Quality is Culture on #TeamHPNE
This week, we explore how HPNE, a Getinge Company integrates quality into our culture to make sure it is always top-of-mind.
Quality, as defined by the American Society for Quality (ASQ), is “products or services whose measurable characteristics satisfy a fixed set of specifications that are usually numerically defined”. At HPNE, a Getinge Company, we strive to maintain the highest quality standards throughout all of our day-to-day operations. Our diligent Quality department is consistently making sure all of our products and services are top-of-the-line.
In order to ensure we are adhering to all of our quality policies, we have worked hard to make sure quality has been folded into the culture at our organization. In this article, we explore the different ways quality is kept at the forefront of all that we do at HPNE.
Our “Quality=Culture” Program
HPNE a Getinge Company implemented our “Quality=Culture” program in January 2023. This program is a training curriculum based on specialized topics and is provided in monthly installments. Personnel from departments such as Manufacturing, Logistics, Quality, and MSAT receive regular training on a range of topics relating to quality, and its impacts on our customers and our organization.
Some of the specific topics that have been covered throughout the program include:
- Root cause analysis & problem solving
- Assembly inspection
- Keys to successful communication
- Good documentation practices
- Team collaboration
- And more
Overall, the goal of the program is to instill the value of having a quality first mindset and keeping quality as the basis for every task and operation within our organization. As the program grows, #TeamHPNE is looking forward to extending the program to all employees.
We consider it critical to have programs such as Quality=Culture in place in order to maintain high standards, and keep up with the fast-pace regulatory landscape of bioprocessing.
ISO 9001:2015 Classification
HPNE has an ISO 9001:2015 certification, which can be viewed on our website. ISO 9001 is a globally recognized standard regarding quality management, and its designation demonstrates an organization's commitment to quality. Benefits of ISO 9001 include process improvement, ongoing optimization, and customer confidence.
The hard work of our MSAT, Quality, and other team members ensures we are conforming to all requirements laid out in this industry standard. We are dedicated to complying with all of the requirements set forth in ISO 9001.
Rx-360 Membership
HPNE, a Getinge Company, is a proud member of the Rx-360 International Pharmaceutical Supply Chain Consortium. Additionally, we participate in the Rx-360 Joint Audit Program.
All audits conducted through the Joint Audit Program use a wide-ranging, comprehensive checklist of standards that were developed by Rx-360 members, which ensures that all industry standards are met. Becoming a part of this program helps us minimize on-site audits for our customers and suppliers, helping us all reduce costs and save valuable time.
#TeamHPNE at ASQ
The American Society for Quality (ASQ) is a global community of over 40,000 professionals across 130 countries that is collaborating in order to advance excellence through quality. Within the community, geographic regions come together to discuss current quality trends, concerns, and more. Programs that can be offered by these regions include meetings, educational courses, conferences, educational courses, and more.
One of the geographic branches of ASQ is the Rhode Island ASQ.HPNE’s Quality department is heavily involved in Rhode Island ASQ activities, with some members of our team holding leadership positions in the RIASQ organization. We believe our Quality team's participation in this group keeps us on the leading edge of advancements in all disciplines of Quality Management.
Continuous Improvement in Our Cleanrooms
Our Manufacturing Science and Technology (MSAT) team has had many active projects to ensure our two cleanrooms produce the best products for our customers. They take proactive measures to monitor our ISO Class 7 cleanrooms and ensure they maintain a state of control.
Other practices we implement to encourage continuous improvement at our facilities includes periodic refresher training for all employees, immediate responses to any anomalies, implementation of corrective and preventative actions, contamination control initiatives, and more.
High Quality Standards for High-Quality Products
Implementing quality in our culture is essential to the identity of HPNE. We are continuously working to ensure we, and our partners are meeting or exceeding industry standard quality regulations. From programs like Rx-360 to our involvement in ASQ, we are consistently working to participate in quality initiatives in our local communities and beyond.
Ultimately, this dedication helps us to ensure that our product portfolio is ready to help you create your life changing treatments and therapies for the patients that need them. To start talking to one of our experts about the bioprocessing solution options that may be right for your process, from biopharma pumps to single-use assemblies, reach out at info@hp-ne.com. Additionally, you can reach us through our contact us page.
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About HPNE
As the industry needs grow, High Purity New England, Inc. continues to supply the biopharmaceutical industry with a range of innovative products, from drug discovery and development to fill-finish, including their flagship product, custom single-use assemblies, as well as pumps, sensors, bioreactor systems, storage and handling solutions and other single-use solutions. Along with their own manufactured products for the global market, they are also a distributor for more than 18 brands in North America.
