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

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

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.

GHTF has posted a proposed guidance document on Corrective and Preventive Action at http://www.ghtf.org/sg3/sg3-proposed.html The document is open for comment for 5 months.

Comments are to be sent to Egan Cobbold at Egan_Cobbold@hc-sc.gc.ca

Egan is the chair of SG3.

Please take the time to review and comment to help GHTF make a better document.

From the problem statement to root cause identification, corrective and preventive actions to effectiveness checking measures, many hours of preparation are needed to compile a strong CAPA project.

In your experience, what is the single item most companies forget to include or struggle with in their CAPA Projects?

Effectiveness Checking Measures
Documentation of Investigation
Identification of Root Cause
Corrective and Preventive Actions
Problem Statement

Repeat Corrective and Preventive Action (CAPA) investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action or preventive action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3. What’s going wrong? Why is this happening to so many of us?

According to an announcement issued this month, the FDA may now issue a Warning Letter “close-out letter” once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. The FDA may issue a close-out letter when, based on evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

This is a great incentive for manufacturers to quickly address and remediate their warning letter findings.