Objective
When deviations occur or are predictable in the production process, there is the timely and accurate process standard to effectively control the impact of deviations and appropriate measures should be taken to prevent the recurrence of such deviations.
Scope
Applicable to all deviations and abnormal situations in the whole process of production quality management.
Responsibilities
Post operator: Identify deviations, and record deviations and anomalies. Responsible for reporting immediately to the head of the Department and notify QA at once.
Department head and / or technical personnel: Responsible for immediate (emergency) handling of deviations. Responsible for reporting immediately to Quality Management Department and senior administrators when necessary.
Deviation investigation team: Responsible for investigating the root cause of deviations; Responsible for assessing the impact of deviations; Responsible for putting forward corrective and preventive actions.
Quality Management Department: Responsible for the classification of deviations; Responsible for approving corrective and preventive actions. Responsible for reviewing and approving deviation investigation reports; Responsible for tracking implementation of corrective and preventive actions, and ending deviations and / or launching CAPA procedures. Responsible for keeping documents and records for deviation investigation and processing; Responsible for the annual review of deviations.
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