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

Excellence in Auditing Presented by Dr. IJ Arora for Exemplar Global

“How Auditing Helps Prevent Tragedy,” presented by Dr. IJ Arora with Wendy Edwards (Project Director of Exemplar Global) at the Exemplar Global’s Excellence in Auditing Expo!

Click the link here to understand the critical role auditing plays in averting potential disasters. Whether you’re in risk management, quality assurance, or simply interested in safety and security, this discussion offers valuable perspectives and actionable takeaways.

Link to the Presentation

Can Boeing Deliver a Long-Term Solution to their 737 MAX Problems?

Dr. IJ Arora

Boeing is in the spotlight again with its 737 MAX planes, which have already had a deeply troubled history. Customer focus (which is clause 5.1.2 of ISO 9001 and AS9100) seems to have been lost somewhere.

I have read several recent articles on these incidents as well as Peter Robison’s book Flying Blind: The 737 MAX Tragedy and the Fall of Boeing, all of which point to a worsening situation for Boeing. The public perception of this great American company, which has always been committed to top-class engineering and trusted products, is changing from one of respect to one of caution. Travelers are wondering, “Should I fly in a 737 MAX?”

Boeing and the aerospace industry in general have high standards for quality and product safety. In this article, I postulate whether a company’s quality management system can guarantee that nothing goes wrong for customers. Can it ensure perfection? If not, what are the alternatives—and why have one at all?

What happened and who is responsible?

For those not familiar with the 737 MAX incident in January, shortly after an Alaska Airlines flight departed from Portland, Oregon, a cabin door panel blew off. As investigations are still ongoing the causes have not yet been fully determined. Boeing also had a software issue on the 737 MAX, resulting in the crash of a Lion Air flight in 2018 and an Ethiopian Airways flight in 2019.

Here in the United States, the Federal Aviation Administration (FAA) plays a critical role in providing regulations to ensure flight safety, and also provides oversight of aircraft manufacturers, airports, and maintenance providers. In the case of the Alaska Airlines flight, it seems that the FAA failed to uphold its trusted role. The FAA’s numerous checks and balances, most of which are intended to focus on customer safety, were like aligning holes in slices of Swiss cheese. It will be interesting to see what changes this incident brings about at the FAA. Then again, can regulatory oversight guarantee safety of flight?

The AS9100 standard, which is specific to the aerospace industry, isn’t the brainchild of a single entity, but rather a collaborative effort driven by two key players:

  1. The International Aerospace Quality Group (IAQG). This international organization brings together representatives from aviation, space, and defense companies across the Americas, Asia/Pacific, and Europe. They actively participate in developing, maintaining, and updating the AS9100 standard.
  2. Standardization organizations. These bodies, such as the Society of Automotive Engineers (SAE) in the Americas and the European Association of Aerospace Industries (now the AeroSpace and Defence Industries Association of Europe), officially publish and distribute the standard.

It is important to note that AS9100 builds upon the foundation of the more general ISO 9001 quality management system standard. While ISO 9001 lays the basic framework, the IAQG adds industry-specific requirements crucial for ensuring safety and quality in the aerospace domain.

In addition to the manufacturer and the FAA, the owner/lessor of the aircraft also plays a role in ensuring the plane is properly maintained. This includes selecting a competent maintenance provider, hiring competent engineers, and having robust processes in place. With so many different stakeholders, can blame be attributed to just one when accidents happen? Furthermore, should blame be the name of the game? Perhaps not! It is important to note that the system is implemented to support each user and that all stakeholders in the value chain play their part as well.

Audits, inspections, and management systems: Are these the solution?

Behind every tragedy, casualty, and mishap is a chain of related events. The immediate suspect when these types of critical failures occur are poor inspection protocols, perhaps even the dreaded “human error.” However, this may be the low-hanging fruit and a deeper dive may identify other causal factors, such as asking if the quality audit failed.

What is the difference between an audit and an inspection? Can they replace each other or are inspections alone enough? The simple answer is no! Both are needed due to fundamental differences in approach. Audits look at the processes to ensure the management system produces conforming products and services. An efficient management system must include the following, to name a few:

  • It must be well-defined, starting with the “as-is” state of the system.
  • Risks must be identified (clause 6.1) based on the context of the organization (clauses 4.1 and 4.2).
  • A clear definition of the product must be identified.
  • Effective audits and periodic review must be undertaken by management.
  • Outsourced processes must be controlled.

Inspections play an important role by identifying defects prior to release, thus protecting not only the client/customer/user/warfighter, etc., but also the reputation of the organization itself. With that said, inspections don’t contribute to continual improvement because they focus on fixes as opposed to long-term solutions. In effect, they do not really add value since the organization has already incurred the cost of producing the defective part or product. The creators of the Toyota Production System (i.e., lean) came up with the Andon process to catch a defect as early in the process as possible so as to fix it before the problem went too far down the line.

Management systems are not just a collection of documents. To function properly, they require commitment at all levels of the organization, including top management providing the needed resources. It takes time to build a culture of quality in which shortcuts are avoided and there is no fear of speaking up. Customer focus must not be compromised. For example, release of conforming product should go through the process specifically called out by clause 8.6; any interference by top management to truncate this process would imply the loss of customer focus. Is this a possibility? Perhaps, but the investigation must reveal the truth. In this case of the Alaska Air incident both the Boeing customers and Boeing as a company have suffered. It is my hope that investigators will identify all failed parts of the system from each responsible party. These may include not only failed inspections, but also suboptimal processes. This could end up taking us back to an inadequate quality management system.

Quality management systems: Can they deliver?

Given the above, can a properly designed and well-audited management system (supported by good inspection techniques to help ensure conforming product) guarantee that nothing goes wrong with an organization’s output? My opinion is that no one can guarantee this completely. However, risk can certainly be greatly reduced when everything is implemented well. This includes the training of personnel, which correlates strongly to competence; unfortunately, this is often the first budget to get cut when resources are scarce.

When high-visibility incidents like these occur, it may be forgotten that airplanes remain the statistically safest mode of travel on earth. This is primarily due to robust quality management systems, well-adopted regulatory frameworks, and regular oversight. Humans play an important role in the success of the management system, from the commitment at the top to the buy-in by the workforce (clause 5 to clauses 7.1.3, 7.1.4, and 10.3). Taken together, this helps create an environment where quality can flourish within the organization.

Boeing may be doing a lot correctly, and yet the results could be unacceptable depending on the performance of outsourced processes (clauses 8.41/8.4.2/8.4.3). After all, the fuselages for the 737 MAX are made by Spirit AeroSystems Holdings Inc. Spirit AeroSystems is located in Wichita, Kansas; once these fuselages are manufactured, they are shipped by rail to Boeing’s facility in Renton, Washington. Therefore, not only is a major component of the 737 MAX outsourced, but the shipping and preservation of product (clause 8.5.4) also could contribute to the product’s nonconformity. Overall, Boeing remains responsible for the entire supply chain (clause 4.3), with their obligation to “ensure conformity of its products and services and the enhancement of customer satisfaction.”

Even with a solid quality management system in place, this or similar failures can occur. There is no way to assure the public of 100-percent performing (i.e., perfect) output. The fear in the minds of air travelers is valid and will remain so until an exhaustive root cause analysis of this issue is performed and those root causes are resolved. The current events beg the question: Did Boeing improve their management system after the Ethiopian Airlines 737 MAX crash? If they had bent to the oars and gone deep into their review to uncover and permanently fix the holes in their management system, this event may never have occurred. Surface corrections, or what some organizations call “fix -it” solutions, only remove the symptoms. The root causes must be addressed and resolved (clause 10.2.1). There are no shortcuts to quality.

In conclusion

It has taken years for air travelers to feel safe and unconcerned about air safety. I travel a lot internationally, and often pick an airline based on their service and comfort, but now I (as well as the broader public, I would imagine) need to consider which aircraft will transport us. It is a new fear about product safety that has its genesis in Boeing not operating its management system efficiently and losing customer focus. The worst is the erosion of public confidence in federal oversight and its intent to keep the customer safe.

I have spent my life studying similar complex problems and leading teams in helping organizations find long-term sustainable solutions. This requires bold and dynamic leadership (clauses 5.3 and 5.1) for leaders to plan and implement change. Appreciating and accepting risks (i.e., keeping the customer in focus) and moving forward is integral to true leadership. Ethics is still not a clause of ISO 9001 and AS9100, but ethical leadership is about doing the correct thing for all stakeholders.

In seminars at which I present, I often ask senior managers: “If you have a choice between following the procedure and/or doing the correct thing, what would you do as a leader?” The answer—I hope—is to do the correct thing at all times. But then, hope is not a plan. Air safety cannot be based on hope and faith. Boeing needs the leadership to redesign their system if they are to bring the public trust back for this great American company.

Hyperlink to the thing characteristic in Exemplar International e-newsletter – “The Auditor”

Audits VS. Inspections

There is often confusion about the difference between audits and inspections. The purpose of each may seem the same, but they are slightly different.  Audits focus on why, while inspections focus on what. The purpose of an audit is to get the confidence that processes are working well.  An audit involves various layers to answer a “why” question. It involves exploratory reviews involving documentation, risk assessments, and nonconformities, etc.  While an audit may need more effort in finding an answer, an inspection is less complicated. The answer to an inspection question will involve a straightforward yes or no answer.

Inspections focus more on the action, while audits are about the process.  Inspections review a single point in time, but an audit follows a process from start to finish.  An inspection simply looks at the product or service. The process of an inspection is quite simple, it either clears the project if it meets the requirements specification or rejects it. If it is rejected, its loss can be reworked at an extra cost. Inspections must be conducted at every step to minimize the chances of product failure.

Why are audits and inspections important to an organization?  Inspections deal with things that cause immediate accidents or other issues. Inspections protect the customer, so the customer is not harmed by a non-conforming product yet from an organization’s point of view that they are too late.  The audit is to cover the root cause of these problems. The audits provide the input and ensure continuous improvement and it is where we take on nonconformities.

Here at QMII, we provide valuable information when it comes to our auditing services. We can give insight on where your system is working well as well as the risks and suggest opportunities for improvement. QMII’s audit services reduce the fear of an audit. Some individuals fear being blamed for non-conformities and often dread the idea of an audit. Our services are to ensure auditees are put at ease while QMII auditors look to find the effectiveness of controls in the system.

Although there is often confusion when differentiating audits and inspections, it can be easier to think of it as the Plan-Do-Check-Act cycle. Inspections are a “do” while audits are a “check.”  Inspections are required to do, and the audits are the process of checking and making sure inspections have been done.

 

 

Is your organization ready for MDSAP?

Quality is important in all industries but perhaps more so in the medical industry and for those organizations producing medical devices. Apart from ISO 13485 that defines the requirement for medical device quality management systems, medical device manufacturers have to also comply with the regulations of the country their devices are going to be used within. In an effort to streamline the program for manufacturers the Medical Device Single Audit Program (MDSAP) was devised. The MDSAP program is an audit done of the company to the regulations of five participating countries. It is thus much longer than a regular ISO audit as it has to assess the system against multiple regulatory requirements.  

As your company prepares for this new audit scheme perhaps the easiest thing to do is a self-assessment. Use the MDSAP audit model guide to assess whether the company processes meet all the requirements. Conduct a gap assessment and then work to fill in the gaps including keeping records as needed by MDSAP. Just because an organization undergoes MDSAP does not mean that it will not have an ISO 13485 audit as these are two separate schemes. In the conduct of the assessment ensure that the person conducting it is competent to do so. This will avoid any last-minute surprises. Make note that the MDSAP model grades non-conformities differently and so use the same scoring scheme to know what are the priorities that need to be addressed immediately.  

Is the leadership prepared? Often in preparing an organization focuses on the lower echelons as also on the processes involved in the design and manufacturing processes. Ensure the leadership is briefed on the model guide and understands the expectations from them. As a part of each audit, the AO focuses on the management and assesses their commitment to the system. The leadership once committed will drive the rest of the organization to follow suit. This will make it easier for those implementing the system and assessing it internally.  

Make sure personnel are trained and understand well the expectations. QMII offers a variety of MDSAP offerings that are tailored to meet the requirements of the organization with training for each level of the organization. In addition, QMII also offers ISO 13485 lead auditor training. Organizations must recognize that participating in MDSAP will not exclude them from regulatory audits from other organizations. While the audit program may seem cumbersome at first there are benefits from participating in it that include reduced costs and a streamlined audit process.  

How to get ISM certified

The ISM Code is the International Code for the safe Operation of Ships and Prevention of Pollution, more popularly knows as the International Safety Management Code. The most recent revision of the code was released in 2018 that provides updates to the Resolutions included as amendments to the code. The ISM Code specifies the methods to attain ISM certification.
The regulations were drafted by IMO in an effort to improve maritime safety and while it has been hailed as a major contributor, it has also led to increased bureaucracy as also increased burden of documentation. As part of the ISM certification scheme there are two certificates needed. One for the company called the Document of Compliance or DoC. This allows the companies to operate vessels under the ISM Code. The DoC is issued by the Flag State, that is the country where the company and its ships are registered. The DoC is issued for each type of vessel that the company operates. This means that it cannot operate a bulk carrier if it only possesses a DoC for a container.
The next certificate under the auspices of the code that is issued is a safety management certificate. This is issued to each ship of the company and in order to get the certificate an audit of the vessel is conducted, and certain criteria needs to be met prior issue of the certificate. The SMC ISM Certification is issued for a period not exceeding five years and where only one intermediate verification is done it should be done within the 2nd and 3rd anniversary of the certification.
The ISM Certification provides validation that both company and ship are operating using a process-based system approach to manage risks and achieve continual improvement. The ISM code is meant to be a preventive tool and asks companies to assess all risks and then take measured to safeguard against them. Responsibilities and authorities are set out for the various entities includes in the ISM process.
Gaining ISM Certification does not guarantee that the ship will be safe or environmental pollution will not occur. It does however provide stakeholder the confidence that non-conformities will be addresses systemically and where an emergency does occur, the company and ship will be prepared to deal with them in the best way possible to mitigate consequences. To be successful it needs active involvement by the leadership and needs them to walk the talk. The system must be built around the users and for the users to enable them to succeed.
To learn more about the ISM Code and ISM certification enroll for QMII’s ISM auditor training.

ISO 9001:2015 – Exclusions

Exclusions to what an organization does were integral to the ISO 9001 standard prior to the 2015 version update. After all an organization cannot do all the work. Clause 7.1.1 lays the foundation on this thought by accepting that an organization must determine and provide resources. In doing so it determines the constraints and capabilities of the existing resources and what needs to be obtained from external providers. As such in previous standards, the organization, when seeking certification, requested exclusion on those processes that it did not perform.

The drawback of this was a major flaw. Over the period of time, some of these organizations, sheltered under the exclusion provision even lost the ability to pick the correct outsourced party! For example, if the organization builds highways, but outsources bridges and tunnels, then it must have the ability to be able to pick the correct vendor/ contractor who will not let the customer down. The revised 2015 version of the standard therefore in the wisdom of TC-176, removed this exclusion provision. It does not imply now the organization cannot outsource what it does not do. All that it means that the organization can review the applicability of the requirements based on its size, complexity and decide on the activities it needs to outsource.

With the exclusion provision removed, the organization would need to do due diligence in appreciating the range of its activities and the risks and opportunities it encounters as also the effect if any of the outsourced vendors not performing to accepted requirements. The organization then remains accountable for the outcome of the outsourced processes and products and services externally obtained. To ensure their consistency and levels of acceptance, it would need to take measures as required by clauses 8.4.1, 8.4.2, and 8.4.3 of the ISO 9001 in enforcing monitoring and measuring to protect its customer and clients.

This assurance that an organization can not and will not outsource those activities which by its decision will not result in failure to achieve conformity of products and services. Clause 4.3 of ISO9001 in determining the scope of the quality management system clearly requires that conformity to the ISO 9001 can only be claimed if the requirements determined as not being applicable do not have an adverse impact on the promises made by the organization. The products it provides, based on externally obtained subproducts or services must not affect customer satisfaction.

In terms of auditing, it is incumbent upon auditors that they carefully seek conformity to this requirement when auditing. Internal audits to ISO 9001 must provide the objective inputs to top management to make better decisions and appreciate the risks of outsourcing to nonperforming and or underperforming outside organizations, remembering they remain accountable and answerable for the final product or service. Ensuring the organization’s accountability for the conforming products and services whether outsourced or not is the responsibility of the organization.

QMII’s ISO 9001 EG (Exemplar Global) certified lead auditor training designed carefully to meet the objectives as envisaged in the standard.

The role of internal audits in MDSAP audits

As MDSAP deadlines draw near companies are asking how to prepare for the MDSAP audit. The most basic step for the success of any management system is to say what you do and do what you say. When the system as documented is captured to reflect the “As-Is” of how it is done then implanting the system leads to conformity at all levels.
Auditing Organizations (AOs) that will come to assess the conformity of the system will be using a process-based approach to the audit as also prescribed by ISO 13485 and ISO 19011. As such internal audit teams too should be trained to conduct process-based audits. This will ensure that the organization will be ready and familiar with the way the AO audit will be conducted. Process-based audits also allow a better look at how the system is working to meet objectives. In the aerospace industry PEAR diagrams are used to identify the inputs, resources and controls for each process to better understand the interrelation of them within the process, whether they are sufficient and how they interact with other processes.
In the process audits for MDSAP the AO will first start with an audit of the leadership (top management) to appreciate their commitment to the system as also their awareness of the risks impacting their system and the actions, they are taking to address them. At each level the auditors will be seeking evidence of competence, documentation and data control and monitoring and measurement being done.
Internal audit teams should use a grading system familiar to those used by MDSAP auditors and as prescribed by HTF/SG3/N19:2012. The grading system follows a scale of 1 to 5 with 5 being the most severe. This will enable a realistic look at the state of the system. Auditors will also focus on the design and development and production controls from a risk perspective. They will assess how well the outsourced providers are controlled and what risks were determined in assessing the type and extent of control to be applied.
As with all systems auditors will want to assess that a system exists to identify and deal with non-conformities including implementation of corrective action within the defined time frame. Internal audit personnel can gain a better understanding of MDSAP audits and how to prepare by enrolling in QMII’s suite of course offerings tailored to various levels of the organization. Keep in mind that MDSAP audits are longer in duration as the audit time is based on tasks and not the number of employees.

Effectiveness of the ISM Code

The ISM (International Safety Management) Code, in itself, is not a magic wand, that will bring safety or prevent pollution. It depends on the organization on how it implements the Code. Safe operation of ships and the prevention of pollution should have been any organization’s objective. Yet all over the world owners to save money compromise these objectives. Did not the Titanic on April 15, 1912, sink, trying to create a record of crossing the Atlantic, by going North to cut distance, run into the iceberg?

The sinking of the Titanic, with a loss of nearly 1500 passengers and the crew was an eye-opener. It led to the SOLAS (Safety of Life at Sea) convention. Did the negligence and continued operation of ships compromising safety stop with SOLAS? Sadly not. The investigation by Justice Sheen into the sinking of the Herald of Free Enterprise, on March 6, 1987, looked at why SOLAS had not helped prevent the tragedy. It brought out the necessity for a process-based management system, and the SOLAS Chapter IX was updated to authorize the ISM Code. It provides the guidelines for the implementation of a system to ensure the safety of vessels at sea.

The Flag State Administrations whose flag the ships sail under, legitimize the use of the code making it mandatory for internationally trading vessels. If any company is bent upon not implementing it in the spirit of it, then of course the objectives of the code as also the functional requirements will not be met. Owners and Operators of the vessels often look to short term gains wherein they compromise the standards and bypass the rules. They have to understand that behind every casualty at sea are many detentions and behind them indicators like Major NCs (non-conformities) and near misses.

The Flag States who do not strictly inspect and audit vessels to the ISM Code and issue SMC (safety management certificates), are actually, to retain the business of ship owners, jeopardizing the same ships! Even some responsible Flag States, due to shortage of manpower outsource their duties to ROs (recognized organizations), often represented by class societies. This results in diluted control, as an outsourced process needs strict monitoring of the process to ensure the performance is not affected. Not managing an outsourced process is as good as not taking responsibility. Authority can be delegated, bot the responsibility.

NCs (non-conformities) drive correction and CA (corrective action), and as such should be welcome as inputs to ensure continual improvement of the system based on the ISM Code. Yet, there are every day common examples of Masters of ships negotiating to somehow get the auditors to not give NCs. This is because the management ashore is not mature to realize, that keeping the master’s pressurized and performance being judged by NCs reported is creating an environment of fear and hiding of NCs. A good SMS (safety management system) based on the ISM Code, if correctly implemented should welcome NCs. The DP (designated person) should know that the “only bad NC, is the one which the organization does not know about.”

For domestic vessels, and for that matter towing and small vessels, and perhaps in due course of time for domestic passenger vessels, one would think a new standard would be required? Sub Chapter M for the towing industry in the USA, is nothing else but the ISM Code domesticated. The ISM Code is a useful well thought of document which provides strong fundamentals based on hundreds of years of sea experience, loss of life, cargoes, ships, and fortunes. The process-based management system it propagates would systematize operations. However, for an effective management system, the implementers have to be motivated and committed. The Flag States have to be strict and vigilant in their issue of certificates. When they outsource the certification to Ros, they must not wash their hands of their responsibility. The strict monitoring of the ROs by ensuring good clear concise MOUs (memorandums of understanding) with clear provisions to audit the ROs must be put in place. The owners and operators through their organization should put in place a robust internal auditing program that gives the objective inputs on the implementation of the ISM Code.

– by Dr. IJ Arora