IATF 16949:2016 Requirements Clause 6

6. Planning

Planning

6.1 Actions to address risks and opportunities

6.1.1

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

6.1.2 The organization shall plan:

a. actions to address these risks and opportunities;

b. how to:

1. integrate and implement the actions into its quality management system processes (see 4.4);
2. valuate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

6.1.2.1 Risk analysis

The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

The organization shall retain documented information as evidence of the results of risk analysis.

6.1.2.2 Preventive action

The organization shall determine and implement action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues.

The organization shall establish a process to lessen the impact of negative effects of risk including the following:

• determining potential nonconformities and their causes;
• evaluating the need for action to prevent occurrence of nonconformities:
• determining and implementing action needed;
• documented information of action taken;
• reviewing the effectiveness of the preventive action taken; utilizing
• lessons learned to prevent recurrence in similar processes 

6.1.2.3 Contingency plans

The organization shall:

• 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;
• define contingency plans according to risk and impact to the customer;
• prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures; interruption from externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions; labor shortages; or infrastructure disruptions:
• 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;
• periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);
• conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required;
• 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.

6.2 Quality objectives and planning to achieve them

6.2.1

The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall:

• be consistent with the quality policy;
• be measurable;
• take into account applicable requirements;
• be relevant to conformity of products and services and to enhancement of customer satisfaction;
• be monitored;
• be communicated;
• be updated as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2

When planning how to achieve its quality objectives, the organization shall determine:

• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated.

6.2.2.1 Quality objectives and planning to achieve them - supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization.

The results of the organization's review regarding interested parties and their relevant requirements shall be considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external).

6.3 Planning of changes

• When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
• The organization shall consider:

1. the purpose of the changes and their potential consequences;
2. the integrity of the quality management system;
3. the availability of resources;
4. the allocation or reallocation of responsibilities and authorities.