Actions to address risks and opportunities (Part 3)

Action to address risk shall be appropriate to the impact of the risk. Some of the possible actions to address risks and opportunities may include:

Avoiding a risk.
Taking a risk in order to pursue an opportunity.
Eliminating the source of a risk.
Changing the likelihood or consequences of the a risk on the Quality management system.
Sharing the risk through the commitment of stakeholders.
Retaining risk by informed decision.
SWOT analysis by the organization as part of its business strategy to identify the internal risk and opportunities and action plans to address them.
Formal business risk assessment performed by the organization taking into consideration its context, associated risk and opportunities and mitigation plan.
Use of process approach by the organization to identify sources of input, activities, output, receiver of output, performance indicators to control and monitor processes, the risks and opportunities associated with them and action plan to address them.

To adequately address risks, one or more of the following may apply:

Corrective action process.
Nonconformity management process.
Defining quality control checkpoints.
Customer feedback survey and complaints management process.
Training and retraining of personnel to achieve competency.
Restructuring by redefining processes and their interactions or reassigning roles, responsibilities and authorities.
Acquisition of new technologies.
Engagement of people.
Internal process review.
Changes to methods and internally defined requirements.
Subcontracting to competent and approved external providers.
Communication with relevant interested parties.

The responsibilities and authorities to address the risk or opportunity shall be assigned. These shall include:

Responsibility to implement the planned action.
Responsibility to verify the conformity of action taken.
The responsibility to evaluate the effectiveness of action taken.
The authority to validate action taken.

Resources shall be adequately provided to include:

Competent people.
Required technologies and machinery fit for use.
Measuring and test equipment fit for use.
Applicable environmental conditions.
Applicable methods and procedures.

Planned action shall be implemented within the assigned time frame.

Integrating the results of planned actions into the Quality Management System

Results from actions to address risk and opportunities shall be integrated into the Quality Management System as appropriate through any of the following:

Awareness training for relevant interested parties on the results of actions to address risks and opportunities.
Review of procedures and work instructions to capture the changes resulting from actions to address risks and opportunities.
Training of personnel to acquire any required additional competence.
Procurement of new technologies.
Re-assigning of roles and responsibilities.
Restructuring of processes and their interactions.

Evaluating the effectiveness of actions taken

Actions to address risks and opportunities shall be evaluated for effectiveness by comparing the results of the actions taken with the planned arrangement or criteria. Effectiveness of the actions taken shall be validated and where the results of the actions taken to address the risk and opportunity is found not to be effective, actions shall be reviewed and re-implemented. Internal audits may be used to evaluate the effectiveness of the actions taken.

Actions taken in addressing risks and opportunities shall form inputs into quality management review for the purpose of informed decision making.