The Role of Management Systems in the Tragic Collision Over the Potomac

by Dr. IJ Arora


A significant tragedy occurred in Washington D.C. on January 29, 2025, with the deadly collision between a U.S. military Black Hawk helicopter and a regional jet flying for American Airlines. The resulting crash caused the loss of 67 precious lives and pointed to a multilayered failure of safety mechanisms.

In a short article like this it is not my intent to explore the reasons for this event, and I have neither the expertise nor the authority to investigate, anyway. The U.S. National Transportation Safety Board (NTSB) and other relevant agencies will do that in a most professional manner. However, I do have a degree of experience relating to the systems approach for managing processes at large and complex organizations. I feel called to share my perspective on this disaster with a systems approach in mind.

Proactive appreciation for risk

Hindsight, it has been said, is 20/20. I am aware that I’m writing this after the tragedy has already occurred. However, management systems should be proactive, where data drives the understanding and mitigation of risk. As a practitioner and advocate of process-based management systems, I believe that well-implemented procedures give an organization the best chance to produce conforming products and services.

A systems approach, based on ISO 9001’s subclause 4.4., which relates to quality management system processes, could have played a role in preventing an incident of this type. Subclause 4.4.1 states, in part, “The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions….”

Following this requirement is no guarantee of safe and successful outcomes, but it is surely the best bet. I had similar thoughts on the tragedy of the implosion of the Titan submersible and the Baltimore Bridge collapse. The core principles of ISO 9001, especially risk-based thinking, continual improvement, and process interaction, align well with safety imperatives, particularly safety management for the aviation industry. The systems approach is a fundamental that organizations often neglect at their (and their customers’) peril.

ISO 9001—and for that matter, the aerospace standard AS9100—is built on risk-based thinking. A structured process aligned with the risk management standard ISO 31000 and aviation safety management systems are required by ISO 9001 subclause 6.1, regarding actions for addressing risks and opportunities, and subclause 8.1 concerning operation planning and controls. Conformance with these requirements can help identify and mitigate collision risks between civil and military aircraft.

Process interaction and communication are vital in such situations.  A failure in communication between air traffic control, military operations, and civilian aviation may have contributed to the crash. Of course, we will wait for the full report from the NTSB investigation. However, it is never too late (or for that matter, too early) to be proactive and implement a process approach to ensure that all stakeholders follow well-defined communication and coordination protocols.

PDCA, SWOT, and FMEA

Being proactive requires an appreciation of risk at the Plan stage of the Plan-Do-Check-Act (PDCA) cycle. Note that preventive actions and continual improvement are integral to the system approach.

The media have reported on the details of numerous previous aviation incidents. Analyzing near-miss incidents and integrating lessons learned into improved procedures could enhance safety protocols. Human factors and process redundancy must be considered in a systematic manner. Human errors (e.g., miscommunication, misinterpretation of airspace usage, etc.) can be minimized with automated systems and via decision-making redundancy checks.

In principle, the process approach found in ISO 9001 emphasizes addressing process issues as opposed to blaming individuals. However, in the aviation field, the human factor is important; clause 10.2.1 b2 of AS9100 expresses the importance of this concept. The industry-specific interpretation of requirements as seen in this standard provides a robust framework (via a clause structure) to design an efficient management system. This, together with auditing and compliance requirements, gives leadership confidence that their system can and will produce conforming products and services.

Further to this point, regular audits of flight coordination between civilian and military aviation could highlight gaps before they lead to accidents. As such, integrating ISO 9001 with AS9100 and AS9110 (the aerospace quality standard specifically designed for maintenance, repair, and operations) as well as ISO 45001 covering the management of operational health and safety will provide a solution to proactively address risks in the context of the aviation industry. This would cover all interested parties, as per clauses 4.1 and 4.2 of ISO 9001. Although aviation already has strict regulatory frameworks (e.g., FAA, ICAO, etc.), the structured process management systems required by ISO 9001 and AS9100 can complement these frameworks by embedding the statutory and legal requirements into the management system.

If the organizations involved focus on how specific elements of ISO 9001 can be applied to aviation safety, particularly in preventing collisions, I would first recommend that they look at risk-based thinking as seen in clause 6.1, addressing actions related to risks and opportunities. This can partially be accomplished by undergoing a strengths, weaknesses, opportunities, and threats (SWOT) analysis. ISO 9001 emphasizes risk assessment and mitigation throughout processes.

In aviation, a structured risk-based approach would identify potential hazards (e.g., conflicting flight paths, miscommunication, system failures, etc.). The system would also assess risk severity and likelihood of occurrence and probability of detection, using tools like a failure modes and effects analysis (FMEA). Controls could be implemented (e.g., enhanced air traffic control coordination, better radar tracking, AI-driven airspace monitoring, etc.). For example, aviation safety bodies could require all civilian and military flights to undergo a real-time risk assessment check before takeoff, considering airspace congestion, weather, and military training exercises.

Potential solutions

Process interaction and communication (as seen in ISO 9001’s clause 4.4.1 b regarding understanding process interactions) would systematically improve the system. Aviation operations involve multiple stakeholders, such as airlines, air traffic controllers, military operations, ground crews, etc. A process approach would ensure defined standard operating procedures for communication between civilian and military aviation. These could include real-time data sharing using standardized digital platforms and/or automated conflict-resolution systems that detect and alert pilots and controllers regarding possible mid-air conflicts. An integrated civil-military coordination dashboard could be established, where both parties have real-time visibility on flight plans, airspace restrictions, and emergency deviations.

Risk appreciation and continual improvement (as seen in ISO 9001’s clause 10.2 regarding nonconformity and corrective action, clause 10.3 on continual improvement, and clause 5.1.2 regarding customer focus) require organizations to analyze failures, investigate causes, and take corrective actions. In aviation safety, this could mean automated reporting and analysis of near-miss incidents and regular safety audits to evaluate procedural weaknesses and machine learning-based predictive analytics to foresee and prevent future crashes.

When a near-miss incident occurs, such a system could automatically trigger a root cause analysis and recommend safety adjustments for all stakeholders. Human factors and redundancy (as seen in clause 7.1.6 regarding organizational knowledge) promote knowledge management and human reliability strategies. In aviation, this could mean mandatory cross-training for military and commercial pilots on shared airspace procedures. AI-assisted decision-making tools that provide secondary verification for pilots and controllers could be a positive outcome of data analysis.

Data drives risk and trends. A digital co-pilot system could use AI to continuously monitor air traffic conflicts and intervene if human errors are detected. Auditing and compliance (as seen in clause 9.2 regarding internal auditing) would provide objective and independent inputs by regular safety audits of flight coordination. Air traffic control systems could ensure compliance with standardized airspace usage protocols, identification of gaps in inter-agency communication, and implementation of best practices from previous incident investigations. A shared civil-military aviation audit framework could ensure uniform compliance with risk management policies, reducing the chance of airspace conflicts.

I am not a technical subject matter expert in the aviation industry. My expertise is in looking at systems. My 30 years of experience suggests the importance of strengthening the Plan stage of the PDCA cycle. Things go wrong at the Do stage (i.e., implementation), however, if the plan itself is deficient and not coordinated, the implementation can and perhaps will go wrong.

By integrating ISO 9001 principles into aviation safety proactively and appreciating the risks, management can prevent mid-air conflicts. Process-driven coordination ensures better civil-military collaboration. Automated monitoring and auditing could improve response times to emerging threats.

Sadly, this tragedy once again bears out the wisdom of W. Edwards Deming when he said that a bad system will beat a good person every time.

Note – The above article was recently featured in Exemplar Global’s publication ‘The Auditor”. Click here to read it.

Looking Ahead at ISO 9001

ISO 9001 has proactively kept up with various industry expectations, over the years, to allow

application by a broad spectrum of industry including the defense forces. The 2015 revision was

a thoughtfully planned giant step. It defined risk (ISO 9001 Clause 6.1) in the context of the

organization (ISO 9001 Clause 4.1 & 4.2) and removed exclusions provision from certification by

redefining what an organization does not do or outsources in the scope (ISO 9001 Clause 4.3). It

also removed preventive action, a reactive concept, and introduced proactive risk appreciation

(Clause 6.1 of ISO 9001 & Clause 8.1 in industry specific standards as AS9100).

This took preventive action from the delayed “Act” stage of the PDCA (Plan-Do-Check-Act) stage

to the more logical sensible “Plan” stage. After all, “look before you leap”, as the historical

fundamental, could not be left as a preventive action decision. It had to be at the look – plan

stage! Risk also needed not just mitigation, but also acted as an input, to be used to bring in

innovation in terms of OFI (opportunity for improvement).

These were all positive steps in keeping with technical advancements and computerization and

AI (artificial intelligence) tools. The HLS (high level structure), later updated to HS (harmonized

structure), recognized the need to enable ease of implementation of integrated management

systems. This in turn leading to efficiency, ROI (return on investment) and where applicable

environmental protection, security of the global supply chain, business continuity, cyber

security and health and safety.

The differentiating of knowledge (ISO 9001 Clause 7.6) from competence (ISO 9001 Clause 7.2)

was also a clever needed change. Organizations needed to define their corporate knowledge

aspects and differentiate it from the individual knowledge of personnel. Knowledge and

competence needed merging and a healthy marriage but needed recognition that they were

different. Removal of the reference to Quality Manager (QM) and Quality Manual from the

standard, took away the narrowness of thinking in quality, and brought the clarity to leadership

to remain accountable and to differentiate authority delegation from retaining the

accountability.

I am a member of the TAG-176 group, and yet have not really contributed much to the next

expected changes to ISO 9001. I am sure the TC-176 is working on this. Nevertheless, it is time

to debate and consider updating the standard.

Since the 2015 version was a major fundamental change, I doubt there would be a significant

departure from this 2015 version in the next major update. Unlikely that the next version may

have revolutionary updates. The emphasis, I think would be to clarify and strengthen the

present thoughts in the 2015 version. I would consider the following:

1. Two Standard Concept: I have over the years thought about the two prongs:

manufacturing and service, approach. Both the service and the manufacturing industry

have been using the standard. Some may consider the need for a separate

manufacturing and a service standard as the next step. However, over the years I have

feared too much bureaucracy which the two standards approach brings. I think the two

standard approaches may actually cause more issues than to resolve them. Might I

opine that Clauses under 8.3 for D&D can, if needed, be strengthened, clarified or more

useful notes as applicable to service version incorporated to assist implementers,

consultants and auditors?

2. Risk be better defined and OFI be clarified, to avoid auditors using it as a tool to sneak in

recommendations. OFI is the outcome of considering risk as an input for innovation. It is

not a recommendation.

3. The knowledge clause needs meat to strengthen it, and to better make it inclusive to

systematizing the requirements for organizations to systematize lessons learnt.

4. An annex added to bring clarity and ease to designing and implementing a combined

management system for an organization.

5. Clause 4.3 Scope, in defining scope requires consideration of the context of the

organization, which is based on Clauses 4.1 and 4.2. However, while the scope has to be

available as documented, 4.1 and 4.2 do not require documentation. I would suggest

both clauses 4.1 & 4.2 to have context as a documented requirement.

In conclusion, I think, updating the standard ground up is not a wise idea at this stage. Perhaps

slight tweaking to include some minor changes would give stability in implementation of an

already robust standard.

P-D-C-A with a Christmas Tree

As a QMII employee, I can sit and observe classes whenever I want, more so since they are virtual instructor led these days. It allows me to get a refresher on the clauses, even though it is so hard to get them. It gets me every time. When the time comes to interview auditees, I smile like a Cheshire cat; not a confident grin but one that hopefully does not betray my nervousness.  Often, I am nervous as a long-tailed cat in a room full of rocking chairs. However, my QMII ISO lead auditor training has prepared me well. I am nervous as the auditee too, even though I know audits are not about pass or fail.  While I call myself a writer and researcher my greatest struggle perhaps lies with Audit Report writing. Oh, man! QMII lead auditor training, however, well prepared me to gather all notes during an audit to present a valuable report to the auditee. Smile.

The aspect of Lead Auditor training I like is the P-D-C-A cycle because I can use that analogy anywhere in my life. I have the responsibility of putting up the tree, however, currently, my application of the P-D-C-A is not going so well. Perhaps a re-plan is needed?

So from the Lead Auditor classes that I have attended, P-D-C-A stands for the following and the task next to it is what I have to do:-

P – Planning: We have to put the tree. Also, the objective of my mission. Considerations include where are the decorations kept, do we have enough, do we need a ladder, what should be the first step, then the next (like testing the lights before we put them on the tree), and more. Most important plan the time to do it in my busy schedule!

D – Do: Now to put my plan into action! Locate the boxes, get them out, unpack, and, get my team to help me even if they don’t want to (just to cheer me on perhaps). Yay! Thanks guys, for your help! Thumbs up for that. Basically, everything else that needs to be completed before the tree is finally up and lit up and everyone is happy. The DO stage can be extremely exhausting. How about that drink to cool me down?

Note – From my Lead Auditor training and also when I am auditing my clients, I know that the ‘DO’ section of the process is where a lot of the “action” happens. Just because “you gotta do it, man, get on with it!” I feel the pain of the “Do’s” as it is easy sometimes to plan but more taxing to put the plan into action. Now getting back to my tree.

C – Check: Once the tree is up and you think the job is over, it is not. You have to wait for the others to “check” the tree out and give their opinions. Pass comments, critique your effort while you are bickering away that they didn’t do anything, but they get to analyze it. What was that? Oh yes, I agree it is just an opportunity for improvement and we love our non-conformities.

A – Act: The verdict is out. The tree looks great. Beautiful decorations. However, the lights seem to flicker at some places, we need better lights for next time. Get more decorations. Good job!

VERDICT

Plan it better next time. Stop bickering when you are doing the job. Be patient and stop being

grumpy when they are “checking” and analyzing your work. Continually Improve this process till you get your Act together – words of a wise Yoda who is enjoying the view of the Christmas tree and listening to the Christmas songs.

Can I get that drink now? Long Island, please. Merry Christmas!

AUDITING RISK-BASED THINKING

 

As we work with clients, we find increasing examples of certification bodies requiring risk to be documented within an organization. This despite ISO 9001 specifically not requiring so!

This then brings up the question, “How should we audit the requirements of risk-based thinking within an organization when the same has not been documented using a formal risks management system or methodologies such as FMEA?”.

Let us start with the intent of including ‘risk-based thinking’ in the standard, replacing the previous requirement for ‘preventive action’. Risk-based thinking has been included as a preventive measure with the intent of making an organization more proactive to identifying and addressing potential non-conformities (NCs) than to be reactive to NCs. Additionally, rather than limit preventive action to the end of the PDCA cycle it is now addressed throughout the standard with the concept of risk-based thinking. To therefore answer the question posed above auditors need to evidence risk-based thinking throughout the system starting with the management down through the operator/service provider.

Before we begin to discuss the process for doing this let us for recall how many times a preventive action has been raised within our organization when the requirement did exist under ISO 9001:2008. In my auditing experience the answer is rarely! This in essence defeats the purpose of what the standard was trying to achieve.

Before we begin to audit risk based thinking the auditor should get an understanding from management of the context of the organization and the needs of the interested parties relevant to the organization as identified by them. Keep in mind the requirement of Clause 4.1 and 4.2 also need not be documented. Further what are the risks that management has associated with the organization achieving its strategic direction. We can also evidence the records of the management review to assess the inputs provided to management per Clause 9.3.2 e.

Once we have the above understanding from leadership, we then look for evidence on how the organization has addressed the risks as identified by leadership. These may include as an example risks to meeting business/process objectives, risks from loss of personnel, risks from new legislation that may impact the organization etc. As we audit the organization, we are looking to assess how the processes have been resourced and controlled in order to manage the risk of not meeting the process objective or customer/regulatory requirements. Risk based thinking is inherent in the clauses for design where organizations are asked to consider the potential causes of failure, in the purchasing process where the organization is asked to select external providers based on their ability to provide products/services meeting requirements, in the planning of audits, in the determination of customer requirements (intended use & unstated requirements), in the resourcing of the system, in the fitness for purpose of monitoring and measuring equipment and in the determination of potential similar non-conformities when taking corrective action.

The above is but a sample of where the application of risk-based thinking can be evidenced. Further information from analysis of data per clause 9.1.3 is further sued as a source for improvement as per clause 10.1 and all of this can be evidenced in the system.

So then why are certification body auditors seeking a documented risk-management system? Auditees too often do not push back when such a “requirement” is brought up. It does make the audit easier if everything is documented including risk but then are, we really ensuring the effective application of the standard. The organization could meet this “requirement” for documentation of risk by just documenting two or three risks and monitoring the effectiveness of actions taken to address them. This would meet the auditors requirement but then what about other applicable risks? These would then do unaddressed as the organization will tend to focus on the documented ones, killing the system!

Let us determine the need to document the risks within our system or NOT and not be pressured into documenting our system to meet the needs of auditors.

Month of May is International Internal Audit Awareness Month

The International Institute of Internal Auditors (IIA) is encouraging Internal Auditors around the world to actively promote internal auditing’s value during Internal Audit Awareness Month .

IIA is recognizing Internal Auditing.

QMII has over 30 plus years propagated the importance of internal auditing and the need to have competent internal auditors. Any tragedy can be connected back to a nonconforming product, which in turn is invariably the outcome of a failed procedure. Internal Auditors play a vital role in recognizing NCs (Non Conformities), and thereby enabling Correction and CA (Corrective Action) to NCs. Managements have to maturely understand the importance of recognizing internal NCs as an integral part of improving process improvement and continual improvement of the system. Internal auditors have a vital role in providing objective inputs at the C-check stage of the P-D-C-A cycle.

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