
6. Review of related incidents, review of historical/trend data, and/or
whether it is a repeat occurrence
This section has discussed the process of investigation that
follows from the observation of a deviation. The next section
will consider the process of CAPA.
￿ ￿ ￿ ￿ ￿
2.3 The process of CAPA
Once the investigation is completed and the root cause
identifi ed, remediation can take place. Remediation takes
the form of corrective actions, to remedy the situation in
the here and now, and preventive actions, to ensure that the
problem does not recur.
 
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