8.4 The organization shall develop, collect, and analyze appropriate data to confirm the suitability and effectiveness of the quality management system and evaluate where the effectiveness of the quality management system can be continuously improved. This shall include data from the results of monitoring and measurement and other relevant sources. Source d) Supplier.
The incoming inspection pass rate was not met and no data was analyzed, let alone measures taken based on the analysis.
2. Does not meet 7.5.3 The organization shall identify the status of the product against monitoring and measurement requirements throughout the product realization.
3 Does not conform to 7.5.1 The organization shall plan and conduct production and service delivery under controlled conditions.
The specification (work instructions) states this, but it is not implemented as required.
4 Does not comply with 8.3 Control of nonconformities d) When nonconformity of the product is detected after delivery or commencement of use, the organization shall take measures appropriate to the magnitude of the effect or potential effect of the nonconformity.
This question can also be checked further,
5 does not conform to 8.2.2 The selection of auditors and the conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors should not audit their own work.
6 Not Compliant 7.5.5 The organization shall provide protection for the product during its internal handling and delivery to the intended location. Where applicable, this guarding shall include labeling, handling, packaging, storage, and protection, and the guarding shall apply to the components of the product.
7 Exceptions to 7.5.3 Where traceability is required, the organization shall control the unique identification of the product and maintain records.
Exception releases are OK with approval, but the release batch identification should be done so that in the unlikely event of a back-channel problem, it can be traced back to lock in the impact of the problem.
8 Nonconformance 7.6 The organization shall establish processes to ensure that monitoring and measurement activities are feasible and performed in a manner consistent with monitoring and measurement requirements.