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

Responsibly Implementing Artificial Intelligence

Artificial Intelligence (AI) entered our lives stealthily and not before long has become an integral part of all we do. From choosing a playlist, to self-driving cars, to providing service desk support to name a few. Some people have openly embraced AI while others approach it more cautiously afraid of the domination and ‘rise of the machines. Along with the opportunities that AI presents, also come risks and therefore responsibility. ISO in December of 2023 published a management system standard, ISO/IEC 42001, that provides a framework for organizations looking to use a process-based approach to managing risks and opportunities associated with use of Artificial Intelligence.

What is AI system?

As defined by ISO/IEC 22989 and artificial intelligence system is and engineered system that generates outputs such as content, forecasts, recommendations, or decisions for a given set of human-defined objectives. Artificial intelligence can then further be broken down into various subcategories from weak AI to strong AI. There are also various associated terms that are used within the industry that wall within the realm of Artificial Intelligence systems. These include Autonomous AI system, Machine Learning, and Cognitive Computing to name a few.

An integrated standard approach

In structuring the standard ISO/IEC follows the harmonized 10 clause structure that is applicable to standards such as ISO 9001 and ISO 45001. This will make it easy for organizations seeking to integrate the requirements into their existing management system. Like other ISO management system standards, ISO/IEC 42001 is not prescriptive within the standard clauses. It does however, similar to ISO/IEC 27001 include an Annex of controls that must be considered and that must be justified when not applicable. Annex A has a total of 38 controls that are split among the 10 control objectives. As a risk-based standard it requires organizations to conduct an impact analysis, conduct a risk assessment and then implement controls to treat the risk to an acceptable level.

ISO/IEC 42001 control areas

The 10 control areas of Annex A intend to:

  • Provide management commitment and direction
  • Establish organizational accountability
  • Determine and provide resources
  • Assess the AI system impacts
  • Provide a framework for managing the AI system life cycle
  • Control data used within AI systems
  • Provide a framework for communication with interested parties
  • Ensure responsible use of AI systems
  • Mange relationships

ISO/IEC 42001 also makes reference to the NIST Risk Management Framework, developed to better manage risks to individuals, organizations, and society associated with artificial intelligence (AI).

Next Steps for Companies seeking to align to ISO/IEC 42001

If your organization is seeking to demonstrate a responsible use of AI systems and choosing to align with the ISO /IEC 42001 framework, the next steps would be to:

  1. Conduct as “As-Is” assessment – Identify what controls and resources are already in place within the existing management system.
  2. Conduct an Impact Assessment – Annex A controls provide a structure of how to achieve this and Annex B provides further guidance. This requirement supports the requirements of the EU AI Act. Inputs to the assessment will come from an understanding of the organizational context and the needs of the interested parties.
  3. Conduct a Risk Assessment – to identify potential risks and opportunities for users and society. The assessment should include the implication for deploying AI systems.
  4. Develop Risk Treatment Controls – Identify measures that the organization will implement to mitigate the risks to an acceptable level and then a plan to ensure the effectiveness of controls implemented.
  5. Implement and monitor the controls and system, with an aim to driving continual improvement and ensuring the responsible use of AI.

To learn more about how QMII can support your implementation of ISO/IEC 42001 reach out to QMII solutions team at info@qmii.com or call us at +1 (888) 357-9001.

-By Julius DeSilva, Senior Vice-President

10 Steps to Safeguard Maritime Property from Cybersecurity Threats

IJ Arora, Ph.D

Cybersecurity threats have become a pressing concern in the modern era due to our lives becoming increasingly dependent on computerization. However, with the convenience of technology comes vulnerability to malicious attacks. The maritime industry, with a growing reliance on technology, faces significant cybersecurity threats. Dr. Jekyll and Mr. Hyde (i.e., good and bad) exist and have always existed. Protecting against cyberattacks is crucial to ensuring the industry’s stability and security.

Understanding cybersecurity in the maritime industry

Cybersecurity in the maritime sector involves safeguarding systems, information, and assets from unauthorized access, disruptions, or manipulations. The industry’s growing reliance on technology, including networks controlling essential functions like navigation and communication, makes it an attractive target for cybercriminals. To maintain business continuity, it is crucial that companies assess their current cybersecurity posture and act to proactively improve it. The maritime industry supports trade and the economy at large, so a cyberattack can have broader consequences beyond just affecting a single vessel or company. For this reason, the intent of the attackers might be broader than simply affecting a specific entity for ransom.

Current challenges in maritime cybersecurity

Before delving into the 10 essential steps to fortify against cyberthreats, it’s crucial to acknowledge the prevalent challenges faced by the maritime industry, which include:

  • Business continuity disruption due to breaches
  • Lack of comprehensive response plans
  • Growing reliance on automation
  • Insufficient awareness
  • Vulnerabilities in cloud computing
  • Rise in phishing and social engineering attacks
  • Internal threats and attacks

Controlling both information technology and operational technology systems is critical to fortifying cybersecurity. Various systems within the small passenger-vessel sector are susceptible to cyberthreats, including bridge systems, access control systems, passenger servicing and management systems, and communication systems.

The 10 steps

When addressing cybersecurity, organizations must consider protecting information itself as well as the asset on which that information is stored. Control of both information technology (IT) and operational technology (OT) systems is critical to fortifying cybersecurity. Additionally, management must consider the confidentiality, integrity, and availability of information and how these three aspects may potentially be compromised.

Step 1: Leadership commitment

Leaders must drive the need for cybersecurity and ensure that it is baked in (not buttoned on) to processes. They need to engage the workforce to contribute to the system. To do this, they can:

  • Appoint a cybersecurity manager to ensure accountability and garner buy-in.
  • Make cybersecurity integral to business processes and consider risks vs. rewards.

Step 2: Use a system framework

Employ the plan, do, check, act (PDCA) cycle as the foundation for a robust cybersecurity approach. This is also the approach prescribed by the Passenger Vessel Association (PVA) safety management system (SMS) framework.

  • Develop and regularly update cybersecurity policies aligning with organizational needs and threat landscape changes.
  • Identify clear roles and responsibilities for all concerned with cybersecurity aspects of the SMS.

Step 3: Contextualize risk

  • Consider the broader context of operations, trade patterns, technology, and legislative factors.
  • Identify stakeholders, online networks, assets, critical components, and business-sensitive information.

Step 4: Risk assessment (3D framework)

Leaving hazards in uncertain states is a drawback for proper risk assessment. It is the responsibility of leadership to convert uncertainty into clearly defined risks within the context of the organization and then prioritize those risks.

  • Organizations must assess hazards in terms of probability, severity, and the likelihood of detection.
  • Risks should be prioritized with consideration given toward confidentiality, integrity, and the availability of information.

Step 5: Build controls into processes

Controls can be split into various categories, including administrative, physical, human, and technological. In some cases one control may suffice, but for the most part a combination of controls must be applied. Identified controls should be implemented based on the feasibility rule, meaning that although they may look good in a vacuum, ease of implementation must be considered. Information security should be a part of everything the organization does—not an add-on. This includes:

  • Implementing technical security controls like firewalls and intrusion-detection systems.
  • Adopting a layered security approach (i.e., “defense in depth”) to effectively mitigate against various threats. This entails creating multiple barriers to prevent access to information—physical, passwords, firewalls, VPNs etc.

Step 6: Maintain basic measures

Basic safety measures are easy to implement and, for the most part, they are cost-effective. This can include cybersecurity awareness training for personnel, physical security, and password security. Below are a few more, although this is not an exhaustive list:

  • Keep hardware and software updated.
  • Enable automated antivirus and anti-malware updates.
  • Limit administrator privileges and control removable media.
  • Avoid public network connections without a VPN.
  • Regularly backup and test information-restoration capabilities.

Step 7: Employee awareness

It is important to make employees aware of the need for good cybersecurity protocols. Employees are often the weakest link in the security chain. Statistics show that almost 36 percent of data breaches are caused by employee negligence. Immediate actions organization can take include:

  • Educate employees on cybersecurity best practices to minimize human error.
  • Train personnel to identify phishing attacks and report incidents promptly.

Step 8: Emergency preparedness

No organization is immune to cyberattacks. It is important to have a plan in place for responding to attacks quickly and effectively. The plan should include steps for mitigating the damage, containing the attack, and investigating the incident. You can use ISO 22301: 2019, “Business continuity,” to develop this plan.

  • Your plan should include comprehensive processes for responding to cyberattacks swiftly and efficiently, including reporting mechanisms.
  • Test and improve your business continuity plan regularly.

Step 9: Assess effectiveness

The check stage of the PDCA cycle is vital to instill confidence in the effectiveness of the organization’s cybersecurity measures.

  • Conduct regular cybersecurity assessments, including third-party evaluations for objectivity.
  • Evaluate assets, vulnerabilities, IT/OT risks, physical access, and breach potentials.

Step 10: Continual improvement

  • Embrace continual improvement through the PDCA cycle to maintain vigilance.
  • Invest in training personnel on cybersecurity standards like ISO 27001.

Conclusion

Taking cybersecurity seriously and implementing these 10 steps can significantly mitigate the risk of cyberattacks. Begin the process by conducting a gap assessment using a qualified person to assess where your system currently stands and what actions need to be taken.

Your action plan should identify risks, gaps, and the controls needed. These controls can easily be integrated into the existing safety management system. Investing in cybersecurity today will better prepare your organization to manage future risks. Leadership involvement is crucial, and these steps serve as a solid foundation to effectively fortify cybersecurity measures.

About the author

Inderjit (IJ) Arora, Ph.D., is the President and CEO of QMII. He serves as a team leader for consulting, advising, auditing, and training regarding management systems. He has conducted many courses for the United States Coast Guard and is a popular speaker at several universities and forums on management systems. Arora is a Master Mariner who holds a Ph.D., a master’s degree, an MBA, and has a 33-year record of achievement in the military, mercantile marine, and civilian industry.

Above article is featured in the following:-

Foghorn Magazine

Exemplar Global Publication “The Auditor”

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.

Exemplar Global Publication “The Auditor”

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.

How to Alleviate Common Management System Pain Points

Implementing ISO standards is not mandatory, however a management system conforming to a standard can have numerous benefits. Some benefits include increased efficiencies, proactive risk management, better interaction among departments and alignment with the needs of interested parties. However, once you are actually in the process of implementation, you may experience the following pain points: 

  1. Lack of top management commitment 
  1. Limited resources to effectively implement the program 
  1. Lack of buy-in from the workforce  
  1. Over documented systems  
  1. Lack of measurable objectives driving improvement  
  1. Teams lack adequate interaction and alignment  
  1. Company is focused on keeping certification at all costs  

Quality Management International, Inc (QMII), having over 37 years of providing sustainable solutions for our clients, recognized how these hurdles can impact an effective management system. QMII has developed and provided solutions to address and alleviate these pain points that continue to benefit our clientele. 

A management system consulting project cannot start without top management present to map the process of what they do (core process) and to identify the core objectives for the system. Policies, objectives, and motivation must be demonstrated from the top-down and evidenced by all the team players. To further reinforce commitment, we get top managers to develop a presentation to launch the system and that will then be used for awareness training as the system progresses. This is done using our Awareness Leaders Workshop. Without authority, responsibility, and resources, middle management and individual contributors cannot improve the business management system.  

We understand that companies have financial restrictions. With a mission to get organizations to appreciate the benefits of a process-based management system, we provide multiple options to work around this challenge. 

(1) We provide free information on our website so you can carry out ISO implementation at your organization.  

(2) Attending a lead auditor training course is a relatively minimal cost. You and your team will gain a comprehensive understanding of the desired ISO standard and gain the skills necessary to implement requirements and conduct audits to determine conformity.  

(3) If you need a little more guidance, we provide scalable consulting services. Our consultants are here to assist you with exactly what you need. You will not have to pay for the full package.  

(4) Our alumni have free email and phone support, for life, to get over average hurdles.  

As far as reluctance among employees, it’s human nature to be reluctant towards change. Keeping this in mind, QMII consultants get key process owners to evidence top management’s commitment and ensure that they are involved in QMS (Quality Management System) development. We analyze with them to capture the system AS-IS and what-should-be. It is essential to get the team buy-in during this process and get their input on the process’s actualities. Teams must also interact and be aligned. We provide team-building workshops where we align objectives to the vision and processes to meet objectives. 

ISO implementation is not an overnight process, it may even seem daunting. QMII’s Action Plan Checklist is readily available, and it focuses on the big picture to simplify the process. If you need more assistance, our consultants would be happy to work with you through the checklist. We appreciate the system you already have; we are simply helping you enhance it to meet requirements and set objectives. Documentation is a significant part of ISO implementation. To remove complexities, we incorporate existing documentation and use a format that works best for you. 

At the end of the day, ISO certification is primarily a marketing decision. QMII strives to help you develop a resilient, integrated management system so that you receive actual benefits. Once set up, your system will work independently and continue to improve while managing risk proactively.  

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!