A corrective action is a mandatory activity for all laboratories approved to ISO 17025 certification in South Africa. It should, yet, not be seen as a “rule” or a singular step, but as a core process of an interrelated, functional Quality Management System.
Laboratories frequently struggle
with nonconformance’s and corrective actions, where they are excessively
time-consuming or the chosen corrective action does not achieve the intended
result. Moreover, the level of control is often not proportionate to the impact
on quality objectives. Typically, this is because a hazard-based approach was
not adopted, or inadequate steps were taken.
This article offers an overview of
applying hazard-based thinking to corrective action. It is presented through
statements of five hazard-based principles and practical steps to improve the
handling of nonconformance’s and root cause analysis to achieve effective
corrective actions.
What has modified in the new
revision of ISO/IEC 17025?
When a laboratory’s consequences or
things to do not conform to its own procedures or client requirements, the
undesired situation is classified as a nonconformance. ISO
17025:2017 certification in Qatar requires laboratories to
follow a procedure to handle nonconformance’s. Where there is doubt about the
compliance, or if there is a hazard that the nonconforming work could recur, a
decision must be made to follow the corrective action procedure. This is
nothing new; the equal used to be required in ISO/IEC 17025:2005, the previous
version.
What has changed is the requirement
for managing corrective actions. There is now no mandatory procedure needed and
laboratories can decide, based on evaluation, if there is a need for action to
eliminate the cause(s) of the nonconformity. This means that laboratories
should take a hazard-based approach and should development any action needed
(in light of the hazard).
Not all nonconformance’s require
corrective action.
A correction addresses the
short-term require, being a remedial reaction to control and correct the
nonconformance. Corrections would be applied to every nonconformance. ISO 17025
Certification in Philippines Corrective action, however, taking
a hazard-based approach, is not always necessary, and in some cases not
possible. As the objective is to control the ongoing hazard so that the same or
a similar problem does not happen again, taking remedial action alone will
require justifying the event as an isolated incident or why the current hazard
level is accepted.
The difficulty for any laboratories
is deciding whether correction alone is sufficient.
Application:
Never more ignore an event, even if
only a correction is necessary. Record it and monitor for any reoccurrence and
change in hazard level.
There are 2 primary reactive
situations that trigger the need for a corrective action after a correction:
- When the evaluation of the nonconformance indicates a
hazard of it happening again.
- When there is problem about the laboratory’s operations
conforming to its own management system. For example, variation in the
quality of operations or lack of competency to meet ISO 17025 needs.
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