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 (SOPs)

SOP Number: ADM-02-04

Date Revised: 11-30-11


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 1 of 15

EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD

Standard Operating Procedure
for

Preparation and Review of Standard Operating Procedures (SOPs)

SOP ADM-02-04
Date Revised: 11-30-11

Initiated By:		Date: / /

Print Name:	

Technical Review: 	Date: / /

Print Name:

Technical Staff

QA Review:		Date: / /

Print Name:	

QA Officer

Approved By:		Date: / /

Print Name:	

Branch Chief

Effective Date:	/ /

Controlled Copy No.:

Withdrawn By:	Date:	/	/


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 2 of 15

TABLE OF CONTENTS

Contents
Page Number

I.0	SCOPE AND APPLICATION	3

2.0	DEFINITIONS	3

3.0	HEALTH AND SAFETY	3

4.0	CAUTIONS	3

5.0	INTERFERENCES	3

6.0	PERSONNEL QUALIFICATIONS	3

7.0	SPECIAL APPARATUS AND MATERIALS	4

8.0	INSTRUMENT OR METHOD CALIBRATION	4

9.0	SAMPLE HANDLING AND STORAGE	 4

10.0 PROCEDURE AND ANALYSIS	4

II.0	DATA ANALYSIS/CALCULATIONS	11

12.0 DATA MANAGEMENT/RECORDS MANAGEMENT	11

13.0 QUALITY CONTROL	12

14.0 NONCONFORMANCE AND CORRECTIVE ACTION	12

15.0 REFERENCES	12

16.0 FORMS AM) DATA SHEETS	 12


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 3 of 15

1.0 SCOPE AND APPLICATION:

1.1 The purpose of this procedure is to provide guidance in the development, revision,
and oversight of Standard Operating Procedures (SOPs) used by the Microbiology
Laboratory staff, quality assurance unit, and Branch Chief. The Microbiology
Laboratory Branch of the Office of Pesticide Programs is located at the
Environmental Science Center, Fort Meade, Maryland.

2.0 DEFINITIONS:

2.1	Standard Operating Procedure (SOP): A document which gives a step-by-step
description of how a specific operation, method or procedure is performed.

2.2	BEAD: Biological and Economic Analysis Division

3.0 HEALTH AND SAFETY: Not applicable

4.0 CAUTIONS:

4.1	Official SOPs are issued and tracked by the Quality Assurance Officer (QA
Officer). The Quality Assurance Officer maintains a log of all official copies.
Photocopying of SOPs is discouraged due to tracking issues. If a temporary copy
is used (for training purposes etc.), it must be appropriately marked as a "Copy"
and destroyed after use.

4.2	Changes to the SOP are made through the official revision process (see 10.2) or
by filing an SOP amendment (see 10.3). Handwritten changes are not permitted.

5.0 INTERFERENCES:

5.1	New SOPs and revisions to SOPs should be issued promptly after being approved
by the Branch Chief.

5.2	SOP addenda should be issued promptly after being reviewed (by the Senior
Science Advisor and Quality Assurance Officer) and approved by the Branch
Chief or designee.

6.0 PERSONNEL QUALIFICATIONS:

6.1 Personnel are required to be knowledgeable of the procedures in this SOP.


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 4 of 15

Documentation of training and familiarization with this SOP can be found in the
training file for each employee.

7.0 SPECIAL APPARATUS AND MATERIALS:

7.1 The SOPs and addenda are prepared using the Agency's acceptable software in
use at the time of their preparation.

8.0 INSTRUMENT OR METHOD CALIBRATION: Not applicable

9.0 SAMPLE HANDLING AND STORAGE: Not applicable

10.0 PROCEDURE AND ANALYSIS:

10.1 Developing New SOPs.

10.1.1	Summary. Each SOP shall be written in the standard laboratory
format. The following procedure describes the organization and
format of SOPs, their review and approval, distribution, and
storage.

10.1.2	SOP Identification. SOPs are organized into groups according to
subject area. Each SOP shall be assigned a unique number. An
example of the identification format is presented below:

ADM-01-01 (Group ID - SOP No.- Revision No.)

The first two to three alphabetical characters identify the grouping.
The middle two to three 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.

The following group letters shall be used to identify SOP
categories:

ADM Administrative
COC Chain-of-Custody
QC Quality Control

EQ Equipment Calibration and Maintenance
MB Microbiology-Test methods
QA Quality Assurance
VTP Virology


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 5 of 15

10.1.3	Title Page. Every SOP shall have a title page (see 16.0) which

shall identify it as an SOP for the OPP Microbiology Laboratory.
The title page contains the title of the SOP, the SOP identification
number, and the date revised. The title page also contains fields
for entry of the effective date, the controlled copy number, and
withdrawal signature and date. Except for the QA-series of SOPs,
the title page also identifies who initiated and reviewed the SOP,
and contains the review signature for QAO and approval signature
for the Branch Chief.

The title page for QA group SOPs contains the dates of
review/approval and signatures of the developer, technical
reviewer (if applicable), Quality Assurance Officer and the Branch
Chief.

10.1.4	Page Identification. The top right corner of each page, including
the title page (Page 1), shall contain the following information:

SOP No.

Date Revised:	-	-	

Page	of	

10.1.5	All SOPs shall contain a Table of Contents (Page 2) and the
following sections and format:

10.1.5.1	1.0: SCOPE AND APPLICATION: This section describes
the reason for writing the SOP, with its intended use and
effect.

10.1.5.2	2.0: 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

10.1.5.3 3.0: HEALTH AND SAFETY: This section will highlight
any unique health or safety issues pertaining to the specific
SOP. All SOPs will refer to the most recent version of
SOP MB-01, Lab Biosafety, for comprehensive health and
safety procedures and policy. When there are no health and


-------
safety practices to define,

SOP No. ADM-02-04
Date Revised 11-30-11
Page 6 of 15

the format shall read:

HEALTH AND SAFETY: Not applicable.

10.1.5.4 4.0: CAUTIONS: This section will identify any known
activities that may result in equipment damage or
degradation of sample, critical 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

10.1.5.5 5.0: 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 as follows:

INTERFERENCES: None

10.1.5.6 6.0: PERSONNEL QUALIFICATIONS: 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:

"Personnel are required to be knowledgeable of the
procedures in this SOP. Documentation of training and
familiarization with this SOP can be found in the training
file for each employee."

10.1.5.7 7.0: 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

10.1.5.8

8.0: INSTRUMENT OR METHOD CALIBRATION:


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 7 of 15

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 OR METHOD CALIBRATION: Not
applicable

10.1.5.9	9.0: 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

10.1.5.10	10.0: 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:

"10.X Resource Management.

10.X.X Water
Conservation. Laboratory

Personnel should be mindful
of water consumption, and whenever
possible, employ practices that

minimize water use."

10.1.5.11	11.0: DATA ANALYSIS/CALCULATIONS: Provides
instructions for equations and formulae necessary to
produce the results of the method. If there are no analyses
or calculations, the format shall read:

DATA ANALYSIS/CALCULATIONS: None


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 8 of 15

10.1.5.12	12.0: DATA MANAGEMENT/RECORDS
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. The standard text is

"Data will be recorded promptly, legibly, and in indelible
ink on the appropriate forms. Completed forms are
archived in notebooks kept in secured file cabinets in the
file room D217. Only authorized personnel have access to
the secured files. Archived data is subject to OPP's official
retention schedule contained in SOP ADM-03, Records and
Archives".

Before electronic transmission of official reports and
associated documents such as raw data sheets and data
summary tables, the files are converted to pdf format. Each
file should be annotated with document control information
such as the date the document was finalized, laboratory
identification information, and version number.

10.1.5.13	13.0: 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
16.0)."

10.1.5.14	14.0: NONCONFORMANCE AND CORRECTIVE
ACTION: 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 is included:

"Any deviations from the standard protocol must be
documented in the paperwork and corrective action applied
if warranted."


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 9 of 15

10.1.5.15	15.0: 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,
unless it is not appropriate to do so. 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
were used, the format shall read:

REFERENCES: None

10.1.5.16	16.0: 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

10.1.6	Submit the SOP for review by a technical reviewer (if applicable),
the Senior Scientist/Team Leader, and the QA Officer. Each
reviewer is responsible for ensuring that the procedures are
adequate and accurate based on his/her area of expertise.

10.1.7	After review and comment by the SSA/Team Leader and the QA
Officer, the SOP is routed to the Branch Chief for approval. The
QA Officer will issue the SOP following approval by the Branch
Chief (see section 12).

10.2 Revising Existing SOPs.

10.2.1	SOPs are reviewed and revised at least every three years to ensure
that policies and procedures continue to be relevant and accurate.

10.2.2	An SOP may be revised prior to the end of three year cycle if a
major modification is required or a number of significant addenda
need to be incorporated. The laboratory analysts are responsible,
in consultation with the QA Officer, for determining whether the
SOP changes are major or minor. Minor changes may be made
through the addendum process (see section 10.3).


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 10 of 15

10.2.3	Revise the SOP as necessary including the SOP identification
number (see section 10.1.2).

10.2.4	Submit the revised SOP for review and approval as per sections
10.1.6 and 10.1.7.

10.2.5	The QA Officer issues the SOP following approval by the Branch
Chief and all controlled copies of the previous version are removed
from circulation (see section 12).

10.3	Making Minor Modifications to SOPs.

10.3.1	Minor modifications to SOPs are made through the addendum
process.

10.3.2	Handwritten changes to SOPs are not permitted.

10.3.3	Any member of the laboratory may request a modification to an
SOP. The changes should be discussed with the Senior Science
Advisor (SSA) prior to preparing the addendum.

10.3.4	Complete the SOP Addendum Form (see 16.0).

10.3.5	Each addendum is sequentially numbered using the following
format: A-Year-addendum number. For example, the first
addendum prepared in 2012 is numbered A-2012-01.

10.3.6	Submit the SOP Addendum Form to the SSA and QA Officer for
review and approval by the Branch Chief or designee. The QA
Officer issues the addendum once the review and approval process
is completed.

10.3.7	Following issuance of an SOP addendum, the QA Officer is
responsible for retaining controlled copy number "0" of the
addendum as an archived copy.

10.4	Withdrawing SOPs.

10.4.1	SOPs that are no longer in use should be withdrawn by the QA

Officer (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.


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 11 of 15

10.4.2	The QA Officer documents the withdrawal of the SOP on the SOP
title page on controlled copy '0' (see section 12.4). The withdrawn
controlled copy "0" is archived. All other controlled copies are
destroyed.

10.4.3	Withdrawn SOPs may be reinstated at a later date, if necessary.

11.0 DATA ANALYSIS/CALCULATIONS: None

12.0 DATA MANAGEMENT/RECORDS MANAGEMENT:

12.1	Documentation used for initiating, revising, issuing, and withdrawal of an SOP
are recorded on the SOP title page. SOPs are written and stored using the
Agency's standard word processing software.

12.2	The QA Officer is responsible for issuing controlled copies of approved SOPs for
the laboratory and to appropriate personnel. The date of issuance is recorded on
the SOP title page (see 16.1). There are seven controlled copies numbered (Copy
"0", and 1-6). The original signed SOP is designated as controlled copy "0". The
remaining controlled copies are assigned and distributed as follows:

Copy 0 - Original copy
Copy 1 - Team Leader
Copy 2 - Branch Chief
Copy 3 - C Wing Office Area
Copy 4 - D Wing Office Area
Copy 5 - Laboratory
Copy 6 - QA Officer

12.3	For each newly developed or revised SOP, controlled copy 0 will be scanned and
converted to a pdf format to prevent unauthorized changes to the SOP. The hard
copy 0 will be archived. The QA Officer is responsible for maintaining archives
of controlled copy 0 and the pdf files. The electronic files will be backed up
monthly by a staff member designated by the Branch Chief.

12.4	When an SOP is revised or withdrawn, the QA Officer is responsible for notifying
the Branch and collecting the previous controlled copies of the SOP. The QA
Officer signs and dates the SOP Title Page of controlled copy 0 in the
"Withdrawn By;" field, thus designating the SOP as withdrawn. The withdrawn
controlled copy 0 is retained as an archived copy. All other controlled copies will
be destroyed.


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 12 of 15

12.5 The QAU maintains archived SOPs in a secured file cabinet located in D217.
Only authorized personnel have access to the secured files. Archived files are
subject to OPP's official retention schedule contained in SOP ADM-03, Records
and Archives.

13.0 QUALITY CONTROL:

13.1 An index of the SOPs is attached to the MLB Quality Management Plan which is
included in the OPP Quality Management Plan as an appendix.

14.0 NONCONFORMANCE AND CORRECTIVE ACTION:

14.1 If a number of addenda have accumulated, the SOPs may be revised earlier than 3
years. If an SOP has not been revised within the 3 year timeframe, the QAU will
notify the Branch Chief, and the SOP will be given immediate attention. If it is
determined that the lab fails to routinely update the SOPs on the established
schedule, the Branch Chief, Senior Science Advisor, and QAU will meet to
discuss the issue and will develop appropriate procedures/schedules to foster
conformance.

15.0 REFERENCES:

15.1 Guidance for Preparing Standard Operating Procedures (SOPs), EPA QA/G-6.
EPA/600/B-07/001. US EPA Office of Environmental Information. April 2007.

16.0 FORMS AND DATA SHEETS:

16.1	SOP Review Summary/Cover Sheet for SOPs except QA SOPs

16.2	SOP Review Summary/Cover Sheet for QA SOPs

16.3 S OP Addendum F orm


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 13 of 15

16.1 SOP Review Summary/Cover Sheet for SOPs except QA SOPs

EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD

Standard Operating Procedure
for

Name of SOP Here
SOP Number:

Date Revised: MM-DD-YY

Initiated By:

Technical Review:

QA Review:

Approved By:

Print Name:

Print Name:

Technical Staff

Print Name:

QA Officer

Print Name:

Branch Chief

Date: / /

Date:

/ /

Date: / /

Date: / /

Effective Date:

/ /

Controlled Copy No.:

Withdrawn By:

Date: / /


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 14 of 15

16.2 SOP Review Summary/Cover Sheet for QA SOPs

EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD

Standard Operating Procedure
for

[Quality Assurance Operations]
SOP QA-01-00
Date Revised: MM-DD-YY

Initiated By:		Date: / /

Print Name:	

Quality Assurance Officer

Approved By:		Date: / /

Print Name:	

Branch Chief

Effective Date:	/ /

Controlled Copy No.:

Withdrawn By:

Date: / /


-------
SOP No. ADM-02-04
Date Revised 11-30-11
Page 15 of 15

16.3 S OP Addendum F orm

Standard Operating Procedure (SOP) Addendum Form
OPP Microbiology Laboratory

Addendum A-20XX-XX

SOP Name :



SOP Number:



Addendum Number:



Changes made by
(name/date):



Description of
Change(s)/ Addition(s):



Justification(s) for the
Change(s):



Reviewed By:
Team Leader



Reviewed By:
QA Officer



Approved By:
Branch Chief



Date Issued:	

Controlled Copy Number:
Addendum A-20XX-XX


-------