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You MUST notify customers immediately if your AQMS certification is withdrawn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!