Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

Automating Quality

Welcome to the 20th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!

This week, Mandy is wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with Lisa Helmonds, the Vice President of MWA Consulting. She is also joined by her co-host, Philippe Gaudreau, the CEO of Solabs.

In this week’s episode, they discuss investigation deviations and non-conformances. Lisa provides many excellent tips to keep in mind as you become familiar with the investigation and deviation management process. These tips will surely help listeners enhance their quality programs! This is a wealth of information for those new to the industry and veterans alike!

This episode officially wraps up the six-part series with Lisa Helmonds! Be sure to subscribe to the podcast for more great episodes on quality management.

Key Takeaways:

[:22] About today’s episode.

[1:22] Lisa Helmonds introduces herself and provides some background on her career.

[2:40] About today’s topic: investigation deviations and non-conformances.

[3:21] Why are investigations of deviations and non-conformances so important in the industry?

[4:52] Are these investigations required by regulatory agencies or voluntary?

[5:57] Is there a difference between a deviation and a non-conformance?

[9:50] What is a root cause analysis?

[10:12] Tools that can be used in the investigation and the root cause analysis process.

[12:23] What do you do after the root cause is identified?

[18:17] What a full investigation report entails.

[22:46] What constitutes a well-written investigation report.

[27:00] From an audit perspective, what do investigators looks for during inspection regarding deviations?

[29:08] Mandy recommends further listening.

[30:17] Mandy thanks Lisa for joining her for this six-part series.

[31:41] Mandy recaps what the six-part series covered.

[33:08] About next week’s episode.

[33:14] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at [e-mail]. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn.

Mentioned in this Episode:

Determine the Root Cause: The Five Whys

Fishbone Diagram for Root Cause Analysis

Failure Mode and Effects Analysis (FMEA)

Design of Experiments

Trend Chart

Part 5: “Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting”

Part 4: “Quality Culture with Lisa Helmonds from MWA Consulting”

Part 3: “Quality Agreements with Lisa Helmonds from MWA Consulting”

Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting”

Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting”

MWA Consulting

Lisa Helmonds (LinkedIn)

[e-mail]