Biomedical Engineering Reference
In-Depth Information
Table 2.3
Illustrative observations that will be triaged
1. Minor documentation errors that are addressed in the record
2. Typographical errors (e.g. misspelled words, grammatical errors,
punctuation errors)
3. Missed periodic maintenance, out of calibration status of
non-GMP equipment
4. Equipment challenge failures that occur during set-up
5. Shutdown of the redundant utility system
6. Utility shutdown that does not disrupt operations
7. Routine service calls
8. Materials spilled during weighing, measuring, or dispensing
operations
lead to investigations and root cause analyses.
This section has discussed the kinds of observations that
are likely to be escalated, and those that are likely to be
triaged. The next section will consider the process of
investigation that follows from an escalation.
2.2 The process of investigation
Faced with a problem (call it P) that is referenced in a NoE
- a manufacturing deviation or out-of-spec lab result, say -
the organization will conduct an investigation to fi nd the
root cause.
Management assigns an employee to lead the investigation,
typically a subject matter expert (SME), and establishes the
due date for the completion of the investigation report. The
lead investigator will review the NoE and also review related
observations (events), trend data, training records, etc. Of
particular interest is determining whether this deviation is a
recurrence, which means that earlier remediations have
