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An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, 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 release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001. Which of the following options for the best description of the nonconformity?
Correct Answer: C
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.
