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ROI CalculatorA Nonconformance Report (NCR) is a document that is created for the purpose of documenting a deviation from established standards, procedures, or requirements. The document serves as a tool for identifying and investigating nonconformances and documenting the corrective actions taken to resolve product or process failures, with an aim to prevent recurrence of the issue. A Nonconformance Report is part of the effort to ensure compliance with regulatory requirements and to facilitate continuous improvement.
There are many different ways of defining a nonconformance and the terminology surrounding it, for example, the definition and terminology used by an organization may depend on its quality management system (QMS), documented procedures, and industry-specific guidelines.
The different terms used by organizations to refer to an NCR are listed below.
Non-Conformance Report (NCR)
Nonconformity Report
Deviation Report (commonly used in pharmaceutical and biotech industries)
Quality Event Report
Out-of-Specification (OOS) Record (typically used in QC labs)
An NCR is used to document an instance in which an approved standard, procedure, drawing, acceptance criteria, or work instruction was not adhered to.
The intent of an NCR is to document and identify quality problems. The use of an NCR also provides a mechanism for preventing the unintentional release of nonconforming products and for initiating necessary actions to resolve the situation, such as segregation, rework, re-inspection, or escalation to corrective actions and preventive actions (CAPA). NCRs are an essential component in the performance of quality audits, regulatory inspections, the management review process, and the overall continuous improvement program.
NCRs can be used across industries that are regulated or deemed to be high risk, which includes, but is not limited to, the following: medical device manufacturers, pharmaceutical manufacturers, biotech companies, healthcare organizations, laboratories, F&B manufacturers, automotive manufacturers, aerospace manufacturers, sheet metal manufacturers, engineers, and large-scale construction or infrastructure projects.
When a product, process, or system produces a noncompliance with defined acceptance criteria or specified requirements, a Nonconformance Report should be issued, indicating that there was a nonconformance.
Nonconformances are classified based on their severity and potential impact. Commonly used categories are listed below.
Critical: Critical nonconformances pose safety risk, regulatory impact, or product recall potential.
Major: Major nonconformances impact quality or compliance, but are not immediately hazardous.
Minor: Minor nonconformances are isolated or low-risk issues that do not directly affect product quality or safety.
A QMS contains the guidelines and rules regarding the NCR process for handling the reporting, evaluation, investigation, and closure of Nonconformances. The purpose of this process is to ensure that all filed Non-Conformances are processed in a similar manner with a record of their processing.
Competent personnel in the QA, QC, manufacturing, inspection, and Regulatory Affairs department, based upon the location of the detection or the regulatory significance of the nonconformance will initiate and process nonconformance records in accordance with the established process outlined above. The QA team will develop and implement a quality impact assessment based on the quality of the product or process. In addition, the QA team will coordinate and conduct nonconformance record investigations, as necessary. Additionally, the QA team will determine whether the nonconformance record will be escalated to a CAPA report.
A nonconformance report template is a controlled document that is used to document any detours from approved specifications, established processes, regulatory guidelines, or documented operation or procedures. The nonconformance report template defines the mandatory areas to document for the detour.
When completing the report template, due-diligence documentation must be provided by including a clear description of the occurrence; appropriate regulatory requirement reference. Impact Assessment documentation must include everything impacted due to the occurrence. The report template must classify each detour by risk level, document the final disposition and include steps taken to immediately separate or contain the impacted product. The report template will assign an investigative owner, link to the required CAPA report and include final signature(s) of the supervisor responsible for the closure of the Non-Conformance.
