QCI-1001 Internal Audits - New.docx

**PURPOSE AND SCOPE** Internal auditing is an independent, objective activity designed to improve Continental Disc Corporation's (CDC) operations by utilizing a systematic, disciplined approach to verify compliance and effectiveness of the Quality Management System (QMS). Internal process audits id...

**PURPOSE AND SCOPE** Internal auditing is an independent, objective activity designed to improve Continental Disc Corporation's (CDC) operations by utilizing a systematic, disciplined approach to verify compliance and effectiveness of the Quality Management System (QMS). Internal process audits identify areas of improvement, mitigate identified risks, and ensure company objectives are being met. This instruction defines the process for planning, conducting, reporting, and maintaining records of internal audits of CDC's QMS at the Liberty, MO location. 2. **STANDARDS AND REFERENCES (CURRENT VERSIONS)** - ISO 9001, "Quality Management Systems" - AS9100, "Quality Management Systems - Requirements for Aviation, Space and Defense Organizations" - ISO/IEC 80079, "Explosive Atmospheres Part 34: Application of Quality Systems for Ex Product Manufacture" - 10 CFR Part 50\_Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants - ASME NQA-1 Part 1, Quality Assurance Requirements for Nuclear Facility Applications - BPVC\_XIII, "ASME Boiler and Pressure Vessel Code Section XIII- Mandatory Appendix III: Quality Control System" - 2014/68/EU, "Pressure Equipment Directive (PED -- Module D: Conformity to the Type Based on Quality Assurance of the Production Process" - ISO 3834-3, "Standard Quality Requirements for Fusion Welding of Metallic Materials" - CDC Quality Assurance Manual - QCI-1015, Corrective and Preventative Action 3. **RESPONSIBILITY** **Quality Assurance Manager** - Manage CDC's internal audit program. - Provide training on auditing techniques, QMS compliance requirements, and CDC audit processes. - Select auditors based on qualifications and competency and perform annual evaluations of audit team. - Develop annual audit schedule to verify compliance to all elements of CDC's QMS. - Create an audit plan in the ERP system that identifies the scope, criteria, schedule, team members, and required documents and standards for each planned audit. - Reconcile disagreements between lead auditor and the audit team or auditee as necessary. - Verify internal audits are carried out in accordance with the published plan and this procedure. - Confirm nonconformances are identified, corrective actions are sufficient, and implementations are effective. - Approve audit reports and corrective actions, when required, in the ERP system and verify records are available and maintained. **\ Auditor / Audit Team Member** - - - - - **Lead Auditor** - - - - - **Auditee / Process Owner** - - - - **Top Management** - - 4. **AUDITOR QUALIFICATION** **Auditors are selected by the Quality Assurance Manager after displaying understanding and competency of** CDC's internal audit program and the elements of QMS compliance detailed in the applicable AS9100 and ISO 9001 standards. **C**ompetency shall be evaluated annually through completed training on QMS standards and requirements, audit participation, and displayed auditing techniques. Qualified personnel can serve as an auditor on an audit team or as a lead auditor based on the audit roles assigned in the audit plan. All auditors **shall have sufficient authority and organizational freedom to make the audit process meaningful and effective.** Lead auditors for nuclear audits shall meet the requirements outlined in ASME NQA-1 Part 1, Quality Assurance Requirements for Nuclear Facility Applications, Requirement 2 - Quality Assurance Program. 5. **AUDIT PROCESS** 6. **AUDIT COMPLIANCE** **Compliance indicates that the interviews conducted, processes observed, and evidence reviewed meets the requirements identified in the applicable standards and documented QMS procedures (quality manual, process maps, work instructions, etc.). Documents required for compliance determination are included in the audit plan and should be carefully reviewed and analyzed throughout the audit process.** - - 7. **AUDIT REPORT** **A written audit report is required for all planned internal audits and shall include the audit scope, participants, processes observed, compliance documentation, audit observations, objective evidence, and an audit summary. The report guarantees that the audit results are useful, understandable, and drive improvement activities.** - - - - **The audit report shall be drafted and reviewed with stakeholders and area management to ensure the accuracy of the findings during the closing meeting. The final audit report will be uploaded to the audit plan in the current ERP system for approval by the Quality Assurance Manager.** 8. **AUDIT CLOSING MEETING** **A closing meeting shall be held within 30 days of the completion of the audit with persons responsible for and management over the audited process and the QMS in attendance. The lead auditor shall present the audit teams' conclusions in a manner that ensures the conclusions are clearly understood and agreed upon by all participants.** **All confirmed noncompliances require a corrective action to bring the process into compliance. The type of corrective action and time for completion shall be determined by the attendees of the closing meeting taking into consideration the severity of the noncompliance and the risk level to CDC's QMS. The lead auditor shall create the corrective action record in the current ERP system detailing the agreed upon completion time and closure criteria.** 9. **RECORD RETENTION** **All records relevant to CDC's internal audit program shall be stored electronically in the current ERP system for a minimum of ten years. These records include:** - **Auditor Training & Qualifications** - **Audit Plans** - **Audit Records and Reports** - **Corrective Actions** - **Management Review** 10. **REVISION CONTROL** +-----------------+-----------------+-----------------+-----------------+ | **Rev.** | **Description** | **Date** | ###### Approved | +-----------------+-----------------+-----------------+-----------------+ | AA | Full document | 7/9/2024 | Valerie Stuart | | | rewrite to | | | | | detail new | | | | | audit process | | | | | and | | | | | requirements | | | | | focusing on key | | | | | processes and | | | | | the required | | | | | standard | | | | | elements. | | | | | Previous | | | | | revisions and | | | | | history can be | | | | | viewed on | | | | | QCI-1001 in the | | | | | current ERP | | | | | system. | | | +-----------------+-----------------+-----------------+-----------------+ | | | | | +-----------------+-----------------+-----------------+-----------------+ | | | | | +-----------------+-----------------+-----------------+-----------------+ | | | | | +-----------------+-----------------+-----------------+-----------------+