IATF 16949 Risk Additions

The automotive quality standard, IATF 16949:2016, expands on the ISO 9001:2015 risk requirements in 6.1.2 with these sub-clauses:

6.1.2.1 Risk Analysis

Include in the risk analysis, at a minimum, lessons learned from:

  • product recalls and product audits;
  • field returns and repairs;
  • complaints, scrap, and rework.

Retain documented information as evidence of the results of risk analysis.

6.1.2.2 Preventive Action

Determine and implement actions to eliminate causes of potential nonconformities to prevent their occurrence. Preventive actions must be appropriate to the severity of the potential issues.

Establish a process to lessen the impact of negative effects of risk, including the following:

a) determine potential nonconformities and their causes;
b) evaluate the need for action to prevent occurrence of nonconformities
c) determine and implement action needed;
d) document action taken;
e) review effectiveness of preventive action taken;
f) use lessons learned to prevent recurrence in similar processes.

6.1.2.3 Contingency Plans

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 impact to the customer;
c) Prepare contingency plans for continuity of supply in event of any of the following:

  • key equipment failures;
  • interruption from externally provided products, processes, and services;
  • recurring natural disaster; fire;
  • utility interruptions;
  • cyber-attacks on IT systems;labor shortages;
  • infrastructure disruptions;

d) include as supplement to contingency plans a notification process to customer and other interested parties for extent and duration of any situation impacting customer operations;
e) periodically test the contingency plans for effectiveness, e.g., simulation, as appropriate;
f) conduct contingency plan reviews (at a minimum annually) using a multi-disciplinary team including top management, and update as required;
g) document the contingency plans and retain documented information describing any revisions, including the persons who authorized the changes.

Include in the contingency plans the provisions to validate that the manufactured product continues to meet customer specifications after restart of production following an emergency in which production was stopped and if the regular shutdown processes were not followed.