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Quality Systems Overview of FDAs Quality System Regulation CFR 820

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Title: Quality Systems Overview of FDAs Quality System Regulation CFR 820


1
Quality Systems Overview of FDAs Quality System
Regulation CFR 820
  • U.S. Food and Drug Administration
  • Center for Devices and Radiological Health

2
Harmonization of Quality System Requirements
  • ISO 13485 revised reissued 2003 as a stand
    alone quality system standard for medical device
    manufacturers
  • ISO 13485 2003 and 21 CFR Part 820 are
    harmonized Each may have additional
    requirements but they do not conflict with one
    another.

3
Definition Quality System
  • Quality system means the organizational
    structure, responsibilities, procedures,
    processes, and resources for implementing quality
    management
  • 21 CFR 820.3(v)

4
How can the QS Regulation cover so many types of
devices?
  • Flexible regulation
  • Requirements are stated in general terms
  • Each manufacturer shall Establish and maintain a
    quality system that
  • Is appropriate for the specific medical device(s)
    designed and/or manufactured
  • Meets the requirements of this part (part 820)
  • 21 CFR 820.5

5
7 Subsystems of the Quality System
Corrective Preventive Action Control
Design Control
Production Process Control
Management Control
Facility Equipment Control
MaterialControl
Documents, Records Change Control
6
Introduction Management Controls
  • Purpose of Subsystem
  • Responsibility and authority
  • Quality Policy
  • Organization
  • Management representative
  • Management review
  • Quality System procedures

7
Management Control Subsystem
  • Purpose
  • To provide adequate resources for operations
  • To monitor the quality system, make necessary
    adjustments, and assure the quality system is
    functioning properly

8
Definition Management with Executive
Responsibility
  • Management with executive responsibility means
    those senior employees of the manufacturer who
    have the authority to establish or make changes
    to the manufacturers quality policy and quality
    system
  • 21 CFR 820.3(n)

9
Definition Quality Policy
  • Quality policy means the overall intentions and
    direction of an organization with respect to
    quality, as established by management with
    executive responsibility
  • 21 CFR 820.20(u)

10
Quality Policy
  • Management with executive responsibility shall
  • Establish its policy and objectives for, and
    commitment to quality
  • Ensure that the quality policy is understood,
    implemented, and maintained at all levels of the
    organization
  • 21 CFR 820.20(a)

11
Organization
  • Establish and maintain an adequate organization
    structure to ensure that devices are designed and
    produced in accordance with the requirements of
    this part.
  • 21 CFR 820.20(b)

12
The Preamble on Organization
  • The organizational structure should ensure that
    the technical, administrative and human factors
    functions affecting the quality of the device
    will be controlled, whether these functions
    involved hardware, software, processed materials,
    or services. All such control should be oriented
    towards the reduction, elimination, or ideally,
    prevention of quality nonconformities.
  • Preamble, Comment 46

13
Appointment of Management Representative
  • Management with executive responsibility shall
  • Appoint a member of management as management
    representative
  • Document such appointment
  • 21 CFR 820.20(b)(3)

14
Management Representatives Responsibilities
  • Ensure that quality system requirements are
    effectively established and effectively
    maintained in accordance with this part
  • Report on the performance of the quality system
    to management with executive responsibility for
    review
  • 21 CFR 820.20(b)(3)

15
Management Review
  • Management with executive responsibility shall
    review the effectiveness of the quality system
  • At defined intervals
  • With sufficient frequency
  • According to established procedures
  • to ensure that the quality system satisfies the
    requirements of this part and the manufacturers
    established quality policy and objectives
  • 21 CFR 820.20(c)

16
Management Review
  • Document dates and results of quality system
    reviews
  • Manufacturers are not required to make management
    review reports available to FDA employees during
    inspections
  • Manufacturers must make procedures for management
    reviews available to FDA employees for review
    during inspections
  • 21 CFR 820.20(c) 820.180(c)

17
Quality System Procedures
  • Establish quality system procedures and
    instructions
  • Establish an outline of the structure of the
    documentation used in the quality system where
    appropriate
  • 21 CFR 820.20(e)

18
Introduction Design Controls
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file
  • Purpose
  • Design Planning
  • Design input
  • Design output
  • Design review

19
Purpose of the Design Control Subsystem
  • To control the design process to assure that the
    devices meet
  • -User needs
  • -Intended uses
  • -All specified requirements, including
    regulatory requirements
  • The design control requirements are not intended
    to apply to development of concepts and
    feasibility studies.
  • Preamble Comment, 62

20
Design Control Scope 820.30(a)
  • Design control requirements apply to
  • All Class II and Class III devices
  • The following class I devices
  • Devices automated with computer software
  • Tracheobronchial suction catheters
  • Surgeon's gloves
  • Protective restraints
  • Manual radionuclide applicator system
  • Radionuclide teletherapy source

21
Design Development Planning - 820.30(b)
  • Establish and maintain plans that
  • Describe or reference design and development
    activities
  • Define responsibility for implementation
  • Identify or describe interfaces with different
    groups or activities
  • Review, update and approve plans as design and
    development evolves

22
Design Input - 820.30(c)
  • Design input means the physical and performance
    requirements of a device that are used as a basis
    for device design
  • Establish and maintain procedures to assure that
    device design requirements
  • Are appropriate
  • Address the intended use of the device
  • Include in procedures a mechanism for addressing
    requirements that are
  • Incomplete
  • Ambiguous
  • Conflicting

23
Types of Design Inputs
  • Intended Use
  • User Needs
  • Physical characteristics
  • Performance characteristic
  • Safety
  • Reliability
  • Environmental limits
  • Standards
  • Regulatory requirements
  • Labeling
  • Human factors
  • Maintenance
  • Compatibility with other devices
  • Sterilization

24
Design Output - 820.30(d)
  • Design output means the results of a design
    effort at each design phase and at the end of the
    total design effort. The finished design output
    is the basis for the device master record. The
    total finished design output consists of the
    device, its packaging and labeling, and the
    device master record
  • Establish and maintain procedures for
  • Defining and documenting design output in terms
    that allow an adequate evaluation of conformance
    to design input requirements
  • Containing or referencing acceptance criteria
  • Ensuring design outputs essential for the proper
    functioning of the device are identified

25
In other words...
  • Design output are the design specifications
    which should meet design input requirements, as
    confirmed during design verification and
    validation and ensured during design review.
  • The output includes the device, its labeling and
    packaging, associated specifications and
    drawings, and production and quality assurance
    specifications and procedures.
  • Preamble, comment 76

26
Design Review - 820.30(e)
  • Establish and maintain procedures for design
    reviews
  • Plan and conduct formal documented design reviews
    of the design results at appropriate stages
  • Include at each design review
  • Representatives of all functions concerned
  • An individual without direct responsibility for
    the stage being reviewed
  • Any specialists needed

27
Design Verification 820.30(f) vs. Design
Validation 820.30(g)
Design Verification Did I make the product
right? i.e. Specified requirements have been
fulfilled Design Validation Did I make the
right product? i.e. device specifications conform
with user needs and intended use(s)
28
Design Verification 820.30(f)
  • Establish and maintain procedures for verifying
    the device design
  • Confirm design output meets design input
    requirements

29
Design Validation 820.30(g)
  • Establish and maintain procedures for validating
    the device design
  • Perform design validation
  • Under defined operating conditions
  • On initial production units, lots or batches or
    their equivalents
  • Under actual or simulated use conditions

30
Design Transfer 820.30(h)
  • Establish and maintain procedures to ensure that
    the device design is correctly translated into
    production specifications
  • FDA did not intend the requirements for Design
    Release to prohibit manufacturers from beginning
    the production process until all design
    activities have been completed.
  • Preamble, comment 86

31
Design Changes - 820.30(i)
  • Establish and maintain procedures for . . .
  • the identification, documentation, validation or
    where appropriate verification, review, and
    approval of design changes before their
    implementation
  • Minimum Design Change Requirements
  • Establish design change control procedures,
    determine the risk presented by the change and
    implement design control requirements to the
    extent appropriate for that risk

32
Design History File - 820.30(j)
  • Establish and maintain a design history file for
    each type of device
  • Include in the DHF or reference records necessary
    to demonstrate that the design was developed in
    accordance with the design plan and part 820
    requirements
  • Design history file (DHF) means a compilation of
    records which describes the design history of a
    finished device

33
Introduction Material Control
  • Purpose of Subsystem
  • Purchasing controls
  • Statistical techniques
  • Receiving, in-process, and finished device
    acceptance
  • Acceptance status
  • Additional Requirements

34
Material Control Subsystem
  • Purpose To assure that all products that are
    accepted, used, and distributed meet
    specifications
  • Products includes components, manufacturing
    materials, in-process devices, finished devices,
    and returned devices

35
Procedures for Purchasing Controls
  • Establish and maintain procedures to ensure that
    all purchased or otherwise received product and
    services conform to specified requirements
  • 820.50

36
Statistical Techniques
  • Establish and maintain procedures, where
    appropriate, for identifying valid statistical
    techniques for establishing, controlling and
    verifying the acceptability of process capability
    and product characteristics
  • 820.250(a)

37
Receiving Acceptance Activities
  • General
  • Establish and maintain procedures for acceptance
    of incoming product
  • Inspect, test or otherwise verify that incoming
    product conforms to specified requirements
  • Document acceptance or rejection
  • 820.80(b)

38
In-process Acceptance Activities
  • Establish and maintain acceptance procedures,
    where appropriate, to ensure that in-process
    product
  • Meets specified requirements
  • Is controlled until required inspections, tests
    or other verification activities have been
    completed, or necessary approvals are received
    and documented
  • 820.80(c)

39
Final Acceptance Activities
  • Establish and maintain procedures for finished
    device acceptance to ensure that each production
    run, lot or batch meets acceptance criteria
  • Hold finished devices in quarantine or control
    them until released
  • 820.80(d)

40
Final Acceptance Activities Release for
Distribution
  • Conduct the following activities before releasing
    finished devices for distribution
  • Complete all activities required in the DMR
  • Review associated data and documentation
  • Designated individual authorizes release by
    signature and date
  • 820.80(d)

41
Acceptance Status
  • Identify by suitable means the acceptance status
    of product to indicate conformance or
    nonconformance with acceptance criteria
  • Maintain identification of acceptance status
    throughout manufacturing, packaging, labeling,
    installation, and servicing to ensure that only
    product that has passed required acceptance
    activities is distributed, used or installed
  • 820.86

42
Material Control Subsystem
  • Additional requirements
  • Traceability 820.65
  • Handling 820.140
  • Storage 820.150
  • Distribution 820.160

43
Introduction Documents, Record and Change Control
  • Purpose of the Subsystem
  • Document controls
  • Records/General requirements
  • Device master record
  • Device history record
  • Quality system record

44
Documents, Records and Change Control Subsystem
  • Purpose - to assure
  • Specifications and procedures are adequate
  • Only current documents are used
  • Changes are reviewed, approved and incorporated
    into documents
  • Documents are maintained for the required length
    of time

45
Document Controls
  • Establish and maintain procedures to control all
    documents required by Part 820
  • Procedures shall provide for
  • Document approval and distribution
  • Document changes
  • 21 CFR 820.40

46
Document Control - Distribution
  • Documents required by Part 820 shall be available
    at all locations for which they are designated,
    used, or otherwise necessary. Remove all
    obsolete documents promptly or otherwise prevent
    their unintended use
  • 21 CFR 820.40(a)

47
Records some general requirements
  • Maintain all records required by Part 820 at
    manufacturing site or location that is reasonably
    accessible to manufacturer and FDA
  • Make required records readily available for
    review and copying
  • Records shall be legible and stored to prevent
    loss
  • Retain all records required by Part 820 for the
    expected life of the device or at least 2 years
    from the date of release for commercial
    distribution -- if the device is short-lived
  • 21 CFR 820.180

48
Definition Device Master Record
  • Device master record (DMR) means a compilation of
    records containing the procedures and
    specifications for a finished device.
  • 21 CFR 820.3(j)

49
Device Master Record
  • Include in the DMR
  • Device specifications
  • Production process specifications
  • Quality assurance procedures and specifications
  • Packaging and labeling specifications
  • Installation, maintenance and servicing
    procedures and methods
  • 21 CFR 820.181

50
Definition Device History Record
  • Device history record (DHR) means a compilation
    of records containing the production history of a
    finished device.
  • 21 CFR 820.3(i)

51
Device History Record
  • DHR shall include
  • Dates of manufacture
  • Quantity manufactured
  • Quantity released for distribution
  • Acceptance records which demonstrate the device
    is manufactured in accordance with DMR
  • 21 CFR 820.184

52
Quality System Record
  • Maintain Quality System Record (QSR)
  • Prepare and approve per 21 CFR 820.40
  • Include or refer to location of
  • Procedures and documentation of activities
    required by Part 820 that are not specific to a
    particular type of device
  • Records required by 21 CFR 820.20
  • 21 CFR 820.186

53
Introduction Facility Equipment Control
Subsystem
  • Purpose of Subsystem
  • Design facilities that work
  • Qualify equipment installation
  • Maintain equipment
  • Calibrate equipment
  • Control environment
  • Implement contamination controls

54
Facility Equipment Control Subsystem
  • Purpose
  • To assure that devices are not adversely
    affected by the manufacturing environment,
    buildings or equipment

55
Buildings
  • Buildings should be of suitable design and
    contain sufficient space to perform necessary
    operations, prevent mixups, and assure orderly
    handling
  • 21 CFR 820.70(f)

56
Equipment Installation
  • Ensure that all equipment used in the
    manufacturing process meets specified
    requirements and is appropriately designed,
    constructed, placed and installed to facilitate
    maintenance, adjustment, cleaning and use.
  • 21 CFR 820.70(g)

57
Equipment Requirements
  • Establish and maintain equipment maintenance
    schedules and procedures.
  • Conduct and document periodic inspections in
    accordance with procedures
  • Post any limitations or allowable tolerances
    visibly close to equipment or make it readily
    available to persons performing periodic
    adjustment
  • 21 CFR 820.70(g)(1),(2) and (3)

58
Environmental Control
  • Where environmental conditions could reasonably
    be expected to have an adverse effect on product
    quality, establish and maintain procedures to
    adequately control environmental conditions
  • Periodically inspect environmental control
    system(s) to verify that the system, including
    necessary equipment, is adequate and functioning
    properly
  • Document and review environmental control
    activities
  • 21 CFR 820.70(c)

59
Contamination Control
  • Establish and maintain procedures to prevent
    contamination of equipment or product by
    substances that could reasonably be expected to
    have an adverse effect on product quality
  • 21 CFR 820.70(e)

60
Introduction Production and Process Control
  • Purpose of subsystem
  • Manufacturing SOPs, control and monitoring
  • Production and Process Changes
  • Personnel practices

61
Production and Process Control
  • Purpose
  • to manufacture products that meet
    specifications

62
General Process Controls
  • Develop, conduct, control and monitor production
    processes to ensure that a device conforms to its
    specifications
  • Where deviations from device specifications could
    occur as a result of the manufacturing process,
    establish and maintain process controls necessary
    to ensure conformance to specifications.
  • 21 CFR 820.70(a)

63
Production and Process Changes
  • Establish and maintain procedures for changes to
    a specification, method, process or procedure.
  • Verify or where appropriate validate changes
    according to 21 CFR 820.75 before implementation
  • Approve changes in accordance with 21 CFR 820.40

64
Personnel Practices - Production
  • Establish and maintain requirements for the
    health, cleanliness, personnel practices, and
    clothing of personnel if contact between such
    personnel and product or environment could
    reasonably be expected to have an adverse effect
    on product quality
  • 21 CFR 820.70(d)

65
Introduction CAPA
  • Purpose of Subsystem
  • Terms, correction, corrective action and
    preventive action
  • Requirements
  • Preamble discussions

66
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 more

67
Purpose of the Corrective and Preventive Action
Subsystem
  • To communicate corrective and preventive actions
    to the appropriate people
  • To provide CAPA information for management review
  • To document CAPA activities

68
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 90002005(E)

69
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 90002005(E)

70
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 90002005(E)

71
CAPA Procedures
  • Establish and maintain procedures for
    implementing corrective and preventive action
  • Employ appropriate statistical methodology where
    necessary to detect recurring quality problems
  • Investigate the cause of nonconformities relating
    to product, processes, and the quality system
  • 21 CFR 820.100 more

72
CAPA Procedures
  • Identify the action(s) needed to correct and
    prevent recurrence of nonconforming product and
    other quality problems
  • Verify or validate the corrective and preventive
    action to ensure that such action is effective
    and does not adversely affect the finished device
  • Implement and record changes in methods and
    procedures needed to correct and prevent
    identified quality problems
  • 21 CFR 820.100 more

73
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
  • Submit relevant information on identified quality
    problems, as well as corrective and preventive
    actions, for management review
  • 21 CFR 820.100

74
The Preamble on Degree of Corrective and
Preventive Action
  • FDA agrees that 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. . . FDA
    does expect the manufacturer to develop
    procedures for assessing the risk, the actions
    that need to be taken for different levels of
    risk, and how to correct or prevent the problem
    from recurring, depending on that risk
    assessment.
  • Preamble, Comment 159

75
The Preamble on User Error
  • User error is still considered to be a
    nonconformity because human factors and other
    similar tools should have been considered during
    the design phase of the device. FDA acknowledges
    that a manufacturer cannot possibly foresee every
    single potential misuse during the design of a
    device, but when the manufacturer becomes aware
    of misuse, the corrective and preventive action
    requirements should be implemented to determine
    if redesign of the device or labeling changes may
    be necessary.
  • Preamble, Comment 159

76
Inspecting CAPA Activities
  • Some manufacturers try to restrict FDAs access
    to information on quality problems and
    nonconforming product by hiding CAPA activities
    in internal audits or management reviews.
    Although current procedures do not have FDA
    investigators reviewing the content of internal
    audits and management reviews specific
    information as it relates to CAPA can be viewed.

77
7 Subsystems of the Quality System
Corrective Preventive Action Control
Design Control
Production Process Control
Management Control
Facility Equipment Control
MaterialControl
Documents, Records Change Control
78
Additional Quality System requirements not
discussed
  • Non-conforming product
  • Labeling and Packaging Control
  • Process validation
  • Training
  • Quality audits (Internal audits)
  • Complaint Files
  • Servicing

79
Summary
  • Overview of 7 subsystems of Part 820 Quality
    System Regulation.
  • Why comply with quality management system
    standard?
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