[Company Name]

[Company Group, Division, Location]

Document Title: Quality Records
Document Number:
Document Filename:

[Document Number]
[Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision
Level
DRAFT
1.00

Revision
Date
DD/MM/Y
Y
DD/MM/Y
Y

DCO/ECO
Number
YY-00000

Description of Revision
Draft

Revision
Author
Author Name

YY-00000

Initial Release

Author Name

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name]
[Company Group, Division, Location]

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

Table of Contents
Table of Contents....................................................................................................................................................1
Table of Figures......................................................................................................................................................1
1.0 Purpose..............................................................................................................................................................2
2.0 Scope..................................................................................................................................................................2
3.0 Definitions ........................................................................................................................................................2
3.1 Design History File (DHF) ....................................................................................................................2
3.2 Device History Record (DHR) ...............................................................................................................2
3.3 Device Master Record (DMR)................................................................................................................2
3.4 Controlled Copy......................................................................................................................................2
3.5 Controlled Document..............................................................................................................................2
3.6 Uncontrolled Copy..................................................................................................................................2
3.7 Quality Records.......................................................................................................................................2
4.0 Responsibilities..................................................................................................................................................2
4.1 Quality Assurance...................................................................................................................................2
4.2 Document Control..................................................................................................................................2
4.3 Departmental Manager...........................................................................................................................3
4.4 [Company Name] Employees.................................................................................................................3
5.0 References and Applicable documents..............................................................................................................3
6.0 Procedure...........................................................................................................................................................3
6.1 Quality Record Requirements.................................................................................................................3
6.2 Approval/Control/Retention...................................................................................................................3
6.3 Document Users......................................................................................................................................4
6.4 [Company Name] Device Master Record Requirements.......................................................................4
6.5 [Company Name] Device History Record Requirements.......................................................................4
6.6 [Company Name] Design History File Record Requirements...............................................................4
Table of Figures
Table 1.Document Matrix Legend..........................................................................................................................5
Table 2.Document Matrix.......................................................................................................................................5

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 1 of 6

[Company Name]
[Company Group, Division, Location]

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

1.0

Purpose
To ensure that all quality records pertinent to the quality system and products are maintained and
managed effectively, and to provide objective evidence of quality system implementation.

2.0

Scope
This procedure applies to all quality records for the operation of the quality system at all facilities of
[Company Name].

3.0

Definitions

4.0

3.1

Design History File (DHF)

A compilation of documents that describes the design history of a finished device.

3.2

Device History Record (DHR)

A compilation of documents containing the production history of a finished device.

3.3

Device Master Record (DMR)

A compilation of documents containing the procedures and specifications for a finished device.

3.4

Controlled Copy
A controlled copy is an exact copy of the original controlled document that must be maintained
for uniformity, process control, and tracking. It has limited and specific distribution, and the
front page is marked in red with "Controlled Copy". Document Control must issue any controlled
copies.

3.5

Controlled Document
A controlled document is the original document that must be maintained for uniformity, process
control, and tracking. There is one original for each document, instruction, procedure, standard,
or form. It may be maintained on paper, or as an electronic file. The master copy of any
document is the electronic file available for viewing on the network. Document Control
maintains controlled documents.

3.6

Uncontrolled Copy
Any copy of a document that is not controlled is an uncontrolled copy. An uncontrolled copy may
be used for informational purposes only. These documents may not be used for operation of the
quality system, manufacture of product, for accept / reject decisions on product or processes and
operation of quality related processes.

3.7

Quality Records
Records that demonstrate conformance to required and adequate operation of the quality system
herein referred to as documents.

Responsibilities
4.1

Quality Assurance
Decides which documents are quality records.
Quality Assurance ensures that all documents meet applicable standards.

4.2

Document Control
Maintains the "master copy" showing approvals and latest revision of documents that are
maintained by Document Control. Maintain a current list of released documents on the network.
Notify Quality Assurance of any document(s) that is added to or removed from the Quality
System that is considered a quality record.

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 2 of 6

[Company Name]
[Company Group, Division, Location]

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

4.3

Departmental Manager
Notify Quality Assurance of any document or report that would be considered a quality record.

4.4

[Company Name] Employees

Identify obsolete versions of documents;
Recommend changes to documents;
Prevent unauthorized copying or amendment of documents;
Not to obtain or use documents other than [Company Name] documents.

5.0

References and Applicable documents

Document Retention, Storage and Disposition
Engineering/Production Document Release and Change Control
Design History File

6.0

Procedure
The majority of all documents are uploaded to computer databases (BAAN and O:\Solidworks) through
electronic procedures for storage, filing, and archiving. The use of computerized storage ensures
legibility, retrievability and a suitable environment that minimizes damage and deterioration. Where
paper documents are utilized, the issuing department is responsible for the establishment and
maintenance of suitable procedures. Quality records shall be made available for evaluation for an agreed
period to a customer when agreed contractually.
6.1

Quality Record Requirements

All documents must be legible.
All paper documents that require information to be filled out must be completed in blue or black
ink. NO PENCIL is permitted. NO RED or colored ink other than mentioned above may be used.
If a mistake is made on a paper document, the mistake shall be crossed out with a single line,
dated and initialed.

6.2

Approval/Control/Retention
A list of quality records is identified in the document matrix. Documents not appearing or
referred to on this list are not quality records and are not governed by this procedure.
Incorporation of external quality related standards into the quality system requires written
approval by the Quality Assurance Manager.
The document matrix indicates the Controller of the document/data. This person/department
manager is responsible for approval and updating documents and records.
Document control will notify affected departments of document and records changes.
Retention period requirements of documents are based on business and regulatory requirements.

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 3 of 6

[Company Name]
[Company Group, Division, Location]

6.3

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

Document Users
Documents must not be changed without the controllers consent.
Users cannot deface, amend, destroy, add or delete information to documents.
Document users are required to destroy or return obsolete versions of paper documents once
revised.

6.4

[Company Name] Device Master Record Requirements

[Company Name] will maintain a device master record for each device manufactured with the
following contents: (Refer to document matrix)

6.5

[Company Name] Device History Record Requirements

[Company Name] will maintain a device history record for each device manufactured with the
following contents: (Refer to document matrix)

6.6

[Company Name] Design History File Record Requirements

[Company Name] will maintain a design history file record for each device manufactured with
the following contents: (Refer to Design History File)

[Document Filename]

COMPANY PROPRIETARY AND CONFIDENTIAL

Page 4 of 6

[Company Name]
[Company Group, Division, Location]

Table 1.

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

Document Matrix Legend

Abbreviation
ADMN
DC
DPML
ENG
HR
MANF
ME
MTN
PM
PURC
QA
QA MGR
QS

Table 2.

Meaning
Administration
Document Control
Departmental
Engineering
Human Resources
Manufacturing
Manufacturing
Engineering
Maintenance
Program Management
Purchasing
Quality Assurance
Quality Assurance
Manager
Quality Systems

Document Matrix

Document
Name
Approved Supplier List
Archival Records:
Admin/Document Control
Artwork

Part of

Part of

DMR

DHR

Maintained
By
PURC
ADMN/DC

Controlled
By
QA
ADMN/DC

DC

ME or ENG

Audit Checklist
Audit Summary Reports
Calibration Procedures

QA
QA
QA

QA
QA
QA

Calibration Record

QA

QA

MANF
QA

ME
QA

QA
DC

QA
ENG

Contracts/ Modifications
Controlled Environment Monitor
Log
Corrective Action Notice
Customer Complaint Form

ADMN
MANF

ADMN
ME

QA
QA

QA
QA

Daily Receiving Log

Daily Shipping Log
Document Approval Record
Drawings

PURC
PURC
DC
DC

PURC
PURC
DC
ME or ENG

Engineering Change Order

DC

ME, ENG, PM
or QA
QA
ME

Cleanroom Cleaning Checklist

Complaint Analysis Form
Complaint Log
Component Specifications

External Audit Records

Hepa Air Velocity Measurement

[Document Filename]

QA MGR
MANF

COMPANY PROPRIETARY AND CONFIDENTIAL

Retention Period
(Minimum)
3 years
Permanently
Product Life + 2
years
Continuing
2 years
Product Life + 2
years
Product Life + 2
years
5 years
Product Life + 2
years
Permanently
Product Life + 2
years
Permanently
5 years
2 years
Product Life + 2
years
5 years
5 years
5 years
Product Life + 2
years
Product Life + 2
years
5 years
5 years

Page 5 of 6

[Company Name]
[Company Group, Division, Location]

Document
Name

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

Part of

Part of

DMR

DHR

Maintained
By

Controlled
By

Log
Incoming Inspection Report

QA

QA

Inprocess Inspection Log

QA

QA

Inspection Procedures

DC

QA

QA
QA MGR
DC

QA
QA
ENG

QSM
DC

QSM
ME

DC

ME

QA

QA

QA
DC

QA
DC

Material Review Report

QA

QA

MDR Event Report Log

MDR Reports

QA
QA

QA
QA

Medical Device Report Analysis

Form
Medical Device Report Event
Form
Mold, Fixture, Jig Certification
Record
Non-Product Specific Work
Instructions
Order Entry Form
Organizational Charts

QA

QA

QA

QA

QA

ME

DPML

DPML

Continuing
Product Life + 2
years
Product Life + 2
years
5 years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
Lifetime of Tool +
2 years
Per Department

ADMN
HR

ADMN
HR

5 years
Continuing

Parts List/BOM

DC

ENG or ME

Preventive Maintenance
Workorder
Process Specification

ME

ME

DC

ENG

Process Validation Records

QA

QA

Product Release Verification

QA

QA

Product Description

DC

PM

Product Manuals/Labeling

DC

ENG

Product Requirements
Document(Functional Specs)

DC

PM

Internal Audit Records

Internal Auditor List (ISO)
Lab Notebooks
Management Review Reports
Manufacturing Procedures
Manufacturing Process
Procedure/Specifications
Marketed Product Correction and
Removal Form
Master Calibration List
Material Disposition Sheet

[Document Filename]

*
*

COMPANY PROPRIETARY AND CONFIDENTIAL

Retention Period
(Minimum)
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
5 years
Continuing
Product Life + 2
years
2 years
Product Life + 2
years
Product Life + 2
years
5 years

Product Life + 2
years
2 years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years

Page 6 of 6

[Company Name]
[Company Group, Division, Location]

Quality Records
[Document Number]
Rev x.xx
DD/MM/YY

Part of

Part of

Maintained
By
QA

Controlled
By
ME

DMR
*

DHR
*

Product Tree

DC

ENG

Project Management Plans

DC

PM

PURC
PURC
DC
QA
ADMN
QA

PURC
PURC
QA MGR
QA
ADMN
QA

QA
DC

QA
ENG or ME

QA MGR
ENG
DC

QA
ENG
ME or ENG

DC

ME or ENG

Stock Purge Request

PURC

PURC

Supplier Evaluation
Technical Report

QA MGR
PM

QA
PM

Temporary Calibration
Extensions

QA

QA

Test Procedure

DC

ME

Test Specification

DC

ME or ENG

ADMN
ADMN
PURC
QA

ADMN
ADMN
QA
QA

QA
ME

QA
QA

Document
Name
Product Travelers

Purchase Orders
Purchase Requisition
Quality Manual
Quality Trend Reports
Quotation Form
Returned Material Authorization
Request
Returned Product Form
Schematic
Scrap Report
Software Problem Report
Software Release
Source Code

Training Exemption
Training Record
Vendor Authorization Request
Vendor History Form
Vendor Notification Report
Workmanship Standard

[Document Filename]

*
*

COMPANY PROPRIETARY AND CONFIDENTIAL

Retention Period
(Minimum)
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
7years,
7 years
Continuing
2 years
5 years
5 years
5 years
Product Life + 2
years
2 years
5 years
Product Life + 2
years
Product Life + 2
years
Product Life + 2
years
2 years
Product Life + 2
years
Lifetime of
Equipment + 1
year
Product Life + 2
years
Product Life + 2
years
Permanently
Permanently
3 years
Product Life + 2
years
5 years
Product Life + 2
years

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