The aerospace industry is an ever-evolving field thanks to recent and upcoming advancements in technology. How has this impacted compliance and management?
While technology is moving along at a very fast pace, regulatory design standards struggle to keep up with the industry. As a result, aerospace organisations are having to self-define what ‘good’ looks like and convince regulators that their designs, production and servicing controls are adequate to meet existing regulations and requirements. With the growing trend of regulators delegating more self-certification authority to ‘certificate holders’, companies are accruing not only authority but also increased responsibility and liability. Such responsibility includes not only meeting regulatory requirements, but also contractual and self-imposed quality requirements. Simply relying on a certificate on the wall as evidence of compliance does not cut it anymore. Organisational management has defined responsibility for compliance to both stated and unstated requirements.
What are the common contractual obligations regarding management responsibility in this field?
Regardless of the applicable national regulatory scheme, nearly all certificated aerospace organisations are required to have a quality management system in place that not only assure design, product, and/or service output, but also mandates processes of capable management oversight that are proactive. The most common quality management standards applied in the aerospace industry are AS/EN9100 and AS/EN9110. These standards are in addition to the regulatory requirements applied to the organisation, and when incorporated as part of the organisation’s conditions for regulatory approval, they carry the same authority as said regulatory requirements. When management does not take into account nor understand the requirements of these standards, a broad minefield of potential liability is created.
From your experience, what regulatory and contractual obligations are commonly overlooked?
The 9100 and 9110 quality management standards require organisations to engage in documented proactive processes that are aimed at preventing non-compliance. However, these are the requirements that are frequently either misunderstood by management or simply ignored, resulting in fodder for auditors and expert witnesses alike. Processes such as management review, understanding both stated and unstated customer requirements, ensuring the organisation has necessary resources, conducting internal audits, and implementing corrective and preventative actions all become non-negotiable requirements of the organisation when they are part of its approved quality system.
What was considered good yesterday may be non-compliant tomorrow.
What are the repercussions of these aspects being overlooked?
Aside from the vast and serious safety implications and expenses related to poor performance, when an organisation is not in compliance with all of its requirements, it exposes itself to all sorts of liabilities. Regulatory agencies have the ability to revoke or suspend an organisation’s design, production, maintenance and operations certifications, as well as, to impose fines. However, when an organisation is found to be non-compliant to its own self-defined quality management system, skilful and experienced experts may be able to create a roadmap of negligence for a court and jury.
Why are these compliance requirements commonly ignored?
Ignorance is one of the most common reasons for non-compliance regarding the quality management system requirements. While an organisation may have been in compliance at one time and it may have drifted away as a result of key personnel changes. Quality management systems are like anything else in an organisation, they must be monitored, maintained, and managed by human beings that know what they are doing. It is when an organisation allows the responsibility for managing its quality system to fall into unskilled hands, is when the problems usually start and grow. The consequences of non-compliance are too great to allow the responsibilities of the quality management system to be handed over to individuals who are not familiar with the industry or its quality and regulatory compliance requirements.
And compliance concerns are quickly growing. The industry has recently taken several big hits, including COVID-19. Many organisations have been forced to lay off personnel and encouraged those close to retirement to retire early. Given that there was an existing industry deficit of professional knowledge, this current ‘brain drain’ presents significant risk. As the industry begins to regain its steam, it is critical that there are professionals in place to understand the requirements to ensure compliance and conformance. Organisations cannot assume those they entrust with managing its quality management system are capable, they are required to ensure such.
What would be an ideal checklist for those wanting to avoid falling foul of such requirements?
Organisational leadership should never assume that they know what all the real requirements are or that their people have all the requisite knowledge and skills.
On the people front:
- Make sure your people know the regulations and standards that apply to the organisation, which includes top leadership.
- Make sure your people have access to the policies and procedures applicable to their roles and responsibilities.
- Make sure your people are kept informed of changes to requirements.
- Make sure your people have the resources they need to meet requirements.
- Make sure your people feel empowered to identify problems, without retribution.
- Make sure the organisation has the knowledge and skills it needs, if not, go get it.
On the requirements front:
- Verify the organisation is continuously monitoring changes in regulations, industry standards, and contractual requirements.
- Make sure the existing system meets current regulatory and contractual requirements – stated and unstated.
- Never accept any purchase order without reviewing it for new or changed requirements.
- Periodically review existing contracts and programs to ensure new or change requirements have not crept in.
Change is constant, and that includes requirements, people, processes, suppliers, and so on. What was considered good yesterday may be non-compliant tomorrow. In my 41 years of aerospace experience the basic Deming principles of Plan-Do-Check-Act have never diminished in value, but with the stated caveat of “Repeat” once the cycle is completed. If your organisation is unsure about its current state, then it is highly advisable to seek out industry experts that can independently provide objective assessment, troubleshoot, and ongoing review to minimise the risk of non-compliance. And, when the organisation suspects there may be issues, it may be best for such engagements to be protected as work product. The risks associated with doing nothing are way too great.
Contact details:
ASD Experts, LLC
+1.239.283.2839
Dr Michael J. Dreikorn is president of ASD Experts, a full service expert witness and expert consulting firm specialised in all aspects of the global aviation, space, and defense industry. Dr Dreikorn has over 41 years of aerospace experience, most notably previously serving as Vice President for Quality Assurance and Product Integrity for engine manufacturer Pratt & Whitney and before that as Assistant Division Manager for the Federal Aviation Administration’s Production and Airworthiness Division. In addition to holding several academic degrees, he also maintains various FAA certificates and has authored several books and numerous articles. He is a fellow of the American Society for Quality and a co-founder of the AS/EN9100 standard-series writing organisation International Aerospace Quality Group. Dr Dreikorn has extensive experience in organisational troubleshooting and as a testifying expert in various state, federal, and international venues.
