Are Medical Audits Improving Systems Or Only Driving Fixes?
Is there a potential downside to medical audits wherein the audits are focused on finding and fixing problems? A recent discussion with a medical professional piqued my interest in the value of Medical Audits given that QMII, a subject matter expert in auditing, has ventured into the medical auditing field. This led to a conversation with a few additional healthcare professionals to understand a little more about medical audits, their findings and how organizations address them. My additional reading outlined a lack of effective systemic corrective action. In this article, I discuss some aspects of the medical audit process and what organizations can do to improve the process of audits and of implement corrective action.
There are various types of medical audits including clinical audits, billing/coding audits, financial audits, operational audits and compliance audits. While there are regulations, protocols and standards against which these audits are conducted, in many cases, industry-best practices are also used as audit criteria. This brings subjectivity into the audit as ‘best practices’ knowledge may vary from auditor to auditor based on their experience. Auditing to an auditor’s experience has a major drawback not just in the medical industry but in all industries. It takes the auditors away from requirements which then results in biased inputs to the leadership that may be inaccurate. This also leaves the auditee (the organization being audited) on the receiving end of findings for which there are no certain requirements. That is, they may make changes to their system based on the finding of one auditor only to find that another auditor objects to the very actions they implemented based on the previous auditor.
Medical Audits and Recommendations
In medical audits, it is common practice for auditors to provide recommendations to address findings. These recommendations are based on experience and industry-best practices. In ISO audits this is not allowed. In most industries, including the healthcare industry, there is no obligation to act upon any of the recommendations of an auditor. However, if auditors are perceived to be in a position of authority, then there is an underlying implication that the audit recommendation must be implemented. This is for fear of the nonconformity occurring again only for someone to say, “the auditor told you what to do and no action was taken”. This then also implies, audits do not delve deeply enough to identify systemic weaknesses within the processes or the workflow.
In speaking with the medical professionals within my professional circle of friends, it was surprising to hear that in many cases the personnel being asked to address the audit findings are unaware of any root cause analysis methodologies nor have they been given any formal training in the subject. Further, they are not clear about what a CAPA is but do know that they need to provide some action to close out the finding. In such cases, is it then fair to expect effective corrective action? Perhaps, the lack of effective corrective actions perpetuated the need for auditor recommendations!
Without proper training, it is but natural for personnel responding to audit findings to default to the recommendations of the auditor and implement those actions prescribed by the auditor as the corrective action in and of itself. Sadly, in such cases the root cause of the issue goes unaddressed. Sometimes such cases may lie in inadequate resources, technology or even lack of guidance/policy from leaders. While the aim of the audits is to identify where the process may require additional controls, all for providing better healthcare for the patient, the outcome may only be a band-aid.
What can be done to change this?
While change may not come overnight, there are a few key steps that can be taken to improve the audit process overall right up until corrective action and meet the end goal of providing better healthcare.
Auditor training – Auditors must be trained to remain objective through the audit process, to focus on the requirements (criteria) of their audit, to focus on factual evidence and objectively assess it (yes, no experience!). Further they must understand the implications of providing recommendations and thus not provide any recommendations. The auditors are but to focus on assessing the effectiveness of the corrective action plan submitted and verifying the effectiveness of actions taken.
Root Cause Analysis Training – Healthcare organizations must invest in providing their personnel with training in the different root cause analysis methodologies and how to apply it to identify the root cause(s) of a problem.
Reinforcing that Recommendations need not be accepted/addressed – Organizations must be professional to build the courage to stand up to auditors and not accept recommendations. Auditors do not know all facets of the process from the short sample of the organization they witness. If their “advice” in the recommendations is wrong/ineffective, who then pays the price?
Auditor Selection – ISO 19011 provides guidance on the behaviors and skills that an auditor should exhibit, and these are applicable to an auditor selected to conduct any type of audit. Auditors must be evaluated periodically to ensure they are remaining objective through an audit and working to identify the effectiveness of controls and adequacy of resources in assessing if the overall objectives have been met. To learn more about how QMII can support your organization’s audit process, click here.
–Julius DeSilva, Senior Vice-President
Can Boeing Ship a Lengthy-Time Period Approach to their 737 MAX Issues?
Dr. IJ Arora
Boeing is within the highlight once more with its 737 MAX planes, that have already had a deeply bothered historical past. Buyer center of attention (which is clause 5.1.2 of ISO 9001 and AS9100) turns out to were misplaced someplace.
I’ve learn a number of contemporary articles on those incidents in addition to Peter Robison’s ebook Flying Blind: The 737 MAX Tragedy and the Fall of Boeing, all of which level to a worsening scenario for Boeing. The general public belief of this nice American corporate, which has all the time been dedicated to top-class engineering and depended on merchandise, is converting from one among admire to one among warning. Vacationers are questioning, “Must I fly in a 737 MAX?”
Boeing and the aerospace {industry} normally have excessive requirements for high quality and product protection. On this article, I postulate whether or not an organization’s high quality control machine can ensure that not anything is going fallacious for patrons. Can it make certain perfection? If no longer, what are the choices—and why have one in any respect?
What took place and who’s accountable?
For the ones no longer acquainted with the 737 MAX incident in January, in a while after an Alaska Airways flight departed from Portland, Oregon, a cabin door panel blew off. As investigations are nonetheless ongoing the reasons have no longer but been totally decided. Boeing additionally had a tool factor at the 737 MAX, ensuing within the crash of a Lion Air flight in 2018 and an Ethiopian Airlines flight in 2019.
Right here in the US, the Federal Aviation Management (FAA) performs a vital function in offering laws to make sure flight protection, and likewise supplies oversight of plane producers, airports, and upkeep suppliers. On the subject of the Alaska Airways flight, it kind of feels that the FAA didn’t uphold its depended on function. The FAA’s a large number of assessments and balances, maximum of that are meant to concentrate on buyer protection, had been like aligning holes in slices of Swiss cheese. It’ll be fascinating to peer what adjustments this incident brings about on the FAA. On the other hand, can regulatory oversight ensure protection of flight?
The AS9100 same old, which is restricted to the aerospace {industry}, isn’t the brainchild of a unmarried entity, however fairly a collaborative effort pushed by means of two key gamers:
- The World Aerospace High quality Staff (IAQG). This global group brings in combination representatives from aviation, house, and protection firms around the Americas, Asia/Pacific, and Europe. They actively take part in growing, keeping up, and updating the AS9100 same old.
- Standardization organizations. Those our bodies, such because the Society of Automobile Engineers (SAE) within the Americas and the Ecu Affiliation of Aerospace Industries (now the AeroSpace and Defence Industries Affiliation of Europe), formally submit and distribute the usual.
You will need to word that AS9100 builds upon the root of the extra normal ISO 9001 high quality control machine same old. Whilst ISO 9001 lays the fundamental framework, the IAQG provides industry-specific necessities a very powerful for making sure protection and high quality within the aerospace area.
Along with the producer and the FAA, the landlord/lessor of the plane additionally performs a task in making sure the aircraft is correctly maintained. This comprises settling on a reliable upkeep supplier, hiring competent engineers, and having powerful processes in position. With such a lot of other stakeholders, can blame be attributed to only one when injuries occur? Moreover, must blame be the secret? Possibly no longer! You will need to word that the machine is applied to toughen every consumer and that each one stakeholders within the worth chain play their phase as effectively.
Audits, inspections, and control methods: Are those the answer?
In the back of each tragedy, casualty, and mishap is a series of comparable occasions. The instant suspect when these kind of vital screw ups happen are deficient inspection protocols, possibly even the feared “human error.” On the other hand, this can be the low-hanging fruit and a deeper dive would possibly establish different causal elements, akin to asking if the standard audit failed.
What’s the distinction between an audit and an inspection? Can they change every different or are inspections by myself sufficient? The straightforward resolution is not any! Each are wanted because of elementary variations in method. Audits take a look at the processes to make sure the control machine produces conforming services and products. An effective control machine should come with the next, to call a couple of:
- It should be well-defined, beginning with the “as-is” state of the machine.
- Dangers should be known (clause 6.1) according to the context of the group (clauses 4.1 and four.2).
- A transparent definition of the product should be known.
- Efficient audits and periodic evaluation should be undertaken by means of control.
- Outsourced processes should be managed.
Inspections play the most important function by means of figuring out defects previous to unlock, thus protective no longer most effective the buyer/buyer/consumer/warfighter, and so forth., but in addition the recognition of the group itself. With that stated, inspections don’t give a contribution to power development as a result of they center of attention on fixes versus long-term answers. In impact, they don’t in reality upload worth for the reason that group has already incurred the price of generating the faulty phase or product. The creators of the Toyota Manufacturing Machine (i.e., lean) got here up with the Andon procedure to catch a defect as early within the procedure as imaginable as a way to repair it sooner than the issue went too a ways down the road.
Control methods aren’t only a choice of paperwork. To serve as correctly, they require dedication in any respect ranges of the group, together with height control offering the wanted assets. It takes time to construct a tradition of high quality wherein shortcuts are have shyed away from and there’s no worry of talking up. Buyer center of attention should no longer be compromised. As an example, unlock of conforming product must cross throughout the procedure particularly referred to as out by means of clause 8.6; any interference by means of height control to truncate this procedure would suggest the lack of buyer center of attention. Is that this an opportunity? Possibly, however the investigation should expose the reality. On this case of the Alaska Air incident each the Boeing consumers and Boeing as an organization have suffered. It’s my hope that investigators will establish all failed portions of the machine from every accountable birthday celebration. Those would possibly come with no longer most effective failed inspections, but in addition suboptimal processes. This may finally end up taking us again to an insufficient high quality control machine.
High quality control methods: Can they ship?
Given the above, can a correctly designed and well-audited control machine (supported by means of excellent inspection tactics to assist make certain conforming product) ensure that not anything is going fallacious with a company’s output? My opinion is that no person can ensure this utterly. On the other hand, possibility can indisputably be very much decreased when the entirety is applied effectively. This comprises the educational of team of workers, which correlates strongly to competence; sadly, that is ceaselessly the primary price range to get minimize when assets are scarce.
When high-visibility incidents like those happen, it can be forgotten that airplanes stay the statistically most secure mode of go back and forth on earth. That is essentially because of powerful high quality control methods, well-adopted regulatory frameworks, and common oversight. People play the most important function within the good fortune of the control machine, from the dedication on the height to the buy-in by means of the body of workers (clause 5 to clauses 7.1.3, 7.1.4, and 10.3). Taken in combination, this is helping create an atmosphere the place high quality can flourish inside the group.
Boeing could also be doing so much accurately, and but the consequences may well be unacceptable relying at the efficiency of outsourced processes (clauses 8.41/8.4.2/8.4.3). In spite of everything, the fuselages for the 737 MAX are made by means of Spirit AeroSystems Holdings Inc. Spirit AeroSystems is positioned in Wichita, Kansas; as soon as those fuselages are manufactured, they’re shipped by means of rail to Boeing’s facility in Renton, Washington. Due to this fact, no longer most effective is a significant part of the 737 MAX outsourced, however the delivery and preservation of product (clause 8.5.4) additionally may just give a contribution to the product’s nonconformity. General, Boeing stays chargeable for all the provide chain (clause 4.3), with their legal responsibility to “make certain conformity of its services and products and the enhancement of shopper delight.”
Even with a cast high quality control machine in position, this or identical screw ups can happen. There’s no technique to guarantee the general public of 100-percent acting (i.e., highest) output. The worry within the minds of air vacationers is legitimate and can stay so till an exhaustive root motive research of this factor is carried out and the ones root reasons are resolved. The present occasions beg the query: Did Boeing make stronger their control machine after the Ethiopian Airways 737 MAX crash? If that they had bent to the oars and long gone deep into their evaluation to discover and completely repair the holes of their control machine, this tournament would possibly by no means have happened. Floor corrections, or what some organizations name “repair -it” answers, most effective take away the indications. The foundation reasons should be addressed and resolved (clause 10.2.1). There aren’t any shortcuts to high quality.
In conclusion
It has taken years for air vacationers to really feel protected and unconcerned about air protection. I go back and forth so much the world over, and ceaselessly select an airline according to their carrier and luxury, however now I (in addition to the wider public, I might consider) want to imagine which plane will delivery us. This can be a new worry about product protection that has its genesis in Boeing no longer working its control machine successfully and shedding buyer center of attention. The worst is the erosion of public self assurance in federal oversight and its intent to stay the client protected.
I’ve spent my lifestyles learning identical complicated issues and main groups in serving to organizations in finding long-term sustainable answers. This calls for daring and dynamic management (clauses 5.3 and 5.1) for leaders to plot and enforce alternate. Appreciating and accepting dangers (i.e., protecting the client in center of attention) and transferring ahead is integral to true management. Ethics continues to be no longer a clause of ISO 9001 and AS9100, however moral management is ready doing the proper factor for all stakeholders.
In seminars at which I provide, I ceaselessly ask senior managers: “When you have a decision between following the process and/or doing the proper factor, what would you do as a pace-setter?” The solution—I’m hoping—is to do the proper factor always. However then, hope isn’t a plan. Air protection can’t be according to hope and religion. Boeing wishes the management to revamp their machine if they’re to carry the general public consider again for this nice American corporate.
Concerning the writer
Dr. IJ Arora, Ph.D., is the President and CEO of QMII. He serves as a workforce chief for consulting, advising, auditing, and coaching relating to control methods. He has carried out many lessons for the US Coast Guard and is a well-liked speaker at a number of universities and boards on control methods. Arora is a Grasp Mariner who holds a Ph.D., a grasp’s level, an MBA, and has a 34-year file of accomplishment within the army, mercantile marine, and civilian {industry}.
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Controlling Sub-Sea Infrastructure
The recent implosion of the Titan, a sub-sea submersible used for taking elite, high-paying tourists to see the wreck of the Titanic, brought the safety protocols of both vessels into focus. There were no statutory requirements for regulating the Titan and neither were there any when the Titanic sank in 1912! As a reactive measure, the maritime community came up with the Safety of Life at Sea (SOLAS) Convention soon after the sinking of the Titanic. Ironically, after the Titan submersible imploded, we have come to realize there are no requirements covering this vessel. Perhaps with time, the involved counties will react.
The question is, why was nothing done proactively? Tourists go up in hot air balloons all the time. Is there any statutory requirement that these tourist companies must meet? Is there even a requirement to have a management system in place so that these companies work systematically, appreciate the risks in the context of the organization, and plan their operations keeping risks in mind? It is true that entrepreneurs do not like regulations and consider requirements a hindrance in a free business environment. And yet the Titanic, which was declared to be “unsinkable,” did, in fact, sink! In the United States, the domestic towing vessel industry functioned without statutory requirements until recently. The industry avoided regulation, but tragedies occurred, and now the industry is regulated under the U.S. regulatory framework. A process-based management system is the best systematic structure to produce conforming products and services, ensure continual improvement, and implement the statutory requirements if available.
The intent of this article is to proactively start a discussion on the need for regulating sub-sea infrastructure to reduce its affect on the marine transportation system. The phrase “sub-sea infrastructure” refers to equipment and technology placed on or anchored to the ocean floor. This infrastructure may include, but is not limited to, cables for telecommunication, cables for power transmission, pipelines for transmission of fluids, and other stationary equipment for scientific research.
The growth of sub-sea infrastructure is a global phenomenon. As an example, is in the interest of all nations, and particularly here in United States, to promote wind farms, which are a source of renewable energy. When these wind farms are placed in selected geographical locations along the continental shelf, they need sub-sea cables. But are there any laws controlling the systematic development of the industry to enable an effective marine transportation system and its protection of maritime community interests and environmental interests? Is there a central agency responsible for this coordination to allow for a balanced approach to risks? The amount of cabling piling up needs management and oversight.
Sub-sea infrastructure, the definition of the problem
Numerous industries have a stake in sub-sea infrastructure. Examples include oil and gas, telecommunications, fishing, scientific research, and perhaps military/defense applications such as sonar and other arrays and obstacles. This infrastructure is a requirement, but it also faces various challenges including those that can lead to accidents, environmental damage, and possible breaches in national security. All these bring out very significant concerns related to sub-sea infrastructure and the lack of comprehensive and globally accepted standards, requirements, obligations, and assurance mechanisms. It is not that organizations such as the United States Coast Guard, the National Oceanic and Atmospheric Administration, the Bureau of Safety and Environmental Enforcement, the U.S. Army Corps of Engineers, the Environmental Protection Agency, and other federal and state agencies do not look at these issues.
Nevertheless, it remains a concern that there is no single agency or overarching requirement to provide a framework to the industry on harmonized implementation of requirements. This lack of harmonization can mean inconsistencies in design, installation, and maintenance practices which may not address risks uniformly. This can generate consequential risks, leading to increased accidents, mechanical failures, and costs to the industry and the nation.
Recent tragedies and accidents
Recent tragedies and accidents involving sub-sea infrastructure have been limited, and yet must not lead to complacency by the agencies involved. The few that have occurred indicate the challenges and trends pointing to the need for proactive requirements. The recent tragedies include:
- Deepwater Horizon. The potential consequences and challenges inherent in deep-water oil drilling were brought out by the Deepwater Horizon tragedy in 2010. The oil rig explosion in the Gulf of Mexico caused a massive oil spill and resulted in the loss of 11 lives. Although not technically a sub-sea incident, it highlighted a series of failures in design, maintenance, and company oversight—all factors pointing to the importance of robust safety standards and requirements, and the implementation thereof. The Deepwater Horizon incident was not directly related to sub-sea infrastructure; however, it heightened the risks associated with offshore oil and gas production and the potential for catastrophic environmental damage.
- Nord Stream 1 and Nord Stream 2. Occurring in September 2022, the damage to these gas pipelines in the Baltic Sea highlighted concerns around sub-sea infrastructure. These pipelines transport natural gas from Russia to Europe; in this incident, they sustained multiple leaks. The exact cause of the damage is unclear, though deliberate sabotage was suspected and is still under investigation. Regardless of the ultimate findings, this incident exposed the vulnerabilities of sub-sea infrastructure to sabotage, and the potential for significant environmental and economic consequences are real. Intentional attacks to the sub-sea infrastructure have the potential for widespread disruption of energy supplies. Apart from the Nord Stream, there have been other sub-sea incidents affecting the gas and oil industry. In 2021 a fire broke out on a sub-sea production control umbilical off the coast of Brazil, causing significant damage to the underwater equipment and resulting in a major oil spill.
- English Channel Internet Disruption. In 2021, a ship dragging its anchor on the seabed in the English Channel cut the three main internet cables to the Channel Islands. Although this only resulted in slower broadband speeds in this instance, there remains the possibility that it could have resulted in a complete outage.
Looking ahead
These incidents represent leading indicators of a tragedy in the making should proactive action not be taken. The critical importance of safety for sub-sea infrastructure underscores the need for a more comprehensive and rigorous approach to standards and assurance. Industry stakeholders together with regulatory bodies within the United States and global organizations such as the International Maritime Organization must work together to establish a harmonized set of safety standards, implement robust assurance mechanisms, and foster a culture of safety throughout the sub-sea industry.
The increasing reliance on sub-sea infrastructure for various industries (including wind farms) necessitates a proactive approach to safety and risk management. There is definitely a need to invest in research and development to enhance the resilience and monitoring capability of sub-sea infrastructure. The various companies in the sub-sea industry are holding their proprietary information close to the vest. This is understandable. However, these organizations are in competition with totalitarian governments, in which control of business practices is the exclusive dominion of the state. It is necessary to enhance transparency and information-sharing among industry stakeholders to facilitate better risk assessment and incident prevention.
Conclusion
Promoting a culture of safety that prioritizes risk identification, risk mitigation, and continual improvement is essential. There is no common ISO standard for sub-sea management systems. Of course, ISO 9001 is interpretable and can be used as the basis for now. Environmental protection is a challenge for a developing industry, and as such, even greater urgency is needed for statutory requirements encompassing all aspects of stakeholder interests, the marine industry in general, and the protection of the environment for generations to come.
Marine transportation remains the most important way for goods to be shipped across the world, as approximately 80 percent of the world’s goods are transported by ships. Vessels need a place to anchor in normal operating conditions as also in emergencies. A crowded seabed in harbors makes this a challenge for the entire maritime industry.
Without adequate and effective regulatory oversight, it may be too late to take action once cables and other sub-sea equipment have already been laid. Further, multiple agencies regulating the same aspects of the industry can potentially lead to bureaucratic delays. There is therefore an urgent need to create a single statutory body to regulate the sub-sea infrastructure industry, which will greatly benefit all parties invested in the maritime transportation system.