第27周的工作日志—7月6日

Question 1: Edit
本周的工作重点是通过IRIS的RCS的网络考试，期待自己能代表公司早点工作，考试多谋，经历了几次的确认和沟通，最终的结果还是能接受了，共15道题，错了一题，共分两部分，第一部分时间比较充裕，也比较简单，是一个案例分析，第二部分共10道题，都是基础题，由于好长时间没有复习了，有点生疏了，因此需求和书本对照，时间有点紧张。但本周的心情是复杂的，期待、焦虑、担忧一应俱有。以下是考试的全部内容，供大家参考。

During the readiness review, you are auditing various departments like Design and Purchasing and you are checking the control of business management process variation. You are provided with review records and documents such as documented procedure, KPIs etc. and you have made a project physical verification. The procedure doesn’t link process variation to product nonconformity. Responsibilities and authorities have been defined.


Which is the most appropriate question?


7.4.1-1 Does the organization establish, document and maintain a process for purchasing of products and is the performance of this process measured by a KPI?





Question 1: Edit


Which is the most appropriate question?


7.4.1-1 Does the organization establish, document and maintain a process for purchasing of products and is the performance of this process measured by a KPI?


7.7-1 Does the organization implement a project management process or new product development process, addressing the applicable areas of project management, describing roles and responsibilities, integrating all relevant functions of the organization into a multidisciplinary team?Is the performance of this process measured by a KPI?


8.3.1-1 Does the organization establish, document and maintain a process to manage business management process variation, which includesa) identification, recording and analysing of the root causes of the variation and if the business management process is non conform, taking appropriate action to correct the nonconforming process?b) evaluation whether the business management process variation has resulted in product nonconformity?c) identification and control of the nonconforming product?


8.3-1 How has the organization established a documented procedure- to ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery and- to define these controls and related responsibilities and authorities for dealing with nonconforming product?


Question 2: Edit


Which is the maturity level to be scored in this case?


ML 2 (defined)


ML 1 (poor)


ML 3 (qualified)


K.O. failed


Question 3: Edit


What is required to improve the current ML?


Systematic approach for correction activities and verification.


Continuous improvement of the project management process


Define and document a design process.


A process to control nonconformity of processes


Question 4: Edit


What is not required to be included in the audit report?


The IRIS score


The dates where the corrective or improvement actions should be closed


An overall summary in the agreed language and in English


The dates and places where audit was conducted.


Question 5: Edit


To manage configuration management, the organization:


Shall ensure that a Process is in place to manage Project Deliverables


Shall establish a Process appropriate to the Product


Shall demonstrate appropriate awareness of the criticality of the product and the function and risks of a product within the system / vehicle of which it forms a part


Should establish a Process appropriate to the Product





7.7-1 Does the organization implement a project management process or new product development process, addressing the applicable areas of project management, describing roles and responsibilities, integrating all relevant functions of the organization into a multidisciplinary team?Is the performance of this process measured by a KPI?


8.3.1-1 Does the organization establish, document and maintain a process to manage business management process variation, which includesa) identification, recording and analysing of the root causes of the variation and if the business management process is non conform, taking appropriate action to correct the nonconforming process?b) evaluation whether the business management process variation has resulted in product nonconformity?c) identification and control of the nonconforming product?


8.3-1 How has the organization established a documented procedure- to ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery and- to define these controls and related responsibilities and authorities for dealing with nonconforming product?


Question 2: Edit


Which is the maturity level to be scored in this case?


ML 2 (defined)


ML 1 (poor)


ML 3 (qualified)


K.O. failed


Question 3: Edit


What is required to improve the current ML?


Systematic approach for correction activities and verification.


Continuous improvement of the project management process


Define and document a design process.


A process to control nonconformity of processes


Question 4: Edit


What is not required to be included in the audit report?


The IRIS score


The dates where the corrective or improvement actions should be closed


An overall summary in the agreed language and in English


The dates and places where audit was conducted.


Question 5: Edit


To manage configuration management, the organization:


Shall ensure that a Process is in place to manage Project Deliverables


Shall establish a Process appropriate to the Product


Shall demonstrate appropriate awareness of the criticality of the product and the function and risks of a product within the system / vehicle of which it forms a part


Should establish a Process appropriate to the Product



第二部分是基础题：






Question 1: Edit


To plan, initiate and conduct a FAI, the organization:


Should define and implement a Process


Shall define and implement a Process


Shall assign a KPI to the Process


Should establish a documented Procedure


Question 2: Edit


The verification of purchased Products activities


should be ensured by a process


shall be ensured by a process


cannot be supported by checklists and templates


shall be part of the purchasing process


Question 3: Edit


The analysis of data to demonstrate the suitability and effectiveness of the quality management system shall include, within the others, information relating to:


Special Processes developed by the organization


External incident reports associated with the organization’s Product


Stakeholders


LCC data collection


Question 4: Edit


the Documental Veto Checker


shall understand the applicable standard and certification requirements


may be part of the audit team, in case of a re-audit or readiness review


should have demonstrated competence to evaluate the audit processes and related recommendations of the audit team


should be nominated by the Certification Body


Question 5: Edit


Design and development


shall define and implement an innovation Process


shall be controlled on its performance by a KPI


shall investigate design for environment


shall determine tasks sequence and mandatory steps


Question 6: Edit


if a client fails an audit due to not meeting a Knock-Out requirement...
�


Company has to close the CAR associated to the failed KO question in order to be certified.


the audit can be continued, if wished by the auditee


the audit shall continue


the audit shall be stopped


Question 7: Edit


in addition to the ISO 9001:2008, the input to the management review shall include information on:


integration of business processes.


results of previous process reviews.


supplier on time delivery performance.


internal and supplier nonconformities.


Question 8: Edit


The analysis of data to demonstrate the suitability and effectiveness of the quality management system shall include, within the others, information relating to:


Customers


Product Safety


Special Processes developed by the organization


RAMS data collection


Question 9: Edit


From 1 January 2010


certification or recertification audits according to IRIS Rev. 01 or IRIS Rev. 02 are allowed


only surveillance audits according IRIS Rev. 02 are allowed


certification or recertification audits according to IRIS Rev. 01 are allowed


certification or recertification audits according to IRIS Rev. 02 are allowed


Question 10: Edit


In cases where a project involves multiple sites, the business management system shall cover as a minimum:


manufacturing practices.


make or buy strategies.


applicable KO questions on each site.


applicable processes, procedures, documents and records on each site.