Ernest M. Posey President & CEO
Posey Company
April 12, 2012
For the past eighteen months, John Sawyer's Company, Realistic Quality Solutions (RQS) has been a consulting partner with the Posey Company in the areas of supply chain issues, vendor audits and compliance, contract manufacturing audits and compliance, and auditing and training to FDA's Quality System Regulations. When necessary, John helped refine procedures and work instructions, and assisted my management team with their implementation at our facilities in the U.S., Mexico. and China.
John was able to work with our Quality and Regulatory team to get the job done without any friction. Often, due to the delicacy of their work. "outside consultants" are not able to develop a bond of trust and work with the "inside" team or make them recognize the necessary refinements and changes, and quickly move forward. John worked across our entire spectrum, from my office to the shop floor, to get everybody to understand the 'big picture' and the importance of making the changes now and in the future. As a result, we didn't have any "turf wars" and everybody moved forward as a team.
In order to cement all the of changes across our three plants, we brought in teams from China. Mexico, and my entire Management Staff in the US, for a week long training program on the FDA's Quality Management System. Several of our vendors, whom John had worked closely with, also sent large teams to attend our class. I am confident that this very expensive training program will benefit our entire company, and help us ensure that the changes we have made over the past eighteen months will become a permanent part of our company culture.
You can also count on John in a pinch. We ran into an issue with one of our European vendors, and John interrupted his Christmas vacation to visit their location for a strategic meeting and audit.
John has become a valued advisor to our management team, and we will continue to use the services of Realistic Quality Solutions in the future.
Joe Rocco President
Eastek International North America
Hong Kong
China
Joe Rocco's experience with RQS Length: 1:07
As a consulting partner with Eastek, RQS has helped us understand the complexities and best methods of applying the requirements of the Food and Drug Administration’s Quality System Regulation as we look to expand our contract manufacturing opportunities.
RQS has helped us create and edit procedures and work instructions, audit of our system and processes, as well as providing training where necessary.
I like the name Realistic Quality Solutions, because, RQS has provided advice that is practical, effective, and makes good business sense.
Thanks to RQS we're confident of our understanding of FDA regulations and our ability to manufacture safe and effective medical devices. We will continue our ongoing association with RQS.
Dr. James Goldstein Director of Research &
Education Cardiology
William Beaumont Hospital
Royal Oaks, MI
I have been associated with John Sawyer and RQS for over ten years. During our working relationship I have assisted John & RQS with clinical evaluations, non-significant risk studies, and health hazard evaluations (HHE’s) relative to various product launches and specific adverse events. He is extremely knowledgeable of FDA regulations as well as understanding of different medical procedures/processes to assist organizations in adequately addressing their concerns/issues in these areas. John’s continued focus is on patient safety and devices performing as intended. John brings a balance of regulatory knowledge and realism into the decision making process that helps everyone involved in making these crucial decisions.
John and RQS has stayed current and on top of all standards relative to quality and regulatory compliance and it has been fun to work with someone from a clinical perspective who has a grasp of how these tasks interact with each other so that the patient, clinician, and manufacturer expectations are met.
Because of his experience and concern for all, I plan to continue my relationship and support for John & RQS, in completing clinical evaluations, non-significant risk studies, and Health Hazard Evaluations (HHE’s). RQS and I will remain strategic business partners.
Randy Zundel President
ECO Cath Lab
Former Chief Operating Officer of OEC Medical Systems
I’ve been associated with John Sawyer and RQS for over eighteen years. During our working relationship at OEC Medical Systems, John Sawyer was instrumental in helping us quickly resolve an FDA Warning Letter. In a follow-up inspection by the FDA, we received zero observations. And in the years following, our inspections also resulted in zero observations. This allowed us as an organization to expand our product lines and markets with the confidence that all quality and regulatory requirements were being met.
As I have gone on to develop other business opportunities, I have continued my working relationship with RQS. John has helped us understand the regulatory complexities of the Food and Drug Administration’s Quality & Regulatory requirements as we’ve looked to launch our medical devices globally.
RQS stays current and on top of all standards relative to quality and regulatory compliance and has helped me with registrations, medical device listings and has helped me identify business partners in contract manufacturing.
Because of my continued association with RQS, I’m confident of my organization’s ability to manufacture safe and effective medical devices.
