I have a conversation with Diane Kulisek in this episode. Diane, a veteran in quality systems and regulatory affairs, shares her journey from Gillette to Rocketdyne to Johnson & Johnson, weaving in the principles of Deming and the realities of complex, high-stakes industries. We dive into W. Edwards Deming’s seminal perspectives on quality and how they’ve shaped Diane’s extraordinary career across aerospace, consumer products, and medical device manufacturing. 

We start with Diane’s early work at Gillette, where she first encountered military-grade quality standards, and move into her groundbreaking experience at Rocketdyne. There, she managed space shuttle main engine avionics and led self-managed teams. Diane highlights the power of elected management and the deep cultural dysfunctions she observed, drawing sharp analogies to adult children of alcoholics and the normalization of deviance in corporate environments.

Our conversation then pivots to regulatory complexity. Diane explains how compliance efforts in medical device manufacturing must transcend minimum standards to uphold the priceless value of human life. She critiques the profit-centric motives of insurance companies and exposes the structural misalignments that can compromise quality in favor of greed and speed.

We also explore the limitations and potential of AI in auditing, with Diane emphasizing the importance of human experience in identifying risk and systemic failures. She proposes the provocative idea of creating an “AI Deming,” using Deming’s extensive body of work to model principled decision-making.

Diane’s reflections bring a critical eye to regulatory frameworks, the ethics of risk management, and the potential of technology to augment human insight. Through it all, she remains grounded in Deming’s enduring vision that quality is a moral imperative and a societal good.

This is Diane's LinkedIn Page:

https://www.linkedin.com/in/dkulisek

Show Notes:

1: https://www.scribd.com/document/451480272/MIL-Q-9858A-Quality-Program-Requirements-pdf

2: https://adultchildren.org

3: https://www.acquisition.gov/far/16.305

4: https://www.wsj.com/articles/SB991862606575154843

5: https://www.nasa.gov/wp-content/uploads/2015/04/708066main_Shuttle_Bibliography_2-ebook.pdf?emrc=c67e14

6: https://www.irvinestandard.com/2023/johnson-johnsons-innovation-irvine-roots-and-credo-to-give-back/

7: https://asq.org/-/media/ASQ-Supplemental-Media-Import/1/3/9/2/6/ar_1106_105018.pdf

8: https://www.dol.gov/sites/dolgov/files/oalj/PUBLIC/WHISTLEBLOWER/REFERENCES/STATUTES/SARBANES_OXLEY_ACT_OF_2002.PDF

9: https://store.pda.org/TableOfContents/Risk_Assessment_Ch01.pdf

10: https://www.healthcarefinancenews.com/news/class-action-lawsuit-against-unitedhealths-ai-claim-denials-advances

11: