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>> ISO-9001-Lead-Auditor学習資料 <<
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質問 # 152
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." Which two. of the following actions would you take to investigate further?
正解：C、E
解説：
According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:
Correction of the nonconformity
Segregation, containment, return or suspension of provision of products and services Informing the customer Authorisation for acceptance under concession The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.
In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.
Based on this information, you can investigate further by taking two actions:
A: Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.
D: Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.
These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.
質問 # 153
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around
14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO
9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:
Employees and executives for interviews and observations.
Documented information to verify compliance with ISO 9001.
This ensures a transparent and objective audit process. The CEO's approval (B) is not required unless restricted information is involved.
Reference:
ISO 19011:2018, Clause 5.3.2 (Access to Information)
質問 # 154
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
How do you assess the situation presented in the last paragraph of scenario 4?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires collaboration between the auditee (TD Advertising), the certification body, and the audit leader when making changes to audit scope.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.2.3 - Conducting the Audit: Any change in audit scope must be agreed upon by all parties before proceeding.
Why is the Correct Answer C?
* TD cannot unilaterally change the scope without agreement from the certification body and audit leader.
* The certification body must ensure the scope remains relevant and that resources are allocated properly.
Why are the Other Options Incorrect?
* A (Anne cannot withdraw) # Incorrect, Anne CAN withdraw if the changes make the audit unfeasible, but she must consult with the certification body first.
* B (TD cannot change the scope) # Incorrect, scope changes are allowed but must be formally approved.
* D (Anne has full authority to reject scope changes) # Incorrect, scope changes require mutual agreement among all parties.
質問 # 155
What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
Auditors must focus on key processes that impact QMS effectiveness to ensure audit risks are minimized.
Clause References:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk: Auditors should prioritize critical processes to obtain reasonable assurance.
Why is the Correct Answer A?
Some processes are critical (e.g., production quality, customer complaints handling).
If these material processes fail, the QMS could collapse.
Why are the Other Options Incorrect?
B (Needs of internal parties) # Important, but not the primary focus for reducing audit risk.
C (Previous audit results) # Useful for improvement but does not directly reduce current audit risks.
D (Financial risks) # ISO 9001 focuses on quality risks, not financial risks.
Reference:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk
質問 # 156
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.
正解：B
解説：
According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:
*the audit objectives, scope and criteria
*the audit team members and their roles and responsibilities
*the audit schedule, including the date, time and location of each audit activity
*the expected time and duration of meetings and interviews
*the allocation of appropriate resources to critical areas of the audit
*the identification of the audit client and the auditee
*the identification of the guides and observers, if any
*the documents and records to be reviewed before and during the audit
*the audit methods and tools to be used
*the audit language and terminology
*the audit report content, format, distribution and expected completion date
*the risk to achieving audit objectives and the contingency plan, if any Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation's management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management's expectations. The management's expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.
References: ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera
質問 # 157
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