Most Quality people I know hear the same things over and over again.
“Management isn’t engaged.” “Management wonders why we even have quality.” “CAPAs are boring and take up too much time.” “We get no benefit from CAPA, it’s just an exercise in paperwork.”
We all know that upper management thrives on making money. As it should. Its chief concern is to keep the lights on, the wheels turning, and the product moving out the door. Nothing - I mean NOTHING - irks a company President more than having to stall things to deal with CAPA and Complaint investigations. It’s a time consuming chore that nets the company nothing in the long run, right?
On the other hand, we all know that Quality Assurance (QA) and Regulatory Affairs (RA) make sure that systems and processes are put into place to not only ensure that things are right every time, but also that everyone is doing things in a standard approach to try and eliminate mistakes, reduce risk, and keep people as productive as they can be, with the least amount of distractions from audit findings.
QA and RA are fundamental aspects of continuous improvement, but upper management still struggles to see why these rules, processes and procedures are so important.
In this free 60 minute webinar presented by Mark Proulx, CQA, cSSBB, you’ll learn how you can put Quality into terms management and the financial decision makers understand - by talking money.
Greenlight Guru is a medical device quality management software that enables companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.
Mark Proulx is a quality/regulatory resource who has owned/operated his consultant business since 2004 and has been working with medical device and pharmaceutical companies to remediate issues for over 25 years. He has been hired by a variety of different regulated organizations, from large multibillion-dollar corporations (such as Johnson & Johnson, Philips, Medtronic, Ethicon, and Boston Scientific) to small startups, nationally and internationally. He has developed various quality systems in their entirety from scratch, remediated hundreds of 483 issues, and worked to implement efficient processes and systems for companies looking to improve their compliance and also their bottom line. Click here to learn more.