航空機開発保証プロセスを応用した一般製品向け品質基準の策定方法と適用

― リスクベースアプローチにおける開発保証概念導入の効果 ―

抄録

Maximizing business continuity and competitiveness with limited resources is a challenge for all organizations, and the risk-based approach (RBA) is considered one effective means of achieving this objective. The concept of RBA has been tried and tested in various fields ranging from the guidelines of ISO 9001, the international standard for quality management, to various fields such as aerospace, cyber security, food, and pharmaceuticals. However, existing guidelines for RBA are, in principle, defined based on circumstances specific to the target high-risk industries. Therefore, it is difficult to apply these RBA guidelines directly to other fields or general products. This paper introduces a method and examples of application of risk assessment and countermeasures based on the concept of the development assurance level (DAL), a type of RBA, to quality standards for general products, with reference to ARP4754B, the guidelines for the aircraft development assurance process established for commercial aircraft.