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Applying Lean Principles to Controlled Documents - Part 2
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In this episode of the Quality Grind Podcast, host Mike Kent and special guest Jose Mora continue exploring the application of Lean principles to controlled documents in regulated life sciences. Jose uses multiple examples to illustrate how ‘Lean’ works to optimize document effectiveness by creating a hierarchy where the 'why,' the 'what,' and the 'how to' are easily identified and differentiated.
The conversation then explores aligning Lean documentation with operational efficiency and audit readiness, underscoring the benefits of an engaged and informed workforce. Jose rounds out our visit by his sharing insights on starting the transformation journey, emphasizing cultural change, training, and involving the right people at the right time.
Contact MEDVACON:
- Message us at @MedvaconLifeSciences on LinkedIn
- Visit our website at www.medvacon.com/contact
- Email us at [email protected]
Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!
Chapters
1. Introduction to the Quality Grind Podcast (00:00:00)
2. Applying Lean Principles to Controlled Documents (00:00:29)
3. The Role of Subject Matter Experts (SMEs) (00:01:46)
4. Practical Tips for Writing Lean Documents (00:04:49)
5. Lean Transformation in Pharmaceutical Plants (00:06:08)
6. Challenges in Creating Lean Quality Documents (00:09:04)
7. Voices of Lean vs. Non-Lean: Is it Working? (00:10:34)
8. Applying Lean to System and Multi-Function Documents (00:12:58)
9. The Real Magic of the Lean Process for Documents (00:18:13)
10. Getting Starting with Lean in Your Organization (00:23:59)
11. Resources and Further Learning (00:29:57)
12. Conclusion and Contact Information (00:33:45)
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