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ments for quality… In order to be effective, Quality Assurance requires a continuing evaluation of factors that affect the adequacy of the design or specification for intended applications as well as verifications and audits of project activities. Project Quality Assurance is a management tool which provides Project Management a measure of confidence that the quality system is being effectively implemented. While the overall responsibility for Project Quality rests with the Project Director, Project Quality Assurance has the overall responsibility for the auditing, surveillance and monitoring of qualityrelated activities for the assessment of effective conformance with approved procedures. Project Quality Assurance activities shall be performed in accordance with approved QA procedures, and include but not limited to the following: 質(zhì)量保證定義如下:“ … .為提供能夠信任和滿意的產(chǎn)品或服務(wù)并達到質(zhì)量管理規(guī)定而采取的必要的計劃和系統(tǒng)性措施” 。為了進行有效的質(zhì)量保證,需要對影響設(shè)計規(guī)范,項目審查工作有影響的因素進行評估。項目質(zhì)保是項目管理的一個工具,他能夠提供項目質(zhì)量體系有效執(zhí)行的可靠性。當(dāng)整個項目的質(zhì)量責(zé)任和項目董事利益沖突時,項目質(zhì)保對相關(guān)批復(fù)程序的有效性評估,質(zhì)量審查,監(jiān)督以及相關(guān)工作負有責(zé)任。項目質(zhì)保工作應(yīng)根據(jù)批準(zhǔn)的質(zhì)保程序進行,并包括但不僅限于以下內(nèi)容: ? Development and maintenance of the XXX Quality Plan 編制和維護 XXX質(zhì)量計劃 ? The performance of planned audits and surveillance39。s of XXX activities during the definition phase. 在定義階段對 XXX的工作進行計劃評審和 監(jiān)督 ? Review of supplier/subcontractor furnished quality submissions in support of supplier/subcontractor bid evaluations 審閱供應(yīng)商和分包商提交的質(zhì)量保證書,以及評標(biāo) ? Providing a status to Project Management on open items which require followup actions, including those identified during QA audits, surveillances, Correspondence, Corrective Action Reports (CARs), etc. 提供狀態(tài)報告,包括開孔項的后續(xù)措 施,以及質(zhì)保審查,監(jiān)督時出現(xiàn)的問題以及整改方案報告( CARs)等。 ? Providing for the control and retention of QA records generated byt QA personnel including records required for the administration of the QA program. 提供有質(zhì)保人員編寫的質(zhì)保記錄控制,包括質(zhì)保管理計劃規(guī)定的記錄。 AUDITS 審查 The audits are conducted on a schedule mensurate with the activities being performed and early enough to ensure that adequate controls have been planned and implemented. 審查工作應(yīng)和正在進行的工作相適并應(yīng)盡量提前,以便有足夠時間充分計劃的實施控制。 XXX activities will be audited at least once within the life of the activity. The audits will be planned and performed on a scheduled or unscheduled basis. Audit frequencies may vary depending upon the nature and importance of the activity being performed and the results achieved. A Master Audit Schedule shall be deve loped at the beginning of the definition phase and shall identify, activities to be audited. The Schedule will be updated as necessary to be consistent with the overall project schedule and activities. Audits will be performed using checklists developed from the governing documents, such as applicable specifications, procedures, instructions and technical and quality requirements contained in purchase and design documents. Audits may be performed using the governing documents in lieu of a checklist. Departures from or failure to fully establish and implement requirements of the governing documents are recorded in the audit report and may result in audit findings. Audit results will be documented in an audit report, normally issued within 30 working days after the postaudit conference. The audit report will include, as the minimum, the following information: XXX在整個項目運作期限內(nèi)至少要進行一次審查。本審查可以是定期或不定期的審查。審查的頻率由現(xiàn)行工作的重要性,性質(zhì)以及結(jié)果決定。審查計劃應(yīng)在定義階段就開始編制并確定需要審查的工作內(nèi)容。本審查計劃應(yīng)和項目實際實施的進度和工作內(nèi)容一致并進行必要的更新。審查時,采用管理文件中編制的檢查清單,例如適用的規(guī)范,程序 ,說明和采購,設(shè)計文件內(nèi)的技術(shù)質(zhì)量要求。審查也可能采用管理文件內(nèi)的檢查清單。偏離或沒有完全建立和執(zhí)行管理文件的規(guī)定都將導(dǎo)致出現(xiàn)問題。審查結(jié)果將記錄在審查報告中,一般在審查會議結(jié)束后的30個工作日內(nèi)發(fā)布。審查報告至少包括如下信息: ? A narrative summary of the scope of the audit ? 審查范圍概述 ? Identification of the auditors and persons contacted during the audit ? 審查中,被聯(lián)系的審查人員確認 ? A summary of the audit results, including a qualitative assessment of quality system effectiveness ? 審查結(jié)果概述,包括質(zhì)量體系有效性的定性評估 ? A clear description of each audit finding, including reference to the specific requirements violated ? 針對每個質(zhì)量問題的清楚描述,包括參考相關(guān)的規(guī)定 ? Corrective/Preventive action mitment dates or date when a formal response is required Audit results will be reported to the management of the audited anization, cognizant Project Management members and the respective XXX39。s of Quality Assurance. ? 整改 /預(yù)防措施執(zhí)行日期或正 式向?qū)彶榻M報告,組織管理人員和質(zhì)保人員進行整改的日期。 TRAINING AND QUALIFICATIONS 培訓(xùn)和資格 XXX Personnel participating in quality auditing and inspection activities shall demonstrate, by objective evidence, that they qualify based on education, experience, and demonstrated proficiency. Qualification records are maintained and periodically reviewed to assure that they are kept current. XXX參與審查工作的人員應(yīng)公正客觀,并且受過教育,有相關(guān)工作經(jīng)驗,并屬于專業(yè)人員。資格記錄要定期查對,以保證審查人員都是合格的。 CORRECTIVE AND PREVENTIVE ACTION 整改和預(yù)防措施 Quality nonconformities encountered in the normal course of operations (such as deviations from drawings, specifications, and purchase orders), are identified, corrected, and controlled be means of procedures established by the anization responsible for the activities. Quality nonconformities are to be documented and processed on a Corrective Action Report (CAR), or equivalent. These nonconformities may be identified as a result of Quality Assurance Audits, review of other source documents, or based on formal or informal munication with 業(yè)主/PMCProject personnel. The respective Project Quality Assurance Manager, will review all CAR39。s issued to determine if the condition(s) identified warrant Project or functional Management attention and/or action. A response due date, agreeable to the anization responsible for the action, is identified and a unique CAR number assigned to each CAR to facilitate tracking and control. The CAR is distributed to appropriate personnel, consistent with the significance