Standard Operating Procedure for Use and Maintenance of Laboratory Notebooks and Project Binders SOP Number: ADM-05-04Date Revised: 06-20-17


US Environmental Protection Agency
Office of Pesticide Programs

Office of Pesticide Programs

Microbiology Laboratory

Environmental Science Center, Ft. Meade, MD

Standard Operating Procedure for

Use and Maintenance of Laboratory Notebooks

and Project Binders

SOP Number: ADM-05-04

Date Revised: 06-20-17

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 1 of 7

SOP Number

ADM-05-04

Title

Use and Maintenance of Laboratory Notebooks and Project Binders

Scope

This standard operating procedure is for laboratory data recorded on
standardized test forms and in laboratory notebooks.

Application

To provide guidance on the use and maintenance of laboratory
notebooks and project binders for laboratory activities.





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Date SOP withdrawn:

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 2 of 7

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

3

12.

PROCEDURE AND ANALYSIS

4

13.

DATA ANALYSIS/CALCULATIONS

7

14.

FORMS AND DATA SHEETS

7

15.

REFERENCES

7

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 3 of 7

1. Definitions

1.	Laboratory notebook = a bound collection of serially numbered pages
used to record the planning and progress of a scientific investigation.

2.	Project binder = a loose-leaf collection of dated hand-written and/or
computer-generated documents and forms, tables, notes and data.

3.	Other abbreviations/definitions are 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

1.	The OPP Microbiology Laboratory conforms to 40 CFR Part 160, Good
Laboratory Practice Standards (GLP). Appropriate quality control
measures are integrated into each SOP.

2.	For quality control purposes, the required information is documented in
the laboratory notebook or on the appropriate record form(s) (see section
14).

7. Interferences

Adequate cross-referencing between a notebook and binder or between two
analysts' notebooks or binders is important. Lack of cross-referencing could
make interpretation of the information difficult.

8. Non-conforming
Data

Any instances of non-compliance with this SOP will be corrected upon
discovery.

9. Data

Management

1.	Active notebooks and binders should be kept by the analyst in a safe
location. After completion of a project, notebooks and project binders
are subject to review by the Quality Assurance Unit (QAU), and final
documents are archived in file cabinets in the room D217. Only
authorized personnel have card access to the archive room D217.

2.	Archived data is subject to OPP's official retention schedule contained in
SOP ADM-03, Records and Archives.

10. Cautions

None

11. Special

Apparatus and
Materials

None

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 4 of 7

12. Procedure and
Analysis

1.	Laboratory notebooks, project binders, their contents, and any
associated documentation are the property of the OPP Microbiology
Laboratory Branch.

2.	These materials should be kept in a safe location while the project is
ongoing. As projects are completed, the materials are archived.

3.	A log of all notebooks and binders is maintained on
G:\DATA\SHARED\MLB\ANTIMICROBIALTESTING
PROGRAMVLAB Notebooks (see section 14).

4.	It is the responsibility of each analyst to populate this notebook log
once the notebook is provided to the QAO for final review.

5.	The notebook log is reviewed by the QAU or designee on a regular
basis to ensure that it accurately reflects the status of notebooks and
binders.

12.1 Purpose

a. The laboratory notebook and/or project binder is a permanent record

of a researcher's activities.

i.	The main purpose of maintaining a laboratory notebook
and/or project binder is to preserve experimental plans, study
design or protocol, procedures that were followed,
observations, results, conclusions, and recommendations.
The information that is documented must be done in a way
that another scientist can replicate the study based on the
information presented in the notebook or binder.

ii.	Quality control activities and practices related to equipment
maintenance and calibration are recorded on the appropriate
forms and maintained in log books as required under other
laboratory Standard Operating Procedures (EQ and QC
series). It is not necessary to also record the data in the
laboratory notebook though the activities should be referred
to and cross-referenced in the laboratory notebook or binder
data sheets.

iii.	A laboratory notebook may cover more than one study.

12.2 Format

a. Title Page or Cover Sheet: On the title cage or cover sheet record
your name, the laboratory name (OPP Microbiology Laboratory,
Branch, Environmental Science Center, Ft. Meade, MD), the date
the notebook was started and ended, the number of the notebook in
the sequential series, and the project title, study protocol or research
protocol, for which the notebook is used. A notebook can be used
for one or several studies.

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 5 of 7



b.	Table of Contents: Table of contents is optional. For ease of use
and retrieval of unique studies, each analyst must separate studies
using binder tabs. If a table of contents is generated, reserve several
pages following the title page for recording a running table of
contents. Record the Study Protocol or Research Protocol title and
project identification number followed by the pages used to
document the study.

c.	Experimental descriptions: Separate experiments using clearlv
stated descriptions and/or dates. List the experiments in the Table
of Contents.

d.	Page numbering: Seriallv number each page. Page numbering is
optional in project binders; however, every page should have at a
minimum the date and initials of analysts conducting the work.

Date and initial all study information and data generated at the end
of each day of data collection.

NOTE: Pages in laboratory notebooks and/or proiect binders should
not be skipped or discarded.

12.3 General
Guidelines

The following are general guidelines documenting work associated with
planning, protocols, lab work, recording study data, observations, and any
additional information required to recreate the day's work.

a.	Document the daily plan of the experiment before initiating lab
work. Date and initial each daily entry. Include a short description
of the purpose of the investigation. If the plan is in the form of a
research protocol, it should be affixed in the notebook. Document
all changes.

b.	Plan how to document the experiment in the notebook or binder
prior to making any entries. Leave room for tables, observations,
graphs, spreadsheets, and statistical analysis. Writing should be
legible, grammatically correct, and factually complete. Do not use
the notebook for scratch work or personal information.

c.	The laboratory notebook and/or project binder should be available
in the lab while conducting a study or research.

d.	Control the location of and access to the laboratory notebook and/or
project binder. Secure them in a closed or locked cabinet or file
drawer when not in use.

e.	All entries should be made in permanent ink and should be
complete. Anyone assisting should initial and date entries.
Documentation should indicate who did what step or portion of the

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 6 of 7

experiment and when.

f.	Make notes and observations clear, concise, yet detailed, and
complete. Unusual or unique observations that could lead to further
experimentation should be entered into the notebook.

g.	Provide full detail of all experimental procedures and conditions.
Any SOPs or portions of SOPs that are being used should be
referenced and any deviations should be documented.

h.	Graphs, drawings, or printouts should be carefully affixed in the
notebook using as permanent a method as possible (glue, staples).
Reference should be made to any affixed material on the bound
page and analysts should sign and date over the interface.

i.	Document the program name and version number used for graphing
programs, spreadsheets, or statistical software.

j. Use clear and descriptive heading for each section

k. Peer-review the contents of the laboratory notebook and/or project
binder during the course of a study. Date and sign each portion that
is reviewed.

1. Define all abbreviations, code names, or product codes.
Abbreviations need only be defined the first time used.

m. Draw a line through all errors followed by a date, initials, and a

brief explanation for the correction (codes may be used for common
error types such as EE for entry error and EEO for entry error
omission). Do not erase or use white out; the original entry should
be visible.

n. To correct a large section, block out with one diagonal line from

corner to corner followed by a date, signature, and short explanation
for the strike out. The original uncorrected section should still be
visible.

o. For more than one page, indicate the continuation at the bottom of
the first and any subsequent pages, along with your initials and date.

p. If a long term experiment is interrupted by other daily entries,
indicate that the experiment is continued on the appropriate page
number, along with your initials and date.

q. If a page is skipped, cross out the whole page, and sign and date the
line.

r. Do not write near the binding as this area may not photocopy well.

-------
SOP No. ADM-05-04
Date Revised 06-20-17
Page 7 of 7



s. Laboratory notebooks and project binders should be numbered

sequentially. Cross-reference multiple notebooks, when necessary.

13. Data Analysis/
Calculations

None

14. Forms and Data
Sheets

1. Test sheets. Test sheets are stored separately from the SOP under the
following file name:

Notebook Log ADM-05-04 Fl.docx

15. References

1.	Writing the Laboratory Notebook, H.M. Kanare, American Chemical
Society, 1985.

2.	US EPA Good Laboratory Practice Standards, Title 40 Code of Federal
Regulations (CFR) Part 160.

-------