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Leaning into Lean Documentation
Manage episode 374949592 series 3504807
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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.
Some of the highlights of this episode include:
- 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
Memorable quotes from Steve Gompertz:
“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.”
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