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  astricks-20Identification by the organization of statutory and regulatory product-safety requirements

astricks-20Customer notification of requirements above

astricks-20Special approvals for design FMEA

astricks-20Identification of product safety-related characteristics

astricks-20Identification and controls of safety-related characteristics of product and at the point of manufacture

astricks-20Special approval of control plans and process FMEAs

astricks-20Reaction plans (see Section 9.1.1.1);

astricks-20Defined responsibilities, escalation process, flow of information, including top management, & customer notification

astricks-20Training identified by the org. or customer for personnel involved in product-safety related products & manufacturing processes

astricks-20Changes of product or process approved prior to implementation, including evaluation of potential effects on product safety

astricks-20Transfer of requirements throughout the supply chain, including customer-designated sources

astricks-20Product traceability by manufactured lot (at a minimum) throughout the supply chain

astricks-20Lessons learned for new product introduction.
   
   

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