2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 Version 12 Quality Assurance Plan SOPAD018.08.07.12 Page 9 of 96 ' 2.4 Audits The purpose of any audit is to verify performance and compliance to documented Quality Assurance and Quality Control policies and procedures, and to identify discrepancies when they exist. In the latter case, any problems must be addressed and resolved in an appropriate manner in order to assure the Quality System is continuously improved on all levels. 1 2.4.1 External Audits External audits are conducted to ascertain compliance with rules, regulations, and additional criteria for certification, and will have a higher degree of formality than internal audits. Where mandatory records are required, compliance with such will be critically evaluated. The search for any corrective actions and the correction of problems identified in a previous audit will also be an important activity. The ease with which important records and information can be retrieved is a criterion for judgment of the management practices of a laboratory and may dictate the depth of the audit. Individual state agencies, its NELAC Primary Accrediting Authority, and current and potential clients typically audit ACZ. ' The on-site assessment is generally a two to four day process during which the regulating agency conducts an entrance interview and tours the facility before performing an in-depth review of documents, workgroups, reports, electronic data files, etc. A critical aspect of the on-site assessment ' is review and verification of bench-level documentation and analyst interviews to determine actual laboratory practices. It is ACZ's policy to always have QA/QC personnel present during an interview. If necessary, the President or Production Manager may attend the interview. An exit interview is ' conducted upon completion of all on-site assessment activates, during which observations and findings are reviewed. The agency will submit a final report to ACZ, generally within 30 days, detailing all pertinent findings and recommendations. ' Upon receipt and review of the agency's report, the QA/QC department will meet with each department manager to develop a corrective action plan, which must be submitted to the agency by the date indicated in their report. Each finding is addressed as a major corrective action as described ' in section 2.5.2. Employees may not make changes to any laboratory or other practice based on comments or opinions expressed by the regulating agency during an interview or any other stage of the on-site assessment. ACZ will revise polices and procedures as necessary upon completion of the major corrective action process. The audit report and all subsequent corrective actions are thoroughly documented, and all documentation is retained for at least five (5) years. 2.4.2 Internal Audits ACZ is responsible for the quality of its data and must take reasonable efforts to assure itself and all interested parties of the confidence that can be placed in it. To this extent, internal audits of its activities must be conducted to verify continued compliance with the Quality System. It is the responsibility of the QA/QC Officer to plan, direct, and organize internal audits; however, a trained and qualified individual, independent from the area or system being audited, may be designated by the ' QA/QC Officer to conduct an internal audit. The area of activity audited, the audit findings, and subsequent corrective actions must be documented, and all documentation must be retained for at least five (5) years. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com 1