How Communication Affects the Outcomes of Quality Activities

Global Medical Device Podcast · 23 Feb 2023 · 48m · Episode 307

What this episode covers

Lesley Worthington, a quality and regulatory expert with 20 years of experience and a law degree, joins host Etienne Nichols to discuss how communication impacts quality activities in the medical device industry. They explore why technical professionals struggle with clear writing, the dangers of jargon, and the importance of tailoring communication to the audience, from shop floor workers to regulators. Worthington argues that clear, human-centered writing improves audit outcomes, reduces errors, and builds a stronger quality culture than rigid, academic-style documentation.

Other shows on the same ground, closest first.

  • Let's Combinate · 1h 42m

    020- "The Right Words" with Kathy Walsh

    Dr. Kathy Walsh, Director and Principal at Quality Systems Now, explains how to write plain language procedures for regulated industries, drawing on her book 'Eliminating the Gobbledygook'. She details techniques such as process mapping, inference building, sentence parsing, and active voice to reduce FDA 483 observations related to documentation. Walsh emphasizes that document design, including font choice and structure, is critical for comprehension and compliance, arguing that clear writing is a civil right and a core component of effective quality management systems.

  • Let's Combinate · 32m

    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

    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.

  • Let's Combinate · 13m

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

  • Let's Combinate · 59m

    071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

    Etienne Nichols, host of the Global Medical Device Podcast and Medical Device Guru at Green Light Guru, discusses his transition from the steel industry to MedTech and his work on combination products. He emphasizes that document control (21 CFR 820.40) is critical for preventing costly errors, illustrating this with an anecdote about saving a $100,000 steel coupling from being scrapped due to a decimal error. Nichols argues that management responsibility is the most important quality system element, as it sets the cultural tone for prioritizing quality over speed, and highlights the importance of strong purchasing controls to ensure quality flows to contract manufacturers.

  • Being an Engineer · 52m

    S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons

    Jesseca Lyons, a mechanical engineer and customer success expert at Greenlight Guru, discusses her passion for engineering, particularly in the medical device sector. She explains how she uses precise documentation and design controls to ensure safety and efficacy, drawing on experiences at Beckman Coulter and CRI. Lyons emphasizes the importance of understanding the 'why' behind customer requirements, such as a specific color choice for a device handle, to avoid misinterpretation and ensure the final product meets the intended perception of quality. She also shares insights on design for manufacturability, highlighting the challenges of assembling complex tubing systems and the need for clear, unambiguous instructions to reduce labor costs and errors.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.