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>> Formal PECB ISO-9001-Lead-Auditor Test <<
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NEW QUESTION # 162
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?
Answer: B,F
Explanation:
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.
NEW QUESTION # 163
Select one option that must be considered when determining the scope of a QMS to ISO 9001.
Answer: B
Explanation:
According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 4.1 and 4.3 ISO 9001:2015 - How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001" ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4
NEW QUESTION # 164
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME' s operations. Which sampling method fits that description?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Stratified sampling is the best method when the population consists of different groups or categories. In this case:
* ME has two areas of operations (electrical and mechanical services).
* Complaints were collected separately for each area.
By choosing representative samples from each category (electrical & mechanical complaints), Li Na ensured a balanced approach.
* Systematic sampling selects samples at fixed intervals, which does not ensure proportional representation of both groups.
* Block selection sampling is used when focusing on a specific time period or section, which does not apply here.
Thus, stratified sampling (B) is the correct answer.
Reference:
ISO 19011:2018, Clause 6.4.5 (Sampling Methods in Auditing)
NEW QUESTION # 165
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
NEW QUESTION # 166
What are the objectives of the Stage 2 audit?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:
* Verify whether the QMS is effectively implemented and operational.
* Ensure compliance with ISO 9001 requirements in actual practice.
* Identify nonconformities that may impact certification.
Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.
Reference:
ISO 17021-1:2015, Clause 9.3.1.3 (Stage 2 Audit)
NEW QUESTION # 167
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