IAQG International Aerospace Quality Group QMS Standards: Change Overview Quality Management Systems (QMS) For Aviation, Space and Defense April 16, 2010 1 Requirements Strategy Stream Team Leadership Team leadership: • Team Mentor Guy Dion (Zodiac Aerospace) • Team Leader Alan Daniels (Boeing) • AAQG Leader Buddy Cressionnie (Lockheed Martin) • APAQG Leader Masahiro Kawamoto (MHI) • EAQG Leader Guy Dion (Zodiac Aerospace) (Proposal) Standards Leaders: • 9100 Guy Dion (Zodiac) • 9110 Jeff Wood (Boeing) • 9120 Dale Gordon (MPC Products Corp) • 9115 Michelle Pierce (Lockheed Martin) • 9137 Francisco Losada (EADS CASA) • 9101 Hans Luijt (OPMT) 2 Standards Revisions Revised in 2009 • 9100 - QMS – Requirements for Aviation, Space & Defense Organizations • 9110 - QMS – Requirements for Aviation & Defense Maintenance Organizations • 9120 - QMS – Requirements for Aviation, Space & Defense Distributors • 9101 – QMS – Aviation, Space and Defense QMS Audits • 9115 – QMS Requirements for Aviation, Space and Defense Organizations – Deliverable Software Standards to be Cancelled (Combined in 9101) • 9111 – QMS Assessment for Maintenance Organizations • 9121 – QMS Assessment Applicable to Stockist Distributors 7 Why 9100:2009? • To standardize Aviation, Space & Defense quality expectations on a global level • To achieve improvements in quality and reduce costs throughout the value stream • ISO 9000 model for quality does not capture regulatory requirements or importance of safety, reliability or maintainability • Captures aerospace supplements agreed to at an international level AS&D products are often complex and high risk 11 ISO 9001 versus 9100 • 9100 version is formatted to match ISO 9001:2008 and added “requirements” that provide for: – Regulatory organizations interfaces – Project Management – Risk Management – Configuration Management – Control of Work Transfers – Design and Development V&V & V&V testing – Control of changes in Production Process – Control of production equipment, tools, NC machines – Control of service operations – Production process verification • These added requirements enables a standardized approach to supplier flow down requirements 13 9100:2009 Key Changes • Clause 3.1 – Risk Management – An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence • Clause 3.2 – Special Requirements – Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process • Clause 3.3 – Critical Items – 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 14 9100:2009 Key Changes Interrelationship between Special Requirements, Critical 7.1 Planning of Product Realization Items, Key Characteristics, and Risk Management process Customer Requirements including Requirements identified as special by the customer Statutory, Regulatory, and Other Requirements 7.2 Determination and Review of Requirements Related to the Product Special Requirements as determined by customer or organization 7.3 Design & Development Design Inputs Design Outputs 7.3.3.e critical items, including Key Characteristics 7.4 Purchasing Vendor/ Supplier Provided Products 7.4.2 flow down req’t to suppliers 7.5 Production & service provision (Drawings, Instructions, Plans. etc.) 7.5.1 appropriate processes to manage critical items 7.1.2 Risk Management 8.2.3/8.2.4 - Monitoring & Measurement of Processes/Products 8.4 Analysis of Data 8.5 Improvement (CI, C/A, P/A) 15 9100:2009 Key Changes • 7.1.1 – Project Management – 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 • 7.1.2 – Risk Management – 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 9100 • 7.1.3 – Configuration Management – Moved from Clause 4.3 to 7.1.3 – Structured in line with ISO 10007 requirement 17 9100:2009 Key Changes • 7.1.4 – Work Transfer – Moved from clause 220.127.116.11 (Production) to clause 7.1.4 – 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) • Clause 7.4.1 – Recognition of Supplier Quality Data – Added note to recognize that one factor that may be used during supplier selection and evaluation is objective and reliable data from external sources • Clause 7.4.1 – Approval Status for Suppliers – 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 18 9100:2009 Key Changes • Clause 7.4.3 – Validation of Test Reports – 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 • Clause 18.104.22.168 – Production Process Verification – Moved from 22.214.171.124 (measurement) to 126.96.36.199 (production) – Requirement to verify the production processes, documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering or manufacturing processes changes, tooling changes) FAI • Clause 8.2.4 –Sampling Inspection – 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) 19 9110:2009 Quality Management SystemsRequirements for Aviation and Defense - Maintenance Organizations 20 9110 QMS Maintenance 9110 Overview • Modeled after AS9100 Standard • Includes nearly every aerospace-unique requirement in AS9100, no clauses excluded • Includes all basic “ISO” requirements in ISO 9001:2008 • Includes a few additional requirements unique to Aerospace Maintenance Organizations • Added Foreword which is similar to AS9100 but tailored for maintenance, repair and overhaul 22 9110 QMS Maintenance Key Points • There are two significant themes in 9110 and they are: – Safety – Management Responsibility 23 9110 QMS Maintenance Key Points • 9110 Safety additions (examples): – 4.2.1.e General – “documented statements of a safety policy and safety objectives” – 5.1.f.g Management Commitment – “establishing the safety policy”, and “ensuring that safety objectives are established” – 5.4.3 Safety Objectives – “Top management shall ensure that safety objectives” – 5.6.1 Management Review – General – “assessing opportunities for improvement and the need for changes to the safety policy and safety objectives” – 5.7 Safety Policy – 3.5, 8.5.3 - Human Factors 24 9110 QMS Maintenance Key Points • 9110 Management additions (examples): – 188.8.131.52 Accountable Executive Manager – “Top management shall appoint a manager with corporate authority” – 184.108.40.206 Maintenance Manager(s) – “Top management shall appoint a manager(s) responsible for assuring that all maintenance required is carried out” – 5.5.2.e Management Representative – “reporting to the Accountable Executive Manager and Maintenance Manager(s) on the performance of the quality management system and any need for improvement” 25 Deployment Support http://www.iaqg.org 34 Questions?