Biomedical Engineering Reference
In-Depth Information
Insofar as the CAPA requires the revision of an operational
SOP, the original observation initiates the chain of events
that lead to the revision.
2.4 Conclusion
This chapter has considered the activities that are triggered
by the escalation of a deviation. These activities include an
investigation, a RCA, and corrective action designed to
remedy the problem in the here and now, and preventive
action designed to prevent the recurrence of the problem.
These activities may lead to the revision of one or more
SOPs. The following chapter will discuss these implications.
2.5 Notes
1. See Margaret Hambleton (2005).
2. See Gary McLean (2005); see also Kaoru Ishikawa
(1990).
3. See FDA
Guidance for Industry
(2006).
4. See Julie D. Honsa and D.A. Mcintyre (2003).
“Sometimes the actual cause cannot be proven but only
speculated by the process of elimination.”
5. See Heidi Wald and Kaveh G. Shojania (2001).
6. See James Reason (2000).
7. See James Reason (2004). Reason goes on to say:
latent conditions possess two important properties:
fi rst, their effects are usually longer lasting than those
created by active failures; and second, they are present
within the system prior to an adverse event and can
be detected and repaired before they cause harm.
