Biomedical Engineering Reference
In-Depth Information
failed. In such a case, the prior corrective action and
preventive action (CAPA) must be reconsidered to determine
why it failed.
It is usually recommended that a team be assembled by the
project lead, since this permits triangulation in assessing the
deviation and its causes. This also improves the likelihood that
the effects of personal biases in assigning causes will be lessened.
Many times the investigation of a deviation involves a
number of departments. This requires a cross-functional
investigation involving employees from various departments
to assess the deviation. The participants should consist of
SMEs from departments that have been impacted by the
deviation, as well as personnel from Quality Assurance (QA).
The investigation will identify a number of elements of the
manufacturing or quality lab system, call them E
n
, where
the variation in E
i
causes variation (deviation) in P. Consider
the following Ishikawa diagram.
2
Six major elements are
included (Figure 2.1).
Elements that are identifi ed as part of E
n
- that is, potential
causes of the deviation - can be considered as elements of the
FDA Quality Systems Approach, including equipment,
production, quality, materials, laboratories, packaging, etc.
3
Consider the Ishikawa diagram displayed in Figure 2.2. Each
of these elements has its own constituents. The investigation
Figure 2.1
Template of Ishikawa diagram
