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 (SOPs) SOP Number: ADM-05-02 Date Revised: 11-03-10 ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 1 of 9 EPA/OPP MICROBIOLOGY LABORATORY ESC, Ft. Meade, MD Standard Operating Procedure for Use and Maintenance of Laboratory Notebooks and Project Binders SOP Number: ADM-05-02 Date Revised: 11-03-10 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/ / Print Name: QA Officer Approved By: Date: / / Print Name: Branch Chief Effective Date: / / Controlled Copy No.: Withdrawn By: Date: / / ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 2 of 9 TABLE OF CONTENTS Contents Page Number 1.0 SCOPE AM) APPLICATION 3 2.0 DEFINITIONS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 3 8.0 INSTRUMENT OR METHOD CALIBRATION 3 9.0 SAMPLE HANDLING AND STORAGE 3 10.0 PROCEDURE AM) ANALYSIS 3 11.0 DATA ANALYSIS/CALCULATIONS 7 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 7 13.0 QUALITY CONTROL 7 14.0 NONCONFORMANCE AND CORRECTIVE ACTION 8 15.0 REFERENCES 8 16.0 FORMS AM) DATA SHEETS 8 ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 3 of 9 1.0 SCOPE AND APPLICATION: 1.1 The purpose of this SOP is to provide guidance on the use and maintenance of laboratory notebooks and project binders for laboratory activities. For the purpose of this SOP, "laboratory notebook" is defined as a bound collection of serially numbered pages used to record the planning and progress of a scientific investigation. A "project binder" is defined as a loose-leaf collection of dated hand-written and/or computer-generated documents and forms, graphs, tables, notes, and data. 2.0 DEFINITIONS: 2.1 ATP = Antimicrobial Testing Program 2.2 GLP = Good Laboratory Practice Standards 2.3 QAU = Quality Assurance Unit 3.0 HEALTH AND SAFETY: Not applicable. 4.0 CAUTIONS: None 5.0 INTERFERENCES: 5.1 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. 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 is 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: ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 4 of 9 10.1 The laboratory notebook and/or project binder is a permanent record of a researcher's activities. The pages are used to preserve experimental data and observations as well as to document the purpose, design, and conclusions of a study. 10.1.1 The main purpose of maintaining a laboratory notebook and/or proj ect binder is to preserve experimental plans, study design or protocol, procedures that were followed, observations, 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. 10.1.2 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. 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. 10.1.3 A laboratory notebook or project binder may cover more than one study. 10.1.4 Laboratory notebooks, project binders, their contents, and any associated documentation are the property of the OPP Microbiology Laboratory. They should be kept in a secure location while the project is ongoing. As projects are completed, the materials are archived. A log of all notebooks and binders is maintained on G:\DATA\SHARED\APPB\ANTIMICROBIALTESTING PROGRAMVLAB Notebooks (see Attachment 1). It is the responsibility of each analyst to populate this notebook log once the notebook is provided to the QAO for final review. 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. 10.2 Laboratory Notebook and Project Binder Format: 10.2.1 Title Page or Cover Sheet: On the title page 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. Depending on the ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 5 of 9 anticipated size of the project, an analyst may use a notebook for one or several studies. 10.2.2 Table of Contents: It is optional to have a table of contents in the laboratory notebook or binder. For ease of use and retrieval of unique studies, it is advised that each analyst 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. 10.2.3 Experimental descriptions: Separate experiments using clearly stated descriptions and/or dates. List the experiments in the Table of Contents. 10.2.4 Page numbering: Laboratory notebook pages are to be serially numbered. Page numbering is optional in project binders; however, every page should have at a minimum the date and initials of analysts conducting the work. All study information and data generated should be initialed and dated before the end of each day of data collection. NOTE: Pages in laboratory notebooks and/or project binders should not be skipped or discarded. 10.3 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. 10.3.1 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. In many cases, the plan is in the form of a research protocol which should be affixed in the notebook. Changes in the plan should be documented. 10.3.2 Plan how to document the experiment in the notebook or binder prior to making any entries. Much of this can be done by using data sheets from SOPs. Consider that room may be needed for tables, observations, graphs, spreadsheets, and statistical analysis. Writing should be legible, grammatically correct, and factually complete. Analysts should avoid using the notebook for scratch work or personal information. Think carefully before writing. ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 6 of 9 10.3.3 The laboratory notebook and/or project binder should be available in the lab while conducting a study or research. Don't rely on memory. 10.3.4 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. 10.3.5 All entries should be made in permanent ink and should be complete. If others are assisting with an experiment or with recording information, they should initial and date entries. Documentation should indicate who did what step or portion of the experiment and when. 10.3.6 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. 10.3.7 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. If in doubt, include the observation or procedure. 10.3.8 Any 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. 10.3.9 If graphing programs, spreadsheets, or statistical software is used, the name of the program and the version number, if available, should be documented. 10.3.10 Each section should have a clear descriptive heading. 10.3.11 The contents of the laboratory notebook and/or project binder should be frequently peer-reviewed during the course of a study. The peer reviewer should sign and date each portion that is reviewed. 10.3.12 Clearly define all abbreviations, code names, or product codes. Commonly used abbreviations need only be defined the first time used. 10.3.13 Draw a line through all errors followed by a date, initials, and a brief ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 7 of 9 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. 10.3.14 If large sections need to be corrected, the section should be blocked and struck 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. 10.3.15 If an experiment takes more than one page, indicate the continuation at the bottom of the first and any subsequent pages, along with your initials and date. 10.3.16 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. 10.3.17 If a page is inadvertently skipped during the course of an investigation, cross out the whole page, and sign and date the line. 10.3.18 Avoid writing too near the binding as this area may not photocopy well. 10.3.19 All laboratory notebooks and project binders for a particular project should be numbered sequentially. Cross-reference multiple notebooks, when necessary. 11.0 DATA ANALYSIS/CALCULATIONS: None 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT: 12.1 Active notebooks and binders should be kept by the analyst in a secure location. After completion of a project, retired notebooks and project binders are subject to review by the Quality Assurance Unit, and archived in secure 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. 13.0 QUALITY CONTROL: 13.1 The OPP Microbiology Laboratory conforms to 40 CFRPart 160, Good Laboratory Practice Standards. Appropriate quality control measures are ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 8 of 9 integrated into each SOP. 13.2 For quality control purposes, the required information is documented in the laboratory notebook or on the appropriate record form(s) (see 16.0). 14.0 NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any instances of non-compliance with this SOP will be corrected upon discovery. 15.0 REFERENCES: 15.1 Writing the Laboratory Notebook, H.M. Kanare, American Chemical Society, 1985. 15.2 US EPA Good Laboratory Practice Standards, Title 40 Code of Federal Regulations (CFR) Part 160. 16.0 FORMS AND DATA SHEETS: 16.1 Attachment 1 Example of Notebook Log ------- SOP No. ADM-05-02 Date Revised 11-03-10 Page 9 of 9 Attachment 1: Example of Notebook Log Notebook Log OPP Microbiology Laboratory Notebook or Binder ID* Project(s) Description(s) Research, Study Protocol or Project Code Date Notebook Started Date Notebook Submitted to QA Officer (Retired) Notebook Archived /Date *Notebook ID = initials of analysts and a chronological # (e.g. XY-1, XY-2, XY-3, etc.) ------- |