Hardware Podcasts

179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

Let's Combinate · 12 Mar 2025 · 9m

What this episode covers

Host Subhi Saadeh argues that the phrase 'everyone owns quality' is flawed because it blurs accountability, asserting instead that top management holds ultimate responsibility for quality systems in medical devices and pharma. He references Joanna Gallant’s article 'Someone, Everyone or No One' to illustrate how clear ownership prevents the cultural disconnects seen in facilities where quality staff are ostracized. Saadeh cites regulatory frameworks like ISO 13485 and 21 CFR 820, which mandate that while authority can be delegated, responsibility cannot, using the Ranbaxy scandal as a cautionary tale of leadership failure.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Ranbaxy
Also
Joanna Gallant, ISO 13485, ICH Q10, Catherine Eban, Dinesh Tucker, FDA

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