- Количество слайдов: 40
AS 9104/1 Transition Presented by: Michelle Barton – Lead Technical Reviewer/Auditor UL DQS Inc.
Welcome Ø New industry requirements that impact both of us. We must continue to work together to satisfy.
AGENDA for AS 9104/1 Transition Webinar Ø General overview of AS 9104/1 Ø Significant Changes Identified Ø Ø Ø OASIS Reporting Audit Day Duration Transfer Process Suspension/Withdrawal Contract Addendum Certification Structure
Customer Communications ØImpact newsletter ØTwo webinars ØDirect mailings ØUL DQS Auditors ØUL DQS website postings
AS 9104/1 Overview ØRequirements for Aviation, Space, and Defense Quality Management System Certification Programs. ØReplaces AS 9104 – currently referenced on all AS 9100/9110/9120 certificates.
AS 9104/1 Revision Ø Audit Process Improvements (AS 9101 Rev D) Ø Consistency of Auditor Training (AATT) Ø Various other changes in the aerospace registration scheme requirements
AS 9104/1 Revision Continued… Ø This revision of AS 9104/1 is a complete rewrite of the original 9104 document Ø The document increased from 30 to 49 pages
Implementation Supplemental Rule 002 (SR-002) Ø document contains supplemental rules for all stakeholders (including certified organizations) to facilitate the transition from the existing AS 9104 standard to the new AS 9104/1 standard. ØAvailable on the SAE OASIS website
Timeline Ø All audits performed on or after January 1, 2013 must be in compliance with AS 9104/1.
Notification Changes Ø You MUST notify UL DQS in case a major finding is issued by a customer Ø You MUST notify UL DQS of significant changes (address, ownership, key management, employee count, scope of operations, etc. ) Ø You MUST notify customers immediately if your AQMS certification is withdrawn
Nonconformance Changes Ø Certified organizations face suspension if you fail to demonstrate conformance within 60 days from issue of NCR. Ø Certified organizations required to notify customer where applicable (containment of potential NC product, major finding, etc. ) Ø More robust corrective action process. Greater emphasis on containment and root cause. Ø Available resources include: Ø ANAB Heads Up #137 – Corrective action guidelines Ø IAQG Supply Chain Management Handbook (best practices)
Role of OASIS Administrator ØMust be identified prior to certificate being issued and inclusion in OASIS ØFailure to maintain an admin. can result in suspension ØResponsible for maintaining data in OASIS ØMust access OASIS at a minimal of every 3 months or will be deactivated.
Significant Changes to OASIS Reporting Certified Organizations must allow CB to post Tier 1 and Tier 2 Audit Data to OASIS Database. ØTier 1 is Public Information ØAgree to provide access to Tier 2 data to their customers and potential customers upon request
OASIS Feedback Process
Significant Changes to CB Requirements Ø Ensure access for audits involving areas and materials which are classified and/or export controlled prior to audit. Ø The scope of certification shall not include processes that were not audited to sufficient depth to verify client (organization) conformance. Ø ‘Control of Purchasing’ process audited annually. Ø NCRs must be left at the end of the on-site audit the remaining documents delivered within 2 weeks. Ø CB and any legal entity may not consult
Changes to Auditor Assignment ØLead auditor MUST rotate after 2 audit cycles ØCan return after being off for 1 audit cycle ØClient may not request auditor changes unless there are significant issues.
Significant Changes to Audit Duration ØNew table specifies Initial, Surveillance, & Recertification Days for 9100/9110, 9100/9110 less Design, and 9120. ØNO reductions from Audit Day Table are allowed, unless specifically defined. ØIncreases to Audit Day Table are both allowed and expected.
Significant Changes to Audit Duration ØAudit Day Table: ØDOES NOT include Non-Audit Time (travel, meals, extended breaks, etc. ) ØDOES NOT include Auditor Time for Audit Planning, Writing of Reports, Filling Out 9101 Forms, etc. ØExtra time for correction and corrective action verification, use of translators, etc.
Significant Changes to Audit Day Ø Audit Day is 8 Hours Ø More than 8 hours = 8 hours Ø Must audit ALL working shifts Ø Shift auditing still meets 8 hour daily limitation Ø If work less than 8 hours per day, extra days must be added to maintain on-site duration Ø If stage 1 is required at recertification, audit time is to be added to the minimal Triennial Days
Significant Changes to Transfer Process Ø Desktop review still required. Ø On-site special visit required by an AEA before certificate issuance. Ø If existing certificate expires within the next 12 months, an S 1 and S 2 are required. Ø If any NCRs from the previous audits were not verified and closed within 90 days of issuance, S 1 and S 2 are required
Significant Changes to Oversight Activity Ø Increased number of witness audits. Ø Industry has access to audit reports in OASIS. Ø Certified organizations must allow 3 rd parties (AB, etc. ) to accompany UL DQS for witness audits. Ø Some AS&D primes are reviewing reports in OASIS.
Significant Changes to Suspension/Withdraw Ø If not in conformance within 60 days of the issuance of the NCR, suspension Ø If no OASIS administrator, possible suspension. Ø If OASIS information is not kept up-to-date, possible suspension. Ø If withdrawn, immediate notification to AS&D customers by client Ø Failure to abide by AS 9104/1 shall be cause for certification withdrawal
Significant Changes to Contract (Addendum) ØAS 9104/1 requires UL DQS to flow down requirements and amend existing contracts. ØContract addendum will be sent to each certified organization.
New additions to Contract Ø ID of appropriate certification structure Ø Access to tier 1 & 2 data Ø Provide access to the Tier 2 data in the OASIS database Ø Notification to customers if AQMS certification is withdrawn Ø Notification to UL DQS in case a major finding is issued by a customer Ø ID of OASIS administrator Ø Robust corrective action process
New additions to Contract Ø Effective complaint resolution process and right to perform short notice audit within 90 days Ø Disclosure of classified material/export requirements relating to UL DQS access to processes/materials Ø Right of 3 rd parties to accompany UL DQS during oversight witness audits Ø Certificate withdrawal due to failure to comply with contract addendum and AS 9104/1 Ø Constraints to request for auditor changes/substitutions Ø Disclosure of top 5 aviation, space & defense customers, contact information & percent of business
Certification Structure Types ØSingle site ØMultiple site ØCampus ØSeveral site ØComplex
Single Site An organization having one location. The organization may be operating under one large building or several buildings at that location. The organization may have one or multiple products or product families flowing though one or multiple processes.
Common eligibility criteria for all certification structures except single site: Ø all sites have a legal, organizational, or contractual link with the central office and are subject to a common management system, Ø the organization’s management system is subject to a common management review; Ø all sites are subject to the organization’s internal audit program, Ø the central office has the authority to require that the site(s) implement corrective action
Common eligibility criteria cont… Ø The organization collects and analyzes data from all sites. Ø The central office is able to demonstrate its authority and ability to initiate organizational change, in regard to: system documentation; system changes; management review; complaints; evaluation of corrective actions; internal audit planning and evaluation of the associated audit results; and Ø legal requirements. Ø Ø Ø
Multiple Site Ø An organization having an identified central function (the central office, but not necessarily the headquarters of the organization) at which certain activities are planned, controlled, or managed and a network of sites at which such activities are fully or partially carried out. Ø With the exception of the central office the processes within each of the sites are substantially the same and are operated to the same methods and procedures.
Campus Ø An organization having an identified central function (the central office, but not necessarily the headquarters of the organization) at which certain activities are planned, controlled, or managed; and that has a decentralized, sequential, linked product realization process.
Several Sites Ø An organization having an identified central function (the central office, but not necessarily the headquarters of the organization) at which certain activities are planned, controlled, or managed and a network of sites, that do not meet the criteria for either a multiple site or a campus organization.
Complex Ø An organization having an identified central function (the central office, but not necessarily the headquarters of the organization) at which certain activities are planned, controlled, or managed and a network of locations that are any combination of multiple site, campus, several sites, or more than one campus.
Appendix B, Page 1
Appendix B, Page 2
Appendix B, Page 3
How Certification Structures are used Ø UL DQS and the certified organization will need to agree on the appropriate certification structure for your organization based on criteria defined in appendix B of AS 9104/1. Ø Certification structure form – Questionnaire to be filled out by UL DQS certified organizations. Ø Certificate and OASIS will identify certification structure
How Certification Structures are used cont… ØAuditors will be required to validate structure type on-site ØThe IAQG/OPMT Certification Structure Oversight Committee (CSOC) is required to review and approve all complex certification structures.
Summary Ø Ø Introduction of new certification structure types New audit day requirements OASIS administrator Requirements related to NCR responses Ø Robust corrective action and complaint resolution process Ø Ø Limits to request for auditor changes Requirements for transferring Additional industry oversight UL DQS contract addendum
Questions? Thank you for attending. If you have any questions, please visit: http: //ul-dqsusa. com/services/qualitymanagement/aerospace-industry/ and send us an email!