Risk generally is associated with ‘uncertainty’ or ‘negativity’. This changed with ISO 9001:2015 and the onset of risk-based thinking that now asks companies to consider the opportunities for improvement that may arise out of taking a ‘calculated’ risk. Further in AS9100, that is built on ISO 9001, there are requirements for consideration of strategic risks and operational risks and the need to take action to address each. The impact of coronavirus or a similar pandemic is a great example of a strategic risk that can affect business continuity.
Risk-based thinking in the AS9100 standard promotes customer focus within an organization. While risk-based thinking has been inherent in previous versions of the standard with preventive action, the new standards address risk at each stage of the PDCA cycle thus enabling the entire As9100 management system at each stage as a preventive tool.
The aerospace and automotive industry are leaders in the implementation of Failure mode and effects Analysis (FMEA) and the Plan-Do-Check-Act Cycle (PDCA) of process management. Originally adopted by the military in the 1950's, FMEA later was embraced by the auto and aerospace industries. The FMEA process identifies risks that can then be addressed using mistake proofing and problem solving with a team approach. FMEA can be used for either product or process. When used properly it can be a very effective at addressing risks. FMEA is a great core tool that can be applied to address the AS9100 clause 8.1.1 operational risk requirements.
AS9100 asks top management to take accountability for the quality of products and services produced by their organization; keeping a customer focus at the core of all they do. The influence of end users, customers and the companies marketing department on the product’s design needs to be constantly reviewed. At each stage of the requirements gathering, design development and manufacturing stages of the AS9100 system there are potential risks. As such doing a single FMEA may not be sufficient but may require a review of the FMEA at periodic intervals as a change in inputs to the process/product may change the associated risks or identify new ones.
Management wants to encourage continuous improvement and innovative recommendations by all stakeholders, but changes must be reviewed. Whenever a change is made to a AS9100 certified product or service, that change should follow the PDCA Cycle approach, the same way it was done when the product was first introduced. This will reduce the number of recalls, and the risk of injuries to end users of the products.
A single non-conforming product that goes out of the organization into the market results in an intangible loss for no value can be put on the loss of reputation. It only takes a single incident! Starting with risk appreciation at the Plan stage of the PDCA cycle and then throughout the rest of the cycle, with a focus on customer satisfaction, will help the aerospace industry improve by preventing non-conformities before they occur as well as hopefully, improve their As9100 certified products.