S017 - Section 188.8.131.52: Contingency Plans
| 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:
disruption conditions -- interruption of externally provided
products, processes, and services, key equipment failures
recurring 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