Transcript Registration Management Committee (RMC) 9104-1 Mike Roberts Boeing OP Assessor Workshop Company Confidential Other Party (OP) Assessor Workshop San Diego, CA January 20, 2011 Registration Management Committee (RMC) Agenda /

Registration Management Committee (RMC)
9104-1
Mike Roberts
Boeing
OP Assessor Workshop
Company Confidential
Other Party (OP) Assessor Workshop
San Diego, CA
January 20, 2011
1
Registration Management Committee (RMC)
Agenda / Contents
• Task & History
• Special Team Recommendations
• OPMT (Executive) Decisions
• Significant Changes From 9104A
• Status
• Latest Schedule+
• What Does This Mean To OP Assessors
•Q&A
[Note: Site Descriptions Included in Presentation Media]
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Original Re-write Task Requirements
• Complete the Trilogy of 9104-series documents, by
revising 9104A
• Remove sections made redundant by the release of
9104/2 (Oversight) and 9104/3 (Auditor Training and
Qualification)
• Address the areas of ICOP concern, by
enhancing/revising topics identified in the OPMT FMEA
(eg. audit days, multi-site, etc.)
• Upgrade to the new ISO and IAF audit docs.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
History
• Project initiated in Melbourne AUS in Apr. ’07
• Team activity at each Spring and Fall IAQG OPMT
meeting
• Full week face-to-face in Long Beach, Jun. ’08
• Several focus meetings due to controversial topics (eg.
audit day table, multi-site, ASRP)
• Formal Preliminary Review 8/09 to 11/09
• Formal Ballot initiated 1/10
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
History
CONTINUED
• Ballot failed in the Americas (3/10) due to controversy
over definition of ‘site’
• Ballot failed in Asia (3/10) due to mandatory audit days
and a variety of individual concerns.
• Ballot stopped in Europe (4/10) due to majority voting
‘disapprove’ due to mandatory (no reductions)
requirements of audit day table
• In total, over 60 pages (over 350 comments) were
collected related to the ballot process.
• It was discovered that Europe and Asia have not been
following IAF audit day requirements. They now feared
the consequences and costs of requiring suppliers to
meet the new “increased day” requirements.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
History
CONTINUED
• At the Wash DC IAQG meeting, the OPMT reached an
impasse; it was unable to achieve consensus as to
what direction would be given to the 9104/1 team to
solve the ballot failure issues.
• The OPMT Sector Leads brought the issue to the SWG
for guidance and direction. Some on SWT questioned
whether ISO 9001-basis and ISO/IAF compliance was
necessary.
• The SWG ordered that a special, ‘non-advocate’ team
be commissioned to review the issues, identify and
resolve conflicts, and define new requirements that,
as a minimum, meet the ISO 17xxx and IAF-MD
standards.
• The team was given a June 23rd deadline to complete.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
History
CONTINUED
The Special Non-Advocate Review Team
Facilitators:
•
Ian Folland & Tim Lee
Team Members:
• Roger Bennett - International Independent Organization for Certification (IIOC) – IAF MD 1
Convener and IAF MD 5 Co-convener
• Reg Blake - Certification Body (CB) representing the Independent Association of
Accredited Registrars (IAAR)
• Norbert Borzek - German AB - DAkkS – Chair of the IAF Technical Committee .
• Patrick Boucheron – Turbomeca, France, OPMT Voting Member
• Buddy Cressionnie - IAQG 9100 International Document Representative (IDR)
• Randy Dougherty – USA AB - ANAB Director – Chair of the IAF
• Michel Jacquaniello – Zodiac Aerospace, France
• Kunihiro Tanabe - Japanese AB - JAB
• Norikazu Tsuchiya – KHI, Japan, OPMT Voting Member
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Team Recommendations
• The special team recommended keeping the
previously developed (first ballot) audit day
table [Table 2] and multiple site
requirements table [Table 6].
• The team developed new definitions and
criteria for ‘sites’.
• The team created a detailed 17 page
“Recommendations” document and “9104/1
Certification Matrix”
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Sites – New Organizational Structures
• Single Site
• Multiple Site
• Campus
• Several Sites
• Complex Sites
These take into
consideration the unique
organizational structures
that exist in the Aviation,
Space, and Defense
industry today.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Audit Day Table 2
[same as balloted 9104/1]
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Multiple Site Table 6
Category
Audit Frequency
Organization Scope
Meets the eligibility requirements of
IAF MD 1 for sampling;
1
[same as balloted 9104/1]
and
Does not meet the eligibility
requirements of IAF MD 3 for
advanced surveillance.
NOTE: See Table 2 for audit day calculations.
Annual Surveillance – Years 1 and 2
o
Year 1 – Central function and approximately
50% of sites.
o
Year 2 – Central function and remaining sites
not audited in Year 1.
Recertification – Year 3
o
Central function and all sites.
Annual Surveillance and Recertification
Meets the eligibility requirements of
IAF MD 1 for sampling;
2
o
Year 1 – Central function and approximately
33% of sites.
o
Year 2 – Central function and approximately
50% of sites not reviewed in Year 1.
o
Year 3 – Central function and remaining sites
not reviewed in Year 1 or 2.
and
Meets the eligibility requirements of
IAF MD 3 for advanced surveillance.
San Diego, CA
January 20, 2011
Audit plan shall ensure that the maximum
duration between each site’s audit
schedule is not greater than 48 months.
Registration Management Committee (RMC)
Reductions (and Additions)
• Some reductions allowed for “Several Sites”
Category
No Human Resources Processes
No Production or Service Realization
No Purchasing
No Customer Related Processes
No QMS documentation control (not applicable for the
central function)
% Decrease
10%
20%
10%
10%
10%
• “No reductions allowed unless applying ASRP or CAAT.”
• “Additions allowed and expected”
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
OPMT (Executive) Decisions
• Accepted the ‘Special Team’ Definitions for
“Sites” and Auditor Day Requirements
– Five Categories of Site ‘Certification Structures’
»
»
»
»
»
Single Site
Multiple Site
Campus
Several Site
Complex
– Table 2 from Previous Ballot Remains the Same
– Table 6 from Previous Ballot Remains the Same
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
OPMT (Executive) Decisions
(Continued)
• Time for filling out forms was not included in
previous Audit Day Table (8.2.2.c), but was
added:
– “Note: The entry of data on the 9101 Obective
Evidence Record (OER) during on site audit time
is acceptable.”
• “Audit calculations shall round up to the
nearest ½ day.”
• “Audit activity shall never be less than 1 audit
day per site.”
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
OPMT (Executive) Decisions
(Continued)
• Combined and Integrated Audits
– Certification of a site to more than one AQMS
» ‘Fully Integrated’ and ‘Partially Integrated Rules
and Criteria Defined
» Audit Team Technical Areas Defined
» Audit Day Requirements
• Add 15% for Fully Integrated
• Add 30% for Partially Integrated
• ASRP and CAT shall not reduce this number
• ‘Not Integrated’ requires separate 100% audits.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Significant 9104/1 Changes Unchanged
From Previous Failed Ballot
• Defines AQMS and ICOP
• Updates with the new ISO-17xxx-series and IAF MD-x –
series requirements standards
• Sets surveillance requirements (# files, # assessments)
• Sets CB requirements (OASIS data responsibility,
administrator, resolution process, suspension and
withdrawal requirements, ASRP and CAAT rules, export
and confidentiality rules)
• Sets auditing rules (team lead must be AEA and on-site,
site-limited to two certification cycles, 8 hour audit day)
• Sampling of sites limited to 9120 and in same country
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
More Significant Changes
CONTINUED
• Rules for certificate issuance and transfers, loss of
certification, scope changes
• Rules for adding and auditing multiple AQMS standards
• Introduces Auditor Authentication Bodies (AABs) and
Training Provider Approval Bodies (TPABs)
• Rules for OASIS responsibility and administration
• Authority of OPMT and SMS structures
• Requirements for OASIS Feedback Process
• Rules for organization access, loss notification, T1 data
• Rules for confidentiality and conflict of interest
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
12
13
14
15
16
17
18
19
20
21
App A
App B
App C
San Diego, CA
January 20, 2011
OASIS
Hans L
Req. OPMT
Rick D
OASIS Feedback
Hans L
SMS
Tim L
Cross Frontier
Ian F
Records
Tim L
Req. Certified Orgs
Mike R
Confidentiality and Confl. of Int. Jean-Louis
Fees and Financials
Mike R
Notes
Jeff W
Acronyms
Mike R
Site Org. Req'mts Matrix
Tim L
Required Data in OASIS
Hans L
Status
Book Boss
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Title
Mike R
Mike R
Mike R
Jeff W
Rick / Mike R
Tim L
Lori S-G
Tim L
Ian F
Tim L
Jean-Louis
Rick D
Tamaki N
Tim L
Tim L
Section
Status
(General)
Rationale
Forward
Table of Contents
Scope
References
Definitions
Req. SMS
Req. ABs
Req. CBs
Req. Auditors
Req. Audits & Reporting
Req. Oversight
Req. AABs
Req. TPABs
Book Boss
G
R
F
ToC
1
2
3
4
5
6
7
8
9
10
11
Title
Section
Status: 1/14/2011
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Complete
Registration Management Committee (RMC)
9104/1 Best-Case Schedule
Date
Activity
Status
Team Lead Emails Draft to All Book Bosses, OPMT Members, SMS Focals
Complete
13-Oct-10
Final Draft to all OPMT and 9104-1 Team Members
Complete
19-Oct-10
OPMT / IAQG 9104-1 Address Major Issues / Review (York England)
Complete
17-Nov-10
Final Comments and Go-Forward Approvals Due to 9104-1 Team Lead
Complete
22-Dec-10
Courtresy Draft Sent to OPMT, RMC, 9104/1 Team, Sector Leads
Complete
14-Jan-11
Final Resolution of Comments and Issues
Complete
26-Jan-11
Complete Comments Matrix - Prepare IAQG Ballot Paperwork
26-Jan-11
Send Ballot Request to Gunter Lessman (SML)
25-Feb-11
Begin Ballot
25-Mar-11
Ballot Complete in Americas (1 month)
22-Apr-11
Ballot Complete in Asia-Pacific (2 months)
27-May-11
Ballot Complete in Europe (assuming short 3 month ballot)
10-Jun-11
Receive comments from IAQG/EAQG Document Focal
24-Jun-11
Complete Review of Comments (2 weeks) / Send to SML
1-Jul-11
SML Sends 9104-1 to Sector Standards Review Councils
29-Jul-11
Complete Review by Sector Standards Councils (30 days)
6-Oct-10
15-Aug-11
Publish (English Version) (2 weeks)
San Diego, CA
January 20, 2011
In Work
Registration Management Committee (RMC)
What Does This Mean To OP Assessors
• The requirements for ICOP have become more controlled
and complex.
• Due to the new ‘site’ structures of the organizations,
better audit planning will be required.
• There is a higher level of expectation of auditor
competency.
• While 9100 focuses on process, 9104/1 adds focus to
the ‘central function’ processes.
• Auditors will be held to a higher standard in the future.
• Publication of 9104/1 will complete the “Trilogy”, fully
describing the aerospace management of quality
systems.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Questions ?
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Back-up Slides
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
9104/1 Rewrite Team
Roll
Name
Sector
Representing
Company
Team Leader
Mike Roberts
AAQG
OPMT
Boeing
Team Sponsor
Rick Downs
AAQG
OPMT Chair (old)
Cessna
Team Member
Tim Lee
AAQG
OPMT Chair (new)
Boeing
Team Member
Vince May
AAQG
OPMT
Honeywell
Team Member
Rich Vinton
AAQG
RMC / AAQG
Raytheon
Team Member
Mike Gallagher
AAQG
OPMT
Lockheed
Team Member
Patrice Bleau
AAQG
RMC
Bombardier
Team Member
Reg Blake
AAQG
CBs
IAAR
Team Member
Lori Scheid-Gillespie
AAQG
ABs
ANAB
Team Member
Gualtiero Arsento
EAQG
OPMT
Alenia
Team Member
Herbert Mairose
EAQG
OPMT
Airbus
Team Member
Ian Folland
EAQG
was ABs, now EAQG
UKAS
Team Member
Hans Luuijt
EAQG
OASIS
ASD
Team Member
Giuseppe Leoni
EAQG
OPMT
Agusta Westand
Team Member
Tamaki Nishio
APAQG
OPMT
IHI
Team Member
Akihiro Iguro
APAQG
Team Member
Shuji Komori
APAQG
JRMC
FHI
SAE Editor
Jeff Wood
AAQG
SAE
SAE
San Diego, CA
January 20, 2011
MHI
Registration Management Committee (RMC)
What Does This Mean To The RMC
• We have been waiting 4 years to complete the Trilogy.
• We had to compensate by preparing alternate plans for
the implementation of 9100C and 9101D.
• Due to the new ‘site’ structures for organizations, new
audit planning will be required for each certified
organization.
• There is a higher level of expectation of auditor
competency.
• While 9100 focuses on process, 9104/1 adds focus to
the ‘central function’ processes.
• OASIS changes will be required.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Issues and Comments
• We have reduced auditor days for organizations with
“no design”. But we also have a number of
organizations with “no manufacturing”. Should we
consider “no manufacturing” be an “or” criteria for the
“no design” reduced audit day table column?
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Site Descriptions
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Sites – New Organizational Structures
• Single Site
• Multiple Site
• Campus
• Several Sites
• Complex Sites
The above takes into consideration the unique
organizational structures that exist in the Aviation,
Space, and Defense industry today.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Single Site Structure
A1.1
Example of a Single Site Organization
The organization has one location. It could be organised under one large building or several buildings
in one location. In either case the organisation is located on one site. The organisation has multiple
products or product families flowing through multiple processes.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Single Site Structure
• Eligibility
– Stand alone self-supporting organization with no
dependencies operating under single QMS
• Audit Day Req’mt
–
–
–
–
–
–
Table 2, using number of employees at site.
Reductions – none, except for ASRP or CAAT
Additions – allowed/expected per MD-5
Initial – one site using Table 2 audit duration
Surveillance – annual using 1/3 Table 2 audit duration
Recertification – using 2/3 Table 2 audit duration
• Certificate/OASIS
– Single address listing
– Scope declared
– Single OIN
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Multiple Site Structure
A1.2
Example of a Multiple Site Organization
The organization has two sites, A and B. They make two product families X and Y. Product family X is
made the same way using the same processes on both sites A and B. Product family Y is only made on
site A. This organization makes to customer specification. The central function is located on site A.
Explanation:
Site B conducts the same but fewer processes than site A making the same
product X. In this way the organization is eligible for a multiple site approach.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Multiple Site Structure
• Eligibility
– All sites have a legal, contractual link with central office.
One QMS, central control, mgt review, and internal audit.
Meets MD-1 criteria. One address per site.
• Audit Day Req’mt
–
–
–
–
–
–
Table 2, separately using number of employees at each site.
Reductions – none, except for ASRP or CAAT
Additions – allowed/expected per MD-5
Initial – all sites audited using Table 2 audit duration
Surveillance – using 9104/1 Table 6 (Cat. 1 & Cat. 2)
Recertification – using 9104/1 Table 6 (Cat. 1 & Cat. 2)
• Certificate/OASIS
– Central function and all sites listed.
– Scope declared for each site. Central function identified.
– Central Function OIN and all other sites OIN listed.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Campus Structure
A1.3
Example of a Campus Organization
The organisation has four sites with four buildings on site A, four buildings on site B and one
building on each site C and D. The organisation has multiple products and product families that
all flow through substantially similar processes i.e. one value stream.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Campus Structure
Explanation:
CONTINUED
Although there are different products that go through different
processes in the organisation the controlling factors are that more
than 80% of the processes in the realisation of the product are the
same and all products flow through the same overall value chain
before being delivered to the customer. Even if site B was split into
four separate sites making different types of detail parts such as
machined, formed, carbon-fibre or similar and where appropriate
using the treatments site this organisation would still be a campus as
all sites contribute to a value steam of processes running through the
organisation with a commonality that 80% of the processes that make
up each product are the same.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Campus Structure
• Eligibility
– All sites have a legal, contractual link with central office.
One QMS, central control, mgt review, and internal audit.
Output (can be dissimilar) of one site feeds input of other
sites. One address per campus.
• Audit Day Req’mt
–
–
–
–
–
–
Table 2, using number of employees from campus.
Reductions – none, except for ASRP or CAAT
Additions – 10% required, plus additions per MD-5
Initial – all sites, Table 2 for campus population + 10%
Surveillance – 1/3 initial per Table 2 plus 10%
Recertification – 2/3 initial per Table 2 plus 10%
• Certificate/OASIS
– Single controlling address listing on certificate
– Scope declared for entire campus. Central function ID’d.
– Single OIN for controlling address. Central function ID’d.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Several Site Structure
A1.4
Example of a Several Site Organization
The organization has three sites A, B and C that make different product families by mainly dissimilar
processes although some of processes such as purchasing are the same. Site C makes to customer
specification. Sites A and B design and manufacture their products. Some of the customers for products
from each site are the same, others are not.
Value Stream
Stream 1
Site A
Customer
Orders
Product X
Customer
Related
Process
Design
Purchasing
Product
Realization
Product X
delivered to
Customers
Central
Function
Site A
Stream 2
Site B
Customer
Orders
Product Y
Customer
Related
Process
Design
Purchasing
Product
Realization
Stream 3
Site C
Customer
Orders
Product Z
Customer
Related
Process
Purchasing
San Diego, CA
January 20, 2011
Product Y
delivered to
Customers
Product
Realization
Product Z
delivered to
Customers
Registration Management Committee (RMC)
Several Site Structure
Explanation:
CONTINUED
This organization has three essentially different sites with three different
sets of processes. The organization does not qualify for multiple site
because of the different processes and does not qualify for campus as
products in the value stream do not flow from one site to another. The
organization is a several site organization.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Several Site Structure
• Eligibility
– All sites have legal contractual link with central office, but
processes and products not substantially similar.
• Audit Day Req’mt
– Table 2, using number of employees separately at each site.
– Reductions – up to 30% for reduced scope complexity, or
reductions for ASRP or CAAT
– Additions – allowed/expected per MD-5
– Initial – all sites using Table 2 audit durations
– Surveillance – 1/3 Table 2 audit duration, reduced as above
– Recertification – 2/3 Table 2 audit duration reduced as above
• Certificate/OASIS
– Central function and all sites listed on certificate
– Overall scope declared, and scope for each site
– Central function and all sites have unique OIN. CF identified.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Complex Organization Structure
A1.5
Example of a Complex Organization
This organization has 6 sites. It has two different product families. One family is made through product
stream 1, the other through product stream 2. The processes carried out within sites C and D are identical
realizing the same product through the same processes. The same is true for sites E and F however the
processes in E and F are dissimilar from those used in C and D. Sites A and B support both product
streams. Sites and A and B use the same facilities for all products even through the types of products
manufactured are different and utilize different technologies in their production. Where during the
realization processes in sites A and B products in value stream 1 and in value stream 2 use the same
processes.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Complex Organization Structure
Explanation:
CONTINUED
This organization is a complex organization because it has elements of
multiple site and several campuses within it. Sites C and D are eligible for
a multiple site approach. Sites E and F would also be eligible for multiple
site approach. However the combination of C, D, E and F are not eligible
for multiple site all together because the processes are different between C
or D and E or F. There are however two campuses within the organization.
The value stream through A, B and C or D and the second value stream
through A, B and E or F. This organization is therefore made up of two
campuses with a multiple site combination within each campus, an
example of a complex organization.
San Diego, CA
January 20, 2011
Registration Management Committee (RMC)
Complex Organization Structure
• Eligibility
– Sites have legal contractual link with central office. One QMS
with combinations of site structures. Requires IAQG OPMT
approval. Individual addresses per sites or campus.
• Audit Day Req’mt
–
–
–
–
–
–
Use Table 2 for each case of single, multiple, campus, several.
Reductions – per individual site type
Additions – per individual site type, & expected per MD-5
Initial – all sites using Table 2 audit duration
Surveillance – dependent upon combination
Recertification – dependent upon combination
• Certificate/OASIS
– Central Function and all sites and/or campuses.
– All sites & campuses scopes declared. CF identified.
– All sites & campuses have unique OIN. CF identified.
San Diego, CA
January 20, 2011