It is said that air travel is statistically one of the safest modes of transportation. The flights that do not land well or go missing make the news more than the 1000’s of those that complete a safe flight. Checklists used in the aviation industry are infamous for how well they assist pilots deal with disasters. However, a lot is to be said for the plane itself, which is built to stringent quality requirements, down to the last rivet. Many aerospace parts manufacturers are certified for AS9100. So, what is AS9100?
It is an internationally accepted standard that defines the requirements for a quality management system for companies. It is built on the foundation of ISO 9001, another globally recognized quality standard. It builds the framework for organizations to identify risks at all stages of the production or service realizations process. The standard sets the baseline for quality and once implemented within an organization is assessed and certified by independent accreditation bodies. So, a part produced by an AS9100 certified organization in India, Brazil or elsewhere will meet the basic quality requirements.
What is AS9100 prescribing that companies do to achieve this? As9100 is not prescriptive in its requirements. It defines the framework, and each company must then interpret the requirements as they best apply to what they do. The leadership of the organization must remain involved and is accountable for the effectiveness of the system. The systems are influenced by regulatory requirements, customer requirements and other business requirements as from various stakeholders. What is AS9100 requirements with respect to control of outsourced processes.
Organizations must control outsourced processes and remain responsible for the output of the process. Based on the performance of the vendor of the criticality of the parts etc., the type and extent of control may vary. AS9100 also requires organizations to determine the competence of personnel needed and then to take steps to achieve this competence. As9100 quality requirements must be flowed down to all suppliers in the supply chain and supply chain risks are to be considered and mitigated as appropriate.
What is AS9100 requirements for audits. External certification audits are conducted on a three-year cycle with annual surveillance audits in the intermediate years. Internal audit frequency is determined and based on the organization needs and the auditors used to conduct the audits must be competent. To achieve this competence, they should compete a certified AS9100 lead auditor training. QMII offers a PROBITAS Authentication lead auditor training in both virtual and on-site format. These stringent quality requirements in the supply chain as advocated by AS9100 help ensure planes meet the highest safety and quality requirements. Thus helping to reduce accidents.
AS9100-Risk-Based Thinking in the Airline industry – It’s about time.
The airline industry statistically has one of the best safest records. AS9100 defines the framework for a quality management system for aerospace parts manufacturers across the globe. Over the past decade there have been several airline accidents however, that have brought the safety of airlines to the forefront. In a most recent case of the Boeing 737-max a software glitch was identified as the cause. As investigations proceed the general consensus is that this glitch should have been previously identified.
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.