AS9104/1 TransitionPresented by:
Michelle Barton – Lead Technical Reviewer/Auditor UL DQS Inc.
New industry requirements that impact both of us. We must continue to work together to satisfy.
Welcome
General overview of AS9104/1 Significant Changes Identified
OASIS Reporting Audit Day Duration Transfer Process Suspension/Withdrawal Contract Addendum Certification Structure
AGENDA for AS9104/1 Transition Webinar
Impact newsletterTwo webinars Direct mailings UL DQS Auditors UL DQS website postings
Customer Communications
Requirements for Aviation, Space, and Defense Quality Management System Certification Programs.
Replaces AS9104 – currently referenced on all AS9100/9110/9120 certificates.
AS9104/1 Overview
Audit Process Improvements (AS9101 Rev D)
Consistency of Auditor Training (AATT)
Various other changes in the aerospace registration scheme requirements
AS9104/1 Revision
This revision of AS9104/1 is a complete rewrite of the original 9104 document
The document increased from 30 to 49 pages
AS9104/1 Revision Continued…
Supplemental Rule 002 (SR-002) document contains supplemental rules for all stakeholders (including certified organizations) to facilitate the transition from the existing AS9104 standard to the new AS9104/1 standard.
Available on the SAE OASIS website
Implementation
All audits performed on or after January 1, 2013 must be in compliance with AS9104/1.
Timeline
You MUST notify UL DQS in case a major finding is issued by a customer
You MUST notify UL DQS of significant changes (address, ownership, key management, employee count, scope of operations, etc.)
You MUST notify customers immediately if your AQMS certification is withdrawn
Notification Changes
Certified organizations face suspension if you fail to demonstrate conformance within 60 days from issue of NCR.
Certified organizations required to notify customer where applicable (containment of potential NC product, major finding, etc.)
More robust corrective action process. Greater emphasis on containment and root cause.
Available resources include: ANAB Heads Up #137 – Corrective action guidelines IAQG Supply Chain Management Handbook (best practices)
Nonconformance Changes
Must be identified prior to certificate being issued and inclusion in OASIS
Failure to maintain an admin. can result in suspension
Responsible for maintaining data in OASIS
Must access OASIS at a minimal of every 3 months or will be deactivated.
Role of OASIS Administrator
Certified Organizations must allow CB to post Tier 1 and Tier 2 Audit Data to OASIS Database.Tier 1 is Public InformationAgree to provide access to Tier 2 data to their customers and potential customers upon request
Significant Changes to OASIS Reporting
OASIS Feedback Process
Ensure access for audits involving areas and materials which are classified and/or export controlled prior to audit.
The scope of certification shall not include processes that were not audited to sufficient depth to verify client (organization) conformance.
‘Control of Purchasing’ process audited annually. NCRs must be left at the end of the on-site audit
the remaining documents delivered within 2 weeks.
CB and any legal entity may not consult
Significant Changes to CB Requirements
Lead auditor MUST rotate after 2 audit cycles
Can return after being off for 1 audit cycle
Client may not request auditor changes unless there are significant issues.
Changes to Auditor Assignment
New table specifies Initial, Surveillance, & Recertification Days for 9100/9110, 9100/9110 less Design, and 9120.
NO reductions from Audit Day Table are allowed, unless specifically defined.
Increases to Audit Day Table are both allowed and expected.
Significant Changes to Audit Duration
Audit Day Table: DOES NOT include Non-Audit Time (travel,
meals, extended breaks, etc.)DOES NOT include Auditor Time for Audit
Planning, Writing of Reports, Filling Out 9101 Forms, etc.
Extra time for correction and corrective action verification, use of translators, etc.
Significant Changes to Audit Duration
Audit Day is 8 HoursMore than 8 hours = 8 hours Must audit ALL working shiftsShift auditing still meets 8 hour daily
limitationIf work less than 8 hours per day, extra days
must be added to maintain on-site durationIf stage 1 is required at recertification, audit
time is to be added to the minimal Triennial Days
Significant Changes to Audit Day
Desktop review still required.On-site special visit required by an AEA
before certificate issuance. If existing certificate expires within the
next 12 months, an S1 and S2 are required.
If any NCRs from the previous audits were not verified and closed within 90 days of issuance, S1 and S2 are required
Significant Changes to Transfer Process
Increased number of witness audits.Industry has access to audit reports
in OASIS. Certified organizations must allow
3rd parties (AB, etc.) to accompany UL DQS for witness audits.
Some AS&D primes are reviewing reports in OASIS.
Significant Changes to Oversight Activity
If not in conformance within 60 days of the issuance of the NCR, suspension
If no OASIS administrator, possible suspension. If OASIS information is not kept up-to-date,
possible suspension. If withdrawn, immediate notification to AS&D
customers by clientFailure to abide by AS9104/1 shall be cause for
certification withdrawal
Significant Changes to Suspension/Withdraw
AS9104/1 requires UL DQS to flow down requirements and amend existing contracts.
Contract addendum will be sent to each certified organization.
Significant Changes to Contract (Addendum)
ID of appropriate certification structure Access to tier 1 & 2 data Provide access to the Tier 2 data in the OASIS
database Notification to customers if AQMS certification is
withdrawn Notification to UL DQS in case a major finding is issued
by a customer ID of OASIS administrator Robust corrective action process
New additions to Contract
New additions to Contract
Effective complaint resolution process and right to perform short notice audit within 90 days
Disclosure of classified material/export requirements relating to UL DQS access to processes/materials
Right of 3rd parties to accompany UL DQS during oversight witness audits
Certificate withdrawal due to failure to comply with contract addendum and AS9104/1
Constraints to request for auditor changes/substitutions Disclosure of top 5 aviation, space & defense
customers, contact information & percent of business
Single siteMultiple siteCampusSeveral siteComplex
Certification Structure Types
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.
Single Site
all sites have a legal, organizational, or contractual link with the central office and are subject to a common management system,
the organization’s management system is subject to a common management review;
all sites are subject to the organization’s internal audit program,
the central office has the authority to require that the site(s) implement corrective action
Common eligibility criteria for all certification structures except single site:
The organization collects and analyzes data from all sites. 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 legal requirements.
Common eligibility criteria cont…
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.
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.
Multiple Site
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.
Campus
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.
Several Sites
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.
Complex
Appendix B, Page 1
Appendix B, Page 2
Appendix B, Page 3
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 AS9104/1.
Certification structure form – Questionnaire to be filled out by UL DQS certified organizations.
Certificate and OASIS will identify certification structure
How Certification Structures are used
Auditors will be required to validate structure type on-site
The IAQG/OPMT Certification Structure Oversight Committee (CSOC) is required to review and approve all complex certification structures.
How Certification Structures are used cont…
Introduction of new certification structure types New audit day requirements OASIS administrator Requirements related to NCR responses
Robust corrective action and complaint resolution process
Limits to request for auditor changes Requirements for transferring Additional industry oversight UL DQS contract addendum
Summary
Questions?
Thank you for attending.
If you have any questions, please visit:
http://ul-dqsusa.com/services/quality-management/aerospace-industry/
and send us an email!
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