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2240 Rev 3

Inception Date: 06-03-96

Title: Correction of Errors Filename: FS1:\lwp\sop\2240v3.lwp Reference: 21 CFR Part 58 (FDA - Non-clinical Laboratories) 40 CFR Part 160 (EPA - FIFRA)

Current Revision Date: 08/21/00 Rev. No. 1. 2. 3. 4. 5. Date Revised 06/03/96 09/01/99 08/21/00 Revision Summary Original version Converted to LWP format. Appendix B: added. Appendix I: Error Code S example corrected.

Prepared or Reviewed by


Approved by


1.____________________________________________________________________________ 2.____________________________________________________________________________ 3.____________________________________________________________________________ 4.____________________________________________________________________________ 5.____________________________________________________________________________ 6.____________________________________________________________________________ 7.____________________________________________________________________________ 8.____________________________________________________________________________

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0 DEFINITIONS 2. 2. The entry correction is accompanied with an error code.4 Accompany the correction with an ERROR CODE for the change. and activities associated with the study which may be needed to verify and evaluate the study. Since magnetic media are not permanent. 2. initialed. notes. 2240 Rev 3 1. 3. If corrections will distort the readability of data note that the correct data has been transcribed accordingly. 2. Raw data also includes maintenance and calibration records from instruments. chromatograms. control and reference substances and samples. or results from original measurements. and dated.2 Record the correct entry on the document above or next to the original error. SEE EXAMPLES. Planned deviations or deviations which become permanent must be documented as revised SOPs. we do not consider them raw data.SOP No. observations.4 The Quality Assurance Unit (QAU) is an independent group or individual responsible for monitoring the quality and compliance to GLP aspects of the study and reporting their findings to the Study Director (Client) or Principal Investigator (WCAS). APPENDIX A Page 2 of 6 . integrals.2 Computer Generated Data: Any data obtained from a data collection system.3 Protocol means a set of Standard Operating Procedures (SOPs) which describe how a study is to be conducted.0 PROCEDURE FOR RAW DATA ALL changes made to raw data must be performed by the following procedure: 3. 3. and as amendments to the Protocol. records.3 Record your initials and the date corrected next to the change. unanticipated changes to SOPs due to sample nature or availability must be documented in data packages. 3. 3. memos. receipt and distribution records for test. 2.1 Raw Data: Means any worksheets. spectra.1 Make a single line in INK through the error.0 SCOPE Inception Date: 06-03-96 To insure that documentation errors are properly corrected and noted as to their nature. Corrected information is documented in ink as close to the occurring error as possible. Deviations to SOPs are generally unacceptable.

130 a 0. 3. e.270 a .290 0.150 a 0. 2240 Rev 3 Inception Date: 06-03-96 3.250 0.. 3.145 a 0. 3.6 To simplify explanation of errors Table 1 lists current error codes to be used. PROPER USE OF STANDARD ERROR CODES CAN BE FOUND IN APPENDIX A.125 a 0. TABLE 1 STANDARD ERROR CODES ERROR CODE E C S W R EXPLANATION Entry or Recording Error (Inadvertent) Calculation Error Spelling Error Wording Change or Write-over error Rounding Error Page 3 of 6 .260 0. footnote the error correction(s) and explain the reason on the same page of the document.0 PROCEDURE FOR FINAL RECORDS 4.7 DO NOT use "white out" or correction tape.SOP No. Example: ppm Ammonium 0. 4.1 Any corrections to the final report must be done with a cover letter which clearly identifies which part of the report is being changed and why.300 0.g. Note: When these codes are used a copy of the codes must accompany the raw data for the study. try to make a 5 a 6. The form in Appendix B is used to create such a cover letter and is required for revisions and corrections of reports. This dilution factor is not a permanent change to the SOP.5 If the error description requires a lengthy statement.8 DO NOT write over data.135 a 0.Data has been corrected due to a dilution factor of two used in the procedure but not in the SOP calculation.

2240 Rev 3 Inception Date: 06-03-96 The following people have read this SOP and are currently using these procedures in the laboratory: Signature Date Page 4 of 6 .SOP No.

Page 5 of 6 ..R 12.0 mL X 0...SOP No. ERROR CODE .S A typical spelling error is : ei S SS 6/1/96 . ERROR CODE . 2240 Rev 3 Inception Date: 06-03-96 APPENDIX A ERROR CODE .W 500 600 W SS 6/1/96 "The number 5 has been overwritten to a 6".C mg Vitamin C = 15.recieved.4 C SS 6/1/96 "A mistake was made in calculation by a factor of 2" ERROR CODE .9 E SS 6/1/96 "An error was made in recording the number" ERROR CODE .E pH = 8..8 0.200 6.85 mg 13 mg R SS 6/1/96 "The number was rounded to 2 significant figures".6 8.085 X 1 = 12.

SOP No. CORRECTED/REVISED LABORATORY REPORT Job Number: ___________________ Client: ________________________ Date: ___________________ Group: _________________ r CORRECTION r REVISION ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ Information rec’d: r from client r internally r from follow-up Analyst: _________________________ Write-up: ________________________ Review: _________________________ Page 6 of 6 Date: ___________________ Date: ___________________ . 2240 Rev 3 APPENDIX B Inception Date: 06-03-96 WEST COAST ANALYTICAL SERVICE. INC.

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