EB SPEC 2678Q Page 10 of 28
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a) The organization shall maintain documented information that defines the nonconformity and corrective action management processes. b) The organization shall retain documented information as evidence of: 1) The nature of the nonconformities and any subsequent actions taken. 2) The results of any corrective action. 10.4 The supplier shall provide notification in the form of a formal Letter of Advisement (LOA) to the purchaser of any non-conformance, latent defect, or suspected fraud or falsification discovered after delivery to the Purchaser. The LOA is required for all non-conformances, or suspected fraud or falsification applicable to the purchaser’s material regardless if the non-conformance or latent defect is discovered from a Purchaser’s audit ( Electric Boat, HII-NNS), DCMA, BPMI, or the supplier’s own audit program, or by some other means. Directions for LOA submittal and an LOA template are available in Appendix E. a) LOAs are required for all non-conformances/deviations from specification or drawing requirements that do not impact form, fit or function of the material. 10.5 The supplier’s CARS must manage the prosecution of any Purchaser-issued Supplier Corrective Action Reports (SCAR) for any nonconformance that the Purchase considers to be significant or systemic. SCARs are written to obtain root cause(s) through a valid Root Causes Analysis (RCA) and/or ensure the supplier actions in response to a non-conformance are adequate by evaluating the resulting corrective action(s) and preventive action(s). 11.0 AUDITS 11.1 The supplier shall establish and maintain a quality audit program It is recommended that the supplier also establish and maintain an external review and quality audit program for non-Level I sub-tier suppliers. These programs shall be designed and implemented to determine compliance to purchase order requirements. See Appendix A for Level I sub-tier suppliers. 11.2 Both internal and external audits must be conducted per a documented schedule and utilize a checklist of audit elements that are capable of determining if contract requirements can or are being satisfied. An audit report must document the level of compliance found during the audit (e.g. SAT, Marginally SAT, UN- SAT). Nonconformance(s) discovered as a result of audits (either internal or external) must be clearly documented through the CARS process with required follow-up actions sufficient to determine satisfactory resolution. Records of audits and corrective and preventive actions shall be maintained by the supplier as Official Records and made available for review by the Purchaser upon request. Audits performed on the supplier by outside entities (DCMA, ISO, etc) that result in finding of a contract specification deviation non-conformance that impact the Purchaser’s material shall be communicated to the Purchaser by VIR or LOA as appropriate. 11.3 The supplier must audit their quality assurance program and internal manufacturing systems and/or processes at a frequency documented in their QMS to ensure compliance to their quality program and the requirements of this specification. NOTE: The supplier may use the NAVSEA PDREP audit checklist in whole or in part as necessary to use or develop an audit checklist. The NAVSEA PDREP audit checklist is available on the Electric Boat Supplier/Quality/Special Process Auditor Guidelines & Audit Checklists website.
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