An interview with expert Jacob Graham, VP QA/RA & Cofounder at Enzyme
All companies want their product to meet the highest quality standards and make it to the market as soon as possible. To accomplish both, it is important for companies to promote a culture of quality and ensure that everyone (from CEO to technician) is on board.
We interviewed our in-house Quality expert Jacob Graham on his thoughts about promoting and initiating a quality culture. Jacob has over 13 years of experience in the medical device industry with a background in quality management, design assurance, and audit planning.
How would you define a “quality culture”?
A quality culture is shared values, expectations, and commitments to ensure “it’s done right” the first time. A quality culture includes a comprehensive organizational approach toward achieving quality products though processes, decisions, and actions that instill and disperse ownership and accountability.
Who is responsible for driving a quality culture?
Ultimately a company will succeed when everyone understands and contributes to the quality culture. It is vital for leadership to commit and promote the culture and for each employee to sustain it. Company leadership must initiate and lead the process.
What is the easiest aspect of implementing a quality culture?
The easiest aspect is to convey that a positive quality culture produces quality products which ultimately benefit patients.
All employees want to contribute to products that help patients — some of whom could even be their own loved ones. How can leadership easily make this connection?
Bring in treated patients whose lives have been changed for the better; have them tell their stories and meet the people who designed and built the device that helped them.
What is the most challenging aspect of implementing a quality culture?
For some, understanding how their daily job tasks impact product quality is easy; product builders are physically touching the product and building them one component at a time. They have to follow their manufacturing instructions to the letter to ensure a consistent product is delivered, and they report issues as they see them to prevent a bad product from escaping company control.
However, most employees are several degrees removed from the manufacturing process. Instilling a culture of quality across a broad spectrum of functional roles can be challenging for leadership to convey to those employees who struggle to relate their work to the patient. Management must help translate the impact into understandable references for their employees who are most removed from the patient.
What is the communication pattern to indicate progress in promoting the culture?
To communicate how the company is tracking toward its quality goals, leadership should share:
- the status and results of metrics that have been implemented
- results of company-wide quality culture surveys and company follow-up action plans
- information/photos from events that focus on the culture-of-quality
- patient success stories
This variety of communication helps all employees keep quality in mind as they complete their daily activities.
What does success look like when a quality culture has been implemented?
Companies will see a decrease in Audit findings, and the number and severity of their Nonconformances (NC’s), Corrective and Preventive Actions (CAPA’s) and Complaints.
Companies will also see fewer recalls and shorter durations of product development lifecycle phases, getting their product to market faster. This will lead to increased revenue, more investments in the company, and higher stock prices.
What are some pitfalls to look out for?
Humans need repetition, however, if they hear the same message too many times, it can be filtered out. The hardest thing as a quality leader is to communicate enough to educate their team and keep them vigilant while avoiding becoming the white noise of redundancy. Having creative, engaging, and valuable internal communication is the most difficult aspect of their role.
How do you convince your team to invest the time and resources toward quality?
Quality initiatives must be supported and reinforced by all levels of management.
Timely reminders are helpful especially when they are coordinated with broad quality announcements and other important company communications.
How do you train/teach your team to have a quality mindset?
Companies can ask their employees to reflect on how their day-to-day work impacts patient safety and product effectiveness. Providing employees the opportunity to share their thoughts and concerns with peers and management will help foster communication, awareness, and commitment toward a culture of quality.
If you have questions about establishing a quality culture at your organization, you can email Jacob at info@enzyme.com.
