Standard Operating Procedure for Preparation and Maintenance of the Master Schedule SOP Number: QA-04-04 Date Revised: 05-17-10


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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 Maintenance of the Master Schedule
SOP Number: QA-04-04
Date Revised: 05-17-10

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SOP No. QA-04-04
Date Revised 05-17-10
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EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD
Standard Operating Procedure
for
Preparation and Maintenance of the Master Schedule
SOP Number: QA-04-04
Date Revised: 05-17-10
Initiated By:		Date: / /
Print Name:	
QA Review:		Date: / /
Print Name:	
QA Officer
Approved By:		Date: / /	
Print Name:	
Branch Chief
Effective Date:	/ /
Controlled Copy No.:	
Withdrawn By:	Date:	/	/

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SOP No. QA-04-04
Date Revised 05-17-10
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TABLE OF CONTENTS
Contents	Page Number
1.0	SCOPE AND APPLICATION	3
2.0	DEFINITIONS	3
3.0	HEALTH AND SAFETY	4
4.0	CAUTIONS	4
5.0	INTERFERENCES	4
6.0	PERSONNEL QUALIFICATIONS	4
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
11.0	DATA ANALYSIS/CALCULATIONS	8
12.0	DATA MANAGEMENT/RECORDS MANAGEMENT	8
13.0	QUALITY CONTROL	8
14.0	NONCONFORMANCE AND CORRECTIVE ACTION	8
15.0	REFERENCES	9
16.0	FORMS AM) DATA SHEETS	9

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SOP No. QA-04-04
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1.0 SCOPE AND APPLICATION:
1.1 As a requirement of the EPA Good Laboratory Practice Standards (GLPs) (see
ref. 15.1) the Quality Assurance Unit (QAU) shall maintain a Master Schedule of
all studies. The studies conducted under the Quality Assurance Project Plans
(QAPPs) for the Antimicrobial Testing (ATP), Homeland Security (HS), Plant
Incorporated Protectant (PIP), Virology Testing (VTP) and Biofilm (BF)
Programs are tracked by the Master Schedule. This protocol describes the method
for preparing, updating, managing and using the laboratory's Master Schedule.
2.0 DEFINITIONS:
2.1	GLP = Good Laboratory Practice Standards (EPA GLPs are codified in 40 CFR
Part 160)
2.2	Test substance = A substance or mixture administered or added to a test system in
a study (see ref. 15.1), for example, EPA-registered hard surface hospital
disinfectants/tuberculocides, including the products' active and inert ingredients
2.3	Test system = Any animal, plant, microorganism, or chemical or physical matrix
to which the test or control substance is administered or added for study (see ref.
15.1), typically the test microorganism for method under investigation [e.g.,
Staphylococcus aureus, Pseudomonas aeruginosa, or Mycobacterium bovis
(BCG)] used in efficacy testing of EPA-registered hard surface hospital
disinfectants/ tuberculocides]
2.4	Study Sponsor = Individual or entity who initiates and supports a study [e.g., OPP
Microbiology Laboratory, Antimicrobials Division (AD), Biopesticides and
Pollution Prevention Division (BPPD)]
2.5	Study Director = Individual responsible for the overall conduct of the study
2.6	Nature of study = Test method used in the study (e.g., test method used to
determine the efficacy of an EPA-registered hard surface hospital
disinfectant/tuberculocide, such as the AO AC Germicidal Spray Products Test)
2.7	Study Initiation Date = The date the study is initiated
2.8	Study Completion Date = The date that the data collection activities are
completed
2.9
Study Status = Current status of the study (e.g., Study in progress, Report in

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SOP No. QA-04-04
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progress, Complete, or Not conclusive/repeat test)
2.10	QAU = Quality Assurance Unit; includes the Quality Assurance Officer (QAO)
and alternate QAO or designee
2.11	Laboratory = OPP Microbiology Laboratory located in the Environmental Science
Center, Ft. Meade, Maryland
2.12	Study Protocol Number: All product performance test studies will be tracked in
the Master Schedule by the study protocol number (see 10.2.1), a unique
identifier.
2.13 QAPP = Quality Assurance Project Plan
3.0 HEALTH AND SAFETY: Not applicable
4.0 CAUTIONS: None
5.0 INTERFERENCES: None
6.0 PERSONNEL QUALIFICATIONS:
6.1 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.
7.0 SPECIAL APPARATUS AND MATERIALS: None
8.0 INSTRUMENT OR METHOD CALIBRATION: Not applicable
9.0 SAMPLE HANDLING AND STORAGE: Not applicable
10.0 PROCEDURE AND ANALYSIS:
10.1 Master Schedule organization (see 16.1): According to GLPs (see ref. 15.1) the
Master Schedule must be indexed by test substance. The test substance for each
study is identified and described in the study protocol, statements of work,
research proposals, or OPP Microbiology Laboratory study notebook. Because
study protocol numbers and project codes are unique identifiers for each study
conducted in the laboratory, it is practical to index the Master Schedule by the
study protocol number/project code. Therefore, indexing by study protocol
number/project code refers the reader to study documentation describing the test

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SOP No. QA-04-04
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substance.
10.2 Master Schedule Preparation (see 16.1): The Master Schedule is maintained
primarily by the QAU as an electronic document. The Master Schedule contains
information pertaining to all unique data collection activities conducted in the
laboratory during the current fiscal year. A new Master Schedule is created for
each calendar year. The following items are contained in the Master Schedule:
10.2.1 Study Protocol number/Project Code. In this column, enter the study
protocol number or research protocol number assigned to the study (see
section 2.12).
10.2.1.1 For product performance tests conducted according to GLPs as
part of the Agency's Antimicrobial Testing Program (ATP) or
research projects associated with other programs, (HS, PIP,
VTP, biofilm), a unique study protocol number is assigned to
each study protocol.
10.2.1.2 The ATP Study protocol numbers are assigned in numerical
order for each calendar year (e.g., the number assigned to the
first study protocol of 2010 would be 2010-01; the number
assigned to the second study protocol of 2010 would be 2010-
02, etc.).
10.2.1.3 Research protocols are assigned numbers starting with R,
followed by the year (2010 ) and chronological number of the
research project, (e.g. the number assigned to first research
protocol in 2010 would be R-2010-01; the number assigned to
second research protocol would be R-2010-02, etc.).
10.2.1.4 The text of the study protocol identifies the title, purpose, test
identification, test substance, controls, sponsor, test facility,
proposed experimental start date, proposed experimental
completion date, test system, and experimental design of the
study.
10.2.2 Test Substance (EPA Reg. No. /Product). If applicable, enter the test
substance (see section 2.2), including EPA Registration Number, and
product name (e.g., EPA-registered hospital disinfectant/tuberculocide to
be subjected to efficacy testing). Enter N/A (not applicable) if there is no
EPA Reg. Number available.

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SOP No. QA-04-04
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10.2.3	Study Sponsor/Study Director/Test Coordinator. Enter the Study
Sponsor(s) (see section 2.4), Study Director (see section 2.5) and Lead
Test Coordinator.
10.2.4	Test System/Method or Description of Study. Enter the test system (see
section 2.3) and nature of the study (e.g., test method) (see section 2.6), or
a brief description of the study.
10.2.5	Study Initiation Date. Enter the date that the data collection activities in
the laboratory are initiated.
10.2.6	QAU Inspection/QAU Inspector. Enter the elements of the
testing/reporting process that have been or will be audited by the QAO or
the alternate QAO during the duration of the study. Examples of such
elements may include, but are not limited to, laboratory notebooks, the
Study Protocol, certain procedures of the study itself, the draft report, and
the final report.
10.2.6.1 QAU Inspector. Enter the first initial and the last name of the
QAO conducting the audit of each of the pertinent elements
described in section 10.2.6.
10.2.6.2 Date of Audit Report (Completion). Add the date the audit
report is sent to the Study Director and management.
10.2.7 Study Status. Enter the most applicable of the following: Study in
progress, Report in progress, Complete, or Not conclusive/repeat test.
10.2.7.1	Enter "Study in progress" to designate the time period
beginning with the study initiation date and ending with the
study completion or study termination date.
10.2.7.2	Enter "Report in progress" to designate the time period during
which the report or data summary is being compiled and
reviewed (see SOP ADM-01, Preparation of Performance
Reports).
10.2.7.3	Enter "Complete" as directed below:
10.2.7.3.1 For studies requiring the development of a report
(e.g., efficacy testing for the Antimicrobial Testing
Program), enter "Complete" once the final report

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SOP No. QA-04-04
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has been reviewed and approved by the QAO and
Branch Chief.
10.2.7.3.2	For all other studies, enter "Complete" once the
Study Director and/or Branch Chief have reviewed
and approved the summary of the data.
10.2.7.3.3	Enter "Not conclusive/repeat test" to indicate that
the study was invalidated (e.g., due to an event such
as low carrier counts, etc.) and/or that the study
must be repeated. Data from a study that must be
repeated will be compiled and submitted to the
Study Director and QAO for review. Preparation of
a final report (see SOP ADM-01, Preparation of
Performance Reports) or data summary is at the
discretion of the Study Director or Branch Chief.
10.2.8	Study Completion Date. Enter the date that the data collection activities
in the laboratory are completed.
10.2.9	Final Report Approval Date (QAU).
10.2.9.1	For the ATP studies, enter the date, using the six-digit MM-
DD-YY format, that the QAU signed the Quality Assurance
Review Form (see SOP ADM-01, Preparation of Performance
Reports).
10.2.9.2	Enter "Not applicable" if the study was invalidated and must be
repeated.
10.2.9.3	For research studies associated with QAPPs (ATP, HS, PIP,
VTP and BF), enter the date when the report is approved by the
Study Director and/or Branch Chief.
Updating the Master Schedule:
10.3.1	The QAU, Branch Chief, Study Director, or lead analysts may
update the Master Schedule as needed to ensure that the schedule
provides an accurate and concise assessment, and current status of
each study. The QAU ensures on a regular basis that the data in
the Master Schedule is current and up-to-date.

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SOP No. QA-04-04
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10.4 Using the Master Schedule:
10.4.1	The QAU, in compliance with GLPs (see ref. 15.1), maintains a
hard copy of the Master Schedule of studies (see section 12.1). In
addition, the Master Schedule is used to develop test method
auditing schedules (see SOP QA-01, Operations of the Quality
Assurance Unit).
11.0 DATA ANALYSIS/CALCULATIONS: None
12.0 DATA MANAGEMENT/RECORDS MANAGEMENT:
12.1 Information pertinent to each study is entered electronically into the Master
Schedule (see 16.1) (G:\Data\share\MLB\Master Schedule\Current Master
Schedule). The QAU maintains a printed copy of the electronic Master Schedule
file on a quarterly basis. At the end of each quarter, the QAU sends out the Master
Schedule for the applicable quarter electronically to branch chief and study
directors and archives it in the Master Schedule Record Book. The Master
Schedule Record Book is kept in a secured file cabinet in file room D217.
Archived records are subject to OPP's official retention schedule contained in
SOP ADM-03, Records and Archives.
13.0 QUALITY CONTROL:
13.1 The OPP Microbiology Laboratory conforms to 40 CFRPart 160, Good
Laboratory Practice Standards. Appropriate quality control measures are
integrated into each SOP.
14.0 NONCONFORMANCE AND CORRECTIVE ACTION:
14.1 Data entry errors discovered in the Master Schedule will be immediately
corrected in the electronic version. If an error is identified in a retired Master
Schedule file (i.e., from a previous year) or a section of the current year's Master
Schedule that has already been printed (section 12.1), the QAU will print out the
page from the electronic Master Schedule file that contains the data entry error,
entry error the incorrect information, and write in the corrected information. The
QAU will then make the correction in the electronic Master Schedule file and
print out the corrected page. The printed page containing the data entry error and
the printed page containing the corrected information will be stapled together and
placed in the Master Schedule Record Book.

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SOP No. QA-04-04
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15.0 REFERENCES:
15.1 US EPA Good Laboratory Practices, Title 40 Code of Federal Regulations (CFR)
Part 160.
16.0 FORMS AND DATA SHEETS:
16.1 Master Schedule

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Master Schedule
OPP Microbiology Laboratory
Calender Year: Quarter:
Study
Protocol
Number/
Project code
Test Substance
(EPA Reg.
No./Product)
Study Sponsor/
Study Director/
Test Coordinator
Test System/Method or
Description of Study
Study
Initiation
Date
QAU Inspection/
Name of Inspector
Date of Audit report
Study Status
Study
Completion
Date
Final Report
Approval
Date (QAU)

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