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Applying QMS Fundamentals to Support Organizational Growth

Posted by Brad Osborne, Director of Quality on Nov 30, 2020 4:42:59 PM

maintaining-quality-in-a-growing-organization

Growth is good—in fact, growth is necessary for survival.  But just as the physical growth in humans comes with challenges, so does organizational growth.  Unlike human growth, however, there are aspects of an organization’s growth that are within their control.  One aspect of organizational growth that must be controlled is the quality of the organization’s processes and products to ensure that quality must never suffer at the expense of growth.   

Growing Forward, Keeping Quality in Mind

Over the past 30+ years, as “certified” Quality Management System standards have evolved, they have taken their fair share of criticism.  But there are three fundamental aspects of every established Quality Management System that are key to helping growing organizations maintain the highest standards of product and process quality, regardless of their growth trajectory.  Those three fundamentals are well-executed Internal Audit programs, robust Corrective and Preventive Action systems, and Management Reviews that are more than “check the box” exercises.

The Three Fundamental QMS Elements

First, Internal Audit programs are fundamental to periodically “taking the temperature” of an organization’s processes.  These audits, whether conducted by trained internal personnel (my personal preference) or subcontracted to external specialists (which has its own benefits in terms of objectivity), are crucial to not only identifying “gaps” in the organization’s Quality Management System, but also in identifying opportunities for improvement, demonstrating where resources are improperly allocated, and highlighting potential sources of product nonconformity.  

The second QMS fundamental that is critical to maintaining high levels of quality in an organization is the Corrective and Preventive Action (CAPA) System. Over time, organizations tend to develop a view of their CAPA systems as punitive measures or ”hand slaps” for failing to follow a procedure or, even worse, they become viewed as bureaucratic measures taken in response to audit findings, customer complaints, or other issues.  Nothing could be further from the truth. 

Continuing the health analogy, CAPAs are like the “prescription” for good health for an organization’s QMS.  A strong CAPA system will drive the organization to think deeply about the problems that it faces.  Regardless of the source of the problems, the CAPA system should aid the organization in identifying the necessary resources to address issues and, in turn, aid those charged with addressing the issues in reaching a root cause that leads to a  permanent eradication of the problem.

The final QMS element that plays a key role in improving quality in a growing organization is Management Review.  The Management Review is the “Annual Checkup” portion of the health analogy.  This is where leadership has an opportunity to review the organization as a whole and determine whether the QMS is functioning as it was intended.  It is the opportunity to ask questions and seek answers on questions ranging from product and process performance to new regulatory requirements.  It is also the opportunity to compare the organization’s performance or “health” to not only the ISO standards but also to the objectives the organization has set, including those for its own growth.

Balancing Quality with Organizational Growth

The real magic is how these three fundamentals work together in a cycle to improve an organization’s QMS and help keep the focus on quality while the organization grows.  Internal Audits are conducted that identify opportunities for improvement and gaps in the system.  The CAPA system is then used to document the issues and harness the necessary resources to address those issues at their root cause.  An engaged management team then meets periodically to review the health of the organization’s QMS, including input from (drumroll please…) the Internal Audit and CAPA systems.  At Micron Solutions, our growth and success continue to demonstrate to us the real value in maintaining and focusing on the improvement of these fundamentals to ensure every customer experience is of the highest quality!

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