David Jensen, Staff Writer, MasterControl 04.09.21
Even with the benefit of a crystal ball, horoscope or a fortune cookie, it’s difficult to know what the future holds. In the life sciences industry, gaining insights on future trends and regulatory changes would be valuable in developing long-term strategies to better compete in your respective industry.
At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about quality assurance. In her presentation, titled “Today’s Challenges to Quality and Future Opportunities,” she identified some key strategies for how your organization can understand the future of quality management and build the appropriate initiatives.
Upfront, Gulbinski asserted that there is no shortage of challenges with quality assurance in product development. Frequent changes to regulatory guidelines and evolving manufacturing technologies will always introduce obstacles that we haven’t seen before. In order to keep combating new issues, she recommended that you change the lens you use to view the world of quality.
If you are a regulated company like a pharmaceutical or medical device manufacturer, you’re well aware that your industry continually evolves. Your quality assurance methods may be sufficient now, but will that always be the case when regulatory standards change, technology becomes more advanced and consumer expectations become higher? Companies in regulated industries are encouraged to explore more of a collective strategy by establishing a culture of quality. “You will only get so far until you address the culture,” she said.
3 Principles You Should Adopt
What does a culture of quality look like? Ultimately, it’s about getting people to act. To understand quality assurance trends and win in quality, Gulbinski recommends using the following three principles as a foundation for your quality initiatives.
#1: Quality starts at the top
It’s a common belief that seasoned ship captains are astute and keenly aware of every crew member, every function and every nut and every bolt on their vessels. Company leaders should be just as cognizant of their operations. When leadership is engaged, it sets the tone and articulates the aligned vision and expectations of the organization. Senior management “walk throughs” nurture an environment of transparency, trust and the pursuit of continuous improvement.
It will be easier for organizational leaders to engage in building a culture of quality when they see the inherent value that comes with this approach. Quality assurance processes that are woven into product design and all manufacturing phases reduce errors, which means there is less time and money spent correcting mistakes and repeating tasks. Depending on the size of your organization, the annual cost savings could reach into the millions.
#2: A culture of quality is a preventative culture
To develop a culture of quality, you must foster an agile mindset throughout the organization. Approaches to quality management are evolving and your organization needs to keep pace with the changes. If you view quality as a safety net or a requirement for compliance, you should consider taking more of a predictive and proactive approach. The ability to foresee changes and potential setbacks that occur due to variabilities in product development processes and materials will help you alleviate surprises and costly oversights.
In order to stay current or even a step ahead of quality assurance trends and the frequently changing regulatory landscape, there needs to be a collective effort toward continuous improvement. Operational excellence means that quality needs to be mobilized early in the product design stage and it should have its own set of metrics in every phase of manufacturing.
#3 Everyone owns quality
A culture of quality means that every employee has the same vision of quality and understands where their contribution fits in that vision. The focus is on the customer and developing products that meet customers’ needs. Everyone in the organization should have an end-to-end view of all products, processes and methods. There should also be a free flow of communication, data and information throughout the supply chain.
This holistic approach to quality will help keep your employees sharp and able to make necessary adjustments faster. Also, implementing a digitized quality management system (QMS) is how you can better control variables, drive right-the-first-time performance and achieve a higher level of product reliability.
David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about quality assurance. In her presentation, titled “Today’s Challenges to Quality and Future Opportunities,” she identified some key strategies for how your organization can understand the future of quality management and build the appropriate initiatives.
Upfront, Gulbinski asserted that there is no shortage of challenges with quality assurance in product development. Frequent changes to regulatory guidelines and evolving manufacturing technologies will always introduce obstacles that we haven’t seen before. In order to keep combating new issues, she recommended that you change the lens you use to view the world of quality.
If you are a regulated company like a pharmaceutical or medical device manufacturer, you’re well aware that your industry continually evolves. Your quality assurance methods may be sufficient now, but will that always be the case when regulatory standards change, technology becomes more advanced and consumer expectations become higher? Companies in regulated industries are encouraged to explore more of a collective strategy by establishing a culture of quality. “You will only get so far until you address the culture,” she said.
3 Principles You Should Adopt
What does a culture of quality look like? Ultimately, it’s about getting people to act. To understand quality assurance trends and win in quality, Gulbinski recommends using the following three principles as a foundation for your quality initiatives.
#1: Quality starts at the top
It’s a common belief that seasoned ship captains are astute and keenly aware of every crew member, every function and every nut and every bolt on their vessels. Company leaders should be just as cognizant of their operations. When leadership is engaged, it sets the tone and articulates the aligned vision and expectations of the organization. Senior management “walk throughs” nurture an environment of transparency, trust and the pursuit of continuous improvement.
It will be easier for organizational leaders to engage in building a culture of quality when they see the inherent value that comes with this approach. Quality assurance processes that are woven into product design and all manufacturing phases reduce errors, which means there is less time and money spent correcting mistakes and repeating tasks. Depending on the size of your organization, the annual cost savings could reach into the millions.
#2: A culture of quality is a preventative culture
To develop a culture of quality, you must foster an agile mindset throughout the organization. Approaches to quality management are evolving and your organization needs to keep pace with the changes. If you view quality as a safety net or a requirement for compliance, you should consider taking more of a predictive and proactive approach. The ability to foresee changes and potential setbacks that occur due to variabilities in product development processes and materials will help you alleviate surprises and costly oversights.
In order to stay current or even a step ahead of quality assurance trends and the frequently changing regulatory landscape, there needs to be a collective effort toward continuous improvement. Operational excellence means that quality needs to be mobilized early in the product design stage and it should have its own set of metrics in every phase of manufacturing.
#3 Everyone owns quality
A culture of quality means that every employee has the same vision of quality and understands where their contribution fits in that vision. The focus is on the customer and developing products that meet customers’ needs. Everyone in the organization should have an end-to-end view of all products, processes and methods. There should also be a free flow of communication, data and information throughout the supply chain.
This holistic approach to quality will help keep your employees sharp and able to make necessary adjustments faster. Also, implementing a digitized quality management system (QMS) is how you can better control variables, drive right-the-first-time performance and achieve a higher level of product reliability.
David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
