PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

 Clause Reference – ISO 9001:2015 Clause 8.6 (Release of Products and Services):

ISO 9001 requires that products and services are not released to the customer until:

All planned verification activities have been completed.

Acceptance criteria have been met.

Any necessary approvals have been obtained.

In this scenario:

The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.

This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.

 Option Analysis:

A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.

B. Release of the product without acceptable test results has been accepted by the customer for Project DK:Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.

C. Products for Project DK have been released before product approval through the quality control process:Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.

D. The untested product was not recalled until the galvanic efficiency of the anodes was verified:Incorrect. The issue is not about recalling the product but about releasing it without completing the required tests. Recalling the product is not mentioned in the scenario.

 Why C is Correct:

The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.

This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.

 Key ISO 9001 Reference:

Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.

In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible. Therefore, the appropriate action to plan the internal audit of A’s quality management system is:

•Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25 . This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.

The other options are not appropriate actions to plan the internal audit of A’s quality management system, according to the web search results from my internal tool. They are:

•Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .

•Visit Plant A2 to interview B’s quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .

•Visit Plant A2 to interview A’s security personnel and B’s maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .

Therefore, the correct answer is D.