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
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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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Establishing Data Sources 

External 

Sources Sources

Internal
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Examples of Internal Data Sources

• Process Control 

Data

• Test/Inspection 

data

• Device History 

Records

• Internal Audits

• Nonconforming 

material reports

• Rework and 

Scrap/Yield Data

• Training records
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Examples of External Data Sources

• Adverse Event 

Reporting (MDR)

• FDA 

• Even similar 

devices from 

competitors

• Supplier Controls

• Customers

• Complaints

• Servicing repairs
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Data Analysis

Analyze processes, work operations, concessions, 

quality audit reports, quality records, service records, 

complaints, returned product, and other sources of 

quality data to identify existing and potential causes of 

nonconforming product, or other quality problems. 

21 CFR 820.100(a)(1) 
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Approach to Data Analysis

Non-statistical & Statistical Techniques

● Use a risk-based approach to rank areas, 

Select items with major impact, i.e. Product related or 

Process related

Proceed with items from high to low impact and 

eventually assure all areas are addressed

• Use of Statistical Methodology; 21 CFR 820.100(a)(1) 

Appropriate statistical methodology shall be employed 

where necessary to detect recurring quality problems
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Investigate to Determine 

Root Cause

Investigate the cause of nonconformities 

relating to product, processes, and the 

quality system

21 CFR 820.100(a)(2)
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The Preamble on Investigations

The requirement in this section is broader than the 

requirement for investigations under Sec. 820.198, 

because it requires that nonconforming product 

discovered before or after distribution be 

investigated to the degree commensurate with the 

significance and risk of the nonconformity. 

More . . .
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The Preamble on Investigations

...the requirement in this section applies to 

process and quality system nonconformities, as 

well as product nonconformities...if a molding 

process with its known capabilities has a normal 5 

percent rejection rate and that rate rises to 10 

percent, an investigation into the nonconformance 

of the process must be performed. 

Preamble, Comment 161
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Identify Corrective and 

Preventive Actions

Identify the action(s) needed to correct and 

prevent recurrence of nonconforming 

product and other quality problems

21 CFR 820.100(a)(3)
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Identify Action(s) to be taken

• No further action necessary

• Correction

• Corrective Action

• Preventative Action
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The Preamble on Risk and Degree of 

Corrective and Preventive Action

...the degree of corrective and preventive action 

taken to eliminate or minimize actual or potential 

nonconformities must be appropriate to the 

magnitude of the problem and commensurate with 

the risks encountered. . . 

Preamble, Comment 159
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Verify/Validate Corrective and 

Preventive Actions

Verify or validate the corrective and preventive 

action to ensure that such action is effective 

and does not adversely affect the finished 

device 

21 CFR 820.100(a)(4)
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The Preamble on Verification 

and Validation

FDA has revised Sec. 820.100(a)(4) to 

reflect that preventive, as well as corrective, 

action must be verified or validated. 

Preamble, Comment 163
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Implement Corrective and 

Preventive Actions

Implement and record changes in methods 

and procedures needed to correct and 

prevent identified quality problems

21 CFR 820.100(a)(5)
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Communicating CAPA Information

• Disseminate information related to quality problems or 

nonconforming products to those directly responsible

for assuring the quality of such product or the 

prevention of such problems. 21 CFR 820.100(a)(6)

• Submit relevant information on identified quality 

problems, as well as corrective and preventive actions, 

for management review. 21 CFR 820.100(a)(7)
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The Preamble on CAPA Activities for 

Management Review

. . . Only certain information need be directed to 

management. The manufacturer’s procedures should 

clearly define the criteria to be followed to determine 

what information will be considered “relevant” to the 

action taken and why. FDA emphasizes that it is always 

management’s responsibility to ensure that all 

nonconformity issues are handled appropriately. 

Preamble, Comment 164
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Documenting Corrective Action and 

Preventive Action Activities

Document all activities required under this 

section, and their results 

21 CFR 820.100(b)
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The Preamble on CAPA and 

Internal Audits and Mgmt Reviews

Two comments stated that the records required under 

Sec 820.100(b) should be treated as part of the internal 

audit. FDA disagrees with these comments...FDA has 

the authority to review such records and the obligation to 

do so to protect the public health. . . Manufacturers will 

be required to make this information readily available to 

an FDA investigator 

Preamble, comments 166
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FDA Inspection 

Manufacturers should consider that their 

Corrective Action and Preventive Action 

documentation can demonstrate to FDA that the 

manufacturer’s quality system is effective and 

enables the manufacturer to identify problems 

quickly and implement effective corrective and 

preventive actions
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Guidance Available

• GHTF: Quality Management System 

Medical Devices – Guidance on corrective action 

and preventive action and related QMS processes; 

SG3; 2010

• GHTF: Quality Management System 

Medical devices - Nonconformity Grading System 

for Regulatory Purposes and Information Exchange; 

SG3; 2012
Providing Industry Education

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§ over 80 modules - videos, audio recordings, power point presentations, software-based 

“how to” modules

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2. Device Advice – Text-Based Education

§ comprehensive regulatory information on premarket and postmarket topics:

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