LSASDPROC-1000-R1
Document Control
Effective Date: January 15, 2020
Region 4
U.S. Environmental Protection Agency
Laboratory Services and Applied Science Division
Athens, Georgia
Operating Procedure
Title: Document Control ID: LSASDDPROC-1000-R1
Issuing Authority: LSASD Deputy Division Director
Effective Date: January 15, 2020 Review Due Date: January 15, 2024
Purpose
This Operating Procedure is specific to the Region 4 Laboratory Services and Applied
Science Division (LSASD) to maintain conformance to technical and quality system
requirements. This procedure defines the process for identifying, storing, maintaining and
controlling documents that form the LSASD Quality Management System (QMS).
Scope/Application
The requirements of this procedure apply to all personnel who perform work under the
LSASD QMS. This procedure does not apply to Records Management. Refer to the
LSASD Operating Procedure for Control of Records (LSASDPROC-1001) for records
requirements. While this Standard Operating Procedure (SOP) may be informative, it is
not intended for and may not be directly applicable to operations in other organizations.
Mention of trade names or commercial products in this operating procedure does not
constitute endorsement or recommendation for use.
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TABLE OF CONTENTS
1 Procedure .................................................................................................................... 3
1.1 Internal Documents .............................................................................................. 3
1.1.1 Development ................................................................................................. 3
1.1.2 Format ........................................................................................................... 4
1.1.3 Review .......................................................................................................... 4
1.1.4 Handwritten Changes .................................................................................... 6
1.1.5 Control .......................................................................................................... 7
1.1.6 Authorization and Approval ......................................................................... 8
1.1.7 Distribution ................................................................................................... 9
1.2 External Documents ............................................................................................. 9
2 Definitions ................................................................................................................ 10
3 References ................................................................................................................. 10
4 Revision History ....................................................................................................... 11
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1 Procedure
1.1 Internal Documents
1.1.1 Development
Internally issued documents include, but are not limited to, management plans,
policies, manuals, operating procedures, forms and guidance. Once the need for a
new document has been identified, the Quality Assurance Coordinator, in
consultation with the appropriate Section/Branch Chief assigns an author and
designates a reviewer. A subject matter expert or primary analyst is usually
assigned as either the author or reviewer of the document. Once these
assignments have been made, the QAC, in consultation with the Section Chief,
will notify the Document author and reviewer of the assignment. The QAC will
provide the author with the appropriate document template, including the
document’s assigned Document Control Number, and the LSASD Document
Review Form (LSASDFORM-1006). It is the Section Chief’s responsibility to
monitor the document development.
The following steps are used to develop, review, authorize, control and distribute
internal documents related to the LSASD Quality Management System:
• Author will prepare the first draft and submit it to the reviewer(s). The
“Track Changes” feature in Microsoft Word will be utilized so the
reviewer(s) can verify the changes being made are correct and applicable
to the procedure. The author will document the review on the appropriate
LSASD Document Review Form (LSASDFORM-1006).
• Reviewers will provide comments to author
• Author will address comments
• Author will provide revised draft to reviewers, if applicable
• Steps are repeated until all comments are addressed
• Once the development and appropriate reviews are complete the author
will submit the document to the QAC for an administrative review. The
QAC will ensure that all documentation is filled out and updated (i.e.,
revision history, table of contents, Document Review Form, etc.) and that
the document is in the proper format.
• Once the administrative review is complete the QAC will assign the
effective date
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• The document and the LSASD Document Review Form (LSASDFORM-
1006) will then be electronically routed to the author, and appropriate
management for final approval and authorization
• The signed document will be scanned and posted to the Local Area
network (LAN) by the QAC. The previous version of the document will
be watermarked with an archive date and moved to the appropriate archive
folder on the LAN. An email notification will be sent to all appropriate
staff and management notifying them of the new revision.
1.1.2 Format
Depending on the application, flexible formatting is permitted for plans, manuals,
procedures and forms, unless otherwise indicated. All internally issued
documents, regardless of format, must contain the following required elements:
• Document number
• Effective date
• Revision number
• Page numbering indicating total number of pages
• Issuing Authority
• Revision history (if practicable)
For consistency of LSASD Operating Procedures a template will be provided by
the QAC. As current LSASD Operating Procedures come up for review, they will
be converted to the new document format. At the time of this issuance, no
additional effort will be made to update the LSASD document format outside of
the scheduled review process.
1.1.3 Review
Internal documents are subject to periodic review, and where necessary, revised to
ensure continuing suitability and conformance with applicable requirements.
Internal documents will be reviewed every 4 years, excluding technical
procedures for drinking water methods, which will be reviewed annually.
The QAC will develop and maintain a document review schedule for internal
documents. The schedule will include the effective date of the most recent
version of the document and the next review start date. The QAC will update the
review schedule as additional reviews are conducted and as new documents are
developed. Documents may be reviewed prior to the next scheduled review date,
if changes are deemed necessary. If an unscheduled review is completed it will
follow the regular LSASD review process as described below. LSASD's
document control system does allow for the temporary amendment of quality
system documents by hand on a limited basis as detailed in Section 1.1.4 below.
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The author and reviewer will document the review process on the LSASD
Document Review Form (LSASDFORM-1006).
The following procedure will be followed for document review:
• Approximately 120 days prior to expiration of the document (4 Years
from the effective date of a document), the QAC will provide the
appropriate document author with the Microsoft Word version of the
document and the review due date. Section Chiefs and reviewers will be
included in this notification, so the review team is aware of the assignment
and associated deadlines.
Note: The120-day review period includes the final administrative review and posting of
the document to the LSASD LAN. Reviewers must be cognizant of these additional
process steps when undertaking a review.
• If it is necessary to extend the review time, the reviewer shall contact the
Section Chief and the QAC via email that an extension is needed
providing an alternative review due date, not to exceed 60 days past
original due date, unless approved by the Branch Chief.
• If a new author is necessary, the QAC in consultation with the Section
Chief will assign a new author.
• The author will review the procedure to determine if updates are needed.
• If procedural changes are not required, the author will notify the Section
Chief providing them with the appropriately filled out LSASD Document
Review Form (LSASDFORM-1006). The Section Chief will then provide
all documentation to the QAC who will revise the document information
and route the document for approval and authorization, as described
below.
• If procedural changes are needed, the author will update the procedure and
provide the first draft to the technical reviewer(s), who have been selected
by management in consultation with the QAC within 60 days of the
assigned review. The reviewers will provide comments to the author
within 30 days of receipt of the edited document. These steps are repeated
until all comments are addressed. The entirety of this process should not
exceed 120 days from the initial assignment date. The review process will
be documented on the LSASD Document Review Form (LSASDFORM-
1006)
• Procedural changes to documents will be tracked in the revision history of
the document, except for forms, which will be indicated in the Form
Revision History section of the LSASD Document Review Form
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(LSASDFORM-1006).
• Before document submission to the QAC, the document author will ensure
that the document is properly formatted, the revision history is updated,
and the table of contents is correct.
• Once the development and appropriate reviews are complete the author
will submit the document to the QAC for final format and quality system
review. The QAC or designee will ensure that all documentation is
completely filled out and updated (i.e., revision history, table of contents,
Document Review Form, etc.) and that the document is in the proper
format. This review shall not exceed 10 days from the receipt of the
document.
• Once the QAC review is complete the QAC will assign the effective date.
• The document and the LSASD Document Review Form LSASDFORM-
1006) will then be routed by the QAC to the author, and appropriate
management for final approval and authorization. The approval process
should be completed with 7 days of routing the document, Final posting of
the document to the LAN and notification to staff of the new revision will
be completed within 3 days of the final approval.
1.1.4 Handwritten Changes
In the rare occurrence that significant changes, changes that if not made would
call into question data quality, to a document need to be made immediately the
following process shall be followed:
• LSASD staff that identified the need for a significant change will make a
handwritten change to the document, initial and date the change and
immediately provide the document to the appropriate Section Chief.
• The Section Chief will review the change and determine its acceptability.
The Section Chief will then initial and date the change on the document.
• The Section Chief is required to provide a copy to every staff member
that might be affected by the change, explain the revision, and obtain an
initial and date from those staff on the back page of the document along
with the signature of the QAC.
• The QAC will hand write a temporary effective date, in the margin,
update the revision number and then upload the document to the
appropriate LAN locations.
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• At the time that the QAC assigns the temporary effective date the formal
document review process will be initiated, starting the 120-day review
timeframe, as described in Section 1.1.3.
• For documents where an immediate change is needed, the complete
review process must be finalized within 120 days of the temporary
effective date of the document. No extensions will be allowed in these
instances.
1.1.5 Control
The official copy of all LSASD quality management system documentation
resides on the Local Area Network (LAN) and are assessable to all staff. All other
electronic or printed copies are unofficial. A watermark of “Uncontrolled When
Printed” will be added to all LSASD procedures.
Additionally, copies of quality management system and technical procedure
documents associated with field activities, reside on the LSASD internet website.
These copies are available to agencies and individuals outside of Region 4 who
conduct environmental investigations and may be required to use these
procedures. By allowing other agencies or individuals access to LSASD operating
procedures, no inference is made that the work is covered under the scope of
LSASD’s accreditation.
A master list identifying the current revision status of quality system documents is
available on the LSASD LAN. The list is maintained by the QAC. When internal
documents have completed final review, they are forwarded to the QAC for a
final format check, authorization and distribution, and placement on the LSASD
LAN system. The QAC will ensure that all procedures on the LSASD LAN and
the public access location of the LSASD web site are the current version.
Document control numbers are assigned to LSASD management system
documents using the following alpha-numeric scheme:
LSASD Document type-sequential #- revision #
Example: LSASDSTND-001-R0
Document Types:
GUID = guidance PLCY = policy PLAN = plan
MANL = manual PROC = procedure FORM = form
METH = method STND = standard
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Number Ranges:
Operating Procedure Category Number Range
Applied Science Branch Quality System 001-099
Field Measurement 100-199
General Field Sampling 200-299
Superfund Section 300-399
Laboratory Services Branch Quality System 100-199
Environmental Sampling Section 500-599
Inorganic Chemistry Section 600-699*
Applied Science Branch Laboratory 700-799
Organic Chemistry Section 800-899*
Facilities 900-999
Management System Documents 1000-1099
Quality Assurance Section 1100-1199
Environmental Management System 1200-1299
* Laboratory Technical Procedures will be assigned a document control number
as listed above; however, the reference method ID number will also be utilized
where applicable.
The original issuance of an LSASD document will be Revision 0. When a
document is reviewed (including hand written changes), no matter if changes are
made or not, the revision number of the document will increase one whole
number (e.g. Revision 0 to Revision 1).
Equipment and software manuals maintained only for general reference purposes
are not subject to document control requirements. In this context, “general
reference purposes” means that personnel are not required to follow specific
procedures or instructions contained in the equipment or software manuals.
1.1.6 Authorization and Approval
Authorization of documents generated by LSASD will be documented using the
Document Review Form (LSASDFORM-1006). Depending upon the document,
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multiple reviewing officials might be needed. These officials range from technical
experts to management representatives and will be assigned based on the
document content. LSASD Documents are subject to authorization by the
following issuing authorities:
Document Type Issuing Authority
Divisional Documents Deputy Division Director
Branch Documents Branch Chief(s)
Section Specific Documents Section Chief
Forms Section Chiefs, QAC
1.1.7 Distribution
The QAC is responsible for ensuring that all internally issued documents that
form the LSASD quality management system are readily available. The official
copy of all quality system documents resides on the LSASD LAN. The QAC will
notify all personnel via email of document updates and will maintain a copy of the
notification. It is the responsibility of the individual to ensure that all hard and/or
electronic copies of documents in their possession are the most recent version.
When documents are revised or retired, the QAC will move obsolete copies to the
restricted access folder “Archived and Retired Procedures” folder of the LSASD
LAN. The QAC will add the “ARCHIVED” or “RETIRED” watermark, as
appropriate, and the archived or retired date to each document. Via email, the
QAC will advise all affected personnel to discontinue use of the archived or
retired document.
1.2 External Documents
Documents of external origin referenced in the implementation of the LSASD
management system may include national and international standards, EPA manuals and
directives, manufacturer’s manuals, equipment software, and other associated types of
information. External documents will be reviewed for context to determine their
applicability before being added to the LAN, if appropriate. This review will be
conducted by the author of the management system document in which the external
document will be referenced.
When applicable, national and international standards, and EPA manuals and directives
will be controlled by documenting the title, document number, most recent and/or
approved revision/edition number, and year of publication. Equipment software is
controlled in accordance with the LSASD Operating Procedure for Equipment Inventory
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and Management, LSASADPROC-1009. All other documents will be assigned
document control numbers. The QAC will maintain a list of all controlled external
documents. The QAC will review the list annually and consult with personnel to
determine if updates are needed. If the QAC updates the list, the obsolete copy will be
removed from service and the updated version will be labeled with the next revision of
the document. On a case by case basis, the QAC, in consultation with affected personnel,
will determine if it is necessary to maintain a copy of the previous version.
2 Definitions
Document Control: the act of ensuring that documents are proposed, reviewed for accuracy,
approved for release by authorized personnel, distributed properly and controlled to ensure
use of the correct version.
Subject Matter Expert: For the purposes of this procedure, the subject matter experts
(SMEs) are personnel deemed competent, experienced, and knowledgeable by LSASD
management in the topic of the procedure, guidance or other subject matter for which the
document is intended.
Author: The personnel that prepares the draft version of the document.
Reviewer: The personnel, assigned by management, responsible for reviewing the
technical content of the document for accuracy.
Procedural Changes: Changes to the LSASD process described in the operating
procedure. This does not include changes administrative in nature such as revision
number or dates.
3 References
LSASD Operating Procedure for Equipment Inventory and Management, LSASDPROC-
1009, Current Version
LSASD Document Review Form, LSASDFORM-1006, Current Version
LSASD Operating Procedure for Records Management (LSASDPROC-1002), Current
Version
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4 Revision History
This table shows changes to this controlled document over time. The most recent version
is presented in the top row of the table. Previous versions of the document are
maintained by the LSASD Quality Assurance Coordinator.
History Effective Date
SESDPROC-1000-R0, Field Quality System Document October 1, 2017
Control, Original Issue
LSASDPROC-1000-R1, Document Control January 15, 2020
Revised to update Division and Branch nomenclature post-
realignment. Removed references to the Document Control
Coordinator and replaced with the Quality Assurance
Coordinator. Also replaced references to the appropriate
system manager with Quality Assurance Coordinator. Added
milestones for the review process to Section 1.1.3. Modified
language in Section 1.1.3 to allow for handwritten changes as
detailed within Section 1.1.4.
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