| Identification by the organization of statutory and regulatory product-safety requirements
Customer notification of requirements above
Special approvals for design FMEA (Failure Mode and Effects Analysis)
Identification of product safety-related characteristics
Identification and controls of safety-related characteristics of product and at the point of manufacture
Special approval of control plans and process FMEAs
Reaction plans (see Section 22.214.171.124);
Defined responsibilities, escalation process, flow of information, including top management, & customer notification
Training identified by the org. or customer for personnel involved in product-safety related products & manufacturing processes
Changes of product or process approved prior to implementation, including evaluation of potential effects on product safety
Transfer of requirements throughout the supply chain, including customer-designated sources
Product traceability by manufactured lot (at a minimum) throughout the supply chain
Lessons learned for new product introduction.
| Documented processes for the management of product-safety related products and manufacturing processes
Process must included, but not limited to (Where applicable) items on the next page
| The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 126.96.36.199).
The organization is responsible for the conformity of outsourced processes
Customer-specific requirements must be evaluated and included in the scope of the organization's Quality Management System.