Analysis of root cause is a primary area of concern when addressing nonconformaties and deviations in life science organizations today.

In your opinion, what is the most common tool your investigators use when conducting a root cause analysis?

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For nearly two decades, the Association for the Advancement of Medical Instrumentation’s (AAMI) human factors standard, HE 48, has been the only existing medical device user interface design standard.

With increased emphasis by global regulatory agencies on eliminating and controlling use error in devices, a new human factors standard with more direct relationship to healthcare contexts has been developed by the AAMI Human Factors Standards Committee. In this article, Pat Patterson and Robert North offer a preview into the new standard and how it applies to manufacturers.

Read the article: http://www.mddionline.com/article/sneak-preview-fdas-human-factors-standard

Step One - The Problem Statement

Last month, we talked about “chart fright” - the struggle I see teams have in dealing with the form. I’d like to continue that theme today and in the months ahead.

The first step in the root cause process is the problem statement. Albert Einstein is credited with saying “If I had one hour to save the world, I’d spend 55 minutes defining the problem and only five minutes finding the solution.” I believe this statement is very indicative of the challenge facing in our investigation teams. You have to start well to end well. And often teams want to get right into the investigation without fully understanding the problem.

My advice: Remember the goal. Find out what’s wrong with what - object and defect. In order to do this, you may need get out of the conference room. Go to where the problem occurred if at all possible. The Japanese call that “Gemba.” At the very least, bring pictures, videos or the problem itself to the room (as a show and tell). Let the team see it, experience it. Storyboard the problem if that helps. Lastly, challenge assumptions. Too many times I see teams assume they all have the same understanding, and it’s not until later in the investigation that this comes out. You’ll hear comments like “I thought we were working on this - or that”! Often it means starting over. Save a lot of time and frustration by fully understanding the problem statement before investigating it.

In 2008, the International Organization of Standardization issued a new standard to which all medical device manufacturers should comply. Yet many organizations are struggling to keep up with ISO 9001 2000. What, in your experience, are the critical areas that organizations need to address in order to comply with the new standard?

Effective Risk Management is a critical initiative for those under increased regulatory scrutiny. In the past decade, ISO 14971 and ICH Q9 have been recognized by the FDA as the standards to which all life science organizations should comply. Now, more than ever, companies need a strong risk system in place and the right resources to allow them to make the right decisons.

What tools do you find most useful when managing risk?

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We have all seen it (and probably did it as well). Groups gather around the investigation wall worksheet while someone tries to write down what the group is saying. Pretty soon he or she gets lost, confused and frustrated. The group then gets concerned about what information to put where, they lose their train of thought and ultimately get off track. Shortly, everyone begins to stare at the worksheet (like the proverbial deer in the headlights) and they start talking “at” each other. Before you know it, the team is lost and going in circles (along with the recorder).

We call this scenario “Chart Fright.” In other words, the confusion and frustration of filling out a worksheet.

Setting up a storyboard can help remedy this situation when it occurs.

Have you ever experienced Chart Fright while training a group? Do you have any suggestions for overcoming it? Please share your experience with us.

This week, the FDA introduced FDA Basics, a web resource intended to answer questions from consumers and patients as well as to discuss other important public health topics in a useful and user-friendly format.

Structurally, FDA Basics consists of the following sections:

• FDA Fundamentals
• Animal & Veterinary
• Cosmetics & Color Additives
• Dietary Supplements
• Drugs
• Food
• Medical Devices
• Radiation-Emitting Products
• Tobacco Products
• Vaccines, Blood, and Biologics

Visit http://www.fda.gov/AboutFDA/Basics/default.htm for more info.

After reviewing many CAPA SOP’s there appears to be two primary directions companies go in to decide if they are going to initiate a CAPA:

1. An issue (nonconformance ect.) is identified and a root cause investigation is conducted. Based on the the investigation a decision is made to address the issue as a CAPA or not.

2. CAPA is initiated (based on risk) and the first action is to conduct a root cause investigation.

Based on your companies current flow process, which comes first; initiation of a CAPA or a root cause investigation?

CAPA Projects are typically allocated a vast amount of organizational resources, and are arguably the most time sensitive project a quality department can endure. Yet despite interference from the FDA, many organizations still struggle to close these projects in the allowed timeframe.

How long does it typically take your organization to close out a CAPA project?

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ISO 9001: 2000 lists 3 types of actions, including Corrections, Corrective Actions and Preventive Actions. While the difference between a Corrective Action and a Preventive Action may be obvious, many quality personnel have difficulty distinguishing between a Correction and a Corrective Action. As a result, many organizations in the market have been treating these requirements as the same, therefore complying to one means violating another, and therefore implementing an ineffective management system.

So what is the difference? What advice do you give employees on distinguishing between the two?

Answer: A “Correction” is an action to eliminate detected nonconformities which have occurred, whereas a “Corrective Action” is an action to eliminate the cause of the nonconformity which has occurred.