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ROI CalculatorThe Nonconforming Product Control process is an essential quality control and regulatory compliance procedure aimed at identifying, segregating, evaluating, and disposing of any raw material, batch, or finished product that does not meet the set technical standards and specifications.
Identification (Detect Deviation/Defect)
Segregation (Physical/Digital Isolation)
Evaluation (MRB / Risk Assessment)
Disposition (Scrap / Rework / UAI)
In any industrial process, be it manufacturing, assembly, or packaging, the creation of defective products or deviation poses an ever-present danger. It can be due to worn-out tools, variance in raw materials, software defects, or human error. Products that fail to conform to the required specifications are likely to find their way through the process.
The main goal of Nonconforming Product Control lies in setting up a comprehensive procedure to ensure that such non-conforming items are not inadvertently installed, processed, or shipped. Through effective implementation of this control measure, manufacturers protect both user satisfaction and themselves against catastrophic risks such as liability lawsuits or product recalls.
The continuous maintenance of a control loop with respect to non-conformance is one of the core requirements in all global quality systems. The FDA requires it according to 21 CFR Part 820.90, applicable to medical devices, whereas ISO mandates nonconformity control under the ISO 9001:2015 (section 8.7) or AS9100 for aircraft manufacturing processes.
Regulatory agencies regard the absence of either physical or digital control with respect to non-conformities as a serious structural failure of an organization’s quality management system. In the absence of any valid documentation concerning the non-conforming stocks, the consistency, safety, and validity of the product deliveries can hardly be demonstrated.
To build a legally defensive nonconforming product control system that ensures that unqualified products never reach a consumer, the organization must follow through on a consistent four-step cycle of operations:
Identification: As soon as a deviation is detected by an operator, vision system, or any analytical instrument, the product must immediately be flagged. Such identification requires physical tagging of materials with clear red tags that state either ‘HOLD’ or ‘REJECTED’ as well as locking out the material from the inventory system via the enterprise resource planning (ERP) or manufacturing execution system (MES).
Segregation: In order to ensure that the flagged materials do not become a part of the production, they must be segregated and moved from the production area to a dedicated, restricted-access location known as a quarantine cage or hold area. This zone must remain and should be accessed only by authorized personnel, preventing any mixing with the rest of the stock.
Evaluation/Investigation: The cross-functional team, commonly known as the Material Review Board or MRB, analyzes the technical reason for the failure. The MRB also analyzes the extent of the risk involved, the impact on other batches, and assesses whether it is an exception or a problem with the entire process.
Disposition: The ultimate disposition of the product/material is decided based on the investigation/evaluation, and it is authorized on the basis of hard facts and can have one of the following dispositions:
Scrap (destruction of the material)
Rework (redone by an authorized process)
RTV (Return to Vendor)
Use As Is (with engineering approval)
Executing a Non-conformance Report (NCR) is more than just an isolated task. It is a fundamental source of data for the continuous improvement framework of the facility. Each instance of a reported non-conformance gives exact data points on where a particular process is leaking money or becoming unstable. Once the trend is observed, indicating that a certain piece of machinery, vendor batch, or production line is producing repeated NCRs, it becomes necessary to open a corrective and preventive action (CAPA) file and initiate the corrective process through the proper channels. With this completed loop, the company does more than just sort material but applies the knowledge gained in optimizing machine settings, upgrading tools, and improving operator skills to increase yield efficiency and ultimately the quality.
