- Why Us
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and has led initiatives in project management, engineering automation, configuration management, audit, and software development.
During today’s episode, we’ll talk about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS. Steve will also discuss what he would do if he were starting a medical device company today. Listen to the episode to learn more about lean documentation and how you can learn to write for your actual audience – the workers – while still pleasing the auditors.
What it means to have lean documentation, and what the norm is in the MedTech community
How to write for employees while meeting auditor requirements
Building a template for a standard operating procedure
Collaboration between the production of a document and ownership of that document
Making repairs on documentation vs. starting over
Proving the ROI on a good or bad QMS
Taking care not to be overly prescriptive
The importance of root cause analysis over treating symptoms
Mapping instead of including every SOP and repeating yourself
What management responsibility looks like
Making documentation work better in terms of root causes
“I’m fond of telling people, ‘The auditors don’t work here. That’s not who these documents are for.’”
“Done correctly, efficiency and effectiveness are not enemies.”
“Everybody has a customer internally; everyone produces a product.”
“On the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...