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IAQG 9120:2009 Revision Overview Prepared by IAQG 9120 Team Rev: 2 Dated: 15 July 2009
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Overview Objectives Provide an overview of: Provide an overview of: 9120 Team Membership9120 Team Membership 9120 Revision Process9120 Revision Process 9120:2009 Key Changes (Revisions/Relocated, Additions, Deletions Requirements)9120:2009 Key Changes (Revisions/Relocated, Additions, Deletions Requirements) 9120 Implementation Schedule9120 Implementation Schedule
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9120 Team Membership 8 Members on 9120 Team 8 Members on 9120 Team Representing: Representing: Americas, Europe, and Asia-Pacific IAQG SectorsAmericas, Europe, and Asia-Pacific IAQG Sectors Distributors, OEMs and AssociationsDistributors, OEMs and Associations Both Production and AftermarketBoth Production and Aftermarket
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9120 Stakeholders Civil Aviation Authorities Civil Aviation Authorities Defense Industry and Authorities Defense Industry and Authorities Space Industry and Authorities Space Industry and Authorities Certification / Registration Bodies Certification / Registration Bodies Trade Associations Trade Associations Suppliers Suppliers IAQG Member Companies IAQG Member Companies IAQG Strategy Streams and Teams IAQG Strategy Streams and Teams
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9120 Revision Objectives Incorporate ISO 9001:2008 changes Incorporate ISO 9001:2008 changes Ensure alignment with IAQG strategy (on-time, on-quality performance) Ensure alignment with IAQG strategy (on-time, on-quality performance) Align with IAQG 9100:2009 changes Align with IAQG 9100:2009 changes Adopt new requirements based on stakeholder needs Adopt new requirements based on stakeholder needs Improve existing requirements where stakeholders identified need for clarification, including when a documented procedure is required Improve existing requirements where stakeholders identified need for clarification, including when a documented procedure is required
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9120 Revision Process Started in Dec 2005 1 st 9120 Team Meeting1 st 9120 Team Meeting October 2006 October 2006 Data mining and Consolidation - 84 items Review process Design Specification & IAQG Strategy > 9100 and 9120 objectivesDesign Specification & IAQG Strategy > 9100 and 9120 objectives 80 % accepted Project Mgmt Design Specification & IAQG Strategy > 9120 objectives MCRT MCRT Accept/Reject/ Proposals/ Comments MCRT MCRT (Master Comments Review Template) StakeholderInput Web survey
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9120 draft 16 April 2007 * IAQG Meeting - October 2007 9120 draft 7 August 2007 Writing the first draft - prepared by the scribe Review of the first draft 9120 coord draft Nov 2007 Review of Coordination Draft (Dec 2007) : Stakeholder Comments Reviewed by:Stakeholder Comments Reviewed by: -Each Sector for consensus response -Entire team (in Naples) for final resolutions prior to formal ballot resolutions prior to formal ballot * IAQG Meeting - April 2008 9120 Revision Process
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Formal Ballot Jan 2009Jan 2009 Limit date for comments Mar 2009Mar 2009 Preparation for Formal Sector BallotPreparation for Formal Sector Ballot Development of deployment support materialDevelopment of deployment support material 9120 Revision Process 9120 Formal Ballot Jan 2009 9120 Formal Ballot Jan 2009 New ISO 9001 schedule (TC176 changed their estimated release date from June 2009 to October 2008) 9100 Revision Effort Completion: Dec 2008 AS/EN 9100 Publication: January 2009 AS/EN 9120 Publication: May 2009
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9120:2009 Key Changes Title – Distributors (removed “Stockist”) Title – Distributors (removed “Stockist”) Clause 1 - 9120 Scope and Application Clause 1 - 9120 Scope and Application Revision:Revision: Scope extended to include Defense as well as Aviation and Space Scope extended to include Defense as well as Aviation and Space Application guidance provided when 9100, 9110, and 9120 are appropriate for use Application guidance provided when 9100, 9110, and 9120 are appropriate for use Rationale:Rationale: The 9120 based QMS is applicable to other complex systems and would receive benefit from implementation including land and sea based applications The 9120 based QMS is applicable to other complex systems and would receive benefit from implementation including land and sea based applications Implementation/Audit Considerations:Implementation/Audit Considerations: Increased use and improved understanding of when the various aviation, space, and defense standards are applicable Increased use and improved understanding of when the various aviation, space, and defense standards are applicable
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9120:2009 Key Changes Clause 3.3 & 3.7 – Counterfeit Part / Suspected Unapproved Part (SUP) Clause 3.3 & 3.7 – Counterfeit Part / Suspected Unapproved Part (SUP) Addition: Define difference between counterfeit and unapproved parts in the supply chainAddition: Define difference between counterfeit and unapproved parts in the supply chain Counterfeit Parts are: Counterfeit Parts are: fraudulent fraudulent imitations of existing products imitations of existing products have no authority for use have no authority for use SUPs are: SUPs are: parts or products that have unknown authority or and may or may not be acceptable parts or products that have unknown authority or and may or may not be acceptable
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9120:2009 Key Changes Clause 3.5 - Risk Clause 3.5 - Risk Addition: Define new term “risk”Addition: Define new term “risk” An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence Rationale: The understanding of risk is important for an organization to develop a proactive quality management systemRationale: The understanding of risk is important for an organization to develop a proactive quality management system Implementation/Audit Considerations:Implementation/Audit Considerations: Understanding this term is important to implement a risk management process in the applicable clauses Understanding this term is important to implement a risk management process in the applicable clauses
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9120:2009 Key Changes Clause 4.1 – QMS General requirements Clause 4.1 – QMS General requirements Revision/Relocation:Revision/Relocation: The organization’s QMS shall address customer and applicable statutory and regulatory QMS requirements (previously located in the QMS documentation § 4.2.1) The organization’s QMS shall address customer and applicable statutory and regulatory QMS requirements (previously located in the QMS documentation § 4.2.1) Rationale:Rationale: Clarify that the requirement is placed at the QMS level and not only at the documentation level Clarify that the requirement is placed at the QMS level and not only at the documentation level Implementation/Audit Considerations:Implementation/Audit Considerations: The concept of “basic QMS” may be used (processes applicable to all customers / activities), but the documents such as Quality Management Plans, which address specific customers requirements, shall be considered as part of the QMS The concept of “basic QMS” may be used (processes applicable to all customers / activities), but the documents such as Quality Management Plans, which address specific customers requirements, shall be considered as part of the QMS
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9120:2009 Key Changes Clause 4.2.2 – Quality Manual Relationships Clause 4.2.2 – Quality Manual Relationships Deletion:Deletion: Requirement to create a document showing the relationship between 9120 requirements and the organizations documented procedures Requirement to create a document showing the relationship between 9120 requirements and the organizations documented procedures Rationale:Rationale: Requirement adds no value to assuring product quality. Requirement adds no value to assuring product quality. Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met Implementation/Audit Considerations:Implementation/Audit Considerations: Auditors need to identify appropriate documented procedures as an inherent part of carrying out the audit Auditors need to identify appropriate documented procedures as an inherent part of carrying out the audit
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9120:2009 Key Changes Clause 4.2.4 – Record Retention Requirement Clause 4.2.4 – Record Retention Requirement Deletion:Deletion: Requirement to maintain records for 7 years min. Requirement to maintain records for 7 years min. Rationale:Rationale: Conflicts with Regulatory / Customer requirements Conflicts with Regulatory / Customer requirements Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met Implementation/Audit Considerations:Implementation/Audit Considerations: Auditors need to identify appropriate record retention requirements per contracts as an inherent part of carrying out the audit Auditors need to identify appropriate record retention requirements per contracts as an inherent part of carrying out the audit
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9120:2009 Key Changes Clauses 5.2/8.2.1 – Customer Focus/Satisfaction Clauses 5.2/8.2.1 – Customer Focus/Satisfaction Addition:Addition: Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. (5.2) Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. (5.2) Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to: Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to: product conformityproduct conformity on-time delivery performanceon-time delivery performance customer complaintscustomer complaints corrective action requestscorrective action requests Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results (8.2.1) Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results (8.2.1)
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9120:2009 Key Changes Clauses 5.2/8.2.1 – Customer Focus/Satisfaction (Continued) Clauses 5.2/8.2.1 – Customer Focus/Satisfaction (Continued) Rationale:Rationale: Establish clear relationship between the QMS and organizational performance, in line with IAQG strategy Establish clear relationship between the QMS and organizational performance, in line with IAQG strategy To promote continuous improvement of customer satisfaction To promote continuous improvement of customer satisfaction Implementation/Audit Considerations:Implementation/Audit Considerations: Review of management focus and organizational process to measure customer satisfaction and plan improvements Review of management focus and organizational process to measure customer satisfaction and plan improvements
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9120:2009 Key Changes Clauses 7.1 – Planning of Product Realization Clauses 7.1 – Planning of Product Realization Addition:Addition: This Clause is NOT EXCLUDED for Distributors This Clause is NOT EXCLUDED for Distributors Rationale:Rationale: Distributors have a “product” (service) they provide Distributors have a “product” (service) they provide Controls and documents the need for product realization to be planned in addition to other requirements of the standard Controls and documents the need for product realization to be planned in addition to other requirements of the standard Allows introduction of other considerations required by the industry (configuration management) Allows introduction of other considerations required by the industry (configuration management) Implementation/Audit Considerations:Implementation/Audit Considerations: Clause 7.1 should be considered in any system assessment for a distributor Clause 7.1 should be considered in any system assessment for a distributor
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7.1.1 / 7.5.3 - Configuration Management 7.1.1 / 7.5.3 - Configuration Management Addition:Addition: Deemed applicable to Distributors Deemed applicable to Distributors Structured in line with ISO 10007 requirements Structured in line with ISO 10007 requirements Rationale:Rationale: Focuses configuration management on the product and how it is sustained throughout product realization Focuses configuration management on the product and how it is sustained throughout product realization Implementation/Audit Considerations:Implementation/Audit Considerations: Some level of configuration management is expected for all products at all levels of the supply chain in compliance with exclusion criteria (see clause 1.2) Some level of configuration management is expected for all products at all levels of the supply chain in compliance with exclusion criteria (see clause 1.2) 9120:2009 Key Changes
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7.1.2 – Work Transfer 7.1.2 – Work Transfer Addition:Addition: The organization must have a process to plan and control the transfer activities The organization must have a process to plan and control the transfer activities Expanded to cover permanent transfer (e.g. from one organization to another, from one organization to supplier, from one supplier to another) Expanded to cover permanent transfer (e.g. from one organization to another, from one organization to supplier, from one supplier to another) Rationale:Rationale: Work transfer can occur at anytime during product realization Work transfer can occur at anytime during product realization Addresses problems that often occur during work transfers Addresses problems that often occur during work transfers Implementation/Audit Considerations:Implementation/Audit Considerations: A process must exist to control the transfer of work including planning and subsequent control of the transfer A process must exist to control the transfer of work including planning and subsequent control of the transfer
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9120:2009 Key Changes Clause 7.4.1 – Recognition of Supplier Quality Data Clause 7.4.1 – Recognition of Supplier Quality Data Revision:Revision: Added note to recognize that one factor that may be used during supplier selection and evaluation is objective and reliable data from external sources Added note to recognize that one factor that may be used during supplier selection and evaluation is objective and reliable data from external sources Rationale:Rationale: Recognition that the industry trend is to use externally provided supplier performance data (e.g. Online Aerospace Supplier Information System – OASIS, Nadcap) Recognition that the industry trend is to use externally provided supplier performance data (e.g. Online Aerospace Supplier Information System – OASIS, Nadcap) Implementation/Audit Considerations:Implementation/Audit Considerations: Note only Note only
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Clause 7.4.1 – Approval status for suppliers Clause 7.4.1 – Approval status for suppliers Revision:Revision: Added and provided examples of “approval status” (e.g. approved, conditional, disapproved) and examples of “scope of approval” (e.g. product type, process family). Added and provided examples of “approval status” (e.g. approved, conditional, disapproved) and examples of “scope of approval” (e.g. product type, process family). The organization must define the process for suppliers approval status decisions or changes The organization must define the process for suppliers approval status decisions or changes Rationale:Rationale: Clarify that the conditions for using a supplier depends on its approval status Clarify that the conditions for using a supplier depends on its approval status Implementation/Audit Considerations:Implementation/Audit Considerations: The process, responsibilities and authority must be defined for this process The process, responsibilities and authority must be defined for this process 9120:2009 Key Changes
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9100:2009 Key Changes Clause 8.2.4 –Sampling Inspection Clause 8.2.4 –Sampling Inspection Revision:Revision: When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability) When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability) Rationale:Rationale: Numerous requests were received to improve clause 8.2.4. The comments ranged from that it was statistically inaccurate, to that it was too prescriptive Numerous requests were received to improve clause 8.2.4. The comments ranged from that it was statistically inaccurate, to that it was too prescriptive Implementation/Audit Considerations:Implementation/Audit Considerations: Validation of recognized statistical principles utilized. Validation of recognized statistical principles utilized. Process used to determine criticality of product Process used to determine criticality of product
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Proposed 9120 Implementation Schedule 9120 Release + 3 Months + 18 Months + 30 Months 3 Months 12 Months Develop Auditor Training Train Certification Bodies and Auditors All Companies to Upgrade to New Standard At Next Surveillance Audit Or Re-Certification Maximum 30 month Implementation from Publication Earliest Opportunity for Certification to New Standard (i.e. the early adopters) Maximum Allowed Time to Upgrade
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In Closing The 9120 Team goals and objectives were to: The 9120 Team goals and objectives were to: Align with IAQG 9100 and overall IAQG goalsAlign with IAQG 9100 and overall IAQG goals Expand the 9120 scope to include Aviation, Space & DefenseExpand the 9120 scope to include Aviation, Space & Defense Provide additional focus on IAQG objective of on-time and on-quality deliveriesProvide additional focus on IAQG objective of on-time and on-quality deliveries Ensure 9120 standard is compatible for use by all stakeholder segments and by organizations of all types and sizesEnsure 9120 standard is compatible for use by all stakeholder segments and by organizations of all types and sizes Ensure 9120 stays recognized by authoritiesEnsure 9120 stays recognized by authorities Ensure extensive stakeholder involvement in revision effort by the use of a project management approach to solicit input and manage the revisionEnsure extensive stakeholder involvement in revision effort by the use of a project management approach to solicit input and manage the revision The key changes are not inclusive of all the changes in the 9120 standard.
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