Biomedical Engineering Reference
In-Depth Information
5. Should sites have a formal risk
register and management
process?
Yes, a risk register (or equivalent title document) should list and track all key risks as perceived by the
organization and summarize how these have been mitigated. There should be clear reference to risk
assessments and indeed a list of risk assessments conducted should be included or linked to the
register. A management process should be in place to review risk management—this may be
incorporated into the quality management review process.
6. What tools are acceptable to
use in QRM?
There is no definitive list, although a number of examples are given in Annex 20 (and ICH Q9). In
some cases, combinations of tools or other approaches may be used. The important criterion is that
the tool used should support the key attributes of a good risk assessment (see the following text).
7. Do formal tools and a full
report have to be issued for
every risk assessment?
As stated in Chapter 1 of the EU GMP guide, “
...
the level of effort, formality, and documentation of
the QRM process is commensurate with the level of risk.” As such expectations of inspectors will be
pragmatic regarding the degree of formality that is required, however, appropriate evidence should be
available of what has been done and as such a written output must be retained. Inspector's
pragmatism will be directly related to the nature of the risk with increasingly more formality and
detail required for more significant risk (risk being the probability of occurrence of harm and the
severity of that harm, often supplemented by the ability to detect the potential harm occurring).
8. What are the key attributes of a
good risk assessment?
The following key attributes should be observed (mindful of the risk significance addressed in the
previous question):
• Clearly identify the process being assessed and what it is attempting to achieve, that is, what the
harm/risk is and what the impact could be on the patient
• Be based on systematic identification of possible risk factors
• Take full account of current scientific knowledge
• Be conducted by people with experience in the risk assessment process and the process being risk
assessed
• Use factual evidence supported by expert assessment to reach conclusions
• Do not include any unjustified assumptions
• Identify all reasonably expected risks—simply and clearly along with a factual assessment and
mitigation where required
• Be documented to an appropriate level and controlled/approved
Search WWH ::
Custom Search