Unplanned Deviations Sample Clauses
The Unplanned Deviations clause defines the procedures and responsibilities when unexpected departures from agreed-upon processes, specifications, or standards occur during a project or contract. Typically, this clause requires prompt notification to the relevant parties, documentation of the deviation, and a review or approval process to determine corrective actions or acceptance. Its core function is to ensure that any unforeseen issues are managed transparently and systematically, minimizing risks and maintaining quality control throughout the project.
Unplanned Deviations. Any unplanned deviations from approved procedures, batch records, specifications or test methods will be immediately investigated, evaluated, documented and approved by Formosa’s QA unit. Formosa QA will notify NGX QA of any significant unplanned deviation occurring during a manufacturing run within [***] and of any other significant deviation within [***]. NGX QA unit will review and approve the investigation plan. NGX reserves the right to request additional or more in-depth investigation by Formosa. The documentation of the deviation, the investigation and any necessary actions required for resolution will be retained as part of the batch document for the batch(es) affected. A copy thereof will be provided [***] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. to NGX no later than [***] after completion of the investigation by Formosa for NGX review and approval.