Risk assessment system for confirmation and verification

Abstract

The invention provides a risk assessment system for confirmation and verification. The system is composed of 18 different risk assessment tables, a work procedure for making a risk assessment report and a work template. During system risk assessment, after the 18 assessment tables of the system are filled in, the work procedure of the system makes the risk assessment report according to the risk assessment report template pre-made for the system. On the basis of the tables, the system can generate a confirmation and verification scheme, a confirmation and verification record, a confirmation and verification report, a confirmation and verification review assessment plan, a confirmation and verification data audit and a confirmation and verification review assessment report for a user according to system template design. The system is suitable for production and monitoring of industrial products for people, the workload of confirmation and verification data writing by the user can be greatly reduced, it is ensured that the confirmation and verification content is completely consistent with the requirements of risk assessment data, and quality risks are effectively controlled.

Description

technical field [0001] This patent is applicable to the production and quality management of human industrial products, providing a quality risk assessment system, standardizing the risk assessment of human industrial product production and quality management and the work based on risk assessment, such as confirmation and verification, maintenance , Calibration calibration, sampling test plan, trend analysis plan. Background technique [0002] Risk management is a special management art. The complete management process includes: risk identification, risk communication, risk control, risk communication, and risk review. Its combination with the production and quality management of industrial products for human use is something that has happened in the past 20 years. "Good Manufacturing Practice for Drugs" (revised in 2010) widely uses quality risk management as one of the basic tools in the field of pharmaceuticals and medical devices. Although risk assessment work and mode...

AI Technical Summary

Problems solved by technology

This has led to the inherent deficiency of confirmation and verification management, because by the time the confirmation and verification is completed, the risk management process of the quality risk factors involved in confirmation and verification has at most completed risk control, but the evaluation of risk control measures, risk communication, The review of risks did not complete the technical work

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