D. Alentorn
Memoria Investigaciones en Ingeniería, núm. 26 (2024). pp. 265-274
https://doi.org/10.36561/ING.26.16
ISSN 2301-1092 • ISSN (en línea) 2301-1106 – Universidad de Montevideo, Uruguay 269
3. Analysis and Discussion.
3.1 Prevention.
3.1.1 Relationship between preventive and corrective actions with risk-based thinking. - The ISO 9001:2015
Standard [1], Annex A, Clause A.4 Risk-based Thinking, establishes: “One of the key purposes of a quality
management system is to act as a preventive tool. Consequently, this International Standard does not have a separate
clause or subclause on preventive action. The concept of preventive action is expressed through the use of risk-based
thinking in formulating quality management system requirements.”
This shows prevention as associated with preventive actions, but it is then worth questioning whether corrective actions
are included in the concept of prevention.
Considering ISO definitions for preventive and corrective actions (see 2.1 and 2.2), it is concluded that preventive
actions are intended to prevent the occurrence of a nonconformity and corrective actions are, in turn, intended to
prevent the recurrence of a nonconformity . Therefore, the concept of prevention should include both. Likewise, from
the cited paragraph, preventive actions have been replaced by risk-based thinking, but it is restricted to "formulating
requirements for the quality management system." It should be noted that, by definition, preventive action not only
refers to this, but also to preventing the occurrence of any non-conformity, for example of a product or a process.
Suppose that a negative trend of a process is observed, which is below the minimum acceptable quality level, the
maintenance of the trend would result in a non-compliant value. A preventive action to solve this is not the formulation
“of quality management system requirements”, but it is a common type of preventive action.
Therefore, the current ISO concept of preventive action (see 2.1) is limiting and the same applies to corrective action,
since it has not been interpreted from a risk-based thinking perspective. According to its current definition, it would
be appropriate to do so as an action taken to eliminate the risk of recurrence of a nonconformity, just as preventive
action should be interpreted as an action taken to eliminate the risk of the occurrence of a nonconformity.
On the other hand, although a similar treatment is observed in the ISO definitions of preventive actions and corrective
actions, the concept of preventive action is more comprehensive than that of corrective action, as it includes not only
the elimination of a cause of nonconformity , but also that of “another potential undesirable situation.” This approach
is much more aligned with risk-based thinking and should be incorporated into the concept of corrective action, to
include the elimination of the cause of other real undesirable situations, for which there is a risk of recurrence.
3.1.2 Prevention and Improvement. - In Note 1 to the continual improvement definition (see 2.5), it is established
that “generally leads to corrective action or preventive action”. The word “generally” refers to other types of
improvement actions that are not corrective or preventive actions as defined by ISO (see 2.1 and 2.2). In fact, this is
where risk-based thinking again contributes to improving the improvement concepts, allowing to consider those actions
that, without eliminating the cause of real or potential non-conformities, reduce the risk associated with recurrence or
occurrence respectively.
Reviewing the meanings of prevention in English and Spanish languages, there are important differences. In English
[13] the main meaning is “the action of keeping from happening or making impossible an anticipated event or intended
act”. So, this concept is only related to negative effects, that is why the action is to make impossible the event. But in
Spanish [9] the main meaning is "to prepare, harness and arrange in advance what is needed for a purpose" . This
concept is more comprehensive in Spanish, because it could be related also to events with positive consequences on
the purpose. Thus, this kind of action should be included in the concept of preventive action, from the risk-based
thinking perspective, not only considering the negative effects on the objectives (undesirable situations or potential
non-conformities) but also the positive effects. Prevention and improvement are not only related to negative effects on
the objectives. Continuing with risk-based thinking, suppose an event or condition that, if it occurs, will have a positive
effect on the objectives. Suppose a strategy to increase its likelihood and/or its positive impacts. In this case, we would
be taking an action that does not respond to the prevention of the occurrence of a negative impact, but to the promotion
of the positive impacts.
3.2 Improvement and Cost of Quality. - The Prevention-Appraisal-Failure (PAF) quality cost model is defined [10]
as “a methodology that allows an organization to determine the extent to which its resources are used for activities that
prevent poor quality, that appraise the quality of the organization’s products or services, and that result from internal
and external failures.” This methodology considers conformance costs (prevention and appraisal) and nonconformance
costs (internal and external failures).