體系審核時(shí)的評分方法

1、IRIS體系審核時(shí)的評分方法 Total questions:255，including 12 K.O.questions。 總共255個(gè)問題，其中包括12個(gè)K.O.問題 1.Knock-out（K.O.）questions關(guān)鍵性問題 2.Open questions which are assessed through a four level approach for assessing the level of maturity ofprocesses and the grade/extension of implementation（Optimized，Qualified，Define

2、d，Poor） 開放式問題：通過在審核時(shí)評分過程的成熟程度和實(shí)施的程度，設(shè)定了四種不同級別（優(yōu)秀，合格?？梢浴２睿?。 3.Closed questions（Yes/No）without progressive maturity levels。 封閉式問題：只有滿足/不滿足，沒有遞進(jìn)的成熟度級別。 Note：Questions indicated as Non applicable（'NA'）are not assessed and relevant justification shall bedocumented。 注：如果問題被指明為“不適用”（即NA），這些問題將不會被審核

3、，但要說明“不適用”的原因，并被形成文件。 knock out questions（K.O.）關(guān)鍵性問題（K.O.問題）： A detailed pre assessment of the Knock Out（K.O.）questions shall be carried out to ascertain the readiness toundertake the audit。 對K.O.問題應(yīng)逐條進(jìn)行預(yù)審核，以確定能否開始正式的審核。 Fulfilment is considered as a prerequisite for IRIS certification。 滿足K.O.問題的要求是

4、開始IRIS認(rèn)證的前提條件。 K.O. questions are not scored。 K.O.問題不打分。 When a K.O.requirement is not met，the whole audit fails。The Certification process has to start with a newrequest（covering the full audit process again）。 一旦K.O.問題沒有滿足，將不能通過審核。組織需要重新遞交認(rèn)證申請（審核過程將重新覆蓋所有要素）。 K.O.問題一共12個(gè)，其中2個(gè)只適用于信號系統(tǒng)的公司。 Quality Man

5、agement System - General requirements 質(zhì)量管理體系-通用要求 In case of transfer or outsourcing of activity with the execution of a contract does a transfer procedureincluding：feasibility study，nsk analysis，planning，communication to customer and FALs to the appropriate levelexist？ 當(dāng)合同執(zhí)行過程中有轉(zhuǎn)讓或者外包的情況發(fā)生，是否有轉(zhuǎn)讓的程序

6、？其內(nèi)容包括：可行性研究，風(fēng)險(xiǎn)分析，策劃，客戶溝通和首件檢驗(yàn)，這些內(nèi)容有在適當(dāng)?shù)乃缴蠁幔?Design and development（For Signalling only）設(shè)計(jì)和開發(fā)（僅適用于信號系統(tǒng)） Does the organization apply the principles in developing high integrity System in line with the CENELEC standardor other agreed equivalent models？The software design process must explicitly imple

7、ment the requirements of EN50128 related to safety integrity of the intended scope of the IRIS certificate。 組織在開發(fā)高集成系統(tǒng)時(shí)是否應(yīng)用在CENELEC標(biāo)準(zhǔn)或其它協(xié)議的等效標(biāo)準(zhǔn)？軟件開發(fā)過程必須實(shí)施EN50128的要求（與IRIS證書范圍的安全集成有關(guān)時(shí)）。 CENELEC-European committee for electro-technical standardization 歐洲電工技術(shù)標(biāo)準(zhǔn)委員會 Design and development inputs 設(shè)計(jì)和開發(fā)輸入

8、Does the organization ensure new technologies / new products are validated before being introduced in a customerproject？ 組織是否確保新技術(shù)/新產(chǎn)品在引入顧客項(xiàng)目前得到確認(rèn)？ Design and development validation 設(shè)計(jì)和開發(fā)確認(rèn) Does the organization ensure that reports，calculation，test results，etc，demonstrate that the productdefinition

9、meets the specification requirements for all the relevant operational conditions？ 組織是否確保報(bào)告、計(jì)算、測試結(jié)果等能夠展示產(chǎn)品定義滿足所有相關(guān)的運(yùn)行條件的規(guī)范要求？ Design approval（For Signalling only）設(shè)計(jì)批準(zhǔn)（僅僅適用于信號系統(tǒng)） Does the organization provide a documented procedure defining the safety case and approval in line with thisstandard？組織是否準(zhǔn)備

10、了文件化的程序，用于按照這個(gè)標(biāo)準(zhǔn)要求明確安全情況和批準(zhǔn)？ Validation of processes for production and service provision 生產(chǎn)和服務(wù)提供過程的確認(rèn) Are special processed managed according to the contractual requirements？特殊過程是否按照合同要求進(jìn)行管理? Project Management 項(xiàng)目管理 Does the organization implement a documented project management（PM）approach or Syst

11、em，or new productdevelopment process addressing the applicable areas of PM，describing roles and responsibilities，integrating thewhole functions of the organization in a multidisciplinary team？ 組織是否實(shí)施項(xiàng)目管理方法或體系，或新產(chǎn)品開發(fā)過程，涉及項(xiàng)目管理的使用領(lǐng)域，描述職責(zé)和任務(wù)，整合組織內(nèi)所有相關(guān)職能形成多功能小組？ Quality management 質(zhì)量管理 Does the organizat

12、ion ensure that the process is in place to manage project deliverables？ 組織是否確保有過程來管理項(xiàng)目是可以交付的？ Change management 變更管理 Are verification，validation AND APPROVAL，activities defined，to ensure compliance with customer requirements BEFORE IMPLEMENTATION？ 在實(shí)施前，是否定義了驗(yàn)證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求？ First article inspec

13、tion（FAI）首件檢驗(yàn) Does the organizations System provide a documented procedure defining inspection，verification and documentationof a representative item from the first serial production run of a new part or following any subsequent change thatinvalidates the previous first article inspection result？ No

14、te：if the product is a one-off or a software，F(xiàn)AI is meant as validation 組織的體系是否有文件化的程序，規(guī)定在新零件首次批量生產(chǎn)時(shí)（或任何隨后的會導(dǎo)致先前的首件檢驗(yàn)結(jié)果失效的變更引入時(shí)）代表性零件的檢驗(yàn)、驗(yàn)證和文件化？ 注：如果產(chǎn)品僅是一個(gè)或是軟件,FAI就是指得是確認(rèn)。 Commissioning / Customer service 測試/客戶服務(wù) Does the organization provide a process for field services/Do field processes provide：a

15、ctions to be taken whereproblems are identified after delivery，including investigation，reporting activities and actions or service Information。 組織是否有現(xiàn)場服務(wù)的過程？現(xiàn)場服務(wù)過程是否提供，在交付后，當(dāng)發(fā)現(xiàn)問題時(shí)，要采取相應(yīng)的措施，包括調(diào)查，報(bào)告活動和服務(wù)信息的措施？ Control of nonconforming processes 不合格過程的控制 In the event of business management process vari

16、ation，does the organization have a process in place to； a）Identify and record the variation，and if the business management process is non-conform to take appropriateaction tot correct the nonconforming process？ b）Evaluate whether the business management process variation has resulted in product nonc

17、onformity？ c) Identify and control the non-conforming product？ 當(dāng)發(fā)生過程偏差時(shí)，組織是否有過程來：a）識別，記錄偏差并采取適當(dāng)行動，糾正不合格的過程，b）評估是否過程偏差已經(jīng)導(dǎo)致產(chǎn)品不合格，并且c）識別并控制不合格的產(chǎn)品？ Quality management/質(zhì)量管理 Does the organization ensure that a process is in place to manage project deliverables？ 組織是否確保有過程來管理項(xiàng)目是可以交付的？ The organization has a

18、 structured，appropriate project related quality system in place with manuals，proceduresand quality plans to manage project deliverables 組織有結(jié)構(gòu)化的、合適的與項(xiàng)目有關(guān)的質(zhì)量體系，包括手冊、程序和質(zhì)量計(jì)劃來管理項(xiàng)目是可以交付的。 Change management/變更管理 Are verification，validation AND APPROVAL activities defined，to ensure compliance with customer

19、 requirements BEFORE IMLEMENTATION？ 在變更實(shí)施前，是否定義了驗(yàn)證，確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求？ Verification，validation and approval activities are defined，to ensure compliance with customer requirementsBEFORE IMPLENMTSTION。Process implemented and records are available 在變更實(shí)施前。定義了驗(yàn)證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求。過程得到了實(shí)施并有記錄。 Open Questio

20、ns 開放式問題項(xiàng) Each individual requirement（question）shall be scored progressively using maturity levels。 每項(xiàng)要求（每個(gè)問題）將按照成熟度級別被評分。 Maturity levels and relevant expected evidences shall be interpreted consistently with audit scope and companycharacteristics。 等級的評定依據(jù)和相關(guān)的審核發(fā)現(xiàn)必須是一致的。Maturity Level成熟度級別Is the requirement met？是否滿足要求？Point分?jǐn)?shù)“Optimized”優(yōu)秀Exceeded and continuously improved4“qualified”合格Exceeded超過要求3“defined”滿足Met in full達(dá)到要求2“poor”差Partially met部分滿足要求1“insufficient”不滿Not met不滿足要求