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-04-05 Date Revised: 05-01-13 ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 1 of7 SOP Number QA-04-05 Title Preparation and Maintenance of the Master Schedule Scope The purpose of this procedure is to provide guidance for the preparation and maintenance of the Master Schedule for the testing activities at the Microbiology Laboratory Branch Application As a requirement of the GLP standards (42 CFR Part 160), the quality assurance unit shall maintain a Master Schedule of all studies. Approval Date SOP Developer: Print Name: Quality Assurance Unit Print Name: Branch Chief Print Name: Date SOP issued: Controlled copy number: Date SOP withdrawn: ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 2 of 7 TABLE OF CONTENTS Contents Page Number 1.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 4 11. SPECIAL APPARATUS AND MATERIALS 4 12. PROCEDURE AND ANALYSIS 4 13. DATA ANALYSIS/CALCULATIONS 7 14. FORMS AND DATA SHEETS 7 15. REFERENCES 7 ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 3 of 7 1. Definitions 1. GLP= Good Laboratory Practices 2. QAU = Quality Assurance Unit 3. MLB = Microbiology Laboratory Branch located in the Environmental Science Center, Ft. Meade, Maryland 4. Abbreviations/definitions are also provided in the text. 2. Health and Safety None. 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. MLB conforms to 40 CFR Part 160, Good Laboratory Practice Standards. 2. For quality control purposes, the required information is documented on the appropriate form (see section 14). 7. Interferences None 8. Non- conforming Data 1. Data entry errors discovered in the Master Schedule will be immediately corrected in the electronic version. 2. 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Master Schedule file (i.e., from a previous year) or a section of the current year's Master Schedule that has already been archived (section 9.0), the QAU will make the correction electronically. The QAU will archive the corrected copy of the Master Schedule. 9. Data Management 1. Information pertinent to each study is entered electronically into the Master Schedule (see section 14) (G:\Data\shared\MLB\Master Schedule\Current Master Schedule). 2. The QAU maintains an electronic copy of the 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 the Branch Chief and study directors and archives a pdf copy in the Master Schedule folder on the G drive. The comprehensive Master Schedule for the fiscal year is archived annually. 3. Master Schedule will be archived consistent with SOP ADM-03, Records ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 4 of 7 and Archives. 10. Cautions None 11. Special Apparatus and Materials None 12. Procedure and Analysis 1. Organization of the Master Schedule: According to GLPs (see ref. 15.1) the QAU shall maintain a copy of a Master Schedule of all studies conducted at the testing facility. 2. The test substance for each study is identified and described in the study protocol, statements of work, research proposals, or each (project) study notebook. 3. Protocol numbers are unique identifiers for each study conducted in the laboratory and it is practical to index the Master Schedule by the protocol number. 12.1 Master Schedule Preparation a. Protocol Number: All product performance test studies are tracked in the Master Schedule by the protocol number, a unique identifier. In this column, enter the protocol number or research protocol number assigned to the study. i. For product performance tests conducted as part of the Agency's Antimicrobial Testing Program (ATP) or research projects associated with other ongoing programs, e.g. Homeland Security (HS), Virology (VTP), and Biofilm, a unique study protocol number is assigned to each study. ii. The ATP Study protocol numbers are assigned in numerical order for each calendar year (e.g., the number assigned to first protocol of 2013 would be 2013-01; the number assigned to the second study protocol of 2013 would be 2013-02, etc.). iii. Research protocols are assigned numbers, starting with a prefix R, followed by the year (e.g.2013 ) and chronological number of the research project, (e.g. the number assigned to first research protocol in 2013 would be R-2013-01; the number assigned to second research protocol would be R- 2013-02, etc.). iv. 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 ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 5 of 7 study. b. Test Substance (EPA Reg. No. /Product). A substance or mixture administered or added to a test system in a study (see ref. 15.1), for example, EPA-registered hospital disinfectants and tuberculocides. i. If applicable, enter the 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 Registration Number available. c. Study Sponsor/Study Director/Test Coordinator: i. Study Sponsor is the individual or entity who initiates and supports a study [e.g., Antimicrobials Division (AD), OPP MLB], ii. Study Director is the individual responsible for the overall conduct of the study. iii. Test coordinator/Lead analyst is the individual responsible for developing the data and for compilation/preparation of (summary) final report. d. Test System/Method or Description of Study. Enter the test system and nature of the study (e.g., test method). i. Nature of study: Typically, it is listed as test method used in the study (e.g., AO AC Use Dilution Method or AO AC Germicidal Spray Products as Disinfectants Test). e. Study Initiation Date. Enter the date when data collection activities in the laboratory are initiated. f. QAU Inspection/QAU Inspector. Enter the elements of the testing/reporting process that have been or will be audited by the QAU during the duration of the study. Examples of study elements may include, but are not limited to, laboratory notebooks, the Study Protocol, certain procedures of the in-progress study, the draft report, and the final report. i. QAU Inspector. Enter the first initial and the last name of the QAU conducting the audit of each of the pertinent elements described in section 12.1. ii. Date of Audit Report (Completion). Add the date the audit is conducted and (optional) when the report is sent to the Study Director and management. g. Study Status. Signifies the current status of the study (e.g., Study in ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 6 of 7 progress, complete) i. Enter the most applicable of the following: Study in progress, Report in progress, Complete, or Non-conclusive/repeat test. ii. 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. iii. 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. iv. 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). v. Enter "Complete" as directed in vi through viii below: vi. For studies requiring the development of a report (e.g., efficacy testing for the Antimicrobial Testing Program), enter "Complete" once the final report has been reviewed and approved by the QAU and Branch Chief. vii. For all other studies, enter "Complete" once the Study Director and/or Branch Chief have reviewed and approved the summary of the data. viii. Enter "Non-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 QAU for review. h. Study Completion Date. Enter the date that the data collection activities in the laboratory are completed. i. Final Report Approval Date (QAU). i. 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). ii. Enter "Not applicable" if the study was invalidated and must be repeated. iii. For research studies associated with a Quality Assurance Project Plan, enter the date when the report is approved by the ------- SOP No. QA-04-05 Date Revised 05-01-13 Page 7 of 7 Study Director and/or Branch Chief. 12.2 Updating the Master schedule a. 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. b. The QAU ensures on a regular basis that the data in the Master Schedule are current and up-to-date. 12.3 Using the Master schedule a. The QAU, in compliance with GLPs (see ref. 15.1), maintains an electronic (pdf) copy of the Master Schedule of studies (see section 9.0). In addition, the Master Schedule is used to develop test method auditing schedules (see SOP QA-01, Operations of the Quality Assurance Unit). 13. Data Analysis/ Calculations None 14. Forms and Data Sheets Test sheets are stored separately from the SOP under the following file name: Master Schedule QA-04-05_Fl.docx 15. References 1. US EPA Good Laboratory Practices, Title 40 Code of Federal Regulations(CFR) Part 160 ------- |