Standard Operating Procedure for Preparation and Review of Standard Operating Procedures SOP Number: ADM-02-05 Date Revised: 04-10-13


US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Microbiology Laboratory
Environmental Science Center, Ft. Meade, MD
Standard Operating Procedure for
Preparation and Review of
Standard Operating Procedures
SOP Number: ADM-02-05
Date Revised: 04-10-13

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SOP No. ADM-02-05
Date Revised 04-10-13
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SOP Number
ADM-02-05
Title
Preparation and Review of Standard Operating Procedures
Scope
The purpose of this procedure is to provide guidance for the
development, revision, and oversight of Standard Operating
Procedures (SOPs) used by the Microbiology Laboratory Branch
Application
MLB follows the guidance document EPA QA/G-6 (see section 15)
for the update and revision of all SOPs.


Approval Date
SOP Developer:

Print Name:
SOP Reviewer

Print Name:
Quality Assurance Unit

Print Name:
Branch Chief

Print Name:


Date SOP issued:

Controlled copy number:

Date SOP withdrawn:

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SOP No. ADM-02-05
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TABLE OF CONTENTS
Contents	Page Number
1.
DEFINITIONS
3
2.
HEALTH AND SAFETY
3
3.
PERSONNEL QUALIFICATIONS AND TRAINING
3
4.
INSTRUMENT CALIBRATION
3
5.
SAMPLE HANDLING AND STORAGE
3
6.
QUALITY CONTROL
3
7.
INTERFERENCES
3
8. NON-CONFORMING DATA
3
9.
DATA MANAGEMENT
3
10.
CAUTIONS
3
11.
SPECIAL APPARATUS AND MATERIALS
4
12.
PROCEDURE AND ANALYSIS
4
13.
DATA ANALYSIS/CALCULATIONS
8
14.
FORMS AND DATA SHEETS
8
15.
REFERENCES
9

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SOP No. ADM-02-05
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1. Definitions
1.	Standard Operating Procedure (SOP): A document which gives a step-
by-step description of how a specific operation, method or procedure is
performed.
2.	MLB: Microbiology Laboratory Branch
3.	Q AU: Quality Assurance Unit of MLB
4.	Abbreviations/definitions are also provided in the text.
2. Health and
Safety
Not Applicable.
3. Personnel
Qualifications
and Training
Refer to SOP ADM-04, OPP Microbiology Laboratory Training.
4. Instrument
Calibration
Not applicable
5. Sample
Handling and
Storage
Not applicable
6. Quality Control
An index of the SOPs is included in the MLB Quality Management Plan.
The MLB Quality Management Plan is an appendix to the OPP Quality
Management Plan.
7. Interferences
1. New SOPs should be issued promptly following approval by the
Branch Chief.
8. Non-
conforming
Data
Not applicable
9. Data
Management
Not applicable
10. Cautions
1.	Official SOPs are issued and tracked by the QAU. The QAU maintains
a log of all official copies.
2.	Photocopying of SOPs is discouraged. If a temporary copy is used (for
training purposes etc.), it must be appropriately marked as a "Copy"
and destroyed after use.
3.	Changes to the SOPs are made through the official revision process
(see 12.6). Handwritten changes are not permitted.
4.	The SOPs and addenda are prepared using the Agency's acceptable

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SOP No. ADM-02-05
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software in use at the time of their preparation.
11. Special
Apparatus and
Materials
None
12. Procedure and
Analysis
1.	Summary. Each SOP is written in the standard laboratory format (see
sections 12.2 through 12.4). The following procedure describes the
organization and format of SOPs, including their review, approval,
distribution, and storage.
2.	The control copy number "0" is the official original version (with
original signatures) of the SOP. Control copy number "0" is archived.
Six copies of each SOP are issued and distributed to 6 binders.
3.	Copy 1: Team Leader, Copy 2: Branch Chief, Copy 3: C wing, Copy 4:
D wing, Copy 5: Lab copy and Copy 6: QA Officer.
4.	When a new version of the SOP is issued, only control copy number
'0' is retained and marked with 'Date SOP withdrawn". The other six
copies are withdrawn from circulation and destroyed.
12.1 SOP
Identification
a.	SOPs are organized into groups according to subject area. Each
SOP is assigned a unique number. An example of the
identification format is presented below:
ADM-01-01 (Group ID - SOP No. - Revision No.)
b.	The following group letters are used to identify SOP categories:
ADM: Administrative
COC: Chain-of-Custody
EQ: Equipment Calibration and Maintenance
MB: Microbiological Test methods
QA: Quality Assurance
QC: Quality Control
VTP: Virology
c.	The first two to three alphabetical characters identify the
grouping. The middle two digit number is the assigned SOP
number in that group. The last two-digit number is the revision
number for that SOP. The revision marked "00" for each SOP is
the original version of the SOP.

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12.2 Title Page
a.	Every SOP shall have a title page (Page 1) which identifies the
SOP as an OPP Microbiology Laboratory SOP. The title page
contains the SOP number, title of the SOP, scope and application
fields. The title page also contains approval signature blocks for
the following: SOP Developer, SOP Reviewer, Quality
Assurance Unit and Branch Chief. At the bottom of Title page
are blocks for: Date SOP issued, Controlled Copy number, and
Date SOP withdrawn.
b.	The QA-series of SOPs may have fewer signature blocks.
However, all SOPs must contain the signatures of the Quality
Assurance unit and the Branch Chief.
c.	The title page for all SOPs includes the dates of review/approval
and signatures of the developer, technical reviewer (if applicable),
Quality Assurance Unit and the Branch Chief (or designee).
12.3 Page
Identification
a.	All pages of the SOP are numbered.
b.	The header on the top right corner of each page, including the title
page (Page 1), shall contain the following information:
SOP No.: (X)XX-XX-XX
Date Revised: XX-XX-XX
Page: XX of XX
12.4 SOP Content
All SOPs shall contain following sections and format as listed below:
a.	Table of Contents is the second cage of the SOP. It lists contents
of the SOP and the corresponding page number.
b.	1. Definitions: This section lists definitions of terms, acronyms,
and abbreviations relevant to this SOP, or with which the reader
may be unfamiliar. When there are no terms to define, the format
shall read:
Definitions: None
c.	2. Health and Safety: This section highlights any uniaue health
or safety issues pertaining to the specific SOP. When there are no
health and safety practices to define, the format shall read:
Health and Safety: None
d.	3. Personnel Qualifications and Training: This section
identifies the minimal education or training that is required to
carry out the procedure covered by the SOP. Modify standard
text as necessary for the specific SOP. The standard text is:

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SOP No. ADM-02-05
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"Refer to SOP ADM-04, OPP Microbiology Laboratory
Training."
e.	4. Instrument Calibration: Describes the method and frequency
of calibrating an instrument or piece of equipment. If this is not
applicable to the SOP, the format shall read:
Instrument Calibration: Not applicable
f.	5. Sample Handling and Storage: Describes the conditions of
preservation and storage required to maintain the integrity of the
sample. Holding times shall be specified. If this is not applicable
to the SOP, then the format shall read:
Sample Handling and Storage: Not applicable
g.	6. Quality Control: This section describes the procedures used
to meet GLP and ISO/IEC 17025 requirements. Insert standard
text, modified as necessary, to fit the specific SOP. The standard
text is: "Appropriate quality control measures are integrated into
each SOP. For quality control purposes, the required information
is documented on the appropriate forms (see section 14)."
h.	7. Interferences: This section discusses any potential or known
problems that may be encountered during the performance of a
method or procedure that may complicate interpretation or
validity of results (e.g., incomplete neutralization, contamination
of pre-sterilized supplies, etc.). If there are no known
interferences, the format shall read:
Interferences: None
i.	8. Non-conforming Data: When a non-conformance is
identified (e.g. deviation, omission), it must be documented. An
effort will be made to prevent recurrence of the non-conformance.
At a minimum, the following statement may be included:
"Management of non-conforming data will be specified in the
study protocol; procedures will be consistent with SOP ADM-07,
Non-conformance reports."
j. 9. Data Management: This section describes the procedures that
are used to meet Agency, OPP, and GLP data
management/records management requirements. Insert standard
text, modified as necessary, to fit the specific SOP. "Data will be
archived consistent with SOP ADM-03, Records and Archives".
k. 10. Cautions: This section will identify any known activities that
may result in equipment damage or degradation of sample, critical

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SOP No. ADM-02-05
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control points, or technique sensitive procedures (e.g., inoculum
production, timing of transfers of carriers, etc.) found in the
protocol. If there are no cautions identified, the format shall read:
Cautions: None
1. 11. Special Apparatus And Materials: Lists special or unique
instruments and supplies needed to perform the method. If there
are no special apparatus or materials specified, the format shall
read:
Special Apparatus And Materials: None
m. 12. Procedure and Analysis: Provides a step-by-step
description of the operation. Method SOPs include a statement
indicating that the staff must demonstrate (e.g., through
documented training) that they can perform a method before using
it in the laboratory. If the procedure changes, confirmation of the
ability to perform the method must be repeated. If relevant to the
topic of the SOP, a statement can be added at the end of the
section on "Resource Management". For example:
"12.X Resource Management.
12.X Water Conservation. Laboratory Personnel should
be mindful of water consumption, and whenever possible, employ
practices that minimize water use."
n. 13. Data Analysis/Calculations: Provides instructions for use of
equations and formulae, including spreadsheets necessary to
produce the results of the method. If there are no analyses or
calculations, the format shall read:
Data Analysis/Calculations: None
o. 14. Forms And Data Sheets: This section lists the forms and
data sheets referenced in the SOP. If no forms or data sheets are
referenced, the format shall read:
Forms And Data Sheets: None
p. 15. References: This section lists any document used as a source
for writing the SOP such as standard methods, QA Manual,
publications, and instrument manuals. References shall be listed
alphabetically. Ensure that the latest version of a standard or
manual is referenced. Citing a reference is not a substitute for a
description of a procedure. Include a description of the procedure
in the SOP to allow for consistent performance of the method.
When no references are used, the format shall read:

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SOP No. ADM-02-05
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References: None
12.5 SOP Review
a.	Submit the SOP for review by a technical reviewer (if applicable),
and the QA Officer. Each reviewer is responsible for ensuring
that the procedures are adequate and accurate based on his/her
area of expertise.
b.	After review and comment by the Technical reviewer and the QA
Officer, the SOP is routed to the Branch Chief for approval. The
QA Officer issues the SOP following approval by the Branch
Chief or designee (see section 12.2).
12.6 Revising
Existing SOPs.
a.	SOPs are reviewed and revised at least every three years to ensure
that policies and procedures continue to be relevant and accurate.
b.	An SOP may be revised prior to the end of three year cycle if a
modification or change to procedure is required
c.	Revise the SOP as necessary, including the SOP identification
number. Create a new version (section 12.1b).
d.	Submit the revised SOP for review and approval as per section
12.2.
e.	The QA Unit issues the SOP following approval by the Branch
Chief and all controlled copies of the previous version are
removed from circulation.
12.7 Withdrawal
and Re-
instatement of
SOPs
a.	SOPs that are no longer in use are withdrawn by the QA Unit
(e.g., SOP for operation of equipment that has been removed from
the laboratory and archived). However, any SOP withdrawal
must be approved by management.
b.	The QA Unit documents the withdrawal of the SOP on the SOP
title page on controlled copy "0" (see section 12.2). The
withdrawn SOP's controlled copy "0" is archived. All other
controlled copies (6) are destroyed.
c.	Withdrawn SOPs may be reinstated at a later date, if necessary,
and re-issued with appropriate revision.
13. Data Analysis/
Calculations
None
14. Forms and
Data Sheets
Test Sheets. Test sheets are stored separately from the SOP under the
following file names:
SOP Review Summary/Cover Sheet for . ^ , ,
c„n c„nJ ADM-02-05 Fl.docx
SOPs except QA SOPs

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SOP No. ADM-02-05
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SOP Review Summary/Cover Sheet for QA . „,. _ . _ .
J ADM-02-05 F2.docx
SOPs -
15. References
1. Guidance for Preparing Standard Operating Procedures (SOPs), EPA
QA/G-6. EPA/600/B-07/001. US EPA Office of Environmental
Information. April 2007.

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