# Guerilla Tactics for Quality Leadership

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-07-20
- Length: 53m
- Episode: 272
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership
- Listen: https://podcast.greenlight.guru/episode/guerilla-tactics-for-quality-leadership

## Summary

Steve Gompertz, founder of QRx Partners, discusses implementing lean Quality Management Systems (QMS) and 'guerilla tactics' for quality leadership in the medical device industry. He argues that regulations are intentionally vague to allow for interpretation, advising companies to focus on the intent of requirements rather than just compliance. Gompertz advocates for 'lean documentation,' such as reducing 45-page quality manuals to single-page summaries, and using metrics that measure process effectiveness rather than just speed. He also shares strategies for influencing organizational culture without formal authority, such as 'hiding vegetables' by embedding best practices into existing workflows.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=0) Introduction: Steve Gompertz and QRx Partners
- [3:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=201) Guerilla Tactics: Getting things done without permission
- [7:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=465) Lean Documentation: Reducing quality manuals and SOPs
- [15:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=949) Process Architecture: The missing layer in QMS pyramids
- [26:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=1584) Hiding Vegetables: Sneaking in best practices like Six Sigma
- [29:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=1783) Metrics: Measuring effectiveness vs. cycle time
- [41:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=2467) Defining the Problem: Requirements and root cause analysis
- [44:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership#t=2657) 7 Habits of Quality Leadership: Stephen Covey and bilingual communication

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Green Light Guru (company)
- QRx Partners (company)
- FDA (other)
- ISO 13485 (other)
- 21 CFR Part 820 (other)
- Stephen Covey (other)
- Six Sigma (other)

## Related episodes from other shows

- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (Let's Combinate)
- [254 - Saying No Is the Easy Part of Quality](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-13-254-saying-no-is-the-easy-part-of-quality) (Let's Combinate)
- [014C - "The Final P: People" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.