Registration Management Committee AS9104/1 Certification Structures July 22, 2015 Tim Lee Chair - IAQG OPMT The Boeing Company1 RMC Workshop July 22-23, 2015 Company Confidential 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 • Adding value RMC Workshop July 22-23, 2015 2 AS9104/1 Criteria 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. 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. 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. RMC Workshop 16 – 17 July 2014 3 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 4 AS9104/1 Cert Structures • 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 Page 5 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 Page 6 AS9104/1 Annex B Eligibility Criteria for each structure Type of Certification Description: Single Site An organization that operates at one site. Multiple Site An organization having an identified central function and a network of sites at which activities are fully or partially carried out. Campus An organization having an identified central function and a decentralized, sequential, linked product realization process. All sites must be doing substantially the same manufacturing and/or value added process. 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. Several Sites 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. Complex Organization 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. All sites shall have a legal or contractual link with the central office. All sites shall have a legal or contractual link with the central office. All sites shall have a legal or contractual link with the central office. All sites shall have a legal or contractual link with the central office. One QMS with central control, management review and internal audit. One QMS with central control, management review and internal audit. One QMS with central control, management review and internal audit. One QMS with central control, management review, and internal audit. Central office can require other sites implement corrective action. Central office can require other sites implement corrective action. Central office can require other sites implement corrective action. Central office can require other sites implement corrective action. Central collection and analysis of data and ability to initiate organizational change. Central collection and analysis of data and ability to initiate organizational change. Central collection and analysis of data and ability to initiate organizational change. 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). Overall structure contains combinations of multiple site, campus several sites or more than one campus. 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. 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. 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. 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. One address per campus. Audit Day Calculations: Initial Audit: Surveillance: 9104/1 Table 2 using total number of employees. 9104/1 Table 2 using the number of employees from each site. No reductions allowed unless applying ASRP or CAAT. No reductions allowed unless applying ASRP as part of Category 2 or CAAT. Additions allowed. 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. 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). 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. No reductions allowed unless applying ASRP or CAAT. No other reductions allowed unless applying ASRP or CAAT. Other additions allowed. Additions allowed. All sites audited with audit duration as defined above. All sites audited. 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. One site with audit duration as defined above. All sites audited with audit duration as defined above. All sites audited. 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. CB to allocate total time between all sites to achieve an effective audit. Requires IAQG OPMT approval. 7 Focus on Structure Eligibility AS9104/1 - Annex B – Single Site Single Site Note: An organization must meet ALL criteria. 8 Focus on Structure Eligibility AS9104/1 - Annex B - Multiple Site, Campus, Several Sites Multiple Site Campus Common Criteria Several Sites 9 AS9104/1 Records • 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. Page 10 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. Example Diagram Page 11 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. Example Diagram Page 12 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. Page 13 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 Example Diagram Page 14 AS9104/1 Definitions Let’s discuss Value Stream: • 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. • Why is it important? • The previous example was a single value Stream? • The following is an example of an organization with multiple value streams. • Look Familiar? • What is this structure? RMC Workshop 16 – 17 July 2014 15 Several Sites Value Stream • Example: 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 Product Y delivered to Customers Product Realization Product Z delivered to Customers ‒ 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. Example Diagram Page 16 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 Example Diagram Page 17 Please make it simple! Page 18 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. Page 19 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 Page 20 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 Page 21 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 Page 22 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. Page 23 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 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 Product Y delivered to Customers Product Realization Product Z delivered to Customers Page 24 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. Page 25 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 Page 26 FAQ’s • Review the AS9104/1 FAQ Log: 27 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 28 Registration Management Committee Adding Value • The correct certification structure provides customers with a better understanding and awareness as to how a certified organization (Supplier) functions. – Customers need accurate site by site scope statements and awareness of the site dependencies. » Supports development of value added customer product/process surveillance plans » Improves supplier selection process • Incorrect structures may drive up certification costs for CB clients – Special Audits – Increased audit duration at next surveillance RMC Workshop July 22-23, 2015 29 THAT WAS: 30