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.
Clause 8.7 Explanation
Identification and Control: The organization is required to identify and control any nonconforming outputs. This includes products, services, or processes that do not meet the specified requirements.
Evaluation and Decision: Nonconforming outputs must be evaluated to determine the significance of the nonconformity. The organization needs to decide whether the nonconformity affects the product's intended use or the customer's satisfaction.
Actions: Depending on the evaluation, the organization needs to take appropriate actions. This could include correction (to make the nonconforming output conform), 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, indicating the nature of the nonconformity, the actions taken, noting any concessions or waivers obtained, and authorized 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, need to be informed about the nonconformity and the actions taken.
Electronic Components Manufacturing Company Clause 8.7 Example
Nonconforming Component: During the quality control process, a batch of components is identified as nonconforming due to a deviation in the manufacturing process.
Evaluation: The quality team evaluates the nonconformity to determine its significance. They assess whether the deviation affects the component's functionality or reliability.
Actions: If the nonconformity is significant, the organization might decide to rework the components to bring them into compliance. If not, the components may be scrapped or used for non-critical applications.
Documentation: The details of the nonconformity, the evaluation, and the actions taken are retianed as documented information . 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 make improvements to the manufacturing process.
ISO 9001:2015 Clause 8.7 Control of Nonconforming Outputs
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.