This Quick Process Guide follows the methodology laid by the requirements in the ISO 9001:2015 standard; in particular, those stated in section 10.2 Nonconformity and Corrective Actions.
In general, this process could be applied to any deviations from target, including positive deviations.
2.1 Identification and documentation
The control of non conformities (NC) starts with the identification and documentation of the event. The documented information should be such that the identification of what failed in terms of the product or service ID and how it failed in terms of the observed manifestation of the NC (e.g. bent, missing parts, loss functionality, etc.).
2.2 Control (Containment)
Once the NC has been identified and documented, the following step is to prevent unintended use or delivery of the NC product or service. This can be achieved by tagging, segregation or both. The organization should also take actions to mitigate the negative effects of the NC when applicable.
2.3 Identify the physical cause
In order to enable chose a suitable Disposition the organization should identify the physical cause of the observed manifestation of the NC. The physical cause may be already identified as the observed manifestation of the NC (e.g. bent). In other cases, further analysis would be required to identify the physical cause of the failure (e.g. loss functionality caused by open circuit)
2.4 Identify the impact
In order to choose a suitable disposition and decide if corrective actions are applicable, the organization should determine the impact or risk associated to the NC. Not all events produce the same losses or represent the same level of risk, therefore organizations need to have a process to prioritize resources for causal analysis and corrective actions. A practical way to implement this is by means of an Impact-Frequency matrix. Quantitative ranges for each parameter varies per organization. A qualitative matrix can be used until enough data is gathered to determine the numeric ranges.
The NC should be analyzed in term of causes and impact and a decision made with respect to the appropriate way to dispose the NC product or service. The alternatives for disposition include rework, repair, re-grade, use or sale as-is, scrap, replace and return-to-vendor.
3 Supplemental Processes
The following process may be used to supplement the Management of Nonconformity process.
Causal Analysis: The organization deploys resources to understand the causes of deviations. Not all deviations should trigger such analysis.
Corrective Actions (CA): The CA process enables the reduction of the risk of recurrence of NCs in scope. Normally not all NC trigger Corrective Actions.
Analysis of data: The Analysis of Data process enables the evaluation effectiveness of management of nonconformities. The analysis may trigger CAs for recurrent low-severity NCs.
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