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Jan 31, 2014

Where Are You in Your Quality Management Maturity?

Robyn Barnes, MasterControl Inc., Public Relations

by Robyn Barnes,  Public Relations Specialist, MasterControl Inc.

We’ve all heard about quality management journeys or trips down the quality lane.  I heard someone recently equate quality to following the yellow brick road.  Quality similes are usually about pathways but this week, I read a new description.
Quality management maturity.
Like the transition from child to senior citizen, Matthew Littlefield says organizations move through levels of quality management maturity.  His commentary is in the January 29 2014 LNS Research Blog.

Jan 29, 2014

What’s in Your Training Toolkit?

by David Hofstetter, Manager, Learning and Development at New England Organ Bank

I have to ask the question: as trainers, are we doing a good enough job at scoping a training request when it comes in? 

The answer is:  sometimes!   

So what tools should we add to build that toolbox to be able to move the answer to yes? 

Jan 27, 2014

How Dole Uses Technology and Proactive Food Safety Program To Save Time, Money

Dole Fresh Vegetables

by Nye Joell Hardy, Senior Food Safety Manager, Dole Fresh Vegetables


 "What terrifies you most in purity?" I asked.


 "Haste," William answered.
-- The Name of the Rose, Fifth Day, Nones, by Umberto Eco


This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.


At Dole Fresh Vegetables, food safety is our first priority, so we have a full-time staff that ensures all our suppliers – growers, harvesters, coolers, and packing sheds – meet rigorous food safety standards before product can be received in our facilities. For that reason, food safety needs to be extraordinarily proactive: we need to identify potential food safety risks and mitigations as early as we can to ensure production continues safely and smoothly.
That is easier said than done.  

Jan 24, 2014

Establishing a Master Harms List: Streamlining Risk Management

David Amor

by David Amor, CQA, MS Managing Partner, MEDgineering


Reprinted with permission from MDDI


Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs - whether from other hazard analyses, customer complaints, instructions for use or otherwise - the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources. 


Jan 23, 2014

Digging up Root Cause

Robyn Barnes, MasterControl Inc., Public Relations

by Robyn Barnes, Public Relations, MasterControl Inc.

Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group.  He was wondering where the term “root cause” came from. 
O'Leary says he disagrees with the terms root cause, true root cause, and ultimate root cause because they “don’t add value and confuse the distinction between symptom and cause.”
I say that adding modifiers to root cause doesn’t help, either.  You either find the cause of the problem or you don’t.
MasterControl’s Ken Peterson, known as our “Death by CAPA” expert, weighed in on the discussion.