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Achieving Certification to AS9100C Roger Ritterbeck

Aerospace Product Manager

Presentation Objectives

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Provide an overview: · IAQG Industry Overview & Implementation Schedule · AS9100 C Requirements · Pursuing Registration to AS9100 · OASIS Database

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Industry Overview

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· Aerospace quality standards developed and maintained by the International Aerospace Quality Group (I.A.Q.G.) www.sae.org/oasis · Standards are internationally harmonized · Utilized as a key supply chain management tool for OEMs and Primes · Scope expanded to Aviation, Space & Defense Aviation

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Industry Overview

IAQG International Aerospace Quality Group

AAQG Q Americas Aerospace Quality Group

EAQG Q European Aerospace Quality Group

APAQG Q Asia/Pacific Aerospace Quality Group

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9100 Stakeholders

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· · · · · · ·

Civil Aviation Authorities Defense Industry and Authorities Space Industry and Authorities Certification/Registration Bodies Trade Associations Suppliers IAQG Member Companies

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What is AS9100C

· Based on ISO 9001:2008 with aerospace industry added requirements · Encompasses ISO 9001:2008 in its entirety · Expands requirements to meet needs of aerospace manufacturers worldwide f t ld id · Expanded requirements are intended to ensure: Safety Reliability Quality of aerospace products · Requirements intended to be complementary to: Contractual requirements Applicable law Regulatory requirements

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AS9100C Revision Objectives

· Incorporate changes to ISO 9001:2008 p g · Add Defense applications (land and sea based systems) · Focus on quality performance on-time (per IAQG on time strategy) · Include additional requirements the aerospace community felt appropriate · Enhance existing requirements and provide clarity where needed

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AS9100C Transition Guidelines

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· 30 month transition plan for transitioning certifications from Re ce tifications f om Rev B to AS9100C · Auditing to AS9100C will require the use of the AS9101 revision D checklist, completion expected July 09 (the 30 month clock begins with the release of AS9101D) · Auditors will be trained on AS9100C requirements and AS9101D usage, then can audit to AS9100C · Auditing to AS9100C expected to commence Q1 2010

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AS9100C Requirements

1. Scope p ­ 1.1 General · All of ISO 9001 is included · AS9100 requirements for Aerospace are indicated in BOLDFACED type · These requirements are complementary to contractual and regulatory requirements · If conflict between AS9100 and statutory/regulatory requirement, latter takes precedence · Legal compliance vs. conformity to standard

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AS9100C Requirements

Scope p ­ 1.2 Application · Permissible exclusions exist · AS9100 intended for organizations that design, develop or produce aerospace products · AS9110 intended for maintenance, repair or maintenance overhaul activities · AS9120 intended for distributors and stockists

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AS9100C Requirements

Terms and definitions ­ 3.1 Risk: An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence t ti ll ti ­ 3.2 Special Requirements ­ Customer or organization identified requirements having high risks & must be included in risk management process ­ 3.3 Critical Items ­ Items having a significant effect on product realization and use ( q p (require specific p actions to ensure they are adequately managed, i.e. fracture critical parts, safety critical items, key characteristics, etc.)

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AS9100C Requirements

3. Terms and definitions (continued) ( ) - 3.4 Key Characteristic ­ an attribute or feature whose variation has a significant effect on p product characteristics ( q (requires specific p actions to control variation) Note: Special requirements and critical items are terms that are interrelated with key characteristics. Terms are reviewed during product review and design activities

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AS9100C Requirements

4.1 General requirements ­ Document, implement, maintain and continually improve the effectiveness of a quality management system (QMS) ­ QMS shall address customer and applicable statutory and regulatory QMS requirements t t t d l t i t ­ Determine QMS processes needed ­ Identify and determine sequence and interaction of processes ­ Determine criteria and methods needed ­ Ensure availability of resources ­ Monitor measure and analyze processes Monitor, ­ Implement actions to achieve planned results ­ Ensure control over outsourced processes

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AS9100C Requirements

4.2 Documentation requirements ­ 4.2.1 Management system documentation · Personnel must be aware of and have access to relevant QMS documentation ­ 4.2.2 Quality manual · Scope of QMS and justification for exclusions · Description of process interaction

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AS9100C Requirements

4.2 Documentation requirements ­ 4.2.3 Control of documents ­ 4.2.4 Control of records · Controls include identification, storage, protection, retrieval, retention and disposition · Define the method of control of records created or retained by suppliers 4.3 Configuration management ­ moved this requirement to 7.1.3

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AS9100C Requirements

5.1 Management commitment g 5.2 Customer focus ­ Measure product conformity and on-time delivery performance ­ Take action if planned results are not, or will not be, achieved , 5.3 Quality policy 5.4 Planning ­ 5.4.1 Quality objectives ­ 5.4.2 Quality management system planning

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AS9100C Requirements

5.5 Responsibility, authority and p y, y communication ­ 5.5.1 Responsibility and authority ­ 5 5 2 Management representative 5.5.2 · Must have the organizational freedom and unrestricted access to top management to resolve QMS issues ­ 5.5.3 Internal communication 5.6 Management Review ­ 5.6.1 General l ­ 5.6.2 Review input ­ 5.6.3 Review output

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AS9100C Requirements

6.1 Provision of resources 6.2 Human resources ­ 6.2.1 General ­ Competence for personnel performing work affecting conformity to product requirements ­ 6.2.2 Competence, training and awareness 6.3 Infrastructure 6.4 Work environment

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AS9100C Requirements

7.1 Planning of product realization Determine, as appropriate: · Quality objectives and product requirements · Note: Quality objectives and requirements include such aspects as product and personal safety; reliability, availability and maintainability; producibility and inspectability; suitability of parts and materials, selection and development of embedded software; disposal at end of product life · Need for processes, documents and resources · Required product acceptance activities and criteria · Records to proved product meets requirements · Configuration management appropriate to the product · Resources to support use and maintenance of the product

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AS9100C Requirements

7.1.1 Project Management ­ Plan and manage product realization in a structured and controlled manner, at acceptable risk, within constraints 7.1.2 Risk Management ­ Assign responsibilities, define criteria, communicate risks throughout realization, mitigate risks, accept after mitigation 7.1.3 7 1 3 Configuration Management (CM) ­ Planning, identification, change control, status accounting, audits 7.1.4 7 1 4 Control of Work Transfers ­ Plan and control temporary or permanent transfer of work

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AS9100C Requirements

7.2 Customer-related processes p ­ 7.2.1 Determination of requirements related to the product · Note: Can include special requirements ­ 7.2.2 Review of requirements related to the product · Determine special product requirements · Identify risks (new technology, short delivery) ­ 7.2.3 Customer communication

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AS9100C Requirements

7.3 Design and development ­ 7.3.1 Planning ­ This set of requirements is rewritten in AS9100C ­ Divide design effort into distinct activities and for g each · Define tasks, resources, responsibilities, design content, input and output data and planning constraints · Base tasks on functional and safety objectives · Consider the ability to produce, inspect, test and maintain the product ­ Base tasks on functional and safety objectives ­ Manage interfaces between groups involved in design and ensure effective communication and clear responsibilities

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AS9100C Requirements

7.3 Design and development ­ 7.3.2 Inputs ­ 7.3.3 Outputs · Are verified against inputs · Specify critical items, key characteristics and specific action to be taken for these items · Define data for product identification, manufacture, inspection, use and maintenance i i d i ­ 7.3.4 Systematic reviews · Participants include functions concerned · Identify authority to move to the next design stage ­ 7.3.5 Verification · Removed the Note on possible verification methods

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AS9100C Requirements

7.3 Design and development g p ­ 7.3.6 Validation · Performed in accordance with planned arrangements · After verification · Under defined operating conditions · Normally on final product

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AS9100C Requirements

7.3 Design and development AS9100C exchanged the content of 7.3.6.1 and 7.3.6.2 from Rev B ­ 7.3.6.1 Verification and validation testing · Test plans identify product, objectives, resources and product objectives conditions · Test procedures define methods and record of results · Correct configuration of product submitted for test · Test plans and procedures are followed · Acceptance criteria are met ­ 7.3.6.2 Verification and validation documentation · Results must demonstrate compliance with requirements ­ 7.3.7 Control of changes · Changes controlled in accordance with configuration management process

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AS9100C Requirements

7.4 Purchasing g ­ 7.4.1 Purchasing process · Organizations are responsible for conformity of purchased product, even from customer designated sources ­ Supplier evaluation and selection · Establish criteria for selection, evaluation and reselection evaluation · Maintain records of supplier control activities ­ Note: Can use supplier quality data from objective and reliable external sources as one component of supplier control

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AS9100C Requirements

7.4 Purchasing ­ 7.4.1 Purchasing process ­ Supplier Evaluation (continued) · Maintain a register of suppliers with approval status and scope (e.g. product type, process t t d ( d tt family) · Periodically review supplier performance to help establish level of control · Define actions to be taken when results are poor · Use customer approved special processes · Define process to approve suppliers change suppliers, approval status and control used of suppliers based on status · Determine and manage risk when selecting and using suppliers

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AS9100C Requirements

7.4 Purchasing ­ 7.4.2 Relevant purchasing information includes · Product, procedures, processes and equipment approval requirements · Personnel qualification requirements · QMS requirements · Identification and revision status of technical data · Include requirements for design, test, inspection and verification, statistical techniques for product acceptance - including critical items and key characteristics · Include requirements for test specimens · Include NCM (nonconforming material) notification and disposition approval requirements

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AS9100C Requirements

7.4 Purchasing g ­ 7.4.2 Relevant purchasing information (continued) · Include notification of change in product, process, supplier, manufacturing location · Flow down the supply chain applicable requirements, including customer requirements · Records retention requirements · Right of access by organization, customer and regulatory authorities at any level of the supply chain

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AS9100C Requirements

7.4 Purchasing g ­ 7.4.3 Verification of purchased product ­ Establish process to ensure product meets requirements AS9100C rearranged this paragraph · Note 1: Customer verification does not relieve organization responsibility to deliver to contract · Note 2: Verification may include: Review of supplier documentation Certificate of Conformity Test reports Statistical records Process control

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AS9100C Requirements

7.4 Purchasing g ­ 7.4.3 Verification of purchased product · Positive identification (sufficient to allow recall if needed) of p ) product released before acceptance · Deleted the requirement for periodic review of test reports for raw material p · Deleted customer (or representative) right to verify product conformity at supplier or organization p g premises

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AS9100C Requirements

7.5 Production and service provision ­ 7.5.1 Control of production and service provision AS9100C rearranged requirements in this section Plan and execute production/service under controlled conditions, i.e.: · Information available to describe product characteristics · Note: Information can include drawings, parts lists, materials, specs i l · Work instruction availability as necessary · Note: Instructions can include flow charts, travelers, routers, routers work orders and inspection documents · Use of suitable equipment · Note: Can include product specific tools (jigs, fixtures, fixtures molds) and software programs

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.1 Control of production and service provision (continued) · Monitoring and measurement and suitable equipment for such · Product release, delivery and post delivery actions · Accountability of all product during production (part quantity, split orders, nonconforming product) · Positive record that all production and inspection operations have been completed as planned

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.1 Control of production and service provision (continued) · FOD (foreign object damage) prevention program · Monitoring of utilities and supplies as applicable ·W k Workmanship standards specified clearly (text, hi t d d ifi d l l (t t samples, illustrations)

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.1 Control of production and service provision (continued) · Consider as applicable: Processes to manage critical items, including process controls for key characteristics Designing and using tooling to measure variable data Identifying in-process inspection points at appropriate locations in the process Special processes

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.1 Control of production and service provision (continued) · 7.5.1.1 Production process verification ­ Perform first article inspection (FAI) to verify production processes, documentation and tooling · 7.5.1.2 Control of production process changes ­ Control and document process changes affecting processes production equipment processes, tools or software programs ­ Identify authority to approve changes ­ Confirm change is effective

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AS9100C Requirements

7.5 Production and service provision ­ 7.5.1 Control of production and service provision (continued) · 7.5.1.3 Control of production equipment, tools and software programs d ft ­ Validate production tools, equipment and software Removed requirement for FAI as the validation tool Removed requirement for documenting this process ­ Define requirements for equipment in storage ­ Relocated the former 7.5.1.4 Control of work transferred to 7.1.4

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.1 Control of production and service provision (continued) ­ 7.5.1.4 Post delivery support ­ Collect and analyze in-service data ­ Define action for problems after delivery ­ Control and update technical information ­ Controls for repair schemes used ­ Controls for off-site work

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.2 Validation of processes for production and service provision · Note: Often referred to as special processes Removed the requirement that processes be qualified prior to use Removed the requirement for documented process specifications

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AS9100C Requirements

7.5.3 Identification and traceability y · Maintain the identification of the configuration of the product to identify differences between p planned and actual p product · Control acceptance authority media (stamps, etc.) Note: Traceability requirements can include Maintaining ID throughout the product life Ensuring raw material batch traceability Traceability of subassembly components Maintaining records of sequential production activities

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AS9100C Requirements

7.5.4 Care of customer property p p y · Verify usability upon receipt · Notify customer if product becomes unusable

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AS9100C Requirements

7.5 Production and service provision p ­ 7.5.5 Preservation of product · Includes constituent parts · Shall also include where applicable: Cleaning FOD (foreign object damage) detection, prevention, prevention and removal Special handling of sensitive parts Marking and labeling including safety warnings i Shelf life control and stock rotation Special handling of hazardous materials

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AS9100C Requirements

7.6 *Control of monitoring and measuring equipment ­ Determine monitoring and measurement required and equipment needed for product acceptance ­ Maintain a register of monitoring and measuring equipment and define the process for their i t d d fi th f th i verification/calibration ­ Note: Equipment includes test hardware, test software, ATE (automated test equipment), plotters, personally equipment) plotters owned and customer supplied equipment ­ Defined method for recall ­ Ensure monitoring and measurement can be and are done per plans Ensure that environmental conditions are suitable for calibration, inspections, measurements and testing being done

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AS9100C Requirements

7.6 *Control of monitoring and measuring equipment · Equipment must be: ­ Calibrated or verified at specified intervals against known standards ­ Adjusted and re-adjusted as necessary ­ Identified to enable calibration status ­ Safeguarded from invalid adjustment ­ Protected from damage and deterioration · Define a process for recall of monitoring and measuring equipment requiring calibration or verification · Ability of computer software to satisfy intended application shall be confirmed ­ Confirmation typically includes verification and configuration management to maintain suitability for use

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AS9100C Requirements

8.1 General ­ Implement monitoring and measurement needed to · Demonstrate conformity to product requirements · Ensure conformity of the QMS y Q · Continually improve effectiveness of QMS 8.2 Monitoring and measurement ­ 8.2.1 Customer satisfaction · Determine whether customer requirements have been met ­ Product conformity ­ On-time delivery ­ Customer complaints ­ Corrective Actions ­ Plan for customer satisfaction improvement

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AS9100C Requirements

8.2.2 Internal audit · Determine if QMS is performing to planned arrangements · Note: Planned arrangements include contractual requirements

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AS9100C Requirements

8.2 Monitoring and measurement g ­ 8.2.3 Monitoring and measurement of processes · Determine if processes achieve planned results · Take corrective action when process nonconformities occur · Determine if process nonconformity led to NCP · Determine if process nonconformity is isolated or could have affected other processes or product · Identify/control any NCP per 8 3 8.3 NCP ­ Nonconforming Product

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AS9100C Requirements

8.2 Monitoring and measurement ­ 8.2.4 Monitoring and measurement of product AS9100C rearranged the order of this paragraph · Verify product requirements have been met Relocated the below requirements from 8.2.4.1, which was removed · Inspection documentation shall include Accept/ eject c ite ia Accept/reject criteria Test/measurement points in process sequence Record of measurement results (accept/reject) Any specific measurement instruments required · Record of person authorizing release of product

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AS9100C Requirements

8.2 Monitoring and measurement ­ 8.2.4 Monitoring and measurement of product · Control identified key characteristics per defined process · Justify sampling plans via recognized statistical principals Removes the requirement to reject a lot if a sample has a known nonconformity · Sufficiently trace product released before acceptance to allow recall and replacement as needed · Maintain records of positive assurance that product meets requirements Relocated the below requirement from 7.5.5 · Ensure documents required to accompany product are present at delivery t t d li

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AS9100C Requirements

8.3 Control of nonconforming product ­ Applies to product returned as nonconforming by customer ­ Defined authority for review and disposition of NCP and process for approving these personnel ­ "Use-as-is" or "repair" must be authorized by design organization representative (can be delegated) ­ Customer must approve "use as is" or "repair" dispositions if NCP d i t from contract requirements deviates f t t i t ­ Conspicuously and permanently mark scrap, then render unusable ­ Timely report delivered NCP to interested parties ­ Contain the effect of NCP on other processes or products ­ Corrected NCP subject to re-verification NCP ­ Nonconforming Material

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AS9100C Requirements

8.4 Analysis of data y Demonstrate suitability and effectiveness of QMS ­ Customer satisfaction ­ Conformity to product requirements ­ Process and product characteristics/trends ­ Suppliers

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AS9100C Requirements

8.5 Improvement ­ 8.5.1 Continual improvement ­ Monitor implementation of improvement activities and evaluate effectiveness Added a Note regarding origin of improvement opportunities ­ 8.5.2 Corrective action (CA) · Flow down CA to suppliers when necessary · Document escalation policy · *Determine if additional NCP exists based on CA situation ­ 8 5 3 Preventive action 8.5.3 · Prevent the occurrence of potential problems Note: Examples include risk management, failure mode y ( ), proofing and input from g p and effect analysis (FMEA), error p external sources

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Pursuing Registration to AS9100

· Organizations p g pursuing registration to AS9100C follow the g g same path as ISO9001 · Define your processes, document the system and implement · Define and document customer and regulatory requirements · 100% Compliance to requirements

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Pursuing Registration to AS9100

· Typical steps to Registration: yp p g

1. Proposal/Quotation Prepared 2. Application accepted/Auditor assigned 3. Documentation reviewed (could be p ( part of Stage 1) g ) 4. Pre-Assessment (Optional) 5. Registration Audit Completed (Stage 1 & Stage 2) 6. Nonconformances cleared (if applicable) ( pp ) 7. Registration reviewed, certificate issued 8. Surveillance audits conducted 9. Re-Registration audit p g performed

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OASIS Database

· International database maintained by SAE, y , required for all AS9100, 9110 & 9120 certifications · Includes all certificate and assessment information, including full audit reports and g p nonconformities · Allows certified supplier to manage data via administrative privileges p g · Used by most major OEMs and Primes as a supply chain management tool · Fee is $500 USD 1st 3 year cycle, $375USD 2nd 3 year cycle.

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Industry Emphasis

Increased Industry Oversight has resulted in many area's that suppliers need to improve and CB auditors pp p are spending extended time. Following are some of those topics: · Depth of auditing ­ Requires auditors to drill down to lower l l levels of the suppliers QMS l f h li · Classification of Nonconformities ­ Term coined "soft grading" means that auditors may have been writing Major NCRs and Minors and Minor NCRs as OFIs. This practice has come to an end and there are now auditor consequences. · 100% Compliance to all requirements of AS9100. p q There is no room for a single lapse in a requirement.

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Industry Emphasis

Increased Industry Oversight - Continued: · Root Cause and Corrective Action. Auditors are Action looking for more robust RCCA and the use of proven tools and methodologies. No more "Operator Error" or "Didn't understand the requirement" i " · Process Effectiveness. Organizations need to ensure they are monitoring and measuring process performance and taking action where targets are not met · Effective review and deployment of customer specific requirements p q · Poor supplier control. Inadequate monitoring techniques, lack of performance data

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Summary

· AS9100C continues the emphasis on business p p process effectiveness to ensure customer satisfaction · Top management have greater accountability and ownership for the Quality Management System Q y g y · The organization is required to measure business performance against objectives · Major Changes from previous revision · Expands scope to aviation, space and defense · Industry expectation is 100% compliance to requirements and ensure effectiveness

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Contact Information

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Roger Ritterbeck QMI-SAI Global Aerospace Product Manager

www.qmi-saiglobal.com q g [email protected] 216-408-5805

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Additional Information

Visit www.qmi-saiglobal for up to date information regarding the transition cycle. Look for upcoming webinars on THE NEW AS9101. For a complete comparison matrix between 9101B and 9101 C, e-mail [email protected]

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