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?

Vote at http://www.surveymonkey.com/s/ZDMGKP8