Documents, Change Control and

Records
Joseph Tartal
Deputy Director
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
2
 Learning Objectives
1. Identify key definitions related to documents and records

2. Describe key categories and how they inter-relate

3. Describe requirements and intent for Document Controls,

General Records, Device Master Records, Device History
Records, and Quality System Records

3
Definitions

4
 Definitions (21 CFR 820.3)
• Establish
define, document (in writing or electronically), and implement
[21 CFR 820.3(k)]

• Design history file (DHF)

compilation of records which describes design history of a finished device
[21 CFR 820.3(e)]

CFR = Code of Federal Regulations

5
 Definitions (21 CFR 820.3)
• Device master record (DMR)
compilation of records containing procedures and specifications for a
finished device
[21 CFR 820.3(j)]

• Device history record (DHR)

compilation of records containing production history of a finished device
[21 CFR 820.3(i)]

6
 Overview of
Documents and Records

7
 Document and Record: Overview
General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
8
 General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
9
 Document Controls
• Establish and maintain procedures to control all
documents required by 21 CFR Part 820
• Procedures shall provide for:
1. Document Approval
2. Document Distribution
3. Document Changes

10
 1. Document Approval
• Designate individual(s) to:
– review documents for adequacy
– approve documents prior to issuance

• Document approval must include:

– date and signature of approving individual(s)

11
 2. Document Distribution
• Required documents shall be available
– at all locations where designated, used, or otherwise
necessary
• Obsolete documents:
– remove promptly or
– prevent unintended use

12
 3. Document Changes
• Changes to documents
– require review/approval
– by individual(s) from same function or organization that
performed original approval
– unless specifically noted otherwise

• Changes must be communicated

– to appropriate personnel in a timely manner

13
 Preamble: Review of Changes
Intent

• Ensure that original document approver has

opportunity to review any changes

• Document approvers typically have best insight on

impact of changes

14
 Preamble: Review of Changes
Flexibility

• Permits manufacturer to designate others (not

original document approver) to review and
approve changes

15
 Preamble: Communicating Changes
to Personnel
“FDA has had many experiences where manufacturers
made corrections to documents, but the changes were
not communicated in a timely manner to the
personnel utilizing the documents. The result of these
untimely communications was the production of
defective devices.”
Preamble, Comment 96
16
 3. Document Changes
Include in change records:
1. Description of change
2. Identification of affected documents
3. Signature of approving individual(s)
4. Approval date
5. Date change becomes effective
17
 General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
18
 Records – General Requirements
• Maintain all records required by Part 820:
– at manufacturing site or
– at location reasonably accessible to manufacturer
and FDA

• Make required records readily available for

review and copy
19
 Preamble: “readily available” records

“FDA expects that such records will be made available

during the course of an inspection. If the foreign
manufacturer maintains records at remote locations, such
records would be expected to be produced by the next
working day or two, at the latest...”

Preamble, Comment 180

20
 Records – General Requirements
• Shall be legible
• Stored in a way that minimizes deterioration
and prevents loss
• Records stored in an automated data processing
system shall be backed up
21
 Records - Confidentiality
• During an inspection manufacturers may mark
records as “confidential”

– to assist FDA in determining whether information

may be disclosed under Freedom of Information Act

22
 Records: Exceptions
Manufacturers are not required to make these
record types available for review and copy by FDA:
• management review reports and results
• quality audit reports
• evaluations of suppliers, contractors and consultants

23
 Records: Exceptions
• However, during FDA inspections manufacturers
must make procedures available for review for:
• management reviews
• quality audits
• evaluating suppliers, contractors and consultants

24
 Record Retention Period

Retain all records required by Part 820 for:

• expected life of device, or
• at least 2 years from date of release for commercial
distribution

25
 General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
26
 Device Master Record

• Maintain a Device Master Record (DMR)

• Prepare and approve DMR in accordance with

21 CFR 820.40, “Document Controls”

27
 DMR: What’s Included
1. Device specifications
2. Production and process specifications
3. Quality assurance procedures and specifications
4. Packaging and labeling specifications
5. Installation, maintenance and servicing procedures

28
 1. Device Specifications
• Bill of Materials • Material Composition
• Drawings and • Formulations
schematics
• Assemblies
• List of Ingredients
• Software specifications
• Component
Specifications

29
2. Production and Process Specifications

• Production environment • Process flow charts

specifications • Set-up procedures
• Cleaning procedures • Production methods
• Equipment • Production procedures
specifications
• Calibration procedures
30
 3. Quality Assurance

• Acceptance criteria • Inspection/test forms

• Testing and • Instrument charts
measurement equipment • Reporting forms
• Inspection/test • Process control
procedures charts

31
 4. Packaging and Labeling

• Packaging and labeling • Packaging/labeling review

specifications and control
• Package/Label drawings • Packing procedures
• Instructions for Use • Shipping procedures
• Service manuals • Customer feedback forms

32
 5. Installation, Maintenance, and
Servicing
• Installation procedures
• Service procedures
• Tools, testers and instruments
– for installation and servicing
• Forms for installation and servicing
– including regulatory forms as necessary
33
 General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
34
 Device History Record
• Maintain device history record (DHR)
– to demonstrate that device is manufactured in
accordance with the Device Master Record and
Part 820

• Establish and maintain procedures for DHR

35
 Device History Record
Shall include:
1. Dates of manufacture
2. Quantity manufactured
3. Quantity released for distribution
4. Acceptance records that demonstrate device is
manufactured in accordance with Device Master Record
36
 Device Labeling and the DHR
Document in the DHR:
• Release of labels and date/signature of person
examining the labeling
• Label/labeling used for each production unit, lot
or batch
37
 Preamble: Automated Readers for
Labeling Inspections
“several recalls on labeling have been attributed to
automated readers not catching errors. The requirement does
not preclude manufacturers from using automated readers
where that process is followed by human oversight. A
“designated individual” must examine, at a minimum, a
representative sampling of all labels that have been checked
by the automated readers.”
Preamble, Comments 169
38
 General Requirements 820.180

Device Master Record

Design History File 820.30(j)
820.181

Device History Record

820.184

Document Quality System Record

Controls 820.40 820.186
39
 Quality System Record
• Maintain Quality System Records (QSR)
• Prepare and approve per 21 CFR 820.40
• Include/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 Subpart B

40
 Quality System Record: Examples
• Training Procedures and Qualification Records
• Internal Audit Procedures and Records
• Management Review Procedures and Records

41
 Your Call to Action
1. Meet your document and record requirements.
2. Take time to learn about documents, document
controls and how to write good documents.
3. Write useful and effective documents that provide
direction and evidence of compliance and quality.

42
 QS Regulation and Guidance
• Quality System Regulation and Preamble
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulati
ons/ucm230127.htm

• Inspection Guide – Pages 8, 15, 21, 22 and 23

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

• Guide to Inspections of Quality Systems [Quality System

Inspection Technique (QSIT)]
www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm

43
 Industry Education:
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: 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 44
45