Management system auditors are responsible for reviewing the response to a nonconformity and verifying the effectiveness of actions taken by the organisation/company.
The organisation/company must address a nonconformity by applying the following:
| Correction, | or | Cause analysis, |
| Cause analysis, and | Correction, and | |
| Corrective action | Corrective action. |
To better understand how to apply the above terms, let us recall their meaning.
Nonconformity: failure to fulfil a requirement.
Correction: action to eliminate a detected nonconformity.
Corrective action: action to eliminate the cause of a nonconformity and prevent recurrence.
Let us now analyse the significance of each in more detail.
“Correction” is the action of eliminating a detected nonconformity. For example, a correction may involve replacing a non-conforming product with a conforming one, or completely replacing the procedure relating to the identified problem, etc.
Corrective action cannot be applied without analysing the cause of the nonconformity. Several methods and tools are available to the organisation/company for determining the cause, ranging from simple brainstorming to more complex systematic problem-solving techniques, such as: root cause analysis (people, equipment, materials, methods, measurements, environment), the fishbone diagram (Ishikawa), 5 Whys, etc.
The scope and effectiveness of corrective actions depend on correctly identifying the true cause of the nonconformity. In some cases this will help the organisation/company to identify and minimise similar nonconformities in other areas.
During the audit, it is verified whether the organisation/company has taken actions to determine the cause of the nonconformity and whether it is systemic or accidental. If a systemic failure is treated as an accidental one, the corrective action will not be successfully applied and there is a likelihood that the problem will recur.
Also, during the audit, particular attention is paid to whether the nonconformity arises from internal factors (due to the management system, including its application) or external factors (the organisation/company’s misunderstanding of customer or supplier requirements).
Some examples of causes of nonconformity:
- Poor quality of raw materials and materials
- Inadequate measurement systems
- Unqualified personnel
- Ineffective training, etc.
Thus, effective corrective actions should prevent the recurrence of a nonconformity by eliminating its cause.
Closing nonconformities.
Before concluding that a nonconformity is closed, the content, correction, cause analysis and results of corrective actions must be verified once more. It must be ensured that objective evidence exists (including documentary support) regarding the description of the implementation of corrective actions and their effectiveness in preventing the recurrence of the nonconformity.
Only when the situation is satisfactory should the nonconformity be closed.
For more information visit the official website of the International Organization for Standardization https://www.iso.org/home.html. We hope this article has provided useful information that you will be able to apply.