The Importance of a QMS

Introduction

Recently I posted a turtle diagram for a ‘Quality Management System (QMS) Consulting’ process. I also posted an article describing the benefits of having turtle diagrams within an organization’s QMS. In this article I describe how a QMS brings success to an organization.

• The conclusion of the previous article was that whether your organization is one person or thousands of persons in size, enabling it to be successful is about getting it to the point at which everyone in it understands what is needed, when is it needed and how best to implement that need. 
• This article discusses how a QMS will do just that. For example, a QMS can make an organization more successful if it is tied to the both the structure and the behaviour of its endeavors to be best-in-class.

What is a QMS?

In short, a QMS is the collection of business processes that are used to focus an organization towards meeting its obligations and improving its ability to ensure customer satisfaction.

What is the purpose of a QMS?

The overall purpose of a QMS is to enrich the culture as well as improve the operation, products, and services of an organization to the delight of its customers and the implicated regulatory and statutory authorities. A QMS is also meant to enable an organization to regularly excel at meeting its business objectives (e.g., return-on-investment, growth, as well as healthy long-term relationships with clients, suppliers, and employees).

How does having a QMS make an organization more likely to succeed?

In my first article I answered that very question. Specifically, the answer is ‘yes’ if:

1. the organization establishes and sustains traditions, programs, and/or events that contribute to the objectives and culture espoused by the processes and measurements defined in its QMS quality manual.

2. the QMS quality manual is simple enough to get things started but is also robust enough to grow with the organization.

So how does an organization go about making that ‘if’ circumstance occur? 

Well, the starting point is when the organization provides a framework within which the QMS can drive all its resources towards its defined goals. And ‘yes,’ that framework often begins with an awareness to its ‘org chart’ and the planning and management activities and roles that are tied to it.

Next, and on-going, the organization must ensure that the QMS is allowed to be a living organic entity. This will enable the organization to grow by selectively engaging new opportunities whilst it develops or acquires best practices, processes and results based upon a risk commensurate amount of modeling, simulations, and decisive actions.

The alignment with organizational structures and a QMS

An organization is divided into three separate but integral levels/structures of planning and management:

1. Strategic … What are the goals? 

The organization’s strategic goals often serve as the foundation of its vision and mission statements. The scope, context and interested parties’ information required in its quality manual by QMS standards (such as ISO 9001, AS9100, TL9000, ISO 13485 and ISO 16949) must also reflect those same goals. For example, the statements used within an organization’s quality manual to describe its scope and context are derived directly from that organization’s strategic goals/plans.

2. Tactical … How are those goals going to be achieved? 

Tactical goals are often associated with the risks or improvement opportunities identified for locations and/or (functional capability based) departments of an organization. Those goals can include but are not limited to reductions in energy consumption or (environmental or raw material) waste as well as goals for improving employee retention or optimizing its supply chain relationships. Senior management’s assessment of external factors (e.g., market space issues and best practices, regulatory/statutory changes, customer needs and feedback) as well as the interaction and actual performance of the organization’s QMS processes serves as the closed-looped mechanism for how the plans to reach these goals are identified and when they are given adequate and suitable resources for their respective implementation. 

3. Operational … Where is the organization now with respect to its goals? 

Middle to lower management are the champions of measurement and measurement analysis/value trending. For an organization to be successful, every member of the organization must be aware of and committed to the QMS in each of their daily activities. More specifically, whether you are the champion or practitioner of a process, you must regularly measure the performance and outputs of it as to identify and escalate awareness to any threats posed to it.

The QMS is the living framework in which the organization’s management and planning activities best thrive. Specifically, the QMS is the organization’s Business Management System (BMS)

The QMS must develop and maintain the culture of best practices 

Best practices are really intended for the people employed by an organization. For example, variances in employee motivation, experience, and competency can significantly affect how well an organization operates. To help mitigate these kinds of variances the organization’s employees must have:

• a strategic plan in which they both desire as well as have the confidence to implement. To this point, a core best practice of any QMS is the requirement for employees to be informed and aware of their contribution to the success of the organization.

• the necessary skills as well as wisdom to make the organization’s tactical plans realities. For example, all employees must be enthusiastic and vigilant in assessing and when necessary, tuning the processes implicated (or going back and updating the implicated plans and/or the implementation activities associated with those plans). To this point, a core best practice of any QMS is that knowledge improvement and training systems must exist such that employees are competent, proficient as well as empowered.

• the ability to track the effectiveness of their operational plans as well as the creativity/inspiration to propose risk commensurate responses to the opportunities shown by the measurement of the intended processes and actual results. To this point, a core best practice of any QMS is the requirement that measurement and feedback play a critical role in assessing the implementation of the planned activities.

Next, an organization might possess multiple business management systems and tools to equip its employees with the means to success. Since the QMS is the overall framework housing those business management systems, then it also must be based on the same principles and best practices that those very systems use/espouse for successful results. To that very point, the diagram below depicts the core principles that enable the culture of best practices to exist and thrive in any organization!

Summary and Conclusion

The success of an organization is predicated upon having all employees being aware of its business objectives and the importance of their contributions to them. 

Examples of business objectives can include but are not limited to:

• tangible gains in productivity and reduction of waste, prevention of defective/non-conforming outputs.
• increased effectiveness in the use of company resources (e.g., equipment, human and training).
• increased customers and/or increased business with existing customers.
• more predictable and responsive supply chain.
• improved employee morale (e.g., sense of belonging and contribution) thereby increasing the chances of reductions in:
  • unwanted turn-over; and/or
  • the cost for training for new or transfer employees.
• improved operational systems or their underlying tooling that provide more timely awareness to risks or further capabilities such as those providing further detection of process gaps and defects or the yielding of more dependable, repeatable, and predictable conforming results.

The importance of a QMS is that it is the organization’s BMS and that it:

• is the organization’s closed loop single point of truth. Specifically, when an organization treats its BMS and QMS as separate systems (with different owners or practices or goals) then that organization is only accelerating its path to failure.
• manages how the organization’s strategic, tactical, and operational goals, plans, risks, and actions are identified and implemented.
• drives all parties towards complete, conforming, repeatable, and timely results. For example, although a focus of a QMS is customer satisfaction, the most efficient and effective QMS also enables an organization to pro-actively keep its knowledge, products, and processes in tune with changes and risks in its regulatory, statutory, employee, as well as its supply chain obligations and engagements.

And now, a sneak peak into my next article

In my next article I will provide a more practical description of a QMS by examining its attributes as well as its relationship to various critical-to-quality objectives that organizations can use to perform effective quality assurance and quality control.