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IAQG 9110:2009 Revision Overview Prepared by IAQG 9110 Team Please contact Jeff Wood at jeffrey.d.wood@boeing.com or jeffrey.d.wood@boeing.com Jean-Francis Suquet at jean-francis.suquet@eurocopter.com for questions or comments.
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Overview Objectives Provide an overview of: Provide an overview of: 9110 Team Membership9110 Team Membership 9110 Revision Process9110 Revision Process 9100:2009 Overview9100:2009 Overview 9110:2009 Key Changes (revised/relocated, additions, and deletions of requirements)9110:2009 Key Changes (revised/relocated, additions, and deletions of requirements) 9110 Implementation Schedule9110 Implementation Schedule IAQG Document RelationshipsIAQG Document Relationships
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9110 Team Membership 12 Members on 9110 Team 12 Members on 9110 Team Representing: Representing: Americas and Europe IAQG sectorsAmericas and Europe IAQG sectors 5 different countries5 different countries 8 different IAQG member companies8 different IAQG member companies 3 different CBs3 different CBs
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9110 Stakeholders Civil Aviation Authorities Civil Aviation Authorities Defense Industry and Authorities Defense Industry and Authorities Airlines Airlines Certification Bodies Certification Bodies Trade Associations Trade Associations Suppliers Suppliers Maintenance Repair & Overhaul Providers Maintenance Repair & Overhaul Providers IAQG Member Companies IAQG Member Companies IAQG Strategy Streams and Teams IAQG Strategy Streams and Teams
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9110 Revision Objectives Incorporate ISO 9001:2008 changes Incorporate ISO 9001:2008 changes Incorporate 9100:2009 changes that are applicable to maintenance activities Incorporate 9100:2009 changes that are applicable to maintenance activities Ensure clarity of requirements to resolve interpretation issues Ensure clarity of requirements to resolve interpretation issues Consider / address stakeholder needs Consider / address stakeholder needs Promote industry standard and ensure that the standard is compatible for use by all stakeholders Promote industry standard and ensure that the standard is compatible for use by all stakeholders Prepare for the forthcoming Safety Management System implementation requirements in accordance with International Civil Aviation Organization (ICAO) directive Prepare for the forthcoming Safety Management System implementation requirements in accordance with International Civil Aviation Organization (ICAO) directive
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9110 Revision Process Data Mining and Consolidation - 136 items - 45 items accepted / 91 items rejected Project Mgmt Design Specification & Objectives (initially drafted July 2006) MCRT MCRT (Master Comments Review Template) StakeholderInput Web Survey Solicited stakeholder / industry input 9110 Coordination Draft Released on 30 June 2008 Released on 30 June 2008
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9110 Revision Process 9110 Ballot Draft Draft Expected release - June 2009 MCRT MCRT (Master Comments Review Template) - Formal Ballot - November 2008 - Development of deployment support materials Data Mining and Consolidation - 92 items - 22 items accepted / 70 items rejected 9110 Release
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The 9110 revision was directly influenced by the revision to ISO 9001 and IAQG 9100 standards; the applicable “9100 Revision Overview” slides have been integrated into this presentation to identify the key changes to this standard The 9110 revision was directly influenced by the revision to ISO 9001 and IAQG 9100 standards; the applicable “9100 Revision Overview” slides have been integrated into this presentation to identify the key changes to this standard Revision Key Changes Revision Key Changes 9100 – (6) additions; (7) revisions / relocations; (3) deletions9100 – (6) additions; (7) revisions / relocations; (3) deletions 9110 – (9) additions; (1) revision9110 – (9) additions; (1) revision Structure of Key Changes Slides Structure of Key Changes Slides Revision / Relocation, Addition, or DeletionRevision / Relocation, Addition, or Deletion RationaleRationale Implementation / Audit ConsiderationsImplementation / Audit Considerations 9110 Change Overview The ‘Key Changes’ are not inclusive of all the changes in the 9110 standard
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Key Changes - Derived from 9100:2009 Clause 3.4 - Critical Items (9100 - clause 3.3) Clause 3.4 - Critical Items (9100 - clause 3.3) Addition: Defined new term - “critical item”Addition: Defined new term - “critical item” Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed Examples of critical items include: Examples of critical items include: safety critical itemssafety critical items fracture critical itemsfracture critical items mission critical itemsmission critical items key characteristicskey characteristics
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Key Changes - Derived from 9100:2009 Clause 3.4 - Critical Items (cont.) Clause 3.4 - Critical Items (cont.) Rationale:Rationale: Improve understanding of “critical items” coming from “special requirements” Improve understanding of “critical items” coming from “special requirements” Ensure these items are systemically addressed and linked to risk management activities and processes utilized by the organization Ensure these items are systemically addressed and linked to risk management activities and processes utilized by the organization Implementation / Audit Considerations: Understanding this term is important to implement “critical items” into applicable product realization processesImplementation / Audit Considerations: Understanding this term is important to implement “critical items” into applicable product realization processes
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Key Changes - Derived from 9100:2009 Clause 3.9 - Risk (9100 - clause 3.1) Clause 3.9 - Risk (9100 - clause 3.1) Addition: Defined new term - “risk”Addition: Defined 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:Rationale: The understanding of risk is important for an organization to develop a proactive quality management system 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 support the implementation of a risk management process Understanding this term is important to support the implementation of a risk management process
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Key Changes - Derived from 9100:2009 Clause 3.11 - Special Requirements (9100 - clause 3.2) Clause 3.11 - Special Requirements (9100 - clause 3.2) Addition: Defined new term - “special requirements”Addition: Defined new term - “special requirements” Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process Factors used to determine “special requirements” include: Factors used to determine “special requirements” include: product or process complexityproduct or process complexity past experiencepast experience product or process maturityproduct or process maturity Examples include: Examples include: performance requirements imposed by the customer that are at the limit of the state-of-the-artperformance requirements imposed by the customer that are at the limit of the state-of-the-art requirements determined by the organization to be at the limit of their technical or process capabilitiesrequirements determined by the organization to be at the limit of their technical or process capabilities
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Key Changes - Derived from 9100:2009 Clause 3.11 - Special Requirements (cont.) Clause 3.11 - Special Requirements (cont.) Rationale:Rationale: Improve understanding of “special requirements” and the potential chain of flow to “critical items” and to “key characteristics” Improve understanding of “special requirements” and the potential chain of flow to “critical items” and to “key characteristics” Ensure these important requirements are systemically addressed and linked to risk management activities by the organization Ensure these important requirements are systemically addressed and linked to risk management activities by the organization Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding this term is important to identify and integrate “special requirements” into a risk management process Understanding this term is important to identify and integrate “special requirements” into a risk management process
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7.1 Planning of Product Realization Key Changes - Derived from 9100:2009 7.4 Purchasing - Vendor / Supplier Provided Products Statutory, regulatory and other requirements Customer requirements including requirements identified as special by the customer 7.2 Determination and Review of Requirements Related to the Product “Special Requirements” as determined by customer or organization 7.3 Design & Development 7.3.3.e critical items, including “Key Characteristics” 7.5 Production & Service Provision (drawings, instructions, plans, etc.) 8.2.3 / 8.2.4 Monitoring & Measurement of Processes / Products 8.4 Analysis of Data 8.5 Improvement (Continual Improvement, Corrective / Preventive Action) Design Inputs Design Outputs 7.1.2 Risk Management Interrelationship between Special Requirements, Critical Items, Key Characteristics and Risk Management Process 7.5.1 appropriate processes to manage critical items 7.4.2 flow down requirements to suppliers
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Key Changes - Derived from 9100:2009 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 a “Basic QMS” (common processes and associated documentation applicable to all customers / activities) may be used, but the documentation (e.g., Quality Management Plans) which address specific customers requirements shall not be overlooked as it is a critical part of the QMS The concept of a “Basic QMS” (common processes and associated documentation applicable to all customers / activities) may be used, but the documentation (e.g., Quality Management Plans) which address specific customers requirements shall not be overlooked as it is a critical part of the QMS
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Key Changes - Derived from 9100:2009 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 9100 / 9110 requirements and the organizations documented procedures Requirement to create a document showing the relationship between 9100 / 9110 requirements and the organizations documented procedures Rationale:Rationale: Requirement added no value to assuring product quality Requirement added no value to assuring product quality Implementation / Audit Considerations:Implementation / Audit Considerations: Auditors need to identify appropriate documented procedures as an inherent part of carrying out an audit Auditors need to identify appropriate documented procedures as an inherent part of carrying out an audit
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Key Changes - Derived from 9100:2009 Clauses 5.2 / 8.2.1 - Customer Focus / Satisfaction Clauses 5.2 / 8.2.1 - Customer Focus / Satisfaction Addition:Addition: Management responsibility for measuring “product conformity” and “on-time delivery” and for taking appropriate remedial actions (5.2) Management responsibility for measuring “product conformity” and “on-time delivery” and for taking appropriate remedial actions (5.2) Requirement to evaluate customer satisfaction using - product conformity and on-time delivery performance, - customer complaints and corrective actions requests, then develop plans that address deficiencies (8.2.1) Requirement to evaluate customer satisfaction using - product conformity and on-time delivery performance, - customer complaints and corrective actions requests, then develop plans that address deficiencies (8.2.1) 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 continual improvement of customer satisfaction To promote continual improvement of customer satisfaction Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate management “customer focus” and associated organizational processes to evaluate / measure customer satisfaction and planned improvements Evaluate management “customer focus” and associated organizational processes to evaluate / measure customer satisfaction and planned improvements
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Key Changes - Derived from 9100:2009 7.1.1 - Project Management 7.1.1 - Project Management Addition:Addition: New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraints New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraints Rationale:Rationale: Most aviation, space and defense products are complex and involve multi-tier partners and suppliers Most aviation, space and defense products are complex and involve multi-tier partners and suppliers This clause provides additional focus on upfront planning and the management of project plans throughout product realization This clause provides additional focus on upfront planning and the management of project plans throughout product realization Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate how the organization manages product realization planning to ensure quality and schedule are not compromised Evaluate how the organization manages product realization planning to ensure quality and schedule are not compromised
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7.1.2 - Risk Management 7.1.2 - Risk Management Addition:Addition: New requirement to implement a “risk management” process applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance New requirement to implement a “risk management” process applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance The concept of “risk” is integrated within the revised standard The concept of “risk” is integrated within the revised standard Rationale:Rationale: Risk management was placed in clause 7.1.2 to provide additional focus on product “risk” during product realization Risk management was placed in clause 7.1.2 to provide additional focus on product “risk” during product realization Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure the organization have a risk management process that addresses all of the applicable requirements Ensure the organization have a risk management process that addresses all of the applicable requirements Ensure the definition of “risk” is understood and appropriately applied in associated processes Ensure the definition of “risk” is understood and appropriately applied in associated processes Evaluate that risks are identified and successfully managed within the organization Evaluate that risks are identified and successfully managed within the organization Key Changes - Derived from 9100:2009
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7.1.3 - Configuration Management 7.1.3 - Configuration Management Revision / Relocation:Revision / Relocation: Relocated content from clause 4.3 to 7.1.3. Relocated content from clause 4.3 to 7.1.3. Structured requirements consistent with ISO 10007 Structured requirements consistent with ISO 10007 Rationale:Rationale: Focuses “configuration management” on the product and how it is sustained throughout product realization (maintenance process / activities) Focuses “configuration management” on the product and how it is sustained throughout product realization (maintenance process / activities) Provided further process definition / requirements Provided further process definition / requirements Implementation / Audit Considerations:Implementation / Audit Considerations: Configuration management processes should be adequate to ensure adequate configuration control of product Configuration management processes should be adequate to ensure adequate configuration control of product Some level of “configuration management” is expected to exist within all organizations / levels of the supply chain; see exclusion criteria (clause 1.2) Some level of “configuration management” is expected to exist within all organizations / levels of the supply chain; see exclusion criteria (clause 1.2) Key Changes - Derived from 9100:2009
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7.1.4 - Work Transfer 7.1.4 - Work Transfer Revision / Relocation:Revision / Relocation: Relocated content from clause 7.5.1.4 to clause 7.1.4 Relocated content from clause 7.5.1.4 to clause 7.1.4 The organization must have a process to plan and control work transfer activities The organization must have a process to plan and control work transfer activities Expanded to cover permanent work transfer (e.g., from one organization facility to another, from one supplier to another, from one supplier to another supplier) Expanded to cover permanent work transfer (e.g., from one organization facility to another, from one supplier to another, from one supplier to another supplier) Rationale:Rationale: Recognition the “work transfer” can occur at anytime during product realization (maintenance process / activities) Recognition the “work transfer” can occur at anytime during product realization (maintenance process / activities) Work transfer processes should address common situations and associated problems that often occur during work transfer to minimize “risk” associated to product conformity and on-time delivery performance Work transfer processes should address common situations and associated problems that often occur during work transfer to minimize “risk” associated to product conformity and on-time delivery performance 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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Key Changes - Derived from 9100:2009 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)] Recognition that the industry trend is to use externally provided supplier performance data [e.g., Online Aerospace Supplier Information System (OASIS)] Implementation / Audit Considerations:Implementation / Audit Considerations: ‘Guidance Note’ provided ‘Guidance Note’ provided
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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, type of service) Added and provided examples of “approval status” (e.g., approved, conditional, disapproved) and examples of “scope of approval” (e.g., product type, process family, type of service) 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 Key Changes - Derived from 9100:2009
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Clause 7.4.3 - Validation of Test Reports Clause 7.4.3 - Validation of Test Reports Deletion:Deletion: Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material. Rationale:Rationale: Misunderstood concept that was frequently misapplied Misunderstood concept that was frequently misapplied Requirement not applicable to all stakeholders (especially small organizations) and for all types of products Requirement not applicable to all stakeholders (especially small organizations) and for all types of products Implementation / Audit Considerations:Implementation / Audit Considerations: If an organization is making critical items where the material chemical/physical requirements are important, are they verifying test reports as part of their risk management process? If an organization is making critical items where the material chemical/physical requirements are important, are they verifying test reports as part of their risk management process?
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Key Changes - Derived from 9100:2009 Clause 7.5.1.1 - Maintenance Process Verification Clause 7.5.1.1 - Maintenance Process Verification Revision / Relocation:Revision / Relocation: Relocated content from clause 8.2.4.2 to 7.5.1.1 Relocated content from clause 8.2.4.2 to 7.5.1.1 Requirement to verify that new maintenance processes, documentation and tooling are capable of supporting maintenance activities; qualified and approved by the customer and/or Authority Requirement to verify that new maintenance processes, documentation and tooling are capable of supporting maintenance activities; qualified and approved by the customer and/or Authority This process shall be repeated when changes occur that invalidate the original results (e.g., engineering or manufacturing processes changes) This process shall be repeated when changes occur that invalidate the original results (e.g., engineering or manufacturing processes changes) Rationale:Rationale: Movement to clause 7 acknowledges that this requirement is not primarily a monitoring and measurement process, but a process used to assure product realization capability under controlled conditions Movement to clause 7 acknowledges that this requirement is not primarily a monitoring and measurement process, but a process used to assure product realization capability under controlled conditions Allows justifiable exclusion (see clause 1.2) Allows justifiable exclusion (see clause 1.2) Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate process definition and effectiveness Evaluate process definition and effectiveness Validation of all requests for exclusion; ensure exclusions do not affect the organization’s ability to provide conforming product and meet applicable customer, statutory and regulatory requirements Validation of all requests for exclusion; ensure exclusions do not affect the organization’s ability to provide conforming product and meet applicable customer, statutory and regulatory requirements
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Key Changes - Derived from 9100:2009 Clause 8.2.2 - Detailed Tools and Techniques Clause 8.2.2 - Detailed Tools and Techniques Deletion:Deletion: “Detailed tools and techniques shall be developed such as check sheets, process flowcharts, or any similar method to support audit of the quality management system requirements. The acceptability of the selected tools will be measured against the effectiveness of the internal audit process and overall organization performance.” “Detailed tools and techniques shall be developed such as check sheets, process flowcharts, or any similar method to support audit of the quality management system requirements. The acceptability of the selected tools will be measured against the effectiveness of the internal audit process and overall organization performance.” Rationale:Rationale: Requirement was previously too prescriptive Requirement was previously too prescriptive Reference to specific tools in a “such as” statement is more appropriate as guidance material Reference to specific tools in a “such as” statement is more appropriate as guidance material Implementation / Audit Considerations:Implementation / Audit Considerations: Methods / effectiveness measures remain intact in the ISO text Methods / effectiveness measures remain intact in the ISO text Tools and techniques may still be needed to support the audit process Tools and techniques may still be needed to support the audit process
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Key Changes - Derived from 9100:2009 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: Further definition provided; numerous requests were received to enhance clause 8.2.4 Further definition provided; numerous requests were received to enhance clause 8.2.4 Implementation / Audit Considerations:Implementation / Audit Considerations: Validate that recognized statistical principles were utilized for sampling plan development / application Validate that recognized statistical principles were utilized for sampling plan development / application Evaluate process used to determine ‘criticality’ of product Evaluate process used to determine ‘criticality’ of product
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Key Changes - Specific to 9110:2009 Clause 1.2 - Application Clause 1.2 - Application Addition: Bold / italic text clarifying standard industry applicationAddition: Bold / italic text clarifying standard industry application “This standard is intended for use by maintenance organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance, repair and overhaul operated autonomously or that are substantially different from their manufacturing/production operations. “This standard is intended for use by maintenance organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance, repair and overhaul operated autonomously or that are substantially different from their manufacturing/production operations. It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification and those that provide maintenance, repair and overhaul services for military aviation products; but the standard could significantly benefit non-certificated maintenance organizations that choose to adopt it.” Rationale: Text added to clarify industry application and promote use by non-certificated maintenance organizationsRationale: Text added to clarify industry application and promote use by non-certificated maintenance organizations Implementation / Audit Considerations: Purchasing process should consider flow down of 9110 QMS standard to suppliers (certificated and/or non-certificated suppliers)Implementation / Audit Considerations: Purchasing process should consider flow down of 9110 QMS standard to suppliers (certificated and/or non-certificated suppliers)
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Key Changes - Specific to 9110:2009 Clause – 3.3 Counterfeit Part Clause – 3.3 Counterfeit Part 3.12 Suspect Unapproved Part 3.12 Suspect Unapproved Part Addition: Defined new terms - “counterfeit part” and “suspect unapproved part”Addition: Defined new terms - “counterfeit part” and “suspect unapproved part” Rationale:Rationale: Improve understanding of what constitutes a “counterfeit” or “suspect unapproved part” Improve understanding of what constitutes a “counterfeit” or “suspect unapproved part” Further clarity provided to critical requirement defined in clause 7.4.1.g – “take appropriate measures to prevent the purchase of counterfeit and suspect unapproved parts” Further clarity provided to critical requirement defined in clause 7.4.1.g – “take appropriate measures to prevent the purchase of counterfeit and suspect unapproved parts” Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding these terms is important to ensure that adequate measures are taken to ensure genuine parts are procured for maintenance activities; evaluate process and measures taken to identify and contain counterfeit or suspected unapproved parts Understanding these terms is important to ensure that adequate measures are taken to ensure genuine parts are procured for maintenance activities; evaluate process and measures taken to identify and contain counterfeit or suspected unapproved parts
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Key Changes - Specific to 9110:2009 Clause – 3.5 Human Factors Clause – 3.5 Human Factors Revision:Revision: Improve understanding of “human factors” Improve understanding of “human factors” “The study of how humans behave physically and psychologically in relation to particular environments, products or services and the potential effect on safety. Recognition that personnel performing tasks are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction, communication and attitude in order to ensure a safe interface between the personnel and all other environmental elements such as other personnel, equipment, facilities, procedures and data.” “The study of how humans behave physically and psychologically in relation to particular environments, products or services and the potential effect on safety. Recognition that personnel performing tasks are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction, communication and attitude in order to ensure a safe interface between the personnel and all other environmental elements such as other personnel, equipment, facilities, procedures and data.” Rationale: Further clarity / definition providedRationale: Further clarity / definition provided Implementation / Audit Considerations: Understanding this term is important as “human factors” are evaluated / addressed for maintenance processes / activitiesImplementation / Audit Considerations: Understanding this term is important as “human factors” are evaluated / addressed for maintenance processes / activities
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Key Changes - Specific to 9110:2009 Clauses: 8.4 – Analysis of Data; Clauses: 8.4 – Analysis of Data; 8.5.2 / 8.5.3 – Corrective / Preventive Action 8.5.2 / 8.5.3 – Corrective / Preventive Action Addition: Analysis of “human factors” has been integrated into these clauses / processesAddition: Analysis of “human factors” has been integrated into these clauses / processes 8.4.e – the analysis of data shall provide information relating to human factor events 8.4.e – the analysis of data shall provide information relating to human factor events 8.5.2.j – define requirements for evaluating the need for action based on human factors to ensure that nonconformities do not recur 8.5.2.j – define requirements for evaluating the need for action based on human factors to ensure that nonconformities do not recur 8.5.3.f – define requirements for evaluating the need for action based on human factors to prevent occurrence of nonconformities 8.5.3.f – define requirements for evaluating the need for action based on human factors to prevent occurrence of nonconformities Rationale: Human factors analysis should be used in the development and continual improvement of maintenance processesRationale: Human factors analysis should be used in the development and continual improvement of maintenance processes Implementation / Audit Considerations: Ensure evidence that analysis of “human factors” are appropriately evaluated / appliedImplementation / Audit Considerations: Ensure evidence that analysis of “human factors” are appropriately evaluated / applied
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Key Changes - Specific to 9110:2009 Clause 3.10 – Safety Policy Clause 3.10 – Safety Policy Addition: Defined new term - “safety policy”Addition: Defined new term - “safety policy” “Management formally expressed commitment to product safety. This policy should reflect the organization’s philosophy of safety management and outlines the methods and processes that the organization will use to achieve desired safety outcomes” “Management formally expressed commitment to product safety. This policy should reflect the organization’s philosophy of safety management and outlines the methods and processes that the organization will use to achieve desired safety outcomes” Rationale:Rationale: Ensure understanding of this term; numerous new requirements associated to the “safety policy” have been added to the standard Ensure understanding of this term; numerous new requirements associated to the “safety policy” have been added to the standard Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding of this term is important to the development and implementation of the organization’s “safety policy” Understanding of this term is important to the development and implementation of the organization’s “safety policy” Ensure the organization’s “safety policy” is adequately defined Ensure the organization’s “safety policy” is adequately defined
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Key Changes - Specific to 9110:2009 Clauses (4.2.1, 5.1, 5.4.3, 5.6.1, 5.7, 7.1) – Clauses (4.2.1, 5.1, 5.4.3, 5.6.1, 5.7, 7.1) – Safety Policy and Safety Objectives Safety Policy and Safety Objectives Addition: Numerous new requirements associated to the “safety policy” and “safety objectives” have been added to the standardAddition: Numerous new requirements associated to the “safety policy” and “safety objectives” have been added to the standard 4.2.1.e – documented statements of a safety policy / objectives 4.2.1.e – documented statements of a safety policy / objectives 5.1.f /.g – management commitment to safety policy / objectives 5.1.f /.g – management commitment to safety policy / objectives 5.4.3 – management to ensure safety objectives are established at relevant functions / levels within the organization 5.4.3 – management to ensure safety objectives are established at relevant functions / levels within the organization 5.6.1 – safety policy / objectives linked to “Management Review” 5.6.1 – safety policy / objectives linked to “Management Review” 5.7 – safety policy requirements further defined 5.7 – safety policy requirements further defined 7.1.g – safety objectives and requirements for the product integrated into planning of product realization 7.1.g – safety objectives and requirements for the product integrated into planning of product realization Rationale: Integrating requirements associated to “safety policy / objectives” is consistent with ICAO directive for implementation of a Safety Management System in maintenance organizationsRationale: Integrating requirements associated to “safety policy / objectives” is consistent with ICAO directive for implementation of a Safety Management System in maintenance organizations Implementation / Audit Considerations: Ensure that safety policy / objectives have been developed, implemented, and are periodically reviewedImplementation / Audit Considerations: Ensure that safety policy / objectives have been developed, implemented, and are periodically reviewed
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Key Changes - Specific to 9110:2009 Clause 4.2.2 – Quality Manual Clause 4.2.2 – Quality Manual Addition: The maintenance organization shall establish and maintain a quality manual that includes a description of key maintenance processes and procedures; these processes and procedures are consistent with most sector Authority requirementsAddition: The maintenance organization shall establish and maintain a quality manual that includes a description of key maintenance processes and procedures; these processes and procedures are consistent with most sector Authority requirements Rationale:Rationale: These processes and procedures are critical to the operation of an effective maintenance organization These processes and procedures are critical to the operation of an effective maintenance organization Although required by most sector Authorities, these requirements were added for emphasis to require application for non-certificated maintenance organizations that choose or are required to implement the 9110 standard Although required by most sector Authorities, these requirements were added for emphasis to require application for non-certificated maintenance organizations that choose or are required to implement the 9110 standard Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure that these processes and procedures are integrated into the maintenance organization’s quality manual Ensure that these processes and procedures are integrated into the maintenance organization’s quality manual Evaluate process performance and effectiveness Evaluate process performance and effectiveness
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Key Changes - Specific to 9110:2009 Clause 5.6 – Management Review Clause 5.6 – Management Review Addition: Expanded management review inputsAddition: Expanded management review inputs “…assessing opportunities for improvement and need for changes to the safety policy and safety objectives” “…assessing opportunities for improvement and need for changes to the safety policy and safety objectives” customer audit results and requests for corrective action customer audit results and requests for corrective action “the achievement, adequacy and effectiveness of the personnel training program” “the achievement, adequacy and effectiveness of the personnel training program” “changes to Authority requirements that could impact the organization” “changes to Authority requirements that could impact the organization” Rationale: Expanded management review inputs to ensure top management visibility and that appropriate decisions and actions are taken to address QMS / process performanceRationale: Expanded management review inputs to ensure top management visibility and that appropriate decisions and actions are taken to address QMS / process performance Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure evidence these topics were management review inputs Ensure evidence these topics were management review inputs Evaluate process performance, and decisions and actions taken Evaluate process performance, and decisions and actions taken
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Key Changes - Specific to 9110:2009 Clause 6 – Resource Management Clause 6 – Resource Management Addition: Added requirements to strengthen text resource management to ensure safe completion of maintenance activitiesAddition: Added requirements to strengthen text resource management to ensure safe completion of maintenance activities 6.1 – system required to continually assess the availability of tools, technical data and necessary qualified personnel 6.1 – system required to continually assess the availability of tools, technical data and necessary qualified personnel 6.2.1 – personnel management expanded to ensure certificated personnel continue to maintain eligibility and process required for qualification and surveillance of non-certificated personnel 6.2.1 – personnel management expanded to ensure certificated personnel continue to maintain eligibility and process required for qualification and surveillance of non-certificated personnel 6.2.2 – training program (initial and recurrent), including personnel training associated to human factors and relevant Authority requirements 6.2.2 – training program (initial and recurrent), including personnel training associated to human factors and relevant Authority requirements 6.3 – facility requirements away from an organization’s fixed location 6.3 – facility requirements away from an organization’s fixed location Rationale: Resource management is critical for effective completion of maintenance activitiesRationale: Resource management is critical for effective completion of maintenance activities Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate maintenance organization’s resource management processes; ensure adequate process definition and evaluate process effectiveness Evaluate maintenance organization’s resource management processes; ensure adequate process definition and evaluate process effectiveness
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Key Changes - Specific to 9110:2009 Clause 7.5.1 – Control of Production and Service Provision Clause 7.5.1 – Control of Production and Service Provision Addition: Added requirements associated to technical data and equipment, tools and material equivalencyAddition: Added requirements associated to technical data and equipment, tools and material equivalency 7.5.1.h – provided further definition regarding use of technical data; “… technical data that has been approved, as applicable…, or that is acceptable to the Authority,” 7.5.1.h – provided further definition regarding use of technical data; “… technical data that has been approved, as applicable…, or that is acceptable to the Authority,” 7.5.1 k - criteria for workmanship, specified in the clearest practical way…in accordance with applicable technical data, 7.5.1 k - criteria for workmanship, specified in the clearest practical way…in accordance with applicable technical data, 7.5.1.o – “the equipment, tools and materials shall be those recommended by the manufacturer of the article…and acceptable to the customer and/or Authority.” 7.5.1.o – “the equipment, tools and materials shall be those recommended by the manufacturer of the article…and acceptable to the customer and/or Authority.” Rationale: Added emphasis items to ensure these requirements are integrated with proper controls into maintenance activitiesRationale: Added emphasis items to ensure these requirements are integrated with proper controls into maintenance activities Implementation / Audit Considerations: Evaluate maintenance organization’s processes associated to use of technical data and equivalent equipment, tools and materials; ensure adequate process definition and evaluate process effectivenessImplementation / Audit Considerations: Evaluate maintenance organization’s processes associated to use of technical data and equivalent equipment, tools and materials; ensure adequate process definition and evaluate process effectiveness
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Proposed 9110 Implementation Schedule Actual IAQG Publication Date? + 6 Months + 18 Months + 30 Months 6 Months 12 Months Develop Auditor Training Train Certification Bodies and Auditors All Companies to Upgrade to New Standard at Next Surveillance Audit or Recertification Maximum 30 month implementation from publication of both the 9110:2009 and 9101:2009 standards Earliest Opportunity for Certification to New Standard (i.e., the early adopters) Maximum Allowed Time to Upgrade
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In Closing The 9110 Team Goals and Objectives were to: Ensure extensive stakeholder involvement in revision effort by use of a project management approach to solicit input and manage the revision; consider / address stakeholder needs Promote industry standard and ensure that the standard is compatible for use by all stakeholders segments and by organizations of all types and sizes Provide emphasis on product and process improvement (e.g., risk management, critical items, project management) Provide additional focus on IAQG strategies / objectives (e.g., product conformity, on-time delivery performance) Prepare for the forthcoming Safety Management System implementation requirements in accordance with International Civil Aviation Organization (ICAO) directive Ensure clarity of requirements to resolve interpretation issues The key changes are not inclusive of all the changes in the 9110 standard
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