What is a Quality Management Systems (QMS)?


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Quality Management Systems (QMS) are today extensively a part of an organization. If the TM (top management) is committed, it uses the ISO 9001 based management system to meet customer requirements, ensure customer focus and provide desired outputs. Where the TM/ leadership is immature, they often may implement a quality management system to get the ISO 9001 certification. This decision to have a QMS certification without effective implementation is a waste of money and resources. It is not worth the paper the certificate is on. Or perhaps it is, because having that ISO 9001 certificate may be the passport to win a contract or run a business.

Failed management systems (MS) invariably have a lack of management commitment or worse a leadership who do not understand the cost of not having quality. Such quality management systems are aligned to ISO 9001, but for easy auditing written to the clause structure of the standard. Such systems are written for auditors, who then audit it effortlessly as they can see the system written to the clause structure of the ISO 9001. Leaders forget that MSs should be designed for implementation by their employees.

Organizations do not work to clauses of the ISO 9001. They use the clauses to design a better MS. The organizational structure of any organization takes its direction from the policy (clause 5.2 of the ISO 9001). The policy leads the organization and its functional departments to convert the policy into measurable objectives (clause 6.2 of ISO 9001). These functional division of the organization work to achieve their objectives by functioning per their key and support processes. A quality management system based on ISO 9001 requires the system to work using a process-based management system approach. The idea is to be systematic about working so that customer requirements and expectations are analyzed before being accepted. Once accepted, the organization with the efficient interaction of its processes produces the desired outputs meeting the requirements and specifications as the case may be, and also ensures, where applicable that the statutory directions are met.

ISO 9001:2015 emphasizes customer focus not only in clause 5.1.2 but throughout the standard to ensure that the Quality Management System based on ISO 9001 appreciates the risks in the context of the organization and consistently produces confirming products and services. It is important that customer focus is maintained throughout, integrity of the quality management system always maintained and if for any reason a non-conforming product is produced then such non-conforming product or service is handled in a manner that the customer is never sent such a product.

For this reason QMSs based on ISO 9001 or for that matter any ISO standard, or an industry specific standard like AS 9100 or say a MS based on ISM Code (for maritime safety) and so on, should work using the accepted PDCA (Plan Do Check Act) cycle. Processes are designed, documented or undocumented to ensure that a good preparation is made at the Plan Stage. Any good QMS interprets the clauses of ISO 9001 for its QMS using clauses 4, 5, 6 & 7 to appreciate the risk and make a good plan before going to the do stage. The implementation of executing the inputs to convert them into desired outputs is done using ISO 9001 clauses under 8.

Any quality management system based on ISO 9001 has to sustain its processes delivering the final product or service by designing them well, resourcing them and monitoring them. Therefore, a strong objective check stage is required to conduct internal audits and to analyze data so that the information provides inputs for better resourcing. Clauses 9 and 10 of ISO 9001 address the check and act phases synonymous with monitoring and decision making by leadership before the next cycle of the PDCA cycle is implemented. The act stage is a vital stage associated with the leadership wherein a management review of the performance of the quality management system is conducted.

For the quality management system to deliver what ISO 9001 is designed around, is only possible if the leadership is genuinely committed to not just have a QMS based on ISO 9001, but uses it to make decisions. The business system and the QMS should be married in a strong unbreakable bond.

 

ISO 45001 Transition: Change is coming to health and safety

Organizations currently certified to BS OHSAS 18001 have until March 21, 2021 for their ISO 45001 transition. Those who are currently implementing management system conforming to BS OHSAS 18001 will notice some similarities and some differences. Those who are certified to other ISO standards such as ISO 9001 will notice the similarities in the standard owing the use of the High-Level Structure in the new ISO 45001 transition standard. This article discussed the key changes to the standard over the BS OHSAS 18001 requirements. It also highlights certain key aspects for those undertaking an ISO 45001 transition.

Keeping with the High-Level Structure, ISO 45001 in clause 4.1 and 4.2 asks organization to consider the context of their organization or the aspects of their business environment that may impact their operations. The business environment includes both internal and external issues such as new regulatory requirements, new technologies, cultural issues and company values to name a few. Companies need to consider the needs of different relevant stakeholders that may impact their system including the needs of their workers. Organizations are asked to have workers participate in the system development as they complete their ISO 45001 transition.

ISO under the high-level structure has removed the need for preventive action as now the entire standard is designed as a preventive tool. Further to support this is the introduction of risk-based thinking’ both from a strategic perspective and from an operational health and safety perspective. Risk-based thinking and the awareness of personnel of this is key to ISO 45001 transition. There is now a stronger stress of leadership’s role in the system. Leaders must take accountability for the effectiveness of the system and cannot wash their hands of the system. Leaders must not only engage in the system themselves but also engage others as the ISO 45001 transition takes place.. The Clauses under 5 also have a requirement for the consultation and participation of workers. They have to remove the barriers to participation and include even non-managerial workers.

Documents and records are not controlled under the common clause for control of documented information and based on the risk-based thinking there is more freedom allowed with the documentation. Outsources contractors will also need to be controlled within the scope of the system.

Organizations undergoing an ISO 45001 transition, will need to incorporate all these aspects into their system. Care must be exercised when setting up the system to design it around the user and not around the auditor or certification body for the system to be useful in the long run and to drive continual improvement.

Aspects and Impacts: Let’s start here

Every organization needs to consider the aspects of their organization, and the impacts they have on the planet.  Understanding the impacts is critical to the sustainability of the organization, and in the long run, the planet.

Most organizations only consider the impacts of their processes in relation to waste created and materials used.  While these are important, an organization should consider all aspects of their operation and processes before they start a business.  This includes the facilities, people, materials and other elements of their operations.  Once operational, they need to continually evaluate all process to look for improvement.

Many aspects are considered by organizations in order to borrow money to launch a product or service.  This is a good place to start.  Clearly understanding the impacts the organization will have on the local environment and community is a good step toward launching a sustainable business.  Lenders, both private and public, will be more generous lending if they know the organization is considering all three pillars of sustainability; social, environmental and economic.

Generally speaking, recycling an existing structure to a new operational use has less impact than building a new facility.  Applying building technics recommended under Leadership in Environmental and Energy Design (LEED) and Energy Star, will also reduce environmental impacts, and improve the operational economics.  If new structures are required, considering the site location, building facing direction and proximity to water, public transportation, and workers, will also help the organization conform to LEED and other building Standards.  Local communities will be much more accepting of an organization operating in their community if the proper design considerations are considered before construction is begun.

Once operational, every group in an organization needs to evaluate their processes on a regular basis to determine what improvements can be made to the aspects of the organization, and the impacts of there processes.  Management is accountable for the operation of the organization, but every department needs to be responsible for their processes.  This is not just the manufacturing or production departments, but also sales, marketing, receiving, packaging, shipping and customer services.  Organizations are also responsible for the performance of their products and/or services, and often the potential recycling of products. 

The International Organization for Standardization (ISO) has established Standards that can be used by an organization to help improve their management system processes and reduce risks.  ISO 14001:2015 Environmental Management Systems and ISO 9001:2015 Quality Management Systems can be used separately, or together, to provide guidance in improving an organization’s operations.  Lenders and communities appreciate the value of a well-run organization that understands the aspects of their operations and addresses the impacts.

What is ISO 14001 Lifecycle Perspective?


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ISO 14001 Lead Auditor training introduces students to the ISO 14001 standard and its interpretation as well as the skills needed to assess the effectiveness of the environmental management system. ISO 14001 in its 2015 revision introduces the lifecycle perspective. In essence, the standard asks organizations to use a lifecycle perspective when designing/manufacturing their products/services. This means that instead of a cradle to grave concept organizations need to think of a cradle to cradle concept.

Cradle to Grave

ISO 9001 ‘Requirements for Quality Management Systems’ ushered in a new era of process-based management systems that could be used to improve the quality of products/services being delivered to customers as well as when well implemented to increase efficiency and productivity. However, as productivity, efficiency and quality were being improved; the by-products of the system were not addressed. During the 1980s there were some regional efforts to address the impact of organizations on the environment and ISO 14001 was ISO’s effort to lay down the requirements for a management system that addressed the aspects and their associated impacts. Organizations were expected to take action on these impacts to reduce them. Auditors undergoing ISO 14001 Lead Auditor training were now ready to assess the effectiveness of these systems.

In its initial publication and subsequent revision in 2004 ISO 14001 asks organizations to take a ‘cradle to grave’ approach to managing their impacts on the environment. This meant reducing the immediate impact on the environment. However, with time we learned that this does not address the growing landfill issues being faced by countries globally. To address this issue as well as to align with international efforts to address climate change, rapid depletion of the planet resources and encourage sustainable operations the ISO 14001 standard introduced the concept of ‘cradle to cradle’ in its 2015 revision.

Cradle to Cradle

ISO 14001 defined lifecycle as “consecutive and interlinked stages of a product (or service) system, from the raw material acquisition or generation from natural resources to final disposal.” Life cycle stages can include the acquisition of raw materials, design, production, transportation/delivery, use, end-of-life treatment, and final disposal. A great example of a lifecycle perspective in manufacturing is the recycling of Lead-Acid Car Batteries. Nearly 99% of these batteries are recycled/reused. Major battery manufacturers have programs in place to encourage the recycling of car batteries.

While ISO 14001 does not call for a formal life cycle assessment ISO 14044 provides the guidelines for a life cycle assessment should an organization wish to do so. In determining the end of life disposal organizations may choose products that are recyclable, sustainable and even perhaps biodegradable. ISO 14001 lead auditor training provided by QMII, highlights the concepts of a lifecycle perspective and how to incorporate it into your environmental management system.

Conclusion

ISO 14001 Lead Auditor training enables participants to go back and implement environmental management systems that will benefit their organization, the environment, and stakeholders. It also enables participants to conduct value-adding audits of their systems. The intent of the audit is to identify opportunities for improvement. With the skills, ISO 14001 Lead Auditor training by QMII and the knowledge of a life cycle perspective participants are ready to hit the ground running in implementing and auditing environmental management systems.

 

Obtaining Top Management Commitment

Who cares about the system? 

Management systems need top management commitment to work well, and yet many systems lack the necessary commitment. You may recognize some symptoms.  Policy – ignored.  Objectives  are barely alive. Corrective actions remain open. Managers seem not to appreciate the value of the requirements.  Employees are unsure about the system’s requirements. Proactive identification and addressing of risks/opportunities is rare. Root causes of failure remain in the system. Consequently, the system is not improved. Employees are unaware of what the system should do for them. Management reviews are embarrassing. Leaders either do not show or do not contribute. Top Management Commitment is lacking. Audits may temporarily energize the players. Management representatives ask, “Am I the only person who really cares?” 

Who trained the leaders? 

Many leaders do not explain their management systems. They may know the importance of certification, but they rarely explain why their system is vital for survival and growth. Why is this? Examine your internal audit program; is it driven by top management’s objectives?  Audit your training records. Do they show that leaders are competent and confident to show their top management commitment? Who trained the leaders in their organizational management system?  Competent leaders take responsibility for their system. They explain how their system works and why its requirements are so important to them. Unaware leaders blame employees for mistakes caused by their system. 

Your system, is it perceived as worthy? 

Even if your system is certified, do not expect leaders to support it.  Every organization is a system. Does the documented part of this system describe how it converts stakeholder needs into cash (or continued funding)?  Is this the management system that was certified or was it some new ISO system built on templates?  

Is your system irresistible to the leaders?  If not, show how your system converts needs into cash so top managers would not want to lead without it. Try our methodology to appreciate how others have developed systems and gained top management commitment beyond certification. Everyone should fulfill their objectives and earn their bonuses by using and improving  the system.  

Awareness Leaders Workshop™ 

Engage us to design and facilitate your one-day Awareness Leaders Workshop™. Select attendees who are leaders by job title and those who are leaders by personality. Include the skeptics! 

We listen to your objectives and design your workshop to fulfill your required outcomes. This may need  system analysis to result in a diagram that explains how the system converts needs into cash. This  workshop is facilitated by our senior management system consultant and auditor, who for over 20 years  has helped many willing and reluctant managers to understand and commit to their systems. 

Prepare for action 

Remove the root causes of what ails many management systems. You want your top management commitment  to the requirements of their management system. Clear the backlog of stale CARs  and pending actions on identified risks to prepare for the surge of improvements flowing from the renewed leadership of your system.  

When you are ready, please email IJ Arora or call 888.357.9001 with your requirements.

What is SMEA and FMEA?


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Success Modes and Effects Analysis

An organization is likely to succeed if it understands the system that runs its business. It can then identify where it needs to make improvements and use its system to succeed. QMII help clients to develop their process-based management systems by using success modes and effects analysis (SMEA). SMEA conversely to FMEA focuses on the success areas (opportunities) the organization is trying to achieve and determining what are the potential risks to achieving them. They then taken action to address these risks. While all risks cannot be eliminated based on resource constraints, SMEA provides an opportunity for organization to prioritize the risks and take appropriate action.

To implement SMEA, top management need to analyze and document what their organization does to convert customer needs into cash (success modes). This enables them to see where waste can be eliminated by applying lean principles to achieve lean design, lean manufacturing, lean administration and lean service.This determines the key processes in the system that runs the business. The next step involves working with the process owners to analyze each of the key processes for the fulfillment of process objectives (effects analysis). This results in a flowcharted procedure for each key process.  If you’re not fond of flowcharts then any other method of documentation will do. These procedures refer to the interacting processes and supporting documents.

Competent employees, from the recruiting and training processes, are coached by their leaders to use their system to eliminate causes of waste and succeed. These systems include procedures for creating new products and new processes with inputs from successful designs (see FMEA below).

Organizations can use SMEA to build and grow the success of their organizations.

Failure Modes and Effects Analysis

FMEAs during product and process design prevent failures of products and processes. A team, representing customers, designers, manufacturers, installers, users and suppliers agrees upon the rules for evaluating risk. The team works through each of the ways in which the process or product could fail (potential failure modes) and assign a score per the rules to signify the frequency and impact of each type of failure (effects analysis).

Failure modes that potentially are the most frequent or could have the biggest impact (or both!) are the highest priority. Teams remove the root causes of such failure modes to prevent their occurrence. These preventive actions make processes and products much more reliable from the beginning.

As you might expect the entire automotive industry now uses FMEA to improve reliability. Yes, not one car maker considered the sudden loss of global financing; a rare failure mode with dire consequences! Organizations that fail to use FMEA have to suffer the many losses due to incapable processes and poor products. Repeated failure may enable them to learn the hard way if they remain in business.

FMEA works best as a preventive action tool within a process-based management system (see above).

QMII facilitates failure modes and effects analysis (FMEA) and success modes and effects analysis (SMEA) for our clients.

Management review: A Necessity or Improvement driver

The management review is a critical step to ensure sustained success of the management system, yet this is often left to the relevant manager to document to meet the system standard requirements. A myriad of reasons is given for a management review not being done within the timeframe as defined by the organization. These include unavailability of senior management due calendar conflicts, waiting on inputs from department heads and sometimes just a lack of commitment by leadership.

Even when conducted ‘timely’ the review is often done purely out of necessity of meeting the requirements of the standard. The review, however, is a critical step for the success of the system and enables the continual improvement of the system. Leadership may, at times question, why money invested in a Quality Management System; that certification to ISO is not delivering the intended ROI. The answer often lies in their lack of commitment to the system as perceived by the users of the system.

Why are my reviews not driving improvement?

Management reviews when done out of necessity become a documentation exercise. The responsible manager collects all the data and analyzes/evaluates it for presentation to management. They proudly share these presentations with whomsoever asks about the management review. The ISO standards (e.g. ISO 9001, ISO 14001 and others) in clause 9.3 give the requirements for what shall be included in a management review. However, the review need not be limited to just these topics.

In consulting, QMII has often heard, “But we do daily reviews with our team and weekly updates with the managers”. Why not record these as a part of your management review? Do keep in mind that ISO standards ask organizations to conduct management reviews at planned intervals. It does not say it has to be a meeting or be held in a boardroom or the planned intervals need to be equally spaced. When the system is incorrectly implemented, or the standard incorrectly interpreted it often leads to a weak foundation of the system. Soon users of the system are complying and doing what has been documented rather than asking “is this really correct for us?”

With the passage of time, the lack of commitment percolates through the system to where the person tasked with championing the system, such as a quality or environmental manager, is fighting a lone battle. This lack of commitment may be apparent from the lack of decisions by management to issues presented in the review.  At times the concerned departments are trying to drive their own agendas, and this creates conflict and disconnect. Also, in recording the outputs of the review, the decision and actions from management must be recorded. QMII, often finds these missing.

How do I improve my management reviews?

To do so the organization must first understand the intent of this clause in the ISO standards. Clause 9.3 (under the high-level structure) asks management to review their systems to ‘ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the system.’ This, in essence, must be the guiding principle for the management reviews.

This is the reason why these reviews must be done holistically. It is this guiding principle that will determine the intervals for the review. Clause 5.1 of the ISO standards (those aligned per the HLS) asks leadership to take accountability for the effectiveness of their systems. The management review is the platform via which they can assess if the system is effective in meeting their policy as set. The management review is also where management reviews the system and determines the required changes in the context of the organization, the needs of the interested parties to determine new risks,  if any changes to the policy / strategic direction needs to be made and resourcing needs.

Engaging Leadership and the rest of the team

There is no mantra that will deliver sure-shot success. I wish there was one, for I know many an organization that would willingly invest in it! However, educating management on the WHY of the management review has often helped. If need be consider external consultants to deliver the message. Additionally, you can consider these three steps to get more engagement:

  1. Gather review inputs from management team: This is a good method to get everyone involved. Pass around a draft meeting agenda so all system users can prepare for the review (should you be having a meeting) and can provide their inputs /items that they need management’s decision on. It is also an opportunity for them to gather opportunities for improvement from users of the system.
  2. Use a review format that works for leadership: Document how your reviews are done exactly the way they are done within your organization. Perhaps some agenda items are discussed on a quarterly basis and others on a weekly basis. The intent is not to please an auditor but to use this tool to drive improvements through the system, as needed. Remember, the guiding principle discussed above.
  3. Communicate the outputs of the review …. including leadership’s decisions. While the standard does not require this, it is implicit in ensuring continual improvement. Communication is important but the outputs of the review need not to be communicated to the entire organization. Perhaps relevant parts to the concerned managers and their teams. It demonstrates to the users of the system that management is involved, is aware of the problems and has provided decisions on various matters presented.

Management Reviews ….  Improvement Driver

When done correctly management reviews become the springboard for improvement throughout the system. It comes at the end of the ‘Check’ stage of the PDCA cycles leading into the ‘Act’ stage for continual improvement. It enables leadership to assess how well their system is doing. It delivers, in the long run, the engagement needed from users of the system and the ROI that leadership are seeking in their quality management system.

Integrated Management Systems AKA ‘A balanced lifestyle’

Integrated Management Systems (IMS) when well implemented enable improvement across various facets of the system. Management system implementation reminds me of the orientation that my gym instructor gave me when I first enrolled at my local health club:- “Losing weight doesn’t happen just in one day and with crash diets: you gotta workout, gotta sleep the right amount, have a little fun in life and yes, food is the most important factor, but everything is in moderation. A combination of all that will give you a satisfying result and you’ll be a happier person. No shortcuts.”

When I look at the anatomy of an organization, I remember these words and know they are applicable to those looking to implement management systems, especially Integrated Management System (IMS). With IMS, they are looking to address multiple concern areas such as quality, environmental protection, safety, security, and overall happier stakeholders.

What is an Integrated Management System?

These days search engines like Google are the go-to source for all the answers, angles, interpretations and everything else. As I thought about the IMS and its benefits, I too turned to the ‘Google’ for insights! This is what I understood: “A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization’s operations including financial success, safe operation, product quality, client relationships, legislative and regulatory conformance, and worker management.” (Source: Wikipedia)

Another applicable example that I can give is how a country runs? There is politics, religion, economics, business all in a blender with a spoonful of “science” and “logic” to it, which is rarely used (winking). A successful balance is needed and the country well-managed for it to be successful and have happy citizens.

There has been an increased demand for integrated management systems in recent years. Organizations are beginning to recognize how these systems enable improvement across various facets of the business. For organizations looking for continual improvement and efficiency as also ensuring the security of information, the question is: why to implement two different systems when one can meet both requirements. Think of a cocktail – If you want Vodka and Tequila together, why not order a Long Island Iced Tea instead of two separate drinks.

The International Organization for Standardization (ISO) has, since 2013, been aligning its standards to the new High-Level Structure in which all ISO requirement standards are published with 10 clauses and identical sub-clauses. The High- Level Structure allows for easier integration of management systems into our existing system and ensures that the policies and objectives for each standard do not conflict with those of another. ISO standards use the basic Plan-do-check-act cycle to achieve continual improvement through vigorous use of the system.

Benefits of Integrated Management System

Integrated management systems allow organizations to identify and address various and different kinds of risks to their system: financial, strategic, competitor, security, safety environmental and others. All this while ensuring continual improvement of the organization. This approach enables organizations to meet the needs of its stakeholders and to adjust to the changing needs through systematic and planned changes.

Back in the good ol’ days, we did not have to worry about computer hackers, though there were other means by which our security was threatened. An information security breach can be a large liability for many organizations these days. How do we ensure that our organization is prepared for such potential breaches? We do not want a cyber-security system operating outside of our business system. We want it integrated into it.

Integrated management systems also are more cost-effective in the long run. There are cost savings in implementation, training, and auditing. Why spend on two/three different system audits in order to meet with the requirements of each Standard, when an integrated audit can assess the common requirements of each standard at the same time. These include competence, control of documented information, system measurement and analysis, etc. For the users of the system, benefits include objectives that align with the integrated policy, reduced duplication of effort and no conflict in the expectations of the management with respect to each policy. This makes the system more efficient, effective and very progressive. It also makes the system more flexible and adaptive in nature to the changing context of the organizations and needs of the relevant interested parties.

Conclusion

Integrated Management Systems can help the organization align its existing system to the requirements of multiple international standards using a single common factor in lieu of discrete systems. Hence, reducing duplication or redundancies. This includes its scope, policies, objectives, programs, processes, protocols and many more. In the maritime field ISO 9001:2015 can easily be merged with ISM Code or in the aviation industry, aerospace requirements along with requirements for occupational health and safety. To meet the growing demand of stakeholders for environmental sustainability, you can also add on the requirements of ISO 14001. Add Security to it, and you got your self a perfect Long Island Iced Tea, I mean your perfectly integrated system.

A lot of time and money is saved in implementing integrated management systems. It also helps in maintaining accountability and consistency for one perfect integrated system. Once your management system is integrated, you will notice reduced bureaucracy along with a reduction in duplication of efforts, redundancy, and expense. It will optimize resources and streamline the process. Integrated management systems will also help with the following: –

  • Curbing conflicting objectives
  • Eliminates conflicting responsibilities and relationships
  • Improves Internal and External communication
  • Harmonizes practice for each Standard in one
  • Business focus is unified to maintain its objective/goal
  • Customer focus is one and not for various tasks

Oh and continuing my health analogy, a well-integrated management system will give you the desired outputs and satisfaction as does those number reducing on the weighing scale! Lastly, remember that there are no shortcuts. Templates come with many promises but do not enable the long-term gains that a well-implemented system will afford. Refer QMII’s time tested approach here.