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  This section requires the organization to define and prepare contingency plans.   A systematic approach should be taken to identify and evaluate risk for all manufacturing processes, particularly external risk.

Contingency plans should be developed for:
 
bullet green arrow 25disruption conditions -- interruption of externally provided


bullet green arrow 25products, processes, and services, key equipment failures


bullet green arrow 25recurring natural disasters, fire, or infrastructure-related disruptions or labor shortages

Customer notification is mandatory in any contingency plan, unless there is no risk to deliver nonconforming product or affect on time delivery