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NEW QUESTION # 141
During an internal audit, a manufacturer of polystyrene packaging products for the electronics industry found that six per cent of finished products being ejected from the moulding machines fell onto the factory floor instead of into collection baskets. The factory floor was wet and dirty in places, so a lot of products were rejected at inspection. Auditors raised a non-conformity to the Maintenance Manager.
Select three options for the corrective action to be taken by the Maintenance Manager that could be needed to prevent rejects from recurring.
Answer: D,F,G
Explanation:
ISO 9001:2015 requires organisations to take corrective action to eliminate the cause of a nonconformity in order to prevent recurrence, not merely to contain or correct individual instances.
Relevant ISO 9001 requirements
* Clause 10.2.1 - Nonconformity and corrective actionThe organisation shall react to the nonconformity, evaluate the need for action to eliminate the cause(s), and implement actions to prevent recurrence.
* Clause 8.5.1 - Control of production and service provisionProduction shall be carried out under controlled conditions, including suitable infrastructure and environmental conditions.
Explanation of the correct corrective actions:
D). Redesign the factory layout to better handle finished products
This addresses a systemic cause of the problem by improving how finished products are handled after ejection, reducing the likelihood of products falling to the floor. This is a true corrective action aligned with Clause 10.2.
E). Set up a system of regular inspection of the floor condition
The dirty and wet floor is a contributing cause to product rejection. Establishing regular inspection and maintenance of floor conditions addresses the environmental conditions for production, as required by Clause 8.5.1, and helps prevent recurrence.
G). Install guides at the point of ejection to better direct products into the baskets This directly eliminates the root cause of products missing the collection baskets by improving equipment control. It is an effective corrective action that prevents the nonconformity from happening again.
Explanation of why the other options are not corrective actions:
* A: Recording nonconformities is detection, not prevention.
* B: Placing a worker is a temporary containment action, not elimination of the root cause.
* C: Asking customers to accept dirty products is unacceptable and contrary to ISO 9001.
* F: Awareness alone does not remove the cause of the problem.
* H: Cleaning products before release is correction, not corrective action, and does not prevent recurrence.
ISO-aligned conclusion:
Corrective actions must remove the root causes of nonconformities. In this scenario, improving product handling design, controlling environmental conditions, and modifying equipment to ensure correct ejection are the only actions that effectively prevent the recurrence of rejected products. Therefore, the correct answers are D, E and G.
NEW QUESTION # 142
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:
Answer: B,D,H
Explanation:
As the audit team leader, it is crucial to manage differing opinions constructively and ensure that the correct clause is selected for the nonconformity based on solid evidence. Here's how the situation should be handled:
E:Invite you and the second auditor to fully explain your point of view and then decide which clause to select: This promotes collaboration and transparency, allowing both auditors to present their rationale for choosing the specific clause.
F: Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply: Reviewing the evidence in relation to the specific requirements of ISO 9001 is essential for determining which clause is most appropriate.
H: Try to obtain a consensus between you and the second auditor after a discussion of the different opinions:
Consensus-building is a crucial skill for an audit team leader. Achieving agreement ensures the nonconformity is addressed accurately and with full team support.
Options such as overruling immediately (D) or deferring the decision without full discussion (B) could undermine team dynamics and the audit process. Consulting the quality manager (A) or selecting an entirely different clause (G) is unnecessary, as the team should resolve the issue internally.
NEW QUESTION # 143
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.11 (Closing Meeting):
* The audit team must proceed with the audit report, even if the auditee disagrees with findings.
* Disagreements do not invalidate audit results.
* The auditee has the right to file a complaint or appeal, but this is handled after the audit report is submitted.
Thus, the audit team acted correctly by proceeding with the audit report despite top management's disagreement.
Reference:
ISO 19011:2018, Clause 6.4.11 (Closing Meeting & Handling Disputes)
NEW QUESTION # 144
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.
Answer: C,D
Explanation:
In a third-party certification audit, auditors are responsible for maintaining confidentiality as part of their professional duties. Here's how they can demonstrate it:
* A. Adhere to the CQI Professional Code of Conduct: The CQI (Chartered Quality Institute) Code of Conduct outlines ethical principles, including confidentiality. Auditors must adhere to professional standards, ensuring sensitive information is protected and not disclosed improperly.
* B. Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices
/cameras: Before using mobile devices or cameras, auditors must seek explicit permission from the auditee and agree on confidentiality terms, preventing unauthorized recording or sharing of sensitive information.
Options C, D, and E involve breaching confidentiality and are not acceptable practices in an ISO 9001:2015 certification audit. Sharing sensitive information, removing evidence without consent, or discussing it with unauthorized parties violates audit principles and the standard's confidentiality requirements.
NEW QUESTION # 145
You are conducting an ISO 9001 audit of a Materials Recycling Facility. 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." After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.
Answer:
Explanation:
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
F # 5.2.2.c
* 8.4.3.a - No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:
"The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider."
* 7.2.b - The picking operators have been trained:This falls under Competence requirements. Clause
7.2(b) requires that persons are competent on the basis of education, training, or experience:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience."
* 10.2.2 - No documentation is retained for rejected materials:This relates to corrective action documentation. Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..."
* 10.2.1 - The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause 10.2.1 discusses actions such as containment or segregation for nonconforming outputs:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..."
* 6.2 - Management has set an objective for the level of recycling:This refers to quality objectives.
Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:
"The organization shall establish quality objectives at relevant functions... The quality objectives shall be measurable..."
* 5.2.2.c - The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:
"The quality policy shall be... available to relevant interested parties, as appropriate." References:
ISO 9001:2015, Clause 8.4.3 - Information for external providers
Clause 7.2 - Competence
Clause 10.2.2 - Corrective action documentation
Clause 10.2.1 - Nonconforming outputs
Clause 6.2 - Quality objectives
Clause 5.2.2 - Communicating the quality policy
NEW QUESTION # 146
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