Biomedical Engineering Reference
In-Depth Information
living documents that are visible and subject to change as required. Risk assessments that were
conducted as one off activities to assess a situation that will not recur need not be controlled in a
“live” manner but must be documented, approved, and retained for assessment of a temperature
excursion on storage of a batch of starting material. Such “one off” activities should be controlled as
live documents if any conclusions are to be used in any future excursions. Ultimately, these may then
need to be reviewed in light of experience or developments.
13. Do risk assessments have to
be supported by factual
evidence or can they just
use professional judgment?
There should be factual evidence recorded to support any conclusions drawn from egg plant design
details in controlling cross contamination—an unsupported assumption that the plant must be suitably
designed as we have used it for 10 yr or we have had an standard operating procedure (SOP) for 5 yr
so it must be suitable is a weak approach that may be unfounded and must be challenged by those
conducting risk assessments. Professional judgment should be used in the interpretation of factual
evidence but must be subject to justification.
14. Scoring in risk assessments
is subjective, is there danger
that risk assessments may be
manipulated to draw desired
conclusions?
The scoring system and trigger points for mitigating action are subjective. However, as important as the
scores in risk assessments is the rationale for the score. If supported by factual evidence, it should be
more obvious what mitigating action is required—the mitigating action is as important as the score
assigned. Companies should not score risks in a blinkered manner without considering the factual
causes, likelihood of detection, and consequences. Inspectors will be alert to improper use of risk
assessments to condone poor practice or exclude patient risk.
15. Is it acceptable to allow
external consultants to
participate in site risk
assessments?
It may be appropriate for consultants to provide support for risk assessments where they can provide
specific expertise or knowledge. Their role in the risk assessment should be clear. The reason for
delegation and resultant accountability must be understood. Inspectors will expect sites to demonstrate
that delegation was effective and that appropriate skill, knowledge, local knowledge, and local
accountability was appropriate for the life cycle of the risk assessment. A technical agreement may be
appropriate with the consultant where GMP responsibility is assumed.
16. Is it acceptable to allow
contract staff to participate in
site risk assessments?
It would be usual for contract staff, for example, contract QPs, to lead or participate in risk assessments.
The extent of involvement as responsibility/accountability must be documented in the technical
agreement between the individual and the organization.
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