Corrective actions principles and root cause analysis in ISO 17025

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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.

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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