IATF16949(ISO9001) {6.1} Actions to address risks and opportunities - Explained

IATF16949(ISO9001) 6.1 Actions to address risks and opportunities - Explained

6.1.1 and 6.1.2
 See ISO 9001:2015 requirements.
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) evaluate 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.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity,eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets,
addressing new customers, building partnerships, using new technology and other desirable and viable possibilities
to address the organization's or its customers' needs.

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.

EXPLAINATION- 

IDENTIFICATION OF RISKS AND OPPORTUNITIES 

Identify external & internal issues which are relevant to purpose of strategic direction of the organization.

Consider internal & external issues to enhance desirable effects & give assurance to achieve the intended result of Quality Management System.

Determine the risk and opportunities need to be addressed to
To give assurance that the quality management system can achieve its intended results;

Enhance desirable effects

Prevent, or reduce, undesired effects

achieve improvement  

Prepare Risk Analysis Sheet to prevent undesired effect & to achieve continual improvement of the QMS. 

Review the Risk Analysis Sheet as per Process Risk Analysis Review Plan at six-month frequency.

After analysis of risk identify opportunities associated in respective process, identify the controls required to reduce the risk.

Take appropriate action to reduce risk and for identified opportunities. 

When planning these actions, shall consider its technological options and its financial, operational and business requirements

Discuss the action taken to reduce the risk and addressed opportunities and effectiveness of action taken in every MRM.

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