— use of risk analysis tools such as fault mode and effects analysis,
— review of customer needs and expectations,
— market analysis,
— management review output,
— outputs from data analysis,
— satisfaction measurements,
— process measurements,
— systems that consolidate sources of information from interested parties,
— relevant quality management system records,
— lessons learned from past experience,
— results of self-assessment, and
— processes that provide early warning of approaching out-of-control operating conditions.