Ep 2: Quality Management Systems, Quality Control, and Quality Assurance

Defining QMS, QA, QC, and ISO

Quality management systems are commonly referred to by the acronym, QMS, and Quality assurance is commonly referred to in industry as QA. Likewise, quality control is commonly referred to as QC. We will use these acronyms as we unpack their roles and how they all fit together.

I.S.O. is the name of an independent, non-governmental organization which develops international standards, called the International Organization for Standardization.  Referred to as either I.S.O. or ISO, both are accepted.

No organization is required to have a quality management system or a quality department by regulation, and many organizations run without a highly structured system in place for achieving correctness in operations. Furthermore, for organizations that choose to implement a QMS, there is no requirement for development of an ISO program or to be certified. That is entirely a business decision.

Lastly, A QMS does not require a QA or QC department, whether or not the company is ISO certified.  In fact, there is no fixed definition for either QA or QC, so if either of these are new concepts, that is not problematic.  Even if you are familiar with one or both of these types of departments, we will cover advanced ways to think of these roles and their value in a quality management system.

Foundations of a Quality Management System

The QMS includes organized corrections to errors, documented changes, and follow up reviews undertaken to adjust operations and the organization over time so that conditions needed for conforming outputs are properly maintained and altered, where necessary.

For very small organizations, the QMS tasks may be performed by the person in charge of all decision making, or it may be the person in charge of operations that also addresses the quality management system.

For mid to large size organizations, often a point is reached where the needs of overseeing the quality management system take up so much time and effort that leadership and operations can no longer devote the proper amount of attention to quality actions while also addressing the other functions of operations, such as, executive business planning, sales, finances, human resources, IT, maintenance and repair.

It is for this reason that dedicated quality departments exist, and one of the immediate benefits of the creation of a quality department is that it can function independently of those other areas of the business we just mentioned, and the independent nature can help keep the focus on quality instead of profit or other business pressures.

The best quality systems establish quality in every aspect of the business – executive business planning, sales, finances, human resources, IT, maintenance and repair – while Quality teams act as guide rails to help focus and maintain the systems.

Quality Control

QC personnel, or a quality control department is responsible for determining how frequently checks of operations and the finished outputs of operation are needed to confirm correctness.  QC need to have knowledge of what the proper checks are that need to take place and identify the equipment and tools that are needed to conduct those checks. QC may only require that a person is familiar with the product or service, and can visually or audibly confirm the basic conditions for correctness.

The only requirement for a properly functioning quality control is that the operational employee cannot perform the quality control check on their own work. 

Lastly, when we are thinking in terms of an ISO program, there are no specific requirements for quality control actions, limits, or departments, only that the organization can demonstrate effective controls during operations and confirmation of correctness is achieved for final products or services.

Effective organizations have a strong understanding of their processes and are able to identify robust quality control parameters to improve their process control.

Quality Assurance

The Quality Assurance function focuses on systemic processes and therefore Quality Assurance personnel are typically tasked with the more advanced project management and documentation tasks of a Quality Management System or ISO Program, such as the creation of schedules and coordinating with internal personnel in other departments or external stakeholders. Both the QA tasks and the QC tasks are necessary to confirm correctness of the products or services. 

Quality Assurance would be associated with  setting of meetings, reviewing maintenance schedules and maintenance records, performing traceability or calibration checks for measuring devices, overseeing a laboratory, performing Internal Audits, and confirming corrective and preventive actions have been properly performed.

Quality Assurance roles are generally more technically demanding, and frequently organizations will require years of specific related work experience, and college or advanced degrees for personnel engaged in QA work, and for those overseeing QA departments.

In the context of ISO, there are not specific requirements for quality controls, however, there are required quality assurance actions such as planning, risk assessments, training, internal auditing, corrective and preventive actions and facilitating management review.  As a result, it is very common for a company that runs a ISO complaint program to have a Quality Assurance Manager.

Potential Pitfalls and Biases

The pursuit of quality is a positive role in businesses focused on efficiency, excellence and improvement, however, it’s important to be aware that the quality management system itself, and the QA, QC or combined QA/QC personnel are political actors in an organization. They have power, biases, and may get along with or conflict with other departments as part of their roles.

This tension may be amplified  for businesses who have chosen to implement an ISO program because they have identified a need to pass an ISO certification audit as part of maintaining key business relationships. It is crucial that all companies with quality management systems of any configuration have strong organizational leadership.

Strong leadership will ensure that the quality personnel or departments are empowered to act independently from the areas of the organization they oversee, and do not themselves become a source of conflict or paralysis within the organization, which would interfere with quality outputs.