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 New-Arrow-Left2 bullet green arrow 25 Identification by the organization of statutory and regulatory product-safety requirements

bullet green arrow 25Customer notification of requirements above

bullet green arrow 25Special approvals for design FMEA (Failure Mode and Effects Analysis)

bullet green arrow 25Identification of product safety-related characteristics

bullet green arrow 25Identification and controls of safety-related characteristics of product and at the point of manufacture

bullet green arrow 25Special approval of control plans and process FMEAs

bullet green arrow 25Reaction plans (see Section 9.1.1.1);

bullet green arrow 25Defined responsibilities, escalation process, flow of information, including top management, & customer notification

bullet green arrow 25Training identified by the org. or customer for personnel involved in product-safety related products & manufacturing processes

bullet green arrow 25Changes of product or process approved prior to implementation, including evaluation of potential effects on product safety

bullet green arrow 25Transfer of requirements throughout the supply chain, including customer-designated sources

bullet green arrow 25Product traceability by manufactured lot (at a minimum) throughout the supply chain

bullet green arrow 25Lessons learned for new product introduction.
   
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