System Documentation-How Much is Enough?


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Overwhelmed by the amount of documentation within your organization. Don’t worry, you are not alone! As organizations and their systems grow so does the amount of system documentation to include procedures, instructions, checklists, SOPs etc.

At times, the documentation is not created because it is needed. It is created to resolve a non-conformity, to ensure a process error does not occur again, to reduce organizational liability and to appease an inspector/auditor. Under these circumstances the need of the hour is to make the problem go away quickly, not to invest time in identifying a long-term sustainable solution. We see our systems grow from 30-page manuals to over 400 pages as time passes. Ineffective reviews perpetuate the problem as duplicated information goes unaddressed.

How much is enough then?

Organizations need to recognize that the documented system is created to enable to users. Too much of it may actually impair the operator rather than enable them. How many of the processes in your house are documented? Now I know some of you are wishing they were and everyone was on board with it! To determine how much is enough companies may be guided by the following:

  1. The competency of the personnel – When the personnel within the organization are well training and competent in what they do and do it well there may be no need for too many of the processes to be documented. However as turnover increases or the organization grows in size additional documentation may be needed to allow for control where needed or to capture knowledge or to simply give confidence that the processes are being carried out as planned.
  2. The structure of the organization – A company with multiple sites, remote sites, or large enough in size, may use documentation to create a system that is uniformly implemented across the breath of the organization. Further documentation may be used to provide clarity on company policy, guidance on what can or cannot be done and/or to allow for decentralized decision making.
  3. The criticality of the process – Where processes are complex and critical and the consequences of failure high the organization may opt for documentation as a means of control to prevent the possibility of human error. Despite the competency of personnel a “zero-trust” environment is adopted to ensure that the process is consistently carried in the way it is intended to be.

Review your system

QMII recently worked with two separate companies to review their existing management system documentation and identify opportunities for reducing the amount of documentation without comprising the quality of operations. In one case we reduced the size of the quality manual from approx. 120 pages down to 30 pages. Information needed by the users was removed form the manual, reviewed and then created as instructions that were more accessible to the users who needed them. Wordy procedures were converted to flowcharts and images used to clarify requirements where needed.

With the other client QMII helped them reduce the number of procedures from approx. 30 to 12. The client realized that a number of procedures could be combined into one and the operator specific information combined in one easy to read document.

A regular review of the documented system is a critical step in ensuring that the documentation does not overburden the user or stop being useful to the user. People change, competencies change, organizations change. The change could be a downsizing or growth. Similarly, our management system documentation too may at times need to be ‘downsized’. Make sure that the documentation is kept relevant and easy to use. The tool used to do this is not as important as the intent and effectiveness of the process. A good review will additionally benefit the organization by allowing for more buy-in by the users and make the system more effective.

Three Steps to Reducing Human Error in Your System


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Reducing Human Error in Your System

As believers in the process-based system approach to management systems, QMII encourages organizations during their root cause analysis to not ask “who” but “how” and “why” the system failed the individual. Human errors primarily occur because the system has failed. Sure, there is a human element to the process, but it is only when the system is assessed that the organisation will look beyond merely training the individual yet again or firing them. This has the added benefit of truly imbibing a no-blame culture because blaming an individual is not going to change the results.

The individual in question may be replaced but unless you assess the system for adequacy, which deemed the person competent, the change of personnel may not lead to improvements.
Where the potential for human error is identified as a risk, the organisation can also choose to put systems in place to mistake-proof in order to reduce the possibility of the individual making errors. In conclusion, when human error occurs, organisations should try to address both aspects of identifying the system failure and mistake-proofing the system.

QMII President & CEO – Dr. IJ Arora presented on the topic “Three Steps to Reducing Human Error in Your System”. The Free Webinar was positively received by participants from various industries.

Click here for the full presentation.

Read more: Implementation of management systems

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Why Safety Management Systems Fail-The Cost of Non-Compliance

Quality Management International President and CEO, Dr. IJ Arora presented on the topic “Why Safety Management Systems Fail-The Cost of Non-Compliance” at the Passenger Vessel Association MariTrends. The presentation was well received and applauded by the packed room.

The PVA Annual Convention was held at Northern Kentucky Convention Center this year on March 4-7. The convention featured a variety of intriguing sessions with various guest speakers that are leaders in the passenger vessel industry.

Click here for the full presentation.

I Don’t See Nothing Wrong


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How often have we heard these words within our organization? Often the evidence is right before the persons eyes and they fail to see it. Perhaps in the hope that the failure to acknowledge it will cause it to go away. Across industries “non-conformities” have come to be recognized as something negative, to be done away with quickly. ISO 9001 2015 training teaches us that a non-conformity is the non-fulfillment of a requirement. It is the system that has failed to meet the requirements and not the individual. Admitting to something being wrong takes courageA well-implemented system can reduce the amount of courage it takes to admit to a mistake or an incorrectly implemented process. 

Why fix it if it ain’t broke 

Another common phrase you may hear across your organization. Yet another “this is how its always been done”. Humans resist change. It causes them to break out of their comfort zone. A common result of completing an ISO 9001 2015 training is personnel returning to their companies to start the mapping of their processes. In this, they may get to hear comments such as those above. Personnel does not want to capture the knowledge in their heads onto a price of paper as it puts their job security at risk. They perceive ISO 9001 as an alien document and the clauses make no sense to them. They do not see the value in audits as auditors are merely seen as policemen out to find fault in what they are doing.  

Is everything really good? 

Non-conformities that are not reported when they occur do not get effective corrective action taken on them and they “magically” occur again and again. Often times a smaller non-conformity unaddressed may lead to a larger non-conformity down the road. ISO 9001 in clause 10.2 asks organizations to implement systemic corrective action by identifying if similar non-conformities can occur in other areas of the system. It asks organizations to assess the root cause(s). ISO 9001 2015 training provided to personnel will educate them on how to interpret the requirements of the system to tailor it to their organization so the changes can be minimal. Organizations can do this by capturing the system as the work is done and not a fictional one. It helps training to be provided to personnel, so they understand their role in the system.  

In conclusion, ISO 9001 2015 training is not a means to complicate the way work is done but by understanding and implementing a system that captures the “as-is” of the organization the changes can be kept to a minimum and small. Once personnel sees how the system benefits them they will learn to admit to things that are going wrong and use a systematic approach to correct them.

 

How Did September 11th Affect Security?


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Two decades ago, the United States was involved in a horrendous tragedy on September 11th, 2001. On September 11th (9/11) four planes flying over the eastern US were seized simultaneously by small teams of hijackers. They were used as giant missiles to crash into well-known landmark buildings in New York and Washington, DC. This attack changed America forever.

The next terror attack will not be perhaps via airplanes, but cyber-attacks. The Department of Homeland Security has geared its focus towards cyber threats and domestic terrorism. A recent Presidential Executive Order has asked all agencies to focus on securing the cyber networks of our nation. Although the United States is more secure than twenty years ago, it is important that we keep track of our cybersecurity. The majority of security risks today are viewed as targeting the networks and hardware that planes and airlines rely on.

The most common cyber threats that we have encountered are phishing, ransomware, and supply chain attacks. It is important to make sure that your organization has a strong cyber security system. Taking an ISO 27001 lead auditor training will provide many benefits to an individual that is seeking to keep information assets secure. This standard is the only auditable international standard that defines the requirements of an information security management system. ISO 27001 contains a set of policies, procedures, and systems that manage information risks such as cyber-attacks, hacks, data leaks, or theft. This specific lead auditor training can help improve your organization’s cybersecurity strategy. Big companies, as well as small and medium firms, should be interested in the ISO 27001 standard.

At QMII, we offer an ISO 27001 (information security) lead auditor training course. Information Security is important to any business. It helps protect companies’ data which is secured in the system from malicious purposes. The goal of information security management is to ensure businesses have balanced protection of confidentiality, integrity, and availability of data. It is important to identify all potential risks to information security in your ISO 27001 risk assessment. Terrorist attacks are one of these threats. By enrolling in an information security course with QMII, students will be given an understanding of the requirements on ISO 27001 as well as how to relate those requirements to an Information Security system. Lead Auditor training gives students an understanding of the requirements of this standard and how to relate it to an Information security management system. Organizations need an effective information security management system in order to effectively manage challenges. To learn more information about ISO 27001 lead auditor training, visit our website and join us in our next course.

Quality Without Question

 

As I was driving home from work, I noticed the following on the back of a vehicle, “Quality without question”. This got me thinking about the message that was being conveyed. Did the organization mean to convey that their quality was great and should not be questioned? That a customer should take their word just because they say so. For many of us that is exactly what we do when we purchase goods off a grocery shelf. We trust the certified organic and non-GMO ratings that we observe on the packaging. But should one question these and how should an organization decide when to?

To check or not to check

ISO 9001 is an internally accepted standard that sets out the requirements for companies looking to implement a quality management system. While ISO 9001 allows an organization to self-declare many organizations choose to go ahead and pursue certification. This is because it demonstrates to the customer an external independent validation by a subject matter expert of the organization’s ability to manage risks and enhance customer satisfaction.

In many cases though, these companies are often audited by customers especially in highly critical industries where the margin for error is very small. ISO 9001 does not require companies to audit their suppliers but asks organizations to determine the type and extent of control they intend to apply. In determining the type and extent of control, consideration should be given to the perceived effectiveness of controls by the supplier. Essentially can the system controls be trusted to effectively manage risks and deliver? This becomes the basis for the need to check or not.

But we don’t have the resources to audit

This is often the case for many small businesses and perhaps even for some governmental organizations that are limited to one or a few suppliers. In these cases, the organization is still obligated to control the externally supplied process, product, or service. Companies can do this by monitoring metrics such as on-time delivery, sampling incoming items for conformity, and in some cases accepting the external organization certification. No matter the approach used, it does not ever absolve the company of ensuring control of the outsourced process/product/service.

In the case of critical items or a single supplier, they may choose to sample 100% of all items coming in and decide over time based on the results if to continue with a large sample size or to reduce to a smaller one. Here also the aspect of resources plays a part. In cases where the resources cannot be made available, the leadership must acknowledge and accept the risk.

In conclusion

Quality must always be questioned, first internally by the organization itself and checked through its processes. It must also be questioned by the customers on a case-by-case basis. Quality and systems that are left unchecked and unmonitored will over time deteriorate and perhaps result in a major incident/accident. To learn more about the requirements of ISO 9001 join QMII’s next lead auditor training.

Problem Solving : The QMII Way

What is problem solving?

What is problem solving? Problem solving is defined as the act of defining a problem, Identifying, prioritizing, and selecting alternatives for a solution and then implementing a solution. A problem – solving process is necessary for all business #management-systems. Why? Because #leadership wants to see continual improvement in their systems and identifying solutions that will effectively prevent recurrence of a problem will enable this. #Leadership needs to ensure their employees are provided with the appropriate training in problem solving techniques to develop and enhance this skill set. Identifying an effective solution can be accomplished by following the proper methodology.

At #QMII, our Problem-Solving workshop  teaches a team-based approach to eliminating root causes through effective corrective action using the eight-discipline problem solving (8D) methodology.

 

What is the Eight Discipline (8D) methodology?

The Eight Discipline Methodology (8D) is a problem-solving approach that we most used in various industries. Originally developed by the Ford company, The purpose of this methodology is to identify, correct, and eliminate recurring problems, making it useful in product and process improvement.  It consists of 8 steps: Create a team, Define the Problem, Contain the problem. Identify the Root Causes, Choose Corrective Actions, Implement and Validate Corrective Actions, Take Preventive Measures, and Thank the Team.

 

Define the problem

Although problems are initially a part of life, we as humans often make the mistake of trying to find a solution right away. We tend to forget that solutions are at the end and not the beginning of a structured process. Often too little time is spent on defining the problem statement well. Time is focused on fixing the issue and dealing with the consequences. Often then, organizations move on to fighting the next fire and a quick problem-solving effort is conducted to “justify” a pre-determined root cause. A well-defined problem is the beginning of a corrective action.

 

The QMII Way

QMII has over 35 years’ experience in systems approach and have successfully applied the 8D approach to problem solving. While there are many approaches to Problem Solving the 8D methodology encompasses the five whys and this is easy for all to understand and then implement. QMII connects the problem-solving approach to the system and in our workshop, we teach students where root cause analysis may lead to other tools as FMEA, Mistake Proofing, and Causal Analysis.  While the workshops help students identify the problem it also helps them understand and implement the remaining steps in the 8D methodology.

Our goal at QMII is educate students/clients on how to identify/appreciate the root causes of the problem to prevent further issues and to address the cause(s), which ultimately leads us to the outcome that should be a conforming product/service/output.  Good management systems ensure that processes remain the focus and result in conforming outputs.

THE BENEFITS OF ISO 9001


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Quality! Why is it so important? Quality can be defined as the standard of something as measured against requirement; the degree of excellence of achieving the requirement. Each day we read through hundreds and thousands of reviews just so we can buy a quality product or service. Even individuals searching for an ISO 9001 training are looking to identify a training provider that will provide quality training.

What is ISO 9001?

ISO 9001 is an international standard set by the International Organization for Standardization (ISO) that defines the framework for a quality management system.  Organizations that seek to deliver a quality product or service can use the framework to build a management system that would help attain this goal.

ISO 9001 Benefits

Even though many people have never heard of ISO or even ISO 9001, one might ask why do we need it?

Why not rely on this framework of reviews. However, those who relied on reviews will find that they are not a sure-shot formula to guarantee success in decision making. ISO 9001 also need not necessarily guarantee this. However, ISO 9001 is not meant for the customer, but for the organization implementing it. Although it is centered around the customer requirements, which primarily focuses on the customer, the benefit is to the organization implementing it.

There are many ways an ISO 9001 certificate can be beneficial.  When an individual obtains this certificate, the benefits are internally and externally. Customer satisfaction is the primary focus of the ISO 9001.  A quality system that Is implemented properly will result in customer satisfaction and a positive reputation for an organization.

ISO 9001 Training

ISO 9001 training provides an in-depth overview of the standard and how it is to be implemented.

ISO 9001 has come to signify a global base minimum for a quality management system. Inherent in the certification that customers see is a commitment from the organization to continually improve, to identify and segregate non-conforming outputs and to design controls to ensure the process can deliver per requirements. An organization purchasing from another halfway around the world has some level of confidence now in their assessment and purchase. ISO 9001 training will demonstrate that ISO themselves say don’t just rely on certification. Determine the type and extent of control on the outsourced provider based on their impact to your processes.

ISO 9001 training can be tailored for all levels of the organization. For management who want to understand their role in the system as also why they should invest in it. The workforce wants to understand how it benefits them and why they should adapt to the changes as they take place. Auditors need to understand the interpretation so they can assess if the system is being well run. So, while an organization may not need ISO 9001 certification, they can surely benefit from ISO 9001 and ISO 9001 training.

Here at QMII, we provide ISO 9001 lead auditor training in a unique format that allows all levels of the organization to attend the same class and leave when their relevant section is complete. Please Join us in one of our classes to learn more about ISO 9001 and how it can better your future.

 

Why we need ISO 9001


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Quality! Who does not want it. We read through hundreds and thousands of reviews each day just so we can buy a quality product or service. Even those searching for an ISO 9001 training are looking to identify a training provider that will provide a quality training. ISO 9001 is an international standard set by the International Organization for Standardization (ISO) that defines the framework for a quality management system. Organizations looking to deliver a quality product or service can use the framework to build a management system that helps them attain this goal.

So why do we need ISO 9001? Why not rely on this framework of reviews. After all many people have not even heard of ISO let alone ISO 9001. However, those who relied on reviews will find that they are not a sure-shot formula to guarantee success in decision making. ISO 9001 also need not necessarily guarantee this. However, ISO 9001 is not meant for the customer but for the organization implementing it. While it is centered around the customer requirements, with a focus on the customer, the benefit is to the organization implementing it. ISO 9001 training provides an in-depth overview of the standard and how it is to be implemented.

ISO 9001 has come to signify a global base minimum for a quality management system. Inherent in the certification that customers see is a commitment from the organization to continually improve, to identify and segregate non-conforming outputs and to design controls to ensure the process can deliver per requirements. An organization purchasing from another half way around the world has some level of confidence now. ISO 9001 training will demonstrate that ISO themselves say don’t just rely on certification. Determine the type and extent of control on the outsourced provider based on their impact to your processes.

ISO 9001 training can be tailored for all levels of the organization. For management who want to understand their role in the system as also why they should spend the money and invest in it. The workforce wants to understand how it benefits them and why they should adapt to the changes as they take place. Auditors need to understand the interpretation so they can assess if the system is being well run. So while an organization may not need ISO 9001 certification they can surely benefit from ISO 9001 and ISO 9001 training.

QMII provides ISO 9001 lead auditor training in a unique format that allows all levels of the organization to sit in on the same class and to leave as and when their relevant section is complete. Join us in a class and learn more about what ISO 9001 can do for you.

Why pursue AS9100 certification


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What is AS9100?

In the aerospace industry, a small error in the supply chain can have catastrophic consequences.  AS9100 was developed to manage the extensive global supply chain of aerospace manufacturers and to ensure that each is implementing an effective quality management system.  AS9100 is based on the framework of ISO 9001 and follows the same high-level structure.  A company conforming to the requirements of AS9100 also meets the requirements of ISO 9001.

AS9100 certification  provides third party validation of the processes an organization has put in place to manage the quality of the product/service they deliver. It can also provide confidence to customers that the organization adheres to the highest standards of quality and safety.

Is AS9100 certification mandatory?

AS9100 and ISO 9001 allow organizations to self-declare conformance.  However, if you are looking to do business in the aerospace industry AS9100 certification is practically mandatory.

AS9100 and ISO 9001 allow organizations to self-declare conformance.  However, if you are looking to do business in the aerospace industry AS9100 certification is practically mandatory.  For a company to be listed on the OASIS supplier database, it will need to have AS9100 certification.  Companies not registered with the OASIS supplier database will have trouble doing any business in the aerospace sector. 

Is it worth it?   

AS9100 certification  comes at a cost, of course.  There are recurring costs as recertification occurs every 3 years and there are annual surveillance audits conducted in the intermediate years.  Developing and maintaining the system will require resources including training time and time spent on improving processes. 

In addition to being listed with OASIS, meeting the requirements of ISO 9001 and AS9100 provides other benefits.  One of these is the creation of feedback loops for communicating and implementing opportunities for improvement.  Another is that it ensures non-conformities are addressed and that effective corrective action is taken.  In addition, it ensures that management remains more involved in the system and that quality is integral to the management system. 

What about audits? 

While AS9100 certification may reduce the possibility or frequency of a supplier audit, it does not imply that an organization will not get audited.  Supplier audits look at an organization’s compliance to supplier requirements as well as the AS9100 standard.  Certification to AS9100 also does not reduce the internal checks required by the company.  AS9100 certification audits will not go to the same depths that internal audits can, which is why internal audits are vital to the success of the system. 

An organization looking to do business in the aerospace industry will need to consider AS9100 certification when implementing a system.  Care must be taken in the system implementation not to use a one size fits all template and to make the effort to build a strong management system that will deliver benefits beyond just the certificate on the wall.