The new AS 9100C-2009 Aerospace Quality Management System Standard requires methods and a process to comply with Risk Management requirements under clause 7.1.2-Risk Management, stating the following:
The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements that include:
- ) assignment of responsibility.
- ) definition of risk criteria.
- ) identification, assessment, and communication of risks throughout the product realization.
- ) Identification, implementation and management of actions taken to mitigate risks that exceed the defined risk acceptance criteria.
- ) acceptance of risks remaining after implementation of mitigating action.
The following illustration shows a step by step risk management process based on Risk Management Methods and Procedures designed by QCSS:
- Input from customer requirements, identified as critical and/or special by the customer.
- Input from statutory and/or regulatory and other environmental requirements.
- Review customer inquiries.
- Use risk management checklist and determine acceptability of inquiry.
- Identify over and above acceptable risks.
- Utilize a Risk Management Planning and Analysis Chart.
- Identify and record risk characteristics.
- Provide and record methods to mitigate or reduce risk to acceptable level.
- Process inquiries accordingly as acceptable or reject-able risk level.
- Proceed with inquiry by providing quote or decline inquiry due to unacceptable risks.
The processes as required by the AS 9100C standard under clause 7 Product realization such as clause 7.2.1- Determination of product requirements. clause 7.2.2 Review of product requirements, clause 7.3-Design and Development, clause 7.4-Purchasing Supplier provided products and flow down of requirements to the supplier, clause 7.5-Production provisions, drawings, etc. and clause 7.5.1 Process controls to manage critical items, pretty much control and meet by default the Risk Management Control Requirements.
Once it is determined to go ahead with product realization, e.g. risks have been determined to be acceptable or are mitigated to an acceptable level, the standard clause 8.2.3 and 8.2.4-Monitoring and Measurement of Product and Processes, clause 8.4.-Analysis of Data and clause 8.5-Improvements are utilized to control the product output and to analyze planned results.