[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/YY
DD/MM/YY
DCO/ECO
Number
YY-00000
YY-00000
Description of Revision
Draft
Initial Release
COMPANY PROPRIETARY AND CONFIDENTIAL
Revision
Author
Author Name
Author Name
[Company Name]
[Company Group, Division, Location]
Quality Records
[Document Number]
Rev x.xx DD/MM/YY
Table of Contents
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 7
[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.
[Document Filename]
COMPANY PROPRIETARY AND CONFIDENTIAL
Page 2 of 7
[Company Name]
[Company Group, Division, Location]
Quality Records
[Document Number]
Rev x.xx DD/MM/YY
Notify Quality Assurance of any document(s) that is added to or removed from the Quality System
that is considered a quality record.
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 7
[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 7
[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
Maintained
By
PURC
ADMN/DC
Controlled
By
QA
ADMN/DC
Part of
DMR
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
Part of
DHR
*
*
*
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 7
[Company Name]
[Company Group, Division, Location]
Document
Name
Quality Records
[Document Number]
Rev x.xx DD/MM/YY
Maintained
By
Controlled
By
Log
Incoming Inspection Report
QA
Inprocess Inspection Log
Inspection Procedures
Part of
DHR
Retention Period
(Minimum)
QA
*
QA
QA
*
DC
QA
QA
QA MGR
DC
QA
QA
ENG
QSM
DC
QSM
ME
*
DC
ME
*
QA
QA
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
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
*
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]
Part of
DMR
*
*
*
*
COMPANY PROPRIETARY AND CONFIDENTIAL
*
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
Page 6 of 7
[Company Name]
[Company Group, Division, Location]
Document
Name
Quality Records
[Document Number]
Rev x.xx DD/MM/YY
Maintained
By
Controlled
By
Part of
DMR
Product Requirements
Document(Functional Specs)
Product Travelers
DC
PM
*
QA
ME
*
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
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]
Part of
DHR
*
*
*
COMPANY PROPRIETARY AND CONFIDENTIAL
Retention Period
(Minimum)
years
Product Life + 2
years
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
Page 7 of 7