STANDARD CLAUSE
6.1.2.3 Contingency plans
REQUIREMENT
The organization shall:
a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met;
b) define contingency plans according to risk and impact to the customer;
c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures (also see Section 8.5.6.1.1); interruption from externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions;
d) include, as a supplement to the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations;
e) periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);
f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required;
g) document the contingency plans and retain documented information describing any revision(s), including the person(s) who authorized the change(s).
The contingency plans shall include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the regular shutdown processes were not followed.
STATEMENT OF NONCONFORMITY
The organization's process for conducting contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required, periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate) was not effective.
OBJECTIVE EVIDENCE
Documented information for annual review of contingency plans and periodically testing of the plans was not available.