# 102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-09-13
- Length: 32m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/102---Human-Error--Doing-Quality-Differently--Defining-Accountability--Written-Human-Guidance--Blue-Line-vs--Black-Line-and-Categorizing-Deviations-with-Amy-Wilson-and-Cliff-Berry-e296s8q

## Summary

Amy Wilson and Cliff Berry, authors of "Do Quality Differently," discuss human and organizational performance in biopharma and manufacturing. They argue that "human error" is a symptom of system design flaws rather than individual failure, advocating for a shift from blaming individuals to analyzing system constraints. The guests explain the "Blue Line vs. Black Line" concept, distinguishing between work as imagined (procedures) and work as actually performed, and emphasize the importance of good written human guidance and appropriate deviation categorization to drive real quality improvements.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=0) Introduction: Amy Wilson and Cliff Berry on Human Performance
- [4:52](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=292) Reframing Human Error and Systemic Constraints
- [9:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=553) Shifting Leadership Mindsets and Defining Accountability
- [13:33](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=813) The Problem with Human Performance as a Root Cause
- [19:09](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=1149) Designing Effective Written Human Guidance
- [24:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=1469) Kappa Striker Categories and Control Measures
- [27:10](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=1630) Reconciling Accountability with Blame-Free Culture
- [30:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human#t=1801) Blue Line vs. Black Line: Work as Imagined vs. Completed

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing (product)
- BioGen (company)
- Devonway (tool)
- Kappa Striker (tool)

## Related episodes from other shows

- [How Communication Affects the Outcomes of Quality Activities](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-23-how-communication-affects-the-outcomes-of-quality-activities) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-13-102-human-error-doing-quality-differently-defining-accountability-written-human. 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 Let's Combinate.