company confidential registration management committee 1 as9104/1 certification structures - client...
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Company Confidential
Registration Management Committee
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AS9104/1Certification Structures -
Client and CB Agreement
July 17, 2014
Tim LeeChair - IAQG OPMT
The Boeing Company
RMC Workshop 16 – 17 July 2014
Registration Management Committee
Objectives• To review the certification structures defined
within AS9104/1– Focus on eligibility criteria
• CB & Client Responsibilities
• Lessons Learned– FAQ’s
– IDR/SDR Feedback
– Certification Structure Oversight Committee (CSOC) reviews
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3.11 Certification Structure• A term utilized to describe how the certification activities of
an aviation, space, and defense organization will be structured and managed by the contracted CB.
AS9104/1 Criteria
8.1.3 Certification Structure Review and Determination
• The CB shall maintain documented evidence of the review and determination of all certification structures, including the audit duration calculation.
8.1.1 Certification Structure Eligibility Criteria
• CBs shall assess the client’s certification structure, site locations, and value streams.
• Both CB and client shall agree upon the type of certification structure.
RMC Workshop 16 – 17 July 2014
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AS9104/1 Definitions
• To understand the structures more fully we need to understand some terms from AS9104/1:– Value Stream (clause 3.27)
» An end-to-end business process which delivers a product or service to a customer. The process steps along the way may both use and produce intermediate goods, services and information to achieve the end product or service.
– Organisation (clause 3.22)
» Any legal entity or defined part of a legal entity owning a single quality management system that is subject to an ICOP audit and certification process
– Central Office (also referred to as Central Function) (clause 3.8)
» The organisation location/activity that controls the ‘common’ quality management system for the organisation under a single AQMS standard certificate.
RMC Workshop 16 – 17 July 2014
• Certification Structures are defined in clause 3.11 of AS9104/1:
• They reflect the unique organisational structures that exist in our industry today
• They can be any one of the following:‒ Single Site‒ Multiple Site - has two sub categories Category 1 and
Category 2 ‒ Campus‒ Several Sites‒ Complex
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AS9104/1 Cert Structures
• CB and client to select and agree on the conforming structure type
• To assess and select the correct certification structure the CB needs to examine the clients:
‒ Site (see 3.25) location(s)» A permanent location where an organisation carries
out work or a service
‒ Value stream(s) (see 3.27)» An end-to-end business process which delivers a
product or service to a customer.
» The process steps along the way may both use and produce intermediate goods, services and information to achieve the end product or service.
• Clients should review customer expectations
– OASIS linkage
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AS9104/1 Cert Structures
AS9104/1 Annex BEligibility Criteria for each structure
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Type of Certification
Single Site Multiple Site Campus Several Sites Complex Organization
Description: An organization that operates at one site.
An organization having an identified central function and a network of sites at which activities are fully or partially carried out.
All sites must be doing substantially the same manufacturing and/or value added process.
An organization having an identified central function and a decentralized, sequential, linked product realization process.
An organization having an identified central function and a network of sites that do not meet the criteria for a multiple site or campus organization.
Several sites are listed on the same certificate.
An organization having an identified central function and a network of locations that are any combination of multiple site, campus, several sites, or more than one campus.
Eligibility Criteria:
NOTE: An organization must meet ALL criteria.
Stand-alone self-supporting organization with no value stream dependencies from related companies operating under the same QMS.
One address.
All sites shall have a legal or contractual link with the central office.
One QMS with central control, management review and internal audit.
Central office can require other sites implement corrective action.
Central collection and analysis of data and ability to initiate organizational change.
Complies with IAF MD 1, “Multi-site Organization” definition and eligibility requirements.
All QMS processes at all sites have to be substantially (i.e., >80%) the same and are operated to the same methods and procedures.
Some sites may conduct fewer processes than others.
Sampling per IAF MD 1 will be allowed for 9120 certifications.
One address per site.
All sites shall have a legal or contractual link with the central office.
One QMS with central control, management review and internal audit.
Central office can require other sites implement corrective action.
Central collection and analysis of data and ability to initiate organizational change.
The outputs from one site are an input to another site to realize the final product or service. A single value stream.
Can be dissimilar processes at different sites or combination of the sites that contribute to the same overall product or service being realized.
More than one product or service may be realized providing they are substantially (i.e., >80%) the same (e.g., a family of products) and realized through the same methods and procedures.
One address per campus.
All sites shall have a legal or contractual link with the central office.
One QMS with central control, management review and internal audit.
Central office can require other sites implement corrective action.
Central collection and analysis of data and ability to initiate organizational change.
Processes at each of the sites is not substantially similar (i.e., <80% similar).
Processes may be operated to the same or different methods and procedures that are controlled through one common management system.
Sites realize different products or services.
One address per site.
All sites shall have a legal or contractual link with the central office.
One QMS with central control, management review, and internal audit.
Central office can require other sites implement corrective action.
Central collection and analysis of data and ability to initiate organizational change.
Overall structure contains combinations of multiple site, campus several sites or more than one campus.
Requires IAQG OPMT approval of rationale, justification, audit day calculations, audit program, and sampling plan (for 9120, multiple site or campus).
One address per site and campus.
Audit Day Calculations:
9104/1 Table 2 using total number of employees.
No reductions allowed unless applying ASRP or CAAT.
Additions allowed.
9104/1 Table 2 using the number of employees from each site.
No reductions allowed unless applying ASRP as part of Category 2 or CAAT.
Additions allowed.
9104/1 Table 2 using the total number of employee from all sites added together as a starting point.
Required 10% addition to support communication and other aspects of audit of a campus.
No reductions allowed unless applying ASRP or CAAT.
Other additions allowed.
9104/1 Table 2 using the total number of employees from each site as a starting point.
30 % maximum reduction allowed at each site for reduced scope complexity (reference Table 4).
No other reductions allowed unless applying ASRP or CAAT.
Additions allowed.
Any combination of campus, multiple sites, and/or several sites. Can include more than one campus.
Calculate using requirements for each type of entity within the organization using 9104/1 Table 2.
Requires IAQG OPMT approval.
Initial Audit: One site with audit duration as defined above.
All sites audited with audit duration as defined above.
All sites audited.
CB to allocate total time between all sites to achieve an effective audit.
All sites audited with audit duration as defined above.
All sites audited.
Surveillance:
Annual surveillance using 9104/1 Table 2 (based upon 1/3 of initial audit duration).
Refer to 9104/1 table 3 for frequency and table 2 for audit day calculations.
All sites audited using 9104/1 Table 2 for surveillance (based upon 1/3 of initial audit duration) plus minimum 10% addition.
All sites audited using 9104/1 Table 2 for surveillance (based upon 1/3 of initial audit duration). Up to 30% maximum reduction per site
Dependent on combination.
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Focus on Structure Eligibility
Note: An organization must meet ALL criteria.
Single Site
AS9104/1 - Annex B – Single Site
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Focus on Structure Eligibility
Multiple Site CampusCommon Criteria
AS9104/1 - Annex B - Multiple Site, Campus, Several Sites
Several Sites
• CB to retain records of the review and structure determination
• Must be more than just the AS9104/1 Audit Calc Tool printout– Evidence of the review and determination of all
certification structures (8.1.3).
• A defined certification structure will: ‒ Assist CBs with the development of a robust
and conforming audit program, and‒ Provide industry with visibility of the
structure within the OASIS database.
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AS9104/1 Records
Single Site
• An organisation having one location. • The organisation may be organised under one large
building or several buildings at one location. • The organisation may have one or multiple products or
product families flowing though one or multiple processes.
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Example Diagram
Multiple Site
• Example: ‒ An organisation 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 organisation makes to customer specification. ‒ The central function is located on site A.
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Example Diagram
Multiple Site
• Explanation: ‒ Site B conducts the same but fewer processes than site A
making the same product X. In this way the organisation is eligible for a multiple site approach.
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Campus
• Example: ‒ The organisation has four sites‒ 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 (>=80%) similar processes and methods i.e. one value stream
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Example Diagram
Several Sites
• Example:
‒ This organisation has three essentially different sites with three mainly different sets of processes and methods.
‒ The organisation 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.
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Example Diagram
CustomerOrders
Product X
Site A
Central Function
Site A
Customer Orders
Product YPurchasing
Customer Related Process
Product Realization
Site B
Product Y delivered to Customers
Design
Customer Orders
Product ZPurchasing
Customer Related Process
Product Realization
Site C
Product Z delivered to Customers
PurchasingCustomer Related Process
Product Realization
Product X delivered to Customers
Design
Stream 1
Stream 2
Stream 3
Value Stream
Complex
• An organisation 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
• A network of locations that are any combination of multiple site, campus, several sites, or more than one campus
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Example Diagram
Certification Structure Oversight Committee (CSOC)• The CSOC has been established to support the review of
complex certification structures and review of certification structure complaints
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http://www.sae.org/iaqg/organization/csoc.htm
• CSOC website contains:• Operating
procedure• Guidance
Material• Application• Link to
FAQ’s
AS9104/1 Certification Structures - Simple Guide
• If it’s one site (one location) it’s a Single Site structure!
– From AS9104/1 FAQ’s» A site may have one or more addresses depending on the
nature of the site. » There may be multiple buildings and addresses on a single
site or more than one address in single building.» There is no relationship between site and distance. » A single site may be small or large. » Normally a single site is contiguous were it not for natural
or man-made features e.g. roads, rivers, canals, railroads, that may happen to cross the site or multiple businesses in the same building.
» Where another feature such as a building, location or site owned or operated by another entity separates the work locations the separated locations would not be considered a single site.
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AS9104/1 Certification Structures - Simple Guide
• For organisations with more than one site there are some common features to all of the certification structures:
– All sites have a legal, organisational, or contractual link with the central office of the organisation and
– Are subject to a common management system, which is laid down, established, and subject to continuous surveillance;
– The organisation’s management system is centrally controlled and is subject to a common management review;
– All sites are subject to the organisation’s internal audit program, controlled by the central office;
– The central office has the authority to require that the site(s) implement corrective action, as needed; and
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AS9104/1 Certification Structures - Simple Guide
• For organisations with more than one site there are some common features to all of the certification structures:
– The organization collects and analyses data from all sites, including but not limited to the listed items below.
– The central office is able to demonstrate its authority and ability to initiate organisational change, as required, 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.
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AS9104/1 Certification Structures - Simple Guide
• The Central Office (or Central Function):
– Within AS9104/1 the Central Office has a specific meaning:» the organisation location/activity that controls the
‘common’ quality management system for the organisation under a single AQMS standard certificate.
– It is not any of the following(although could be the same site):» The Headquarters of the organisation» The location of centralised processes such as;
• Design• Purchasing• Manufacturing or Production Engineering• Human Resources
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AS9104/1 Certification Structures - Simple Guide
• Spotting a ‘Multiple Site’ Structure:
– All quality management system processes at all sites have to be substantially (i.e., >80 %) the same and are operated to the same methods and procedures.
– Some sites may conduct fewer processes than others.
– One address per site
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AS9104/1 Certification Structures – Simple Guide
• Spotting a ‘Campus’ Structure:
– The outputs from one site are an input to another site to realise the final product or service; a single value stream.
– Can be dissimilar processes at different sites or combination of sites that contribute to the same overall product or service.
– More than one product or service may be realised provided they are substantially (i.e., >80 %) the same (e.g., a family of products) and realised through the same methods and procedures.
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AS9104/1 Certification Structures - Simple Guide
• Spotting a ‘Several Sites’ Structure:
– Processes at each of the sites are not substantially similar (i.e., <80 % similar).
– Processes may be operated to the same or different methods and procedures that are controlled through one common quality management system.
– Sites realise different products or services.
– One address per site
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CustomerOrders
Product X
Site A
Central Function
Site A
Customer Orders
Product YPurchasing
Customer Related Process
Product Realization
Site B
Product Y delivered to Customers
Design
Customer Orders
Product ZPurchasing
Customer Related Process
Product Realization
Site C
Product Z delivered to Customers
PurchasingCustomer Related Process
Product Realization
Product X delivered to Customers
Design
Stream 1
Stream 2
Stream 3
Value Stream
AS9104/1 Certification Structures - Simple Guide
• Spotting a ‘Complex’ Structure:
– Overall structure contains combinations of multiple sites, campus (can be more than one campus), or several sites.
– Requires IAQG OPMT approval of rationale, justification, audit duration calculations, audit program, and sampling plan (for 9120, multiple site, or campus).
– One address per site and per campus.
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AS9104/1 Certification Structures - Simple Guide
• In ALL cases:– CBs shall assess the client’s certification
structure, site locations, and value streams.» If in doubt, draw them out!
– Both the CB and client to agree upon the type of certification structure» Do not forget the Customer
– The CB shall maintain documented evidence of the review and determination of all certification structures, including the audit duration calculation. » This does not mean a tick box» Nor does it mean ‘because the last auditor said so’» Requires documentation of why the clients fits each
criteria with an explanation or evidence
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Lessons Learned
• AS9104/1 and Certification Structure Oversight Committee (CSOC) FAQs can be accessed via the IAQG website.
• Links:– AS9104/1 FAQ– CSOC FAQ
• The IAQG IDR/SDR process can be used to obtain clarification on the intent of the standard– Access via OASIS feedback function– Questions asked are used to generate FAQs
• The OPMT also issues Resolutions when specific clarification is needed for any one of the AS9104 series of standards. (Refs: AS9104/1, Section 4.16)– Link: IAQG OPMT Resolutions