Corrective and Preventive Action Basics


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Corrective and Preventive Action Basics
November 4, 2014
Joseph Tartal
Postmarket and Consumer Branch Chief Division of Industry and Consumer Education
Office of Communication and Education Center for Devices and Radiological Health
U.S. Food and Drug Administration

Learning Objectives
• Know the purpose of Corrective and Preventive Action • Have the ability to distinguish between each defined
term • Understand the requirements in 21 CFR 820 Quality
System Regulation • Identify various types of data and tools • Recognize examples and best practices • Be aware of compliance concerns
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Purpose of the Corrective and Preventive Action Subsystem
• To collect and analyze information to identify actual and potential product and quality problems
• To investigate product and quality problems and take appropriate and effective corrective or preventive action
• To verify or validate the effectiveness of corrective and preventive actions
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Purpose of the Corrective and Preventive Action Subsystem
• To communicate corrective and preventive actions to the appropriate people
• To provide information for management review • To document activities
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Definition: Correction
“Correction” action to eliminate a detected nonconformity.
1. A correction can be made in conjunction with a corrective action. 2. A correction can be, for example, rework or regrade
ISO 9000:2005(E)
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Definition: Corrective Action
“Corrective action” action to eliminate the cause of a detected non-conformity or other undesirable situation.
1. There can be more than one cause for a nonconformity.
2. Corrective action is taken to prevent recurrence. 3. There is a difference between correction and
corrective action. ISO 9000:2005(E)
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Definition: Preventive Action
“Preventive action” action to eliminate the cause of a potential non-conformity or other undesirable situation
1. There can be more than one cause for a potential nonconformity.
2. Preventive action is taken to prevent occurrence.
ISO 9000:2005(E)
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21 CFR 820 Regulatory Requirement - Procedures
Establish and maintain procedures for implementing corrective and preventive action 21 CFR 820.100(a)
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The Preamble on Procedures
The procedures (for implementing corrective and preventive action) must provide for control and action to be taken on devices distributed, and those not yet distributed, that are suspected of having potential nonconformities.
Preamble, Comment 158
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Where to Start? Planning
Plans should include… I. Establishing Data Sources and Criteria II. Measuring and Analysis of Data Sources III. Improvement Plans IV. Input to Management
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Corrective and Preventive Action Basics