Biomedical Engineering Reference
In-Depth Information
TABLE 3.3 (
Continued
)
MHRA QRM Frequently
Asked Question
MHRA Response
9. What is the difference between
a planned and unplanned risk
assessment?
A planned risk assessment is one that is conducted in advance of conducting an activity, either before
any activity is conducted or before further activity is conducted. This would often allow quality to be
built in to activities and risk reduced (quality by design), for example, design of facilities for
manufacture of cytotoxic products or organization/design of a label-printing room. An unplanned risk
assessment is one that is conducted to assess the impact of a situation that has already occurred, egg
impact of a deviation from normal ways of working.
10. Should we expect there to be
no risk to patient safety as a
conclusion to a risk
assessment?
In reality, there is always a degree of risk in all situations but mitigation controls should minimize the
likelihood to an acceptable level of assurance. The degree of risk tolerated very much depends on the
circumstances, the proximity to the patient, and other controls that may follow the process being
assessed before the product is used by the patient. It should be expected that risk mitigation plans are
identified and implemented where any risk to patient safety is posed. Companies should take a
holistic view and be mindful that critical issues often occur where multiple failures in systems occur
together, so mitigation plans should be sufficiently robust to tackle such potential. Inspectors will be
assessing if risk assessments underrate either the likelihood, consequences, or detection of
occurrences in order to make it appear that there is minimal risk to the patient. The factual evidence
behind statements may be challenged.
11. Are any areas out of bounds
for risk assessment?
It would be unacceptable for risk assessment to conclude that statutory, regulatory, or GMP
requirements should not be followed or are not appropriate, for example, risk assessment could not
conclude that it was appropriate for licensed products to be released by someone who was not a
qualified person (QP). Otherwise, risk assessments can be used within GMP systems as a tool to
identify, quantify, and minimize risk to patient safety.
12. How should risk assessments
be controlled?
Risk assessments should be controlled within a defined document management system. If risk
assessments are conducted to justify controls for an ongoing process, then the assessments should be
subject to change control and periodic review, egg line clearance risk assessment. Frequency of
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