{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Febc09bcb-8810-4bf3-8c41-4fb1f627c599","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Leaning into Lean Documentation\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/ebc09bcb-8810-4bf3-8c41-4fb1f627c599\"></iframe>","title":"Leaning into Lean Documentation","description":"<p>What is lean documentation and how can you achieve it? Our guest on today\u2019s live podcast is an expert on quality management systems, audits, and most importantly for today\u2019s 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.</p><p>During today\u2019s episode, we\u2019ll 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 \u2013 the workers \u2013 while still pleasing the auditors.</p><h3>Some of the highlights of this episode include:</h3><ul><li>What it means to have lean documentation, and what the norm is in the MedTech community</li><li>How to write for employees while meeting auditor requirements</li><li>Building a template for a standard operating procedure</li><li>Collaboration between the production of a document and ownership of that document</li><li>Making repairs on documentation vs. starting over</li><li>Proving the ROI on a good or bad QMS</li><li>Taking care not to be overly prescriptive</li><li>The importance of root cause analysis over treating symptoms</li><li>Mapping instead of including every SOP and repeating yourself</li><li>What management responsibility looks like</li><li>Making documentation work better in terms of root causes</li></ul><h3>Memorable quotes from Steve Gompertz:</h3><p><em>\u201cI\u2019m fond of telling people, \u2018The auditors don\u2019t work here. That\u2019s not who these documents are for.\u2019\u201d</em></p><p><em>\u201cDone correctly, efficiency and effectiveness are not enemies.\u201d&nbsp;</em></p><p><em>\u201cEverybody has a customer internally; everyone produces a product.\u201d</em></p><p><em>\u201cOn the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.\u201d</em></p><h3>Links:</h3><p><a href=\"https://www.linkedin.com/in/stevegompertz/\" rel=\"noopener noreferrer\" target=\"_blank\">Steve Gompertz LinkedIn</a></p><p><a href=\"https://www.qrxpartners.com/\" rel=\"noopener noreferrer\" target=\"_blank\">QRX Partners</a></p><p><a href=\"https://www.linkedin.com/in/etiennenichols/\" rel=\"noopener noreferrer\" target=\"_blank\">Etienne Nichols LinkedIn</a></p><p><a href=\"https://www.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru</a></p><p><br></p>","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/bbe7e6af-d2bb-46fc-ae67-1f743a113eb4/9ca34964-2311-443c-b5c9-58e157488c33.png"}