Control of Nonconformities. Contractor shall: · Issue Nonconformance Reports (“NCRs”) for nonconformance of Work with the Quality Plan and applicable Project Drawings and Specifications. Contractor shall maintain a status summary of open NCRs and provide them to Owner as part of the Monthly Progress Report; · Segregate nonconforming materials and assemblies to a clearly designated rejection site. Contractor shall track and control nonconforming Equipment or materials until it is repaired, exported, or otherwise disposed. The responsibility for review and authority for disposition of non-conformances against Owner approved procedures shall be defined in the Contractor Quality Plan and applicable project procedures.
Control of Nonconformities. Contractor shall: Issue Nonconformance Reports (“NCRs”) for nonconformance of Work with the Quality Plan and applicable Project Drawings and Specifications. Contractor shall maintain a status summary of open NCRs and provide them to Owner as part of the Monthly Progress Report; and Segregate nonconforming materials and assemblies to a clearly designated rejection site. Contractor shall track and control nonconforming Equipment or materials until it is repaired, exported, or otherwise disposed. Y-3
Control of Nonconformities. The organization shall ensure that situations that do not conform to the requirements of this standard are identified and controlled to prevent undesirable consequences. Records of the nature of the non-conformity and any subsequent action taken shall be maintained. The controls and related responsibilities and authorities for dealing with non-conforming situations should be defined in a procedure. Intent: The organization should establish a mechanism to identify nonconformities and take action to control and prevent them from reoccurrence. Typical input may include: performance management and analysis data; audit reports, inspections and periodic reviews; measurement and analysis of matrix; root cause analysis of nonconformities identified. A systematic approach is necessary for the ongoing effectiveness of the biorisk management system to address nonconformities. The approach should include: procedures to identify, investigate and correct nonconformities; reviews of operations to prevent anticipated reoccurrence; analysis of the impact of the nonconformity on other aspects of the biorisk management and correction of potential effects; revision of the biorisk management and documentation of the changes made; communication of relevant nonconformities and corrective and preventive actions to impacted individuals; addressing responsibilities, authority, and the steps to the process. The result should be the establishment of a mechanism to identify nonconformities and take action to control and prevent them from reoccurrence.
