Serving and ensuring the best quality to one will make a difference to many. A good quality system is the backbone of any organization. Successful implementation of a QMS helps the product or service meet the customers’ and organizations’ requirements, which allows the company to run more efficiently and deliver the best service to their customers.
A successful QMS strategy long-term is not only accompanied by agility, but the constant practice of being agile. Agility and quality are complementary to one another. The ability to move and think quickly in conjunction with the ability to quickly document that progress is necessary for the operations of any QMS.
With an agile mind, unique approaches are used to improve and regulate product quality. The ability to try, fail, and adjust accordingly is key to long-term QMS success.
What is a Quality Management System (QMS)?
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Quality management ensures that an organization, product or service consistently functions well. This is why leadership and oversight is critical in quality management.
How to Launch a Successful QMS?
The most important factor in establishing a quality management system is having a quality person in charge.
From student to master, John Gunn—Casana’s Director of Quality Assurance—lives by the tenets he teaches at his martial arts school, embracing the attributes that resemble and embody a true Samurai warrior. John’s dedication to martial arts directly translates to his dedication to upholding high quality standards within his life and his career in quality management systems.
The word Samurai can be roughly translated to those who serve, and it is this service component that still influences John today.
“The one thing from martial arts that has had the most impact on me personally is the phrase ‘masakatsu agatsu’,” says Gunn. “True victory is victory over oneself. Having a beginner's mind and always striving to refine what I have learned and continue to learn. Having a quiet confidence in my abilities, and the control to utilize attained skills, (both martial & civil) at the appropriate times.”
Gunn explains how agility in martial art’s footwork is key to being one step ahead of an opponent. Similarly at a medical device startup, building an agile QMS will enable the organization to be adaptable to the market and flexible when obstacles arise.
Top Three Components for a Successful QMS:
A strong QMS can ensure successful outputs. Over the course of John’s career, the experience he has compiled can be boiled down into what he believes are the top three features of an agile quality system.
Executive Leadership Commitment: Executive Leadership has to be committed to the importance of establishing a QMS and provide adequate resources to assure it is running properly, monitored effectively and adjusted appropriately. A QMS has to be viewed as a tool to support success, not a roadblock to impede progress. This is paramount to the success of a QMS. Leadership needs the ability to think quickly and understand different avenues that may be taken if a function or system fails. Nothing is ever set in stone, and having a committed and flexible leader will take the company to the finish line.
Well-written SOPs (Standard Operating Procedure) : SOPs are not static documents. They should be dynamic, living, and allow for flexibility while maintaining compliance. It’s very easy to overwrite SOP requirements that can hinder daily workflows. Well-written SOPs create firm guidelines that allow the product or service to function properly and provide clarity to an organization’s goals. Not unlike a rubber band, SOPs should provide parameters with the ability to expand accordingly.
Training! Training! Training! : A robust training program that is utilized & maintained can make or break a company. This includes establishing consistent training from onboarding to post-market activities. Purposeful training creates repeatable procedures, processes and outcomes across the organization as a whole. A well-trained workforce also equips employees with the necessary skills to adapt to both shifts in leadership priorities and market demands. Looking through an agile lens, it’s imperative to evolve the content of training programs to align with business objectives as well.
Building a successful QMS is not an easy task. However, if you start with a malleable foundation that aligns with the overall business priorities you’ll be off to a great start. If you’re interested in working in an agile startup environment, check out Casana’s open career opportunities here.