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Quality Management System Procedure: QSP 4-3-1 - Document Control

1. This document control procedure ensures that authorized, up-to-date versions of quality documents such as the quality manual, test methods, and standard operating procedures are available and prevents obsolete documents from being used. 2. It describes maintaining a master list of controlled documents, identifying revisions, reviewing and approving changes, and archiving obsolete documents. 3. Controlled copies are identified by a colored stamp and electronic documents are password protected and stored in current and obsolete folders.

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528 views5 pages

Quality Management System Procedure: QSP 4-3-1 - Document Control

1. This document control procedure ensures that authorized, up-to-date versions of quality documents such as the quality manual, test methods, and standard operating procedures are available and prevents obsolete documents from being used. 2. It describes maintaining a master list of controlled documents, identifying revisions, reviewing and approving changes, and archiving obsolete documents. 3. Controlled copies are identified by a colored stamp and electronic documents are password protected and stored in current and obsolete folders.

Uploaded by

jeric bañadera
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Quality Management System Procedure Issue Date: Rev.

[Laboratory Name] YYYY/MM/DD 0


Page #:
QSP 4-3-1 - Document Control
1 of 5

Prepared by: Date:

Reviewed by: Date:

Approved by: Date:

The colored ink stamp indicates this is a controlled document. Absence of color indicates this copy
is not controlled and will not receive revision updates.

Purpose
To control all quality management system documents (internally generated and from external
sources).

To identify changes made to documents.

To control amendments to documents by hand [if applicable].

To control documents maintained in computerized systems.

Document control ensures that:


 authorized editions of appropriate documents are available at all locations where operations
essential to the effective functioning of the laboratory are performed
 documents are periodically reviewed and where necessary revised to ensure continuing
suitability and compliance with applicable requirements
 invalid or obsolete documents are promptly removed from all points of issue or use to assure
against unintended use
 obsolete documents retained for either legal or knowledge preservation purposes are suitably
marked

Scope / Field of Application


This procedure applies to the Quality Manual, test methods, and standard operating procedures. Also
applies to externally generated quality management system documents.
Note – While there are standard formats for writing test methods and SOPs, documents may take on
different formats. These formats may consist of signs, flowcharts, pictures, drawings, sketches,
forms, and bulletized lists. Regardless of the format, all quality management system documents
must be controlled through this procedure.

Effective Date: YYYY/MM/DD


Quality Management System Procedure Issue Date: Rev.:

[Laboratory Name] YYYY/MM/DD 0


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Definitions and Acronyms
Quality manual – document stating the quality policy, quality management system, and quality
practices of an organization.
Standard operating procedure (SOP) – a document that specifies or describes how an activity is
to be performed. It may include methods to be used and sequence of operations.

Responsibilities
Laboratory management ensures that this document control procedure is established, implemented
and maintained. The Quality Manager oversees the day-to-day operations of document control.
Laboratory personnel are responsible for following this procedure in its entirety.

Materials Required
Controlled copy colored ink stamp
Master list

Procedure
The Quality Manager maintains a master list of all controlled documents.

Quality Manual:
1. The Quality Manual is approved by the President and the signature of this approval is kept on
file by the Quality Manager.

2. Controlled hard copies are indicated by the “Controlled Copy” colored ink stamp at the bottom
of each page.

Procedures:
1. Test methods and standard operating procedures are controlled documents with limited
distribution. They are kept in three-ring binders. The Table of Contents includes all current and
dormant procedures assigned to a given work area and the following information:
 the code and title of each procedure
 the revision number of each procedure
 the effective date of each procedure
 review date – the date each procedure was last reviewed
 the status of each procedure (current or dormant)

2. Unique codes are assigned for each procedure.

3. Test methods are written with the following headings:


 Scope
 Description of Test Items
 Holding Times

Effective Date: YYYY/MM/DD


Quality Management System Procedure Issue Date: Rev.:

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 Quantities to be Tested
 Materials and Equipment Required
 Physical Environmental Conditions Required
 Procedure
 Sample Identification
 Documentation
 Safety Measures
 Method for Data Analysis and Presentation
 Sensitivity
 Quality Control Plan
 Reference Procedures
 References
 Revision History
 Appendix

4. SOPs are written with the following headings:


 Purpose
 Scope / Field of Application
 Definitions and Acronyms
 Responsibility
 Materials Required
 Procedure
 Documentation
 Reference Procedures
 References
 Revision History
 Appendix

5. Procedures are peer-reviewed, authorized by management, copies uniquely identified, and


distributed to users. Signatures indicate the approval of the procedure and the “Controlled Copy”
colored ink stamp indicates document control is in effect for the procedure.

Note – The issue date (see header) is the date the document was issued to the user for review. The
effective date (see footer) is the date the document is effectively in place and followed.

6. Obsolete master copies are clearly marked obsolete and archived for at least seven years. All
other draft copies and obsolete versions are destroyed to prevent inadvertent use.

7. The Quality Manager maintains the master copies of the most current procedures.

8. The master list of procedures includes:


 code
 title
 revision number
 review date

Effective Date: YYYY/MM/DD


Quality Management System Procedure Issue Date: Rev.:

[Laboratory Name] YYYY/MM/DD 0


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 status (current, obsolete, dormant, or assigned)
 distribution list (copy number)

Document Review:
1. Quality manual is reviewed annually by the Quality Manager. Records are kept of this review.

2. Written procedures are reviewed on a biennial basis. The reviewer makes a record of this
review, any required changes, and forwards to the Quality Manager.

Document Changes:
1. Changes to the Quality Manual or a procedure require the same review and approval that
performed the original review and approval.

2. Changes are indicated by a vertical line in the left-hand margin adjacent to the revised area. The
master index is updated to reflect the changes in revision status and revision release date.

3. Personnel affected by the issue of a revised procedure are informed in writing. Holders of
obsolete copies return them to the Quality Manager and place the replacement into the manual.

4. An index of obsolete quality manual sections and procedures is maintained.

Amendments by Hand:
1. Where permitted, hand written amendments are clearly marked, initialed, and dated on all copies.

Computerized Documents:
1. Electronic copies of documents are maintained under the authority of the Quality Manager.

2. Access to electronic copies is password protected.

3. Documents that are revised are maintained in a folder identified as current; the obsolete version
is moved to a folder identified as obsolete.

Documentation
Revisions to Quality Manual sections and procedures are accompanied by a transmittal notice,
which details the appropriate additions, removals, and replacements.

Required Record Custodian


Approved master copies of Quality Manual Quality Manager
and procedures
Controlled hard copies of Quality Manual As assigned
and procedures
Master list Quality Manager

Effective Date: YYYY/MM/DD


Quality Management System Procedure Issue Date: Rev.:

[Laboratory Name] YYYY/MM/DD 0


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Required Record Custodian
Document reviews Quality Manager
Transmittal Notices Quality Manager

Reference Procedures
Templates for writing SOPs and test methods.

References
Garfield, F.M., Kleska, E., Hirsch, J. 2000. Quality Assurance Principles for Analytical
Laboratories. 3rd Edition. AOAC. Gaithersburg, MD.

Revision History
Revision 0

Effective Date: YYYY/MM/DD

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