Why Horizontal Expansion Is Not a Preventive Measure
When the author conducts seminars on CAPA (corrective and preventive actions), he is often asked. One of them is about the rationale that “horizontal deployment is not preventive action.” One of them is about the rationale that “horizontal deployment is not a preventive measure.
The author explains at CAPA seminars and other events that “horizontal deployment is not preventive action, but corrective action.
Root causes that occur in one event may also exist in other products or processes, making horizontal deployment extremely important.
The concept of corrective and preventive actions is as follows
corrective action (measure)・・・Prevent recurrence of events (past tense) that have occurred
preventive measure・・・Prevention of risk (future form)
In ISO 9000:2015 (JIS Q 9000:2015), the definition of preventive action is “ An action to eliminate a possible nonconformity or other possible cause of an undesirable situation.” It states.
In this definition, a “possible nonconformity” is a problem that has not yet occurred, i.e., a “risk preventing the problem before it occurs.
Horizontal development is never future tense (not risk) because it is an application to other products or processes for an event that has occurred (past tense).
In other words, if the root cause is a treatment for the same thing, the risk has not been discovered and the risk has not been prevented.
However, the author believes that the debate over whether horizontal development is corrective or preventive action can go either way.
What is important is to prevent recurrence and preventative measures whenever possible to ensure patient safety, product quality, etc., and not whether horizontal deployment is a preventive measure.
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