There may be no ‘I’ in TEAM, but the ‘I’ in QUALITY should never be overlooked.

Several aspects of quality are essential for an effective Quality Management System, but which is most important to meeting critical performance standards and keeping customers satisfied? The answer to that question may differ from one product developer to another, but one of the essential factors that often escapes focus is the human factor – the very people responsible for ensuring all other elements are in place.

Maintaining focus on all aspects of Quality Management Systems can be a difficult task since there is no single metric for quality. In addition, each team in the product development process may have a different idea of what aspect of quality matters most. Quality can be as individual as each person utilizing the system — what quality means to me may not be what it means to you. So how do we bring everyone together? To do that we need to break down some of the components of the system and look at the human factors of quality.

The Significance of ISO Certifications

Quality certifications such as ISO 9001, AS9100, and ISO 13485 often serve as a first step in understanding if a product development partner is experienced and qualified for development in specific industries. These certifications don’t exist simply to show that a company can pass an audit. Instead, they establish procedures that make the business more efficient in its production of consistent, quality product that satisfies customers’ expectations.

This is precisely how ISO measures quality. To accomplish these goals, the Quality Management System needs input from everyone involved in the development and production of the products going to market. ISO Auditors want to see evidence quality being built into every step of the process, no matter how insignificant it might seem.

The human component of this system relies on knowing the processes, working to improve them if they don’t reflect what workers actually do, and taking time to make sure each part of the job is done right the first time. Each worker, as well as his or her individual skills and knowledge, matters. When a product fails, neither your customer (nor his or her customer) cares that the faulty component was manufactured in an ISO-certified facility.

ISO knows that companies stand a better chance of producing a consistently high-quality product when procedures are followed. These levels of quality can’t be achieved without the input from the “experts” throughout the company (i.e., each employee!) working together to make the system the best it can be. ISO audits add an independent set of eyes to assist in evaluating a company’s Quality Management System.

Key human factors that drive a Quality Management System

Human Factor 1: Planning

There is no substitute for planning in a Quality Management System. Only the individuals working within the system can establish a plan and achieve it. Everyone plays a part and everyone is their brother’s keeper to ensure that product is correct when it comes to us and correct when it leaves us.

Human Factor 2: Documentation

Accurate and comprehensive documentation is essential to building and assembling parts the right way, every time. To achieve this, it’s crucial to solicit input at all stages of product development and production. Remember, every person involved in design and production is responsible for making the documentation in the Quality Management System the best it can be, because excellence is only repeatable if it is well-documented.

Human Factor 3: Traceability

Regulatory requirements that intend to trace all the steps of how a product was made are essential in the event of a product failure. They are important not only to find out what went wrong, but also to identify who worked on that product. Though this is often viewed as a way to assign blame, in reality it is best used as a way to identify a failure in the system itself, not in the people within a system. It allows a product developer to find flaws in documentation and training so they can be clarified and improved, to eliminate identified flaws moving forward. Developers of products and processes bump into the risks and difficulty of human factors at every step.

Human Factor 4: Training

Training for compliance with a Quality Management System is much more than just reading and learning procedures, drawings, and programs. Product development partners need to ensure required training is completed and current, per regulations and requirements. Training means that employees know about their immediate processes, as well as how and what they do affects those processes before and after they’ve played their part. Employees should strive to learn how they impact the big picture and think about how their training affects how they do their job. We need to ask the tough questions to determine if there is a better way to train for and perform specific job functions.

Human Factor 5: Verification

Within a Quality Management System, it’s everyone’s responsibility to verify that what they are doing and producing meets the customer’s requirements. Customer satisfaction is not only a key aspect of meeting ISO certification criteria – it is also the key to the ongoing success of any organization. A Quality Management System is generically a business process that defines a process. It includes internal verification steps to assure that processes remain working and improving. Humans using these business processes need to understand how their contribution is being verified, and what parts they are responsible for verifying. Most elements of Quality Management System verification start and stop with human factors. Without verifying thegoodness of your Quality Management System, you will not understand if your customers are satisfied. Without customer satisfaction, most companies would eventually cease to exist.

Internal quality requires quality processes and employees.

Quality begins with the individual – everyone should ask themselves if they have an attitude of quality. How important is quality to my role? What does quality mean to me? Producing quality products is a choice and that choice starts and stops with each person in the process, often in a unique way. It has little to do with obtaining a certification or being forced to make a product a certain way per a regulation. Rather, it has everything to do with producing devices that meet customer requirements, work every time, and are delivered on time. Regardless of how you define it or what industry you’re in, the only way quality can be achieved is by paying attention to the human factors of your Quality Management System.

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