Management Controls

Tonya A. Wilbon

Deputy Director, Acting

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

• Provide background about management controls

• Explain purpose of the management controls 

subsystem

• Review the Quality System Regulation requirements for 

management controls

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Background

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The 7 Subsystems of a Quality System 

Design Controls

Material Controls

Records, Documents,

and Change Controls

Equipment and 

Facility Controls

Production and 

Process Controls

Corrective and 

Preventive Actions

Management

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Background

Major subsystem

Key quality indicator of your quality system

Basic foundation of an effective quality 

management system

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Background

Management is ultimately responsible for the 

entire Quality System

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Background: Definition

Quality System

Organizational structure, responsibilities, 

procedures, processes, and resources for 

implementing quality management.

21 CFR § 820.3(v)

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Purpose of 

Management Controls

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Purpose

1. Provides adequate resources for operations

Qualified people

Equipment (including manufacturing equipment)

Adequate facilities

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Purpose

2. Ensures an adequate and effective quality 

system has been established

Controlled manufacturing processes

Controlled documentation

Calibrated, inspected, and tested equipment

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Purpose

3. Monitors the quality system and make 

necessary adjustments

Management Representative ensures quality 

system is monitored

Adjustments are based on periodic management 

reviews

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Requirements of 

Management Controls

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Quality System Regulation

Management Controls Subsystem:

21 CFR 820.20: Management responsibility

21 CFR 820.22: Quality audit

21 CFR 820.25: Personnel

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Management Responsibility

1. Establish a quality policy and objectives

• Quality policy is established by management with 

executive responsibility

• Addresses quality

• Quality policy must be understood and implemented by all 

employees

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Manager with Executive Responsibility

• Senior employee

• Able to establish and change quality policy and quality 

system

• Definition consistent with ISO 9001

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Management Responsibility

2. Establish and maintain organizational 

structure

• Must be adequate for time and employees

• Must control all functions affecting device quality

 Technical functions

 Administrative functions

 Human factors

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Organizational Structure

• Consider device type, organizational goals, and 

customer needs

• May vary based on:

– Class (i.e., Class I, II, or III) of medical device

– Size of manufacturer

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Sample Organization Chart

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Organization

Establish appropriate responsibility and authority

• Independent to every function affecting quality

• Individuals must be able to perform assigned tasks

• Teams are not limited to single specialty; may be 

inter-disciplinary

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Organization

Provide adequate resources

• Assure quality objective can be achieved

• Must be available

• Assign trained personnel

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Examples of Inadequate Resources

• Not meeting deliverables/timelines

• High volume of non-conforming product awaiting 

disposition

• Lengthy time to resolve investigations

• Lengthy time to implement corrective actions
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Organization

Appoint a management representative

• One member of management (not multiple)

• Appointment must be documented

• Ensures quality system is established and maintained

• Reports to Executive Management on performance 

of quality system

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Management Responsibility

3. Conduct management reviews

• By management with executive responsibility

• With sufficient frequency

• Measure firm’s quality system

• Use internal audit outcomes to consider 

updates to quality system

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Management Reviews

• Must be documented

• Must have management review instructions 

and procedures

• Not routinely reviewed by FDA

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Management Responsibility

4. Establish a quality plan 

• Define quality practices, resources, and activities

• Plan to document quality system activities

• may be an independent document

• may reference Device Master Record, Quality System Record, 

and other quality system records already in place

• No specific format required

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Management Responsibility

5. Establish quality system procedures

• Composed of both system level procedures and device 

specific procedures

• Outline of structure of documentation used in quality 

system only required where appropriate

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Quality System Regulation

Management Controls Subsystem:

21 CFR 820.20: Management responsibility

21 CFR 820.22: Quality audit

21 CFR 820.25: Personnel

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Quality Audits

Conduct quality audit of entire quality system

• Quality System Inspection Technique is limited; is not 

comprehensive for internal audit

• Assure quality system is in compliance

• Determine effectiveness of quality system

• Conducted by individual without direct responsibility

• Conducted with sufficient frequency

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Quality Audits

• Take corrective action when necessary

• Results reported to executive management and 

reviewed during management reviews

• Date and results of audits/re-audits documented

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Quality Audits

 Quality Audit procedures may include:

• Responsibilities for each part of the audit process

• Schedule of audits

• Auditor qualifications

• When to re-audit

• Scope and purpose of audit

• Checklist

• Documentation format
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Quality System Regulation

Management Controls Subsystem:

21 CFR 820.20: Management responsibility

21 CFR 820.22: Quality audit

21 CFR 820.25: Personnel

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Personnel

 Have sufficient personnel with necessary education, 

background, training and experience

• Ensure all quality system activities are performed

• Identify training needs

• Ensure all personnel are trained

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Personnel

Determine personnel qualifications:

Review resume

Interview employees

Contact references
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Personnel

Personnel are trained and made aware of device 

defects

Trained personnel prevent non-conforming 

product from being released to market
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Personnel

• Document training

• Staff conducting verification and validation activities 

must be informed of device defects

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Summary

 Management Controls is one of the basic foundations of 

the quality management system.

 Management Controls provides adequate resources, 

monitor, and make adjustments to the quality system.

 Management controls involve audit of entire quality 

system.

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Summary

 Requirements are codified under:

• 21 CFR 820.20

• 21 CFR 820.22

• 21 CFR 820.25

 Management is ultimately responsible for the entire 

quality management system.

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Call to Action

The role of management is to ensure evaluation 

of the suitability and effectiveness of the entire 

quality management system. 

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Industry Education Resources

Three Resources

1. CDRH Learn – Multi-Media Industry Education  over 115 modules  videos, audio recordings, power point presentations, software-based “how to” modules  mobile-friendly: access CDRH Learn on your portable devices

http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education  comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question  Email: DICE@fda.hhs.gov  Phone: 1(800) 638-2041 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)  Web: www.fda.gov/DICE

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