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IRIS體系審核時的評分方法
編輯：中國驗廠網(wǎng) 來源：中國驗廠網(wǎng) 日期: 2009-04-29 17:29:13
導(dǎo)讀：
Total questions:255，including 12 K.O.questions。
總共255個問題，其中包括12個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 of
processes and the grade/extension of implementation（Optimized，Qualified，Defined，Poor）
processes and the grade/extension of implementation（Optimized，Qualified，Defined，Poor）
開放式問題：通過在審核時評分過程的成熟程度和實施的程度，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 be
documented。
documented。
注：如果問題被指明為“不適用”（即NA），這些問題將不會被審核，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 to
undertake the audit。
undertake 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 new
request（covering the full audit process again）。
request（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，其中2個只適用于信號系統(tǒng)的公司。
Quality Management 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 procedure
including：feasibility study，nsk analysis，planning，communication to customer and FALs to the appropriate level
exist？
including：feasibility study，nsk analysis，planning，communication to customer and FALs to the appropriate level
exist？
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？其內(nèi)容包括：可行性研究，風(fēng)險分析，策劃，客戶溝通和首件檢驗，這些內(nèi)容有在適當(dāng)?shù)乃缴蠁幔?/DIV>
Design and development（For Signalling only）設(shè)計和開發(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 standard
or other agreed equivalent models？The software design process must explicitly implement the requirements of EN
50128 related to safety integrity of the intended scope of the IRIS certificate。
or other agreed equivalent models？The software design process must explicitly implement the requirements of EN
50128 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)過程必須實施EN50128的要求（與IRIS證書范圍的安全集成有關(guān)時）。
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)計和開發(fā)輸入
Does the organization ensure new technologies / new products are validated before being introduced in a customer
project？
project？
組織是否確保新技術(shù)/新產(chǎn)品在引入顧客項目前得到確認(rèn)？
Design and development validation 設(shè)計和開發(fā)確認(rèn)
Does the organization ensure that reports，calculation，test results，etc，demonstrate that the product
definition meets the specification requirements for all the relevant operational conditions？
definition meets the specification requirements for all the relevant operational conditions？
組織是否確保報告、計算、測試結(jié)果等能夠展示產(chǎn)品定義滿足所有相關(guān)的運行條件的規(guī)范要求？
Design approval（For Signalling only）設(shè)計批準(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 this
standard？組織是否準(zhǔn)備了文件化的程序，用于按照這個標(biāo)準(zhǔn)要求明確安全情況和批準(zhǔn)？
standard？組織是否準(zhǔn)備了文件化的程序，用于按照這個標(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 項目管理
Does the organization implement a documented project management（PM）approach or System，or new product
development process addressing the applicable areas of PM，describing roles and responsibilities，integrating the
whole functions of the organization in a multidisciplinary team？
development process addressing the applicable areas of PM，describing roles and responsibilities，integrating the
whole functions of the organization in a multidisciplinary team？
組織是否實施項目管理方法或體系，或新產(chǎn)品開發(fā)過程，涉及項目管理的使用領(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 organization ensure that the process is in place to manage project deliverables？
組織是否確保有過程來管理項目是可以交付的？
Change management 變更管理
Are verification，validation AND APPROVAL，activities defined，to ensure compliance with customer requirements BEFORE IMPLEMENTATION？
在實施前，是否定義了驗證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求？
First article inspection（FAI）首件檢驗
Does the organizations System provide a documented procedure defining inspection，verification and documentation
of a representative item from the first serial production run of a new part or following any subsequent change that
invalidates the previous first article inspection result？
of a representative item from the first serial production run of a new part or following any subsequent change that
invalidates the previous first article inspection result？
Note：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（或任何隨后的會導(dǎo)致先前的首件檢驗結(jié)果失效的變更引入時）代表性零件的檢驗、驗證和文件化？
注：如果產(chǎn)品僅是一個或是軟件,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：actions to be taken where
problems are identified after delivery，including investigation，reporting activities and actions or service Information。
problems 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，要采取相應(yīng)的措施，包括調(diào)查，報告活動和服務(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 variation，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 appropriate
action tot correct the nonconforming process？
action tot correct the nonconforming process？
b）Evaluate whether the business management process variation has resulted in product nonconformity？
c) Identify and control the non-conforming product？
當(dāng)發(fā)生過程偏差時，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？
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目是可以交付的？
The organization has a structured，appropriate project related quality system in place with manuals，procedures
and quality plans to manage project deliverables 組織有結(jié)構(gòu)化的、合適的與項目有關(guān)的質(zhì)量體系，包括手冊、程序和質(zhì)量計劃來管理項目是可以交付的。
and quality plans to manage project deliverables 組織有結(jié)構(gòu)化的、合適的與項目有關(guān)的質(zhì)量體系，包括手冊、程序和質(zhì)量計劃來管理項目是可以交付的。
Change management/變更管理
Are verification，validation AND APPROVAL activities defined，to ensure compliance with customer requirements BEFORE IMLEMENTATION？
在變更實施前，是否定義了驗證，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 requirements
BEFORE IMPLENMTSTION。Process implemented and records are available
BEFORE IMPLENMTSTION。Process implemented and records are available
在變更實施前。定義了驗證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求。過程得到了實施并有記錄。
Open Questions 開放式問題項
Each individual requirement（question）shall be scored progressively using maturity levels。
每項要求（每個問題）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 company
characteristics。
characteristics。
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 improved |
4 |
|
“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 |
0 |
|
Compliance 符合性 |
Level 等級 |
Points 分?jǐn)?shù) |
Action requested 要求措施 | |
|
Open questions 開放式問題項 |
Closed questions 封閉式問題項 | |||
|
Compliant 符合 |
Optimized 優(yōu)秀 |
4 |
no specific action expected 審核中沒有更高的改進(jìn)要求被提出 |
|
|
Qualified 合格 |
3 |
Improvement action might be expected 可能要求采取改進(jìn)措施 |
| |
|
Defined 滿足 |
2 |
Improvement action requested；Closed within 12 months 被要求采取改進(jìn)措施，并在12個月內(nèi)關(guān)閉改進(jìn)項 |
No specific action expected 審核中沒有更高的改進(jìn)要求被提出 | |
|
Compliance 符合性 |
Level 等級 |
Points 分?jǐn)?shù) |
Action requested 要求措施 | |
|
Open questions 開放式問題項 |
Closed questions 封閉式問題項 | |||
|
Non Compliant 不符合 |
Poor 差 |
1 |
Corrective action requested；Closed within 90 days 被要求采取糾正措施，并在90天內(nèi)關(guān)閉整改項。 |
|
|
Insufficient 不滿足 |
0 |
Corrective action requested；Re-Audit within 90 days 被要求采取糾正措施，并在90天內(nèi)接受重審。 |
Corrective action requested；Re-Audit within 90 days 被要求采取糾正措施，并在90天內(nèi)接受重審。 | |
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