How to Filter Corrective Actions: Not Everything Needs to be a CAPA!

[fa icon="calendar'] Thu, Jul 07, 2011 / by Tim Lozier

Over the July 4th weekend, my kids and I watched "Chicken Little".  A cute little tale about an over-reactive little chicken (or poultry-American for you PC types) who essentially freaks out at the first sign of trouble. In the end...well, I fell asleep....but the "freaking out" part got me thinking....

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Quality Management CAPA Management Enterprise Risk Management

For Many Enterprise QMS Rollouts, Quality is a Dirty Word

[fa icon="calendar'] Mon, Jun 13, 2011 / by Tim Lozier

Many people hate to change. It happened to my father with TV and media. He fought tooth and nail to avoid switching to cable - "Too many channels." Once he switched, however, he loved it.  Same thing with movie rental.  Up until recently, he was the only person still renting VHS (whatever that is). He finally moved to DVDs, and now Blockbusters are folding faster than an origami competition.  We're now working with him on NetFlix - it's a long road ahead.

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Quality Management Enterprise Risk Management

Quality Management Seminar Wrap-Up: Risk and Harmonization, Part 2

[fa icon="calendar'] Mon, Apr 25, 2011 / by Tim Lozier

In the last post, I began my in-depth retelling of EtQ's Life Sciences Seminar on Risk Mitigation and Global Harmonization in Quality Management Systems. Overall the seminar was a great success, and we managed to keep everyone's attention for a few hours.

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Quality Management Enterprise Risk Management FDA Compliance Medical Devices Pharmaceuticals

Quality Management Seminar Wrap-Up: Risk and Harmonization , Part 1

[fa icon="calendar'] Mon, Apr 18, 2011 / by Tim Lozier

This past week, we finished up a in-depth seminar in New Jersey.  The seminar, focused in the Life Sciences market, touched on the concepts of Global Harmonization and Standardization.  It also had a focus on Risk mitigation in Quality Management systems.  Overall, the seminar went well - great turnout, great speakers (great food), and overall a great response. 

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Quality Management Enterprise Risk Management FDA Compliance

Risk Mitigation and Global Harmonization in Quality Systems Seminar

[fa icon="calendar'] Thu, Mar 31, 2011 / by Tim Lozier

Normally, I'm not one to push the "events agenda" on the blog, but I wanted to speak about this particular event, simply because the topics and the speaker lineup are right in line with what I typically yammer on about here.

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Quality Management Enterprise Risk Management

Quantitative Risk Assessment in HACCP Plans - Decisions, Decisions...

[fa icon="calendar'] Mon, Mar 14, 2011 / by Tim Lozier

Last week, I spoke about how to set up a Risk Matrix and the considerations on how to determine risk scales. I mentioned how Risk methods provide the objectivity needed for many organizations, but a team is need to ultimately make the decision.

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Enterprise Risk Management HACCP ISO 22000 Food and Beverage Safety

Risk Assessment: Creating a Risk Matrix

[fa icon="calendar'] Fri, Mar 04, 2011 / by Tim Lozier

In this day and age, Risk is the biggest buzzword in the compliance industry.  We've talked about it, you can't go anywhere without hearing about it, and everyone's got a Risk-Based solution.  I think the primary reason why we focus on Risk Assessment and Risk Management, is because in business, we need to quantify our actions.  We can no longer rely purely on "gut instinct" to execute on events, whether Quality, Financial, Social or similar areas.  The world moves too fast, and one misstep can make or break you as a business.  Risk provides the objective metric to help the decision-making process.  But, you need to know how to use risk.

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EHS Management Quality Management Compliance Management Enterprise Risk Management

The Importance of Risk in the Complex Quality Lifecycle

[fa icon="calendar'] Mon, Jan 24, 2011 / by Tim Lozier

I'm big into Mountain Biking.  I've been an avid biker for over 10 years now - if it's on two wheels, sign me up.  As I matured as a biker, my confidence grew and I began to move faster on the trail.  But as I moved faster, things become more complex.  I had to process more information in less time - the bend in the trail, the slight angles and indentations of the topography before me.  I upgraded my equipment, and got even faster, requiring more quick decision-making.  If I made the wrong decision, I could end up eating tree bark or breaking my bones.

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Quality Management Enterprise Risk Management

Why Risk is Important to Corrective Actions

[fa icon="calendar'] Wed, Jul 01, 2009 / by Morgan Palmer

The Corrective Action process is at the heart of your quality management system, transforming quality issues into opportunities for improvement. Unfortunately, in most organizations the Corrective Action process is clogged with too many Corrective Actions, slowing everything down, diluting everyone's efforts, and frustrating management. To unclog the system, you need to focus on only the Corrective Actions you have capacity for. The difficulty lies in picking the ones you should work on and the ones you can put on hold until later.

Risk assessment provides a quantitative technique for picking the Corrective Actions you need to work on now and the ones you can leave to later. Using a rating of probability and severity (and optionally detectability), supported by clearly documented guidelines, you can calculate a risk level for each Corrective Action. With this information, you can set a risk threshold for determining which Corrective Actions to work on. Complete all those Corrective Actions first, regardless of their issue date or "priority" level, before moving to lower-risk Corrective Actions.

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Enterprise Risk Management

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