Where risks and opportunities overlap, the best appropriate method for managing them shall be ascertained, given the situation at hand. Elements of such “blended” uncertainties may require methods which both address the negative risk and positive opportunity. Management of Risks.
QSP 6.1 Actions to address risks and opportunities (Preview)[email protected] System ProcedureQSP 6.1Subject: RisksRevision A This document is UNCONTROLLED if printed Page 1 of 3Date Check master computer files for latest revisionQSP 6.1 Actions to address risks and opportunities01. PurposeMake actions to address risks and opportunities a part of decision making on all levelsof the Organization and one of the improvement mechanisms of processes and qualitymanagement system (QMS).02. ScopeThis procedure covers all processes of QMS and regulates the activity of theOrganization's Leadership, Quality Manager, Risk Manager, Process Owners, RiskOwners, experts regarding risk management.03. Responsibility and AuthorityThe responsibility and authority of the Organization's Leadership, Quality Manager,Risk Manager, Process Owners, Risk Owners, experts to ensure this procedure aregiven below, in the sec.
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CLAUSE 6: PLANNING IntroductionClause 6 Planning brings to the front. Once the organization has highlighted risks and opportunities in clause 4, it needs to stipulate how these will be addressed through planning. The planning phase looks at what, who, how and when these risks must be addressed. This proactive approach replaces preventative action and reduces the need for corrective actions later on. Particular focus is also placed on the objectives of the management system. These should be measurable, monitored, communicated, aligned to the policy of the management system and updated when needed.
After much deliberation, the decision to make risk explicit has been made – here it is in clause 6. Having highlighted the issues and requirements in clause 4, now it is time to address the risks and opportunities the organization faces through planning. How will the organization prevent, or reduce, undesired effects? How will the organization ensure that it can achieve its intended outcomes and continual improvement? It will do it here in planning. Planning will address what, who, how and when. Not difficult.
This proactive approach is easier to understand than preventive action and should reduce the need for correction and corrective action at a later date. The requirements around the Quality objectives have also been made more detailed. They are to be consistent with the Quality policy, measurable (if practicable), monitored, communicated, and updated as appropriate. They have to be established at relevant functions and levels.
Clause 6 puts a greater emphasis on the organization’s Planning which is integral to the business. Auditors should be familiar with risk – the consequences of an event and the associated likelihood of occurrence – and how to avoid, eliminate, minimize or mitigate it. They also need to focus on the positive aspect – opportunities for the business and how to optimize them.
The risks and opportunities identified will lead to policies and objectives. I do not claim to be original author to many of the articles you find in my blog. I would like to thank all the original writers like Art Lewis and many others and websites like advisera.com and many others for the material available. I would also like to thank all my visitors like you for their continued support.
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