ARTICLES BY JOANNA GALLANT

• Someone, Everyone, Or No One: Who Owns Quality? (And Who Should)

  5/7/2018

  Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.

• Flipping The Org Chart: Rethinking Where A Company’s Focus Should Be

  7/31/2017

  I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"

• Training Your Personnel To Think Beyond The SOP

  5/10/2017

  We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking. 

• Do You Make This Critical Root Cause Analysis (RCA) Mistake?

  11/14/2016

  In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.