BS/EN 9138-2019 pdf download.Aerospace Series-Quality Management Systems Statistical Product-Acceptance Requirements.
4.8 Non-conformances (within the sample)
No discretion shall be permitted for measurements or conditions outside of the tolerances. Any deviations from design tolerance shall be reported as non-conforming and the affected production represented by the sample shall be controlled per the organization’s quality instructions that govern non-conformances. In the event that any characteristic is rejected by the plan when lot or batch sampling is applied, the entire lot or batch shall be rejected and dispositioned in accordance with EN 9100-series standard requirements for non-conforming material.
NOTE The primary options for disposition are to inspect the remaining product in the lot, scrap the product, or return the product to its source. A material review decision to accept the product as-is with no further inspection Is not recommended due to the high probability that other uninspected units contain even more extreme non-conformances than the sample did (see Annex 0 for guidance). This policy is known as C=O.
When the sampling Is continuous or skip-lot (see Clause 9). or when the sampling uses reduced sampling levels that are less than would be required under isolated lot sampling (see Clause 7), then the sampling plan shall accommodate adequate retrievability. Replacement or rectification of product is required. Production rates and frequencies of inspection shall be linked so that if non-conforming product is found, any product skipped since the previous inspection can be retrieved. Refer to the EN 9100:2009/EN 9110:2012/EN 9120:2009 quality management system standards (see 8.2.4) for Instructions on monitoring and measuring of product.
4.9 Statistical product acceptance plans and records
The documentation of the sampling plan shall not provide for the acceptance of characteristics that are inadequately inspected in the samples. A sampling plan shall show the number of units of product from each lot or batch that are to be inspected and the criteria for determining the acceptability of the lot or batch. Both the statistical product acceptance plan and associated acceptance records shall show conformance to design requirements, account for all non-conformities in the sample, and shall be maintained in accordance with established procedures.
Plans for compiling and retrieving statistical acceptance information and acceptance data shall provide for adequate retrievability and shall provide for the verification that the plan is being executed correctly (see Annex D for guidance).
4.10 Alternate statistical techniques for product acceptance
Alternate statistical techniques and unique applications intended for special cases are covered in Clause 9. Techniques, other than those stated in this standard, that are developed and used shall be justified on the basis of recognized statistical principles to meet or exceed the required consumer protection quality parameter value or IRR (see 4.4 and 5.2). Reference Clause 5 requirements for documentrng these alternatives In written procedures and plans (see Annex D for guidance).
4.11 Auditing of statistical techniques for product acceptance
Any statistical technique for product acceptance shall be reviewed as a part of periodic internal audits conducted in accordance with the EN 9100:2009/EN 9110:2012/EN 9120:2009 quality management system standards (see 8.2.2). A technical review of the statistical application should also be performed regularly. A technical review shall be conducted by individuals who understand the design of the statistical techniques used [see Annex D (D.10) for guidance].
5 Required information to be documented
5.1 Documented procedure requirements
The organization shall document their procedures, plans, and implementation activities of statistical product acceptance applications. The organization shall perform their planning and implementation of statistical product acceptance activities in accordance with those documented procedures and plans. At a minimum, these documents shall address the requirements of this clause.
5.2 Initial Reliability Requirement or quality parameter values for product acceptance
The documentation governing application of statistical techniques for product acceptance shall provide
Instruction on how to obtain specific JRR values for specific product characteristics (see Annex A and
Annex E for guidance).BS/EN 9138-2019 pdf download.