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U.S. Department of Health and Human Services

Medical Devices

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Presentation: Quality System Regulation 21 CFR 820 - Basic Introduction

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Kimberly A. Trautman
FDA’s Medical Device Quality Systems Expert

Overview
  • Background
  • Definitions
  • Subsystems
    • Management
    • Design and Development Controls
    • Production and Process Controls
    • Corrective and Preventive Actions
  • Resources
Background

Effective June 1, 1997, replacing the 1978 GMP for medical devices
Preamble to the 1997 regulation - VERY Important
Requirements are not prescriptive
Provides framework of basic requirements for manufacturers to follow

Quality Management System

manufacturer must develop a Quality Management System (QMS) commensurate with:

  • risk presented by the device
  • complexity of device and manufacturing processes
  • size and complexity of organization
Quality System Regulation

820.3 Definitions

Establish means define, document (in writing or electronically), and implement.

Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Quality Management Subsystems

Diagram. The Seven Subsystems of the Quality System Regulation are as follows: Management Subsystem, Design Controls Subsystem, Material Controls Subsystem, Records, Documents and Change Controls Subsystem, Equipment and Facility Controls Subsystem, Production and Process Controls Subsystem and Corrective and Preventative Action Subsystem. Additionally each of these subsystem can further be broken down into more specific regulatory requirements and quality system procedures and operations.

Management Subsystem

820.20 Management Responsibility
820.22 Quality Audits
820.25 Training

820.20 Management Responsibility

Quality Policy.

  • Must be established by management with executive responsibility.
  • Must be understood, implemented, and maintained at all levels of the organization.

Must establish and maintain an adequate organizational structure, including

  • Appropriate responsibility, authority, and interrelation of personnel
  • Adequate resources
  • Appointed management representative

Management Review

Management with executive responsibility shall review the suitability and effectiveness of the quality system
At defined intervals

  • With sufficient frequency
  • According to established procedures

Management Representative

  • Member of management.
  • Responsible for ensuring establishment of quality system and reporting on quality system performance to management with executive responsibility.
820.22 Quality Audit
  • Establish procedures for quality audits.
  • Conduct audits to assure compliance by individuals not having direct responsibility for areas audited.
  • Perform corrective action(s), including reaudit of deficiencies.
  • Generate a written report of audit results for management review.
820.25 Personnel
  • Hire sufficient personnel with necessary education, background, training, and experience.
  • Establish procedures for identifying training needs and to ensure personnel are adequately trained.
  • Document training.
  • Make personnel aware of device defects that could occur from improper job performance.
  • Make personnel aware of defects and errors that could be encountered as part of their job.
Design and Development Subsystem
  • 820.30 Design Controls
  • 820.70(b) Production and Process Changes
  • 820.181 Device Master Record
  • 820.250 Statistical Techniques
820.30 Design Controls
  • Since 1984, the FDA has identified lack of design controls as one of the major causes of device recalls.
  • The SMDA provided the FDA with the authority to add preproduction design controls to the device GMP regulation.
  • The design control requirements are not intended to apply to development of concepts and feasibility studies.
    Preamble #62
  • FDA will evaluate the process, the methods, and the procedures that a manufacturer has established to implement the requirements for design controls.
  • The FDA has amended the IDE regulation, reaffirming that an IDE device is exempted from complying with the GMP’s … with the exception of Sec. 820.30 “Design Controls.”
  • FDA will not inspect design controls during bioresearch monitoring inspections.

Applicable to all class II and III and the following class I devices

  • Devices automated with computer software
  • Tracheobronchial suction catheters
  • Surgeon's gloves
  • Protective restraints
  • System, radionuclide applicator, manual
  • Source, radionuclide teletherapy
Formal Design Controls Begin

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

Design and Development Planning

Describe design and development activities.

  • Define responsibility for implementation.
  • Identify and describe interfaces between different groups or activities.
  • Review, update, and approve plans as design and development evolves.
Design and Development Plan Approved

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

 

Design Input
  • Ensure requirements are appropriate and address intended use of device.
  • Address incomplete, ambiguous, or conflicting requirements.
  • Document, review, and approve input requirements.
Design Inputs Initially Developed and Approved

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

Design Output
  • Define and document design output in terms that allow evaluation to design input.
  • Reference acceptance criteria.
  • Identify design outputs essential for the proper functioning of device.
  • Document, review, and approve design outputs before release.
  • Results of design effort at each phase and the end of the total design effort.
  • Finished design output is basis for the DMR.
Design Verification
Design Output = Design Input

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

Design Review
  • A documented, comprehensive, systematic examination to
    • Evaluate adequacy of the design requirements
    • Evaluate capability of the design to meet requirements
    • Identify problems
  • Ensure that formal reviews of design results are planned and conducted at appropriate stages.
  • Ensure participants include representatives of all functions concerned with design stage being reviewed.
  • Document results in the Design History File (DHF).
Design Reviews

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

Design Verification
  • Verify the device design.
  • Confirm that design output meets design input requirements.
  • Document results in the DHF.
Design Verification

One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.

When explaining design verification, design input circles to design output through design verification. Through consecutive input to output verifications the process builds upon itself. Each output must be verified against its input to ensure that the design was made correctly

 

Design Validation

820.3 Definitions – Design Validation

Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

  • Validate the device design.
  • Perform under defined operating conditions on initial production units or equivalent.
  • Ensure devices conform to defined user needs and intended uses.
  • Test of production units under actual or simulated use conditions.
  • Perform software validation and risk analysis, where appropriate.
  • Document results in the DHF.
Design Validation
One of the questions that every specification developer and manufacturing firm must answer is when does research end, and development begin, design controls. A overlaid two hump diagram best illustrates the interaction between these two processes. The first hump represents research activities and the second hump represents development activities. Both humps meet with the shape of an X in the middle of the two humps.
Design and Development
This waterfall diagram explains the flowing effect and interaction between the different phases of a devices design. The diagram also includes how design verification ensure that design outputs meet design inputs and how design validation ensures the final device meets the end-users needs. Additionally design reviews can take place at any time throughout the design process and is shown here to occur at each waterfall step.
Design Transfer
  • Ensure the device design is correctly translated into production specifications.
Design Transfer

Once again using the hump diagram that shows the overlay between research and development, design transfer is shown to be started prior to the end of the development process. Also design validation activities are performed with production units, or their equivalent, and that the design validation is used to ensure that the end device meets the end-users needs and its intended use.

Design Validation

Once again using the hump diagram that shows the overlay between research and development, design transfer is shown to be started prior to the end of the development process. Also design validation activities are performed with production units, or their equivalent, and that the design validation is used to ensure that the end device meets the end-users needs and its intended use.

Does the design meet user needs and intended use?

Design Changes
  • Identify, document, validate or verify, review, and approve design changes before implementation.
Design Changes

The graphic shows the full spectrum of how design change can encompasses everything from early development design input changes to post design production changes and lists that these can include product, process, packaging, labeling and testing changes.

Design History File

820.3 Definitions – Design History File

Design history file (DHF) means a compilation of records which describes the design history of a finished device.

  • Establish and maintain a DHF for each type of device.
  • Maintain records to demonstrate development was in accordance with design plan and requirements of 820.30.
  • Forms the Device Master Record (DMR)
Production and Process Controls Subsystem
  • 820.50 Purchasing Controls
  • 820.60 Identification
  • 820.65 Traceability
  • 820.70 Production and Process Controls
  • 820.72 Inspection, measuring, and test equipment
  • 820.75 Process Validation
  • 820.80 Receiving, in-process, and finished device acceptance
  • 820.86 Acceptance Status
  • 820.120 Device labeling
  • 820.140 Handling
  • 820.150 Storage
  • 820.160 Distribution
  • 820.170 Installation
820.50 Purchasing Controls

Establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements

Evaluate suppliers, contractors and consultants

Establish and maintain purchasing data/documents that describe or reference specified requirements (including notification of change agreements)

Approve purchasing data/documents

GHTF Guidance Document:

“Quality management system-Medical Devices-Guidance on the control of products and services obtained from suppliers”

A supplier is anyone that is independent from the manufacturer’s quality management system and not apart of their Quality Audit.

  • Internal Supplier
  • External Supplier

An internal supplier:

  • Part of the manufacturer’s organization
  • Operates under a separate quality management system
  • Not part of the manufacturer’s internal audit scope (quality audit)

Internal suppliers are to be controlled in a similar way as external suppliers

Both internal and external suppliers are required to be controlled under 21 CFR 820.50.

820.70 Production and Process Controls

Develop, conduct, control, and monitor production processes to ensure devices conform to specifications.

Production and process changes.

  • Establish procedures for changes to a specification, method, process, or procedure according to §820.30 Design Controls
  • Verify/ validate according to §820.75.
  • Approve in accordance with §820.40.

Environmental control.

  • Establish procedures to adequately control environmental conditions.
  • Inspect control system(s) to verify adequacy and proper functioning.
  • Document and review these activities.

Automated processes.

  • Validate computer software used as part of production or the quality system for its intended use.
  • Validate according to an established protocol.
  • Validate all software changes before approval.
  • Document validation activities and results.
820.75 Process Validation

Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Process Validation

  • Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.

Control of Validated Processes.

  • Monitoring and control methods and data
  • Date performed
  • Individual(s) performing the process, where appropriate
  • Major equipment used, where appropriate

Revalidation.

  • When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate.
820.80 Receiving, In-Process, & Finished Device Acceptance

Receiving acceptance activities.

  • Establish procedures for acceptance
  • Inspect, test, or otherwise verify as conforming
  • Document acceptance or rejection

In-process acceptance activities.

  • Establish acceptance procedures to ensure specified product requirements are met.
  • Control in-process product until appropriate acceptance activities are completed and documented.

Final acceptance activities.

  • Establish and maintain procedures for finished device acceptance to ensure each production run, lot, or batch meets acceptance criteria.
  • Control finished devices until appropriate activities required for release are completed.
Corrective and Preventive Actions (CAPA) Subsystem
  • 820.100 CAPA
  • 820.90 Nonconforming Product
  • 820.198 Complaints
  • 820.200 Servicing
  • 820.250 Statistical Techniques
820.100 Corrective and Preventive Action
  • Collect and analyze data to identify nonconforming product and other quality problems
  • Investigate cause
  • Identify and implement corrective and preventive action
  • Verify and validate actions and effectiveness
  • Communicate information on the quality problems and the necessary actions to appropriate staff
  • Forward information to management review
Correction vs. Corrective Action

“Correction” refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity

“Corrective action” relates to the elimination of the causes of an existing nonconformity

“Healthy” CAPA subsystem procedures include provisions to
  1. Identify and correct existing nonconforming product or other quality problems (“Correction”);
  2. Identify and eliminate the causes of existing nonconforming product and other quality problems (“Corrective Action”); and,
  3. Identify and eliminate the causes of potential nonconforming product and other quality problems (“Preventive Action”)
820.90 Non-Conforming Product

Establish and maintain procedures, including

  • Identification
    • Documentation
    • Evaluation
    • Segregation
    • Disposition
  • Document the evaluation and any investigation

Nonconformity review and disposition.

  • Establish and maintain procedures defining the responsibility for review and the authority for the disposition, including the review and disposition process.
  • Document disposition of nonconforming product, including the justification for use and the signature of individual(s) authorizing use.

Nonconformity review and disposition.

  • Establish and maintain procedures for rework, including retesting and reevaluation.
  • Document rework and reevaluation activities in the DHR.
820.198 Complaint Files

All manufacturers must

  • Maintain complaint files.
  • Designate a formal complaint handling unit.
  • Establish and maintain procedures for receiving, reviewing, and evaluating complaints.

Procedures must ensure that

  • All complaints are processed in a uniform and timely manner.
  • Oral complaints are documented upon receipt.
  • Complaints are evaluated to determine whether the complaint represents an Medical Device Report.

Investigations.

  • Review and evaluate all complaints to determine whether an investigation is necessary.
  • Records of investigation shall be maintain with certain specified information as required

Investigations.

  • When no investigation is made, maintain a record that includes the
    • Reason no investigation was made and name of the individual responsible for the decision.
Quality Management Subsystems

Diagram. The Seven Subsystems of the Quality System Regulation are as follows: Management Subsystem, Design Controls Subsystem, Material Controls Subsystem, Records, Documents and Change Controls Subsystem, Equipment and Facility Controls Subsystem, Production and Process Controls Subsystem and Corrective and Preventative Action Subsystem. Additionally each of these subsystem can further be broken down into more specific regulatory requirements and quality system procedures and operations.

Close the loop...

This shows how the quality system closes the loop back upon itself by continuing to follow through on the following actions, Plan, Do, Check and Act.

Additional Resources