ISO 9001 Clause 8.7, “Control of nonconforming outputs,” focuses on how organizations should handle products, services, or processes that do not meet specified requirements. It outlines the requirements for managing products and services that do not conform to specified requirements. The purpose of this clause is to ensure that nonconforming products or services are identified and controlled to prevent their unintended use or delivery.
Clause 8.7 Control of Nonconforming Outputs Explanation
- Identification and Control: The organization must identify and control any nonconforming outputs, including products, services, or processes that do not meet the specified requirements. They should be segregated from known (conforming) outputs, red tagged, or placed in a “hold” area awaiting proper disposition.
- Evaluation and Decision: Nonconforming outputs must be evaluated to determine their significance. The organization must decide whether the nonconformity affects the product’s intended use or the customer’s satisfaction. This may include a material review board (MRB) composed of personnel from quality, engineering, production, and others to determine the disposition of the output.
- Disposition Outcomes: The output’s disposition can be either scrapped, used as is (which means it’s fine as is), reworked, returned to the vendor, or a customer waiver or concession can be obtained in writing to use it.
- Actions: Depending on the disposition evaluation, the organization needs to take appropriate actions. This could include correction (to make the nonconforming output conform), continued segregation or red-tagging (to contain the nonconforming output and prevent its unintended use), or other measures to address the nonconformity.
- Documentation: Documented information is required for nonconforming outputs. This information must indicate the nature of the nonconformity, the actions taken to address the nonconformities, any concessions or waivers obtained, and the authority responsible for the actions taken.
- Review and Analysis: The organization should review nonconforming outputs to identify trends, potential causes, and areas for improvement. This contributes to ongoing process improvement.
- Communication: Relevant parties, including those responsible for the nonconforming output and those who could be affected, must be informed about the nonconformity and the actions taken.
Practical Steps for Implementation
To comply with ISO 9001 Clause 8.7, organizations typically follow these steps:
- Identify Nonconforming Outputs: Establish procedures for identifying nonconforming products or services at various production, delivery, or post-delivery stages. This includes inspections, testing, and customer feedback.
- Segregate Nonconforming Outputs: Implement methods for segregating nonconforming items to prevent unintended use. This can involve using designated areas for holding nonconforming products and labeling them appropriately.
- Determine and Implement Actions: Decide on the appropriate actions to address the nonconformance. Actions can include reworking the product, accepting it for an alternate use, rejecting it, or obtaining a concession from the customer.
- Authorize Disposition: Ensure that all dispositions are authorized by personnel with the appropriate authority. This typically involves quality managers or other designated individuals.
- Document Nonconformance and Actions: Maintain detailed records of all nonconformances and their actions to address them. This includes the nature of the nonconformance, the corrective actions, any concessions obtained, and the personnel responsible for the decisions.
Electronic Components Manufacturing Company Clause 8.7 Example
XYZ Manufacturing Co. produces precision components for the aerospace industry. Given the critical nature of their products, managing nonconforming outputs is essential to maintain quality and compliance with regulatory standards.
- Nonconforming Component: During the final inspection, a batch of precision components was found to have dimensional deviations that did not meet the specified tolerances.
- Segregate Nonconforming Outputs: To prevent unintended use, the nonconforming components were immediately labeled and moved to a designated “Nonconforming Product” area in the warehouse.
- Evaluation: The quality control team assessed the nonconformance and decided that the components could be reworked to meet the specified tolerances. A rework plan was developed and implemented.
- Documentation: Detailed records were maintained documenting the nature of the nonconformance, the rework actions taken, the results of the rework, and the quality manager’s authorization of the disposition. This provides a record for future reference and analysis.
- Review and Analysis: The organization regularly reviews instances of nonconforming outputs to identify patterns or recurring issues. This information is used to take corrective action and improve the manufacturing process.
By effectively managing nonconforming outputs, XYZ Manufacturing Co. ensured that no nonconforming components were used or delivered to customers. This approach helped maintain high-quality standards, comply with regulatory requirements, and protect their reputation in the aerospace industry.
ISO 9001:2015 Clause 8.7 Control of Nonconforming Outputs
ISO 9001 Clause 8.7 emphasizes the importance of controlling nonconforming outputs to maintain product quality and prevent the unintended use or delivery of defective products. Organizations can effectively manage nonconforming outputs and ensure continuous improvement in their quality management systems by identifying, segregating, determining actions, authorizing dispositions, and documenting nonconformances.
By adhering to Clause 8.7, the organization ensures that nonconforming outputs are contained and handled systematically, contributing to the overall effectiveness of the quality management system.
