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U.S. EPA New England
Office of Environmental Measurement and Evaluation
Document Control
Standard Operating Procedure
The controlled version of this document is the electronic version viewed on
-
line only.
If
this is a printed copy of the document, it is an uncontrolled version and may or may not be
the version currently in use.
Prepared for: The Office of Environmental Measurement and Evaluation (OEME), U.S. EPA
New England
Carol Wood, Director (Acting), OEME
Effective Date
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Office
of
Environmental
Measurement
and
Evaluation
(OEME)
Document
Control
Standard
Operating
Procedure
1
.0
Summary
-
Document
control
ensures
documents
are
able
to
be
located;
reviewed
periodically
and
revised;
approved;
available
as
the
current
revision
at
the
locations
needed;
and
removed
when
obsolete
and
archived.
Controlled
documents
are
legible,
dated
(with
effective
date
of
revision),
readily
identifiable,
maintained
in
an
orderly
manner
and
retained
for
a
specified
period.
Document
control
helps
ensure
that
documents
are
created
and
maintained
in
a
manner
sufficient
to
implement
the
management
systems
at
OEME
including
the
Environmental
Management
System,
Elealth
&
Safety
program,
laboratory
and
field
operations,
and
Quality
System.
2
.0
Purpose
-
The
purpose
of
this
SOP
is
to
introduce
and
establish
a
unified,
electronic
system
of
document
control
for
OEME.
It
describes
procedures
and
responsibilities
for
the
creation
and
modification
of
controlled
documents.
3
.0
Scope
and
Application
-
This
procedure
applies
to
controlled
documents
across
all
OEME
units.
Typically,
controlled
documents
are
those
used
on
an
ongoing
basis,
reviewed
and
revised
regularly,
and
approved
for
release.
Controlled
documents
may
include
manuals,
plans,
policies,
guidance,
quality
assurance
project
plans,
SOPs,
forms,
and
any
other
documents
used
to
implement
the
management
systems.
The
electronic
document
control
system
is
a
Lotus
Notes
database
named
Lab
SOPs
.
Controlled
documents
are
accessible
to
all
OEME
personnel
as
portable
document
format
(
PDF
)
files.
Write
access
for
entering,
editing,
and
archiving
controlled
documents
is
limited
to
designated
Document
Control
Contacts.
A
master
list
of
controlled
documents
including
the
current
status
is
available
from
the
database.
4
.0
Procedure
4.1
Database
Structure
and
Organization
-
The
document
control
database
is
organized
according
to:
DOCUMENT
VIEW
DEPARTMENT
and
CATEGORY/SUB-DEPARTMENT
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4.1.1
DOCUMENT
VIEWS
-
Document
views
are
listed
on
the
far
left
side
of
the
Lab
SOPs
database.
Each
document
view
has
its
own
input
form
and
three
letter
abbreviation.
The
following
document
views
are
included;
n
Archived
Documents
(all
abbreviations
apply)
o
Standard
Operating
Procedures
(SOP)
o
Forms
(ERM)
o
Plans
(PEN)
&
Policies
(POL)
n
Guidance
(GUI)
-
to
be
added
n
Quality
Assurance
Project
Plans
(QAP)
-
to
be
added
n
Single
Analysis
-
laboratory
only
o
Multi
Analysis
-
laboratory
only
4.1.2
DEPARTMENT
-
The
following
departments
are
included
within
each
document
view:
Biology
Chemistry
EMS
(Environmental
Management
System)
Field
Sampling
Health
&
Safety
Investigations
Miscellaneous
QA
(Quality
Assurance)
4.1.3
CATEGORY/SUB-DEPARTMENT
-
Each
department
may
be
divided
into
Categories
or
Sub-Departments.
The
current
listing
of
categories/sub-
departments
includes:
AIR
BIOLOGY
CONTRACTOR
ESAT
FACILITY
FIELD
GC
GCMSBNA
GCMSVOA
HPLC
INORG
MICROBIOLOGY
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MISC
MISC-ORG
QC
SAMPLE
CONTROL
SUBCON
4.2
Unique
Identifier
Convention
-
Each
controlled
document
is
given
a
imique
identifier
(document
number)
in
the
form
of
an
abbreviated
title.
The
convention
for
identifying
controlled
documents
is:
(Unit
Code)(Document
Type)-(Abbreviated
Title)(Revision
#)
20
character
maximum
eg.,
EIASOP-AIRCAN7
The
original
document
is
Revision
0.
Subsequent
revisions
are
numbered
sequentially
as
integers.
A
maximum
of
twenty
characters
total
is
used
for
each
identifier.
4.3
Header
-
For
document
types
where
headers
are
appropriate,
such
as
SOPs,
the
following
minimum
information
should
be
included
in
the
header:
UNIQUE-IDENTIFIER
Title
of
Document
Revision
number
(if
desired)
Date
of
Current
Revision
Page
#
and
Total
Pages
in
Document
e.g.,
EIASOP-AIRCAN7
Air
Toxics
by
GC/MS
08/09/02
Page
1
of
26
4.4
Effective
Date
-
Each
controlled
document
must
have
the
effective
date
of
that
revision.
The
effective
date
is
the
last
management
approval
date
unless
otherwise
specified.
4.5
PDF
Files
-
To
ensure
that
one,
and
only
one,
version
is
maintained,
controlled
documents
are
entered
in
the
document
control
database
as
PDF
files.
Documents
may
be
converted
to
PDF
files
by
scanning
the
document
on
the
Canon
Imagerunner
400E
scarming
equipment
in
the
Ecosystem
Assessment
Unit
(ECA)
photocopy
area.
Scanning
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a
document
allows
inclusion
of
an
approval
signature
page
and
other
non-text
elements
in
the
controlled
electronic
version.
Alternatively,
documents
may
be
written
as
PDF
files
and
signed
electronically
{First
M.
Last
/s).
4.6
Unit-Specific
Document
Control
Procedures
-
Each
unit
is
responsible
for
determining
which
of
its
documents
are
controlled;
what
procedures
are
used
for
developing,
reviewing,
approving,
revising
and
archiving
these
documents;
and
the
frequency
of
review
for
controlled
documents.
4.7
Document
Control
Contacts
-
Each
unit
designates
a
Document
Control
Contact(s)
who
has
write
access
to
the
electronic
document
control
database.
The
Document
Control
Contact
is
responsible
for
entering,
editing
and
archiving
the
unit
s
controlled
documents.
The
current
Document
Control
Contacts
are:
UNIT
CONTACT
EAA
Scott
Pellerin
EAF
Dave
Coveney
ECA
Greg
Hellyer
EI
A
Agnes
Van
Langenhove
EQA
Denise
DePierro,
Ann
Jefferies
OARM
System
Manager
Phil
Warren
5
.0
Location
and
Control
of
Documents
-
The
current
version
of
each
controlled
document
resides
in
the
electronic
document
control
system.
Printed
copies
of
controlled
documents
may
be
maintained
at
workstations
and
other
appropriate
areas
for
easy
access.
Printed
copies,
however,
are
uncontrolled
versions.
The
only
controlled
version
of
a
document
is
the
electronic
version
viewed
on-line.
5.1
Disclaimer
-
The
following
disclaimer,
or
a
similar
statement,
should
appear
on
the
first
page
of
each
controlled
document:
The
controlled
version
of
this
document
is
the
electronic
version
viewed
on-line
only.
If
this
is
a
printed
copy
of
the
document,
it
is
an
uncontrolled
version
and
may
or
may
not
be
the
version
currently
in
use.
Use
of
the
disclaimer
statement
eliminates
the
need
for
a
distribution
list.
It
is
the
user
s
responsibility
to
check
the
document
control
database
and
verify
that
he/she
is
using
the
current,
controlled
version.
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5.2
Archives
-
When
a
new
version
of
a
document
becomes
effective,
the
unit's
document
control
contact
replaces
the
old
version
with
the
new
one
in
the
document
control
database.
The
status
of
the
previous
version
is
changed
from
approved
to
archived
on
the
input
form.
The
archived
documents
are
maintained
in
a
separate
document
view
of
the
database
named
Archived
Documents.
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6
.0
References
6.1
BS
EN
ISO
14001
:
1996
Environmental
Management
Systems
-
Specification
with
Guidance
for
Use,
British
Standards
Institution,
ISBN
0
580
26708
3,
September
1996.
6.2
National
Environmental
Laboratory
Accreditation
Conference
Constitution,
Sylaws.
and
Standards,
Approved
May
2001
-
Effective
July
2003.
6.3
National
Environmental
Laboratory
Accreditation
Conference
Constitution,
Bylaws,
and
Standards,
Approved
July
2002
-
Effective
July
2004.
6.4
U.S.
Environmental
Protection
Agency.
2002.
EPA
Guidance
for
Quality
Assurance
Project
Plans
(QA/G-5).
EPA/240/R-02/009.
Washington,
DC.
6.5
Van
Langenhove,
Agnes.
1998.
Guidance
for
the
Development
of
Standard
Operating
Procedures.
EPA
Region
1,
Investigations
and
Analysis
Unit,
OEME.
6.6
Wilson,
W.
Gary.
2000.
EMS
Implementation
Workshop,
U.S.
EPA
Region
1
Regional
Laboratory.
Environmental
Science
&
Engineering,
Inc.