Biomedical Engineering Reference
In-Depth Information
The investigation activities need to begin immediately. All operators and line
management involved in the manufacturing process should participate in the
investigation and subject matter experts should be consulted for their input.
A good starting place to investigate a process failure is to perform a risk
assessment. A risk assessment works just as well when conducted on a reactive
basis as on a proactive one to gather information and determine the relative risk of
failure on product quality. It is a good problem-solving tool because it organizes
the fact finding process by laying out a road map of every process step, each
control measure, and monitoring method in place. Each of these aspects can then
be reviewed in a systematic manner. The underlying questions may change the
focus from what could go wrong and why in the proactive setting to what did go
wrong and why in the reactive setting but the overall process is still the same.
Some of the questions to ask the operators should also include the following:
• Were procedures adequate to describe the activity and were procedures fol-
lowed?
• Was the equipment involved in proper working order?
• Were there any changes implemented recently?
• What are the recommendations for correction?
If laboratory testing was involved, a similar investigation of the laboratory
work should also be conducted.
The review may uncover that a CCP was not properly identified, not prop-
erly controlled or monitored, or a change was implemented whose impact on the
process was not adequately assessed. Corrective actions, designed to prevent reoc-
currence of the failure, need to be implemented. Corrective actions may include
new controls, new monitoring methods or criteria, and revised or new procedures
to ensure that the new actions are carried out as planned. One additional aspect
is to determine if and how the changes implemented in the corrective actions
may have impacted other CCPs. Corrective action may also need to address the
impact of the failure on product disposition. All fact finding results and actions
taken must be documented. Deviation and product disposition procedures must
be in place and documented in the HACCP record keeping. Finally, it must be
determined that the manufacturing process is again under control, which can be
shown through another risk assessment.
11.3.4.12 Principle 6: Establish Procedures for Verification Any HACCP plan
must be verified initially and on an ongoing basis to ensure that the process is
being maintained in a state of control, that all hazards have been identified,
and identified hazards are either being eliminated or controlled at acceptable
levels. Verification involves activities other than routine monitoring ones and may
A risk assessment may be performed by using any one of several risk assessment tools such as
failure mode and effect analysis (FMEA) or fault tree analysis (FTA).
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