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<br />ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 ' <br />SOPAD018.08.07.12 Page 10 of 96 <br />Whenever any internal audit finding casts doubt on the effectiveness of the operations or on the <br /> <br />correctness or validity of the test results, timely corrective action must be taken, and the client(s) , <br />must be notified in writing, as soon as the extent of the problem can be determined, if investigations <br />show that the laboratory results may have been affected. , <br />At a minimum, internal audits are conducted for the following departments. Method audits performed <br />for all analytical departments listed below encompass both qualitative evaluation of the operational <br />details of the QA/QC program and quantitative evaluation of the accuracy of data generated by the <br />laboratory staff. These evaluations do not include the real-time review of laboratory raw data or final <br />reports for routine quality control sample verification. <br />¦ Log-In ' <br />¦ Reporting <br />¦ Wet Chemistry Manual <br />¦ Wet Chemistry Instrument (Prep and Analytical) , <br />¦ Inorganic Instrument <br />¦ Inorganic Metals Prep <br />¦ Soils ' <br />¦ Radiochemistry (Prep and Analytical) <br />¦ Organics (Prep and Analytical) <br />More frequent internal audits may be scheduled depending on the following criteria: ' <br />¦ Number and type of corrective actions filed for a method or activity <br />¦ Client complaints <br />¦ Continued failure to achieve acceptable results for a Proficiency Testing sample <br />¦ Findings from an external audit <br />¦ Request from management , <br />All findings from internal audits are directed through ACZ's corrective action system. Each finding is <br />assigned a corrective action number (similar findings may be combined). A general description of the I <br />process is as follows: <br />1) Findings and observations are summarized in a memo. ' <br />2) The memo is distributed to the department supervisor, Production Manager, and President. <br />3) The supervisor reviews the memo with their staff and develops a response for each finding. <br />4) The supervisor informs the QA/QC Officer of all resolutions and expected implementation date(s) <br />within two (2) weeks from the date indicated in the memo. <br />Additionally, an in-depth review will be conducted if there is any evidence of inappropriate actions or <br />vulnerabilities related to data integrity. This review shall be handled in a confidential manner until a ' <br />follow up evaluation, full investigation, or other appropriate actions have been completed and the <br />issue(s) clarified. Refer to ACZ's SOP Ethics and Proactive Prevention Program (SOPAD039). All <br />documentation related to the investigation must be maintained for at least five (5) years. ' <br />2773 Downhill Drive <br />Steamboat Springs, CO 80487 <br />970-879-6590 , <br />www.acz.com <br />n