A Brief on Six systems Inspection Approach by
Автор: Hitendrakumar Shah
Загружено: 2024-09-21
Просмотров: 644
Описание:
This training session helps to understand in brief on six system inspection approach by FDA.
Quality professionals are aware that good intentions alone will not ensure good products. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. Specifically, successful quality systems share the following characteristics, each of which has been discussed in detail above:
Science-based approaches
Decisions based on an understanding of the intended use of a product
Proper identification and control of areas of potential process weakness
Responsive deviation and investigation systems that lead to timely remediation
Sound methods for assessing and reducing risk
Well-defined processes and products, starting from development and extending throughout the product life cycle
Systems for careful analysis of product quality
Supportive management (philosophically and financially)
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