Overview of the Quality System

Regulation
Tonya Wilbon
Branch Chief
Division of Industry and Consumer Education
Office of Communication Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
 Do you want to
• Improve processes?
• Reduce waste?
• Identify training opportunities?
• Engage Your Staff?
• Set organizational-wide direction?
• Lower costs?

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 Learning Objectives
• Summarize Background Information
• Define Key Terminology
• Explain the purpose of a Quality System (QS)
• Explain the QS Regulation using the 7 Major
subsystems approach

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Background Information

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 QS Regulation: Background
• 1976: Medical Device Amendments to Federal Food, Drug, and
Cosmetic Act (FD&C Act)

• 1978: Current Good Manufacturing Practices

• Late 1980s: FDA evaluates voluntary device recalls

– from 1983 – 1989
– determined that faulty design attributed to 44%
– may have been prevented with adequate design controls

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 QS Regulation: Background
The Quality System Regulation
• 1990: Congress passes Safe Medical Device Act of 1990
– gave FDA authority to add pre-production design controls to regulation
• FDA revised CGMPs, resulting in new regulation
– titled Quality System Regulation, or QS Regulation
• Became effective on June 1, 1997
• Regulation found under 21 CFR 820

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 QS Regulation: Background
• Harmonized with ISO 9001 and 13485
• Requirements are not prescriptive
• Provides framework of basic requirements
• Preamble to the 1997 regulation - VERY Important

ISO = International Organization for Standardization

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 Preamble
• Reveals intent and FDA's interpretation of regulation

• Total of 204 Industry/Public Comments to proposed

rule include:
– FDA response
– FDA rationale for agreeing or disagreeing
– Changes made to regulation (from proposed to final)

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 Preamble Example
“A few comments stated that design controls should not be retroactive and that
ongoing design development should be exempted. FDA agrees in part with the
comments. FDA did not intend the design requirements to be retroactive, and
Sec. 820.30 Design controls will not require the manufacturer to apply such
requirements to already distributed devices. When the regulation becomes
effective on June 1, 1997, it will apply to designs that are in the design and
development phase, and manufacturers will be expected to have the design and
development plan established.”

Preamble, Comment 64
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Key Terminology

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 Key Terminology
• Establish - 21 CFR 820.3(k)

 Define
 Document (in writing or electronically)
 Implement (Do)

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 Key Terminology
• Finished device - 21 CFR 820.3(l)
any device or accessory to any device suitable for use or capable of
functioning, whether or not it is packaged, labeled, or sterilized

Finished Device Accessory

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 Key Terminology
• Component - 21 CFR 820.3(c)
any raw material, substance, piece, part, software, firmware, labeling, or
assembly which is intended to be included as part of the finished,
packaged, and labeled device

Example:
• reagents in an in vitro diagnostic test kit

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 Key Terminology
• Manufacturer - 21 CFR 820.3(o)
– any person who designs, manufactures, fabricates, assembles, or processes a
finished device
– includes, but is not limited to, those who perform functions of contract
sterilization, installation, relabeling, remanufacturing, repackaging, or
specification development, and initial distributors of foreign entities performing
these functions

Example:
• Sterilization Facility
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 Key Terminology
• Quality System - 21 CFR 820.3(v)
organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management

Example:
Establishment has the following documents:
– Procedures for making a device
– Documents of employee roles and responsibilities
– Documents of individuals assigned to roles

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 Key Terminology
• Quality Control
Test and inspect components or finished products against
approved specifications

Example:
– Does red light appear when you press power button?

• Quality Assurance
Manufacture quality into product
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Purpose of a Quality System

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 Purpose of Quality System
Governs methods used in, and facilities/controls used
for:
• Design • Storage
• Manufacture • Installation
• Packaging • Servicing
• Labeling

of all finished devices intended for humans

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 Bottom line:
It’s Your Quality System!
• A manufacturer must develop a Quality System
consistent with risk presented by device

• Device risk will determine depth/level of actions

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 Bottom line:
It’s Your Quality System!
A manufacturer must develop a Quality System (QS)
consistent with:
• Complexity of device
• Complexity of manufacturing processes
• Size and complexity of manufacturing facility

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Quality System Regulation

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7 Subsystems of a Quality System

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 Quality System
• Management is key to quality system and processes
– can delegate performance of activity, but not responsibility
– is ultimately responsible to ensure that QS is implemented and
effective

• Subsystems are interrelated and linked

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Continuous System: close the loop

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 Quality System
• Manufacturers should:
 PLAN to define and implement effective procedures
 DO what they say they are going to do
 CHECK system and make necessary changes
• corrections, corrective actions, and preventive actions
 ACT upon changes and ensure they are implemented

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4 Major Subsystems of a Quality System

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 4 Major Subsystems
• Focus of FDA medical device inspection
• Considered key quality indicators
• Detailed information about major subsystems in CDRH
Learn (see Postmarket Activities section)

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7 Subsystems of a Quality System

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 Corrective and Preventive Action
(CAPA)
• Purpose:
 Collect and analyze information
 Identify and investigate nonconforming products and
quality problems
 Identify cause(s) of nonconforming products
 Take effective corrective and preventive action

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 CAPA
• Sources of quality problems:
Results of monitoring manufacturing processes
Inspection and testing of incoming product
 Complaints

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7 Subsystems of a Quality System

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 Design Controls
• Purpose:
– To control design process to assure:
• user needs and intended uses are met
• design is adequately transferred into manufacturing

• Identify applicable conformance standards as design

input

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7 Subsystems of a Quality System

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 Management Controls
• Purpose:
 Provide adequate resources for operations
 Monitor quality system
 Make necessary adjustments
 Assure quality system is functioning properly
• Quality System monitored through periodic reviews
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7 Subsystems of a Quality System

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 Production and Process Controls
• Purpose:
 To manufacture devices that meet specifications

• Controlling and monitoring processes is essential

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7 Subsystems of a Quality System

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 Equipment & Facility Controls
• Purpose:
 Ensure devices are not adversely affected by manufacturing
environment, buildings or equipment

• Make sure buildings are adequate for operation being

conducted

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7 Subsystems of a Quality System

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 Record, Documents, and
Change Controls
• Purpose:
 specifications and procedures are adequate
 only current documents are used
 changes are reviewed, approved and incorporated into documents
 documents are maintained for required length of time

• System to control documents - manual or electronic

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7 Subsystems of a Quality System

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 Material Controls
• Purpose:
 To ensure that all products that are accepted, used, and
distributed meet specification
• Includes identification and traceability requirements

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 Identification
21 CFR 820.60
• Establish and maintain procedures for identifying
product during all stages:
of receipt, production, distribution, and installation
to prevent mix-ups

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 Identification
21 CFR 820.60
Examples:
• Electronic systems: using bar codes
• Part Number
• Describe the product, material, finished device
• Revision number
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 Traceability
21 CFR 820.65
• Establish and maintain procedures to identify finished devices
• Identify with control number
• Required for devices intended for surgical implant or to
support or sustain life
• Procedures must facilitate corrective action

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 Summary
• Medical device manufacturers must comply with the
Quality System Regulation
• The Quality System Regulation is grouped into 7
interrelated subsystems
• Quality System is a continuous system

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 Your Call to Action
• Review quality system regulation and ensure you
implement applicable requirements
• Demonstrate interfaces between subsystems
• Close the loop when establishing your quality system

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 Industry Education:
Three Resources for You
1. CDRH Learn: Multi-Media Industry Education
 over 125 modules
 videos, audio recordings, power point presentations, software-based “how to” modules
 mobile-friendly: access CDRH Learn on your portable devices
www.fda.gov/Training/CDRHLearn

2. Device Advice: Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics
www.fda.gov/MedicalDevices/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question
 Email: [email protected]
 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 48
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