123
Quality and risk management tools
Table 7.3 Suggested list of consequences of Failure Effects (“risks”) in an FMEA. The real range that might be encountered is 1 to 10, although the ranking of a risk as 9 or 10 should only refer to Failure Modes that are assessed as very unlikely (see Table 7.2) Consequence
Rating
Comments
0 1 2
None Trivial Minimal
4
Minor
6
Serious
8
Major
Hence it cannot be considered a real risk. In reality, there is no measurable adverse risk. The effect is, in reality, more of a nuisance or inconvenience with no identifiable effect on patient care. e.g. an adverse effect upon efficiency, but without any measurable effect on treatment outcome. e.g. significant adverse effect upon a patient’s treatment outcome. e.g. loss of embryos, OHSS,a infection of patients or staff. e.g. loss of life, damage to facility. e.g. loss of multiple lives, destruction of facility.
9 10 a
Extreme Catastrophic
OHSS Ovarian Hyperstimulation Syndrome
A Risk Matrix is a tabulation of the scores for all the risks identified by an organization in a way that allows them to be deemed, according to a partitioning of the Criticality scores, as (for example) no risk, low risk, medium risk, significant risk or high risk. These classifications can then be used in prioritizing the identified risks for management. In engineering, Pareto methodology is commonly used to identify the 20% of “significant risk” issues that cause 80% of the process variability (Hutchison, 1994), i.e. the most important Failure Modes to address. However, in biology this sort of relationship is not always apparent or easy to determine, and decisions are often based on experience; this is a significant part of the reason why an IVF lab needs to have a senior, experienced scientist acting as its Director. The endpoint of the FMEA is the creation of an Action Plan which must then be implemented. It is vital that for each change that is instituted within the Action Plan there is a system for monitoring its effectiveness and efficacy – without this there will be no evidence of positive