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AS9104/1 Transition and Oversight Assessment of Certification Bodies

AS9104/1 Transition and Oversight Assessment of Certification Bodies. Mike Roberts 12 March 2012. AS9104/1 Transition for CBs. Turn to SR-002: Read what is required from the SMS / CBMC and OP Assessors for AS9104/1 transition of CBs Question: What is required? Office Assessment ?

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AS9104/1 Transition and Oversight Assessment of Certification Bodies

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  1. AS9104/1 Transition andOversight Assessment of Certification Bodies Mike Roberts 12 March 2012

  2. AS9104/1 Transition for CBs • Turn to SR-002: • Read what is required from the SMS / CBMC and OP Assessors for AS9104/1 transition of CBs • Question: What is required? • Office Assessment ? • Witnessed Assessment ? • Any Assessment?

  3. Exercise CB AS9104/1 Transition • In groups: • Look at SR-002 • On your flip charts, make a list answering the question • What is the AB required to assess to transition a CB to AS9104/1?

  4. Questions?

  5. Introducing AS9104/1 for CBs • AS9104/1 has a number of sections that are the requirements for CBs: • Section 6 - Requirements for CBs • Section 8 - Requirements For Audits And Reporting which contains the requirements around the audit process including: • Certification Structures (see also Appendix B) • Minimum Audit Durations • Audit Teams • Certificate content • Transfers • ASRP and CAAT • Section 18 – Requirements for Certified Organisations

  6. Introducing AS9104/1 for CBs • Spend 15 mins reading AS9104/1 section 6 • Any questions

  7. Introducing AS9104/1 for CBs • We are going to spend the next section looking at AS9104/1 section 8 • We will review: • Certification Structures • Audit Durations • Audit durations when combined with 91XX:2009 transition

  8. New Organisational Structures • AS9104/1 section 8 and Annex B describes new certification structures: • Single Site • Multiple Site • Campus • Several Sites • Complex • These reflect the unique organisational structures that exist in the Aviation, Space, and Defence industry today.

  9. 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. • Site (clause 3.25) • A permanent location where an organisation carries out work or a service.

  10. Definitions • To understand the structures more fully we need to understand some terms from AS9104/1: • 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.

  11. Certification Structures (clause 3.11) • A term utilised to describe how the certification activities of an A, S and D organisation will be structured and managed by the contracted CB. • The defined 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 • In all structures there is (8.1.1.c): • One common quality management system • Central control of management review and internal audit • The ability to initiate change and corrective action centrally. • The organisation centrally collects and analyses organisational performance.

  12. The Certification Structures 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

  13. The Certification Structures Multiple Site • An organisation having an identified central function (the central office, but not necessarily the headquarters of the organisation) at which certain activities are planned, controlled or managed • The organisation has 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 (>=80%) the same and are operated to the same methods and procedures (see IAF MD 1, “Multi-site Organization” definition and eligibility requirements).

  14. The Certification Structures 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.

  15. The Certification Structures Multiple Site • Example: • 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

  16. The Certification Structures Campus • An organisation having an identified central function (the central office, but not necessarily the headquarters of the organisation) at which certain activities are planned, controlled, or managed • Has a decentralised, sequential, linked product realisation process, which is • Referred to as a value stream in which the outputs from one site is an input to another site which ultimately results in the final product or service

  17. The Certification Structures 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

  18. The Certification Structures Campus • Example:

  19. The Certification Structures Campus • Explanation: • 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 single value steam of processes running through the organisation with a commonality that 80% of the processes and methods that make up each product are the same.

  20. The Certification Structures Several Sites • An organisation having an identified central function (the central office, but not necessarily the headquarters of the organisation) at which certain activities are planned, controlled or managed • A network of sites that do not meet the criteria for either a multiple site or a campus organisation • Example: • The organisation has three sites A, B and C that make different product families by mainly dissimilar processes and methods 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.

  21. The Certification Structures 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.

  22. The Certification Structures 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

  23. The Certification Structures Complex • Example: • The organisation has 6 sites and 2 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 realising the same product through the same processes. • The same is true for sites E and F however the processes and methods in E and F are dissimilar from those used in C and D. • Sites A and B support both product streams. • Sites 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 realisation processes in sites A and B the products in value stream 1 and in value stream 2 use the same processes.

  24. The Certification Structures Complex • Example:

  25. The Certification Structures Complex • Explanation: • This organisation is a complex organisation 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. • 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 organisation is therefore made up of two campuses with a multiple site combination within each campus.

  26. The Certification Structures Complex – More Information: • When a CB determines with its client that the certification structure will be ‘Complex’ they have to (clause 8.2.1.5): • Document the rational for the subset organisational types • The justification to be sent to the IAQG OPMT Certification Structure Review Sub-Team • The justification includes: • applied methodology, • audit duration calculation, • planned audit program, • sampling plan for multiple site organizations, processes for campus organizations • Review results to be received from the IAQG OPMT before proceeding to stage 2 audit (clause 8.1.3) • Question - What about application of ‘complex’ certification structures during transition?

  27. AS9104/1 Annex B

  28. AS9104/1 Annex B • Keep Annex B with you • It will be your guide for answering questions and evaluating certification structures • Remember in order to qualify for a particular structure the client organisation must meet ALL of the eligibility criteria and not just a few (see 8.1.1 and Appendix B) • Follow the justification the CB has made and agreed with its client • Watch out for incorrect use of ‘Campus’ • There will be a demand from existing 9104 ‘multiple-site’ client organisations • Many will not be eligible • Use a major nonconformity if you find errors in this area because the focus is reduction of audit time and not effective audits

  29. Certification Structures Summary • AS9104/1 section 8 and Annex B describes new certification structures: • Single Site • Multiple Site • Campus • Several Sites • Complex • Each structure type is unique in terms of description, eligibility criteria, audit day calculations, certificate contents and OASIS entry requirements • Most EAQG member companies are likely to be categorised as ‘complex’ • Today 85% of issued certificates are for single site

  30. Questions

  31. Exercise Certification Structures • In groups: • Examine the description you have for an organisation and determine the correct certification structure • On your flip charts, record the structure you selected and the justification for why you selected it • If you can’t all agree go with the majority and record the split • Choose a member of the group to feed back • Exercise duration 20 minutes

  32. Exercise Certification Structures Description: • One organisation of 4 sites, meets all of the criteria of AS9104/1 8.1.1.c) • Procedures are > 80% the same although Product Families 1 and 2 use different technologies in their manufacture but both produce an aviation vehicle • Product Family 1 is metal framed and jet propelled • Product Family 2 is carbon framed and high technology turbo-propeller propelled • Sites and flows are as per the diagram:

  33. Exercise Certification Structures Description: • What is the structure? – Justification?

  34. Introducing AS9104/1 for CBs • We are going to spend the next section looking at AS9104/1 section 8 • We will review: • Certification Structures • Audit Durations • Audit durations when combined with 91XX:2009 transition

  35. Audit Duration • Calculating audit duration is one of the most difficult parts of the certification process • It is not an absolute process nor does it produce an absolute answer • We know it is used as one of the ways some Certification Bodies (CBs) try to differentiate themselves from other CBs • This presentation does not focus on the cost of AQMS standard certification only the methodology for calculating audit duration

  36. ISO 17021 and Audit Duration • ISO / IEC 17021 clause 9.1.4 and 9.1.5 set out the basic requirements for a CB to determine audit time • The CB shall have documented procedures to determine audit time, and • For each client the CB shall determine time needed to plan and accomplish a complete and effective audit ….. • Determined audit time and the justification for the determination shall be recorded ….

  37. ISO 17021 and Audit Duration • Clause 9.2.1 - CB to collect significant information about the clients organisation from an authorised representative • Clause 9.2.2 - CB to conduct an application review to consider all of the information gathered, resolve any lack of understanding and to ensure that scope, locations, time required to complete audits and other factors are considered • Then determine competencies needed for audit and decision-making • And … record a justification for the decision to undertake the audit

  38. IAF and Audit Duration • ISO 17021 requires a process and procedures but does not state what the time for an audit should be • This creates an open market in which competitive pressure is to constantly reduce the cost of the certification service and therefore to reduce audit days • ISO 17021 recognises this and in clause 4.2.2 states • ‘It is recognized that the source of revenue for a certification body is its client paying for certification, and that this is a potential threat to impartiality.’

  39. IAF and Audit Duration • To help the CBs and the ABs the IAF produce Mandatory Documents (MD Series) • Their status is that they are mandatory requirements however the CB may propose and utilise alternates that are equivalent to the MD. • There are two principle documents affecting audit duration and time on site: • IAF MD 5:2009 IAF Mandatory Document for Duration of QMS and EMS Audits • IAF MD 1:2007 IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling • MD 5 is mainly for single site and MD 1 for multiple sites

  40. AS9104/1 and Audit Time • AS9104/1 tells CBs how to calculate on-site audit duration • To reduce commercial competitive pressures on CBs • To simply the calculation process • AS9104/1 Clause 8 and Appendix B contain the requirements • There is a process as before but it is simplified as follows: • Use AS9104/1 Appendix B table to select the correct certification structure using the eligibility criteria in addition to the definitions and requirements • Use section 8 instructions for the certification structure to determine minimum on-site audit days

  41. AS9104/1 and Audit Time • AS9104/1 Table 2 is used as the basis for all structures • The table is IAF MD 5 plus 9104:2006 Table 2 • It is audit days on-site and not audit duration: • Read AS9104/1 sections 8.2 and 8.2.2 for application • For 9110 / 9110 ‘including design’ no reduction has been made on the IAF MD 5 times • Some limited reduction has been incorporated for ‘no design’ and ‘9120’ based on the removal of requirements • There is therefore no need to make reductions to Table 2 and for most certification structures audit time reductions are NOT ALLOWED

  42. AS9104/1 and Audit Time • As a result when comparing AS9104/1 Table 2 to existing contacts based on 9104:2006 • The more creative the CB has been, the bigger the increase in on-site audit time will be • If the CB has not correctly applied IAF MD 1 for multiple site you may see a big increase • If you CB has not made reductions and has been effective and fair you will see little or no change in audit days • The IAQG OPMT will use of the IAQG OPMT Complex Certification Structure Oversight Committee (CSOC) to review complaints including alleged large increases in audit days! • Complaints: see IAQG OPMT Procedure 201

  43. AS9104/1 and Audit Time Single Site • Description • An organisation that operates at one site • Eligibility • Stand-alone self-supporting organisation with no value stream dependencies from related companies operating under the same QMS. • One address. • Audit Day Requirement • Table 2, using number of employees at site. • Reductions – none, except for ASRP or CAAT • Additions– allowed and expected per MD-5 • Initial – one site using Table 2 audit days • Surveillance –using Table 2 surveillance audit days • Recertification – using Table 2 recertification audit days

  44. AS9104/1 and Audit Time Multiple Site • Description • An organisation 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. • Eligibility • 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 organisational change.

  45. AS9104/1 and Audit Time Multiple Site • Eligibility (continued) • Complies with IAF MD 1, “Multi-site Organisation” 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.

  46. AS9104/1 and Audit Time Multiple Site • Audit Day Requirement • Table 2, separately using number of employees at each site. • Reductions – none, except for ASRP (Cat. 2) or CAAT • Additions– allowed and expected per MD-5 • Initial – all sites audited using Table 2 audit days • Surveillance – using 9104/1 Table 3 (Cat. 1 & Cat. 2) for sampling frequency and Table 2 for audit days at each site • Recertification – using 9104/1 Table 3 (Cat. 1 & Cat. 2) for sampling frequency and Table 2 for audit days at each site Note: • Category 1 (Cat. 1) = meets IAF MD 1 criteria only • Category 2 (Cat. 2) = meets MD 1 and MD 3 criteria

  47. AS9104/1 and Audit Time Campus • Description • An organisation having an identified central function and a decentralised, sequential, linked product realisation process. • Eligibility • 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 organisational change.

  48. AS9104/1 and Audit Time Campus • Eligibility (continued) • 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 the sites that contribute to the same overall product or service being realised. • 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 realised through the same methods and procedures. • One address per campus.

  49. AS9104/1 and Audit Time Campus • Audit Day Requirement • Table 2, using total number of employees from campus. • Reductions – none, except for ASRP or CAAT • Additions– +10% required, plus additions per MD-5 • Initial – all sites using Table 2 for total campus population + 10% to Table 2 audit days • Surveillance – all sites using surveillance per Table 2 for total campus population + 10% to Table 2 audit days • Recertification – all sites using recertification per Table 2 for total campus population + 10% to Table 2 audit days

  50. AS9104/1 and Audit Time Several Sites • Description • An organisation having an identified central function and a network of sites that do not meet the criteria for a multiple site or campus organisation. • Several sites are listed on the same certificate • Eligibility • 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 organisational change.

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