AS9100 Risk Opportunities Management Procedure
The Risk and Opportunities Management Procedure assesses threats related to the organizational context, interested parties, and the quality management system in order to determine how to manage the risks it faces and how to best allocate its resources to manage those risks in conformance with the company’s QMS and AS9100:2016 Rev D. This procedure describes the Organization’s identification, assessment, and management of risks (threats) and pertains to any and all risks the Organization may face. (7 pages, 2034 words)
AS9100 Risk Opportunities Management Procedure Responsibilities
The Quality Manager is responsible for directing the Organization’s risk assessment and management processes and identify potential nonconformities, ensuring that preventive actions appropriate to the nature of the potential nonconformities are taken, and ensuring that preventive actions yield the desired results.
The Organization’s Top Management is responsible for creating the Risk Management Committee, providing the resources needed to assess and manage risk, and initiating preventive actions and following up on there effectiveness at Management Review
AS9100 Risk Opportunities Management Procedure Definition
Failure Modes and Effects Analysis (FMEA) – Stepwise approach to identification of possible field failures in a design, process, or product, and their consequences.
Preventive Action – Measure put in place to eliminate, or reduce the likelihood of, a potential nonconformity.
Hazard – Source of danger or specific situation that may influence the probability and/or extent of loss.
Risk – 1. Possibility that the quality management system may not achieve its intended result(s); Something that may enhance desirable effects; prevent, or reduce, undesired effects; or that may limit improvement.
Risk assessment – Identifying and ranking potential hazards (threats) in the work environment.
Risk management – Actions to address risk 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.
Threat – Indication or source of impending danger.
Vulnerability – Weakness; inability to withstand an attack or cope with a disaster.
- AS9100 Risk Management Committee
- AS9100 Risk Assessment Guidelines
- AS9100 Risk Assessment
- AS9100 Risk Management Actions and Review
AS9100 Risk Opportunities Management References
- ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
- Quality Procedures
- AS9100 SITUATIONAL ANALYSIS
- Statutory and Regulatory Requirements: Certain businesses (e.g., food processors, medical, chemical and pharmaceutical manufacturers) are required to identify, evaluate, and manage risks (a) to comply with laws and regulations and (b) because their products or processes have the potential to adversely affect worker or consumer health and safety. These organizations are strongly urged to seek the help of qualified and competent legal counsel, as well as certified and experienced health and safety experts.
- “Business Impact Analysis”, Federal Emergency Management Agency (FEMA), Jan., 2014 – http://www.ready.gov/business-impact-analysis.
- “Example Risk Assessments”, Health & Safety Executive (no date) – http://www.hse.gov.uk/risk/casestudies/.
- “Failure Mode Effects Analysis (FMEA)”, ASQ International – http://asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html.
- ISO 31000:2009, “Risk Management Principles and Guidelines,” International Organization for Standardization (ISO) – http://www.iso.org/iso/iso31000.
- IEC 31010:2009, “Risk Management-Risk Assessment Techniques”, ISO – http://www.iso.org/iso/catalogue_detail?csnumber=51073.
- Marden, Hannen, and Olstein, “Process Maps and FMEA Help Prepare Utility for Disaster”, iSixSigma, Feb. 26, 2010 – http://www.isixsigma.com/tools-templates/fmea/process-maps-and-fmea-help-prepare-utility-disaster/.
AS9100 Risk Opportunities Management Forms
- Risk Assessment / Management Worksheet
- Risk Controls Cost-Benefit Worksheet
- Preventive Action Report