Biomedical Engineering Reference
In-Depth Information
1. High risk scores (RIs or RPNs): address those with highest severity first
for risks with identical RIs or RPNs.
2. High severity: consider controlling items of extreme severity even if total
RI or RPN is not very high.
3. High occurrence: recurring problems indicate improvement opportunities.
4. Low detection: improving detection can allow the risk to be noticed when
it occurs and managed before it impacts product quality or patient safety.
5. Risk acceptance: if it is not practicable to reduce the risk further the ratio-
nale for why the risk is being accepted (e.g., a risk benefit analysis) and the
persons accountable for the risk acceptance decision, as well as monitoring
plan, should be documented.
Results of the RA and risk control implementation should be documented
and residual risks should be evaluated to determine if further risk reduction
is required. Formal acceptability of the residual risk should be approved by
appropriate decision makers.
Risk Management Report The risk management report summarizes the results
of the RA, risk control strategies, residual risk, and rationale for why the level
of risk is acceptable and the frequency for periodic review. The report should
be approved by the appropriate decision makers including process owner and
quality unit.
Risk Review On the successful technology transfer and operational startup of
the process, completion of the initial RAs and implementation of risk control
strategies, residual risks need to be monitored to ensure that risk controls are
appropriate and that no new risks have been introduced without appropriate con-
sideration. The RA and risk control strategies should be reviewed and updated to
maintain risk management as a “living” process. One or more of the following
instances will require updates to the RA document:
1. identification of new risks or changes to existing risk profile during routine
operations;
2. introduction of new controls or changes made to existing controls; and
3. need for change in previous risk control decisions.
Some instances where changes to risks or controls can occur are changes
that could potentially impact system/process configuration (e.g., changes to open
vs closed processing), changes to QC testing requirements, changes that could
potentially impact filter design, use, or operation, or in case of significant events
such as investigations (e.g., contamination, etc.) or adverse monitoring trends.
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