8.4 The organization shall formulate, collect and analyze appropriate data to confirm the suitability and effectiveness of the quality management system, and evaluate the areas where the effectiveness of the quality management system can be continuously improved. This should include the results of monitoring and measurement and data from other relevant sources. Source d) supplier.

The qualified rate of incoming inspection did not meet the requirements, no data analysis was carried out, and no measures were taken according to the analysis.

2. The organization that does not conform to 7.5.3 shall identify the product status according to the requirements of monitoring and measuring the whole process of product realization.

3 The organization that does not conform to 7.5. 1 shall plan and provide production and services under controlled conditions.

The specification (work instruction) stipulates this, but it is not implemented as required.

4 nonconformities 8.3 Control of nonconformities d) When nonconformities are found after delivery or use, the organization shall take measures appropriate to the impact or potential impact of nonconformities.

This problem can be further investigated.

5 Non-conformance 8.2.2 The selection of auditors and the implementation of audit shall ensure the objectivity and impartiality of the audit process. Auditors should not audit their own work.

6 Non-conformance to 7.5.5 The organization shall provide protection during the internal processing and delivery of the product to the intended place. Where applicable, such protection shall include identification, handling, packaging, storage and protection, and protection shall apply to the components of the product.

When the traceability requirements in 7.5.3 are not met, the organization shall control the unique identification of products and keep records.

Exceptional release is allowed after approval, but the release batch should be marked, so that the scope of the problem can be traced and locked in case of subsequent problems.

8 The organization that does not conform to 7.6 shall establish procedures to ensure that the monitoring and measurement activities are feasible and carried out in a manner consistent with the monitoring and measurement requirements.