Update on ASA s Audit Programs to ASA-100 & ISO/AS Quality System Standards

Transcription

1 Update on ASA s Audit Programs to ASA-100 & ISO/AS Quality System Standards Presenters: Stephanie Brown Michele Dickstein George Ringger Kelly Lyon 11 July ASA

2 ASA-100 Accreditation ASA-100 Standard and FAA AC 00-56A. Let s go through the steps! 11 July ASA

3 ASAAP Contacts Stephanie Brown, Director of Programs Kelly Lyon, ASA Auditor Michelle Billoir, ASA Auditor Richard Smith, ASA Auditor George Ringger, ASA Auditor 11 July ASA

4 Additional ASA Contacts: Michele Dickstein, President Jason Dickstein, General Counsel Diane Leeds, Financial Services George Ringger, ISO Accreditation Manager Arthur Schweitzer, Programs Assistant Dawn Carberry, Coordinator, Member Svcs. 11 July ASA

5 Just the facts! Very few countries regulate distributors, and until recently many did not specifically address distributors at all. EASA s comment period on a new NPA that addresses oversight of distributors is closed. CAAC has recently released an advisory document similar to FAA AC FAA does not regulate distributors specifically, but continues to encourage third-party accreditation and FAA AC July ASA

6 FAA AC FAA created a program by which a distributor complies with the requirements in FAA AC 00-56A. Compliance with FAA AC 00-56A includes a third party audit (ex. ASA-100, ISO 9001). Once accredited, a distributor can be listed in the database of accredited distributors, maintained on the ASA website. Many customers search the database to check the accreditation status of the distributor(s) they use. 11 July ASA

7 Requirements for Accredited Distributor 17 Requirements Receiving Inspection Personnel Training Identification and Qualification of QA Decision Makers Incoming Discrepant Measuring Equipment Self Evaluation Program Shelf-Life Controls Technical/Reference Data Inspection Stamp Control Packaging Controls Environmental Controls Documentation Control Lot Redistribution Procedures Documentation Retention Recall Controls Notification of Changes Hazmat Control and Shipping 11 July ASA

8 ASA-100 Accreditation The ASA-100 Standard is owned by ASA. ASA regularly reviews the standard. The Standard is currently on revision 3.6 (3/2012). Any need for clarification is issued via a Letter of Interpretation (LI). There is one (1) active LI. There is a Best Management Practice published pertaining to Disposition of Unsalvageable Aircraft Parts, and is referenced for guidance in the Standard. 11 July ASA

9 ASA-100 Accreditation Over 290 facilities are accredited via the ASA-100 Program globally. Companies are located: US, UK, Ireland, Switzerland, Netherlands, France, Canada, Russia, Slovakia, Nigeria, Singapore, Malaysia, Indonesia, Hong Kong, China, U.A.E., Saudi Arabia. Several US based companies have multiple ASA- 100 accredited locations throughout the world. 11 July ASA

10 What Are the Steps to Becoming Accredited to ASA-100? Six Step Process: 1. Review FAA AC 00-56A, ASA-100, and LIs. 2. Perform a self-evaluation audit of your quality system using the ASA-100 Self-Audit Checklist. 3. Complete ASAAP application and forward the application with payment to ASA. 11 July ASA

11 What Are the Steps to Becoming Accredited to ASA-100? 4. Upon receipt of the completed application and payment, ASA will contact you to arrange the date of your audit. Prior to the audit, ASA must have a controlled copy of your quality manual and the self-audit must be completed. 11 July ASA

12 What Are the Steps to Becoming Accredited to ASA-100? 5. ASA conducts the audit at your facility. The audit is typically conducted by one auditor and takes one day to complete. Upon completion of the physical audit, the auditor may leave the client with any corrective action(s) associated with the audit. The client will be given a timeframe to complete the corrective action(s). Upon successfully providing corrective action responses, ASA will provide the distributor with a certificate and certifying letter that supports the requirements of FAA AC 00-56A. ASA will also provide the distributor with a logo license agreement, which allows the use of the ASA-100 Accreditation logo on client s website, business cards, P.O. s and other documentation. 11 July ASA

13 What Are the Steps to Becoming Accredited to ASA-100? 6. Accreditation to FAA AC 00-56A does NOT become effective until your company is listed in the Voluntary Industry Distributor Accreditation Program database. The Aviation Suppliers Association has been designated by the FAA as the database manager and the database is maintained on the ASA website. To become listed, you must forward a copy of the accreditation certificate and a database letter to ASA. The database letter asserts that your company will continue to comply with AC (Complete details can be found in AC page 9, Para. 10) 11 July ASA

14 Supplemental Items ASA Quality Manual Template Developed to guide companies in writing a manual that complies with the ASA-100 Standard. Distributor will still need to make sure that they are operating the quality system in compliance with the company s manual and FAA AC 00-56A. Self-Audit Checklist Created as a supplement to the ASA-100 standard in order to help companies perform an extensive and appropriate self-audit. ASA-100 Test Available for companies to use for OJT on ASA-100, and can be modified to reflect the companies quality system. *Note: An answer key is provided. 11 July ASA

15 Monitoring Lists Simple to monitor: FAA AC 00-56A Database of Accredited Distributors: Quick Reference: Lists/Databases Tab 11 July ASA

16 FAA AC 00-56A Participation Other TAC ISO ASA

17 FAA AC As of June 25 th there were 672 companies listed on the Database of Distributors, thus being FAA AC 00-56A Accredited Breakdown among applicable quality system standards ASA -ASA-100 (42%) ISO 9001 (27%) Includes those accredited to AS/EN 9120 TAC 2000 (29%) Note: This number is constantly changing. 11 July ASA

18 Future of FAA AC 00-56A FAA leadership affirmed their commitment to AC and stated that they will be releasing an update to AC Things to look for: Removal of obsolete references Addition of aerospace specific ISO standards Update to the documentation matrix Global marketplace feel throughout the document SMS and Risk Assessment reference 11 July ASA

19 Future of FAA AC 00-56A Thinking Global EASA has a draft rule, known as NPA Control of suppliers of components and material used in maintenance. Under the proposed rule, maintenance organizations, like repair stations, would be provided with guidance about acceptable practices for managing sources of supply. The rule is similar to FAA AC in that it list officially recognised standards. Comment period for this rule has closed. This rule is impacted by other documents and there is concern that it will be delayed in release. The CAAC has developed its own guidance for Chinese distributors that require an audit by a Chinese Association. 11 July ASA

20 Future of ASA-100 Audit Program In general, ASA is moving to make many of the auditing documents and processes electronic and automated. Greater focus on responses to CARs. May be changes to ASA-100 to support a new AC or NPA. 11 July ASA

21 ASA-100 Discussion Topics 1.B.- Quality System and Quality Manual Are all procedures documented in sufficient detail to be used as operating instructions? 4.C. Training documentation. Who needs documented training? What does the training record need to include? 5.A. Trace to a prior source. What is the difference between trace documentation and certification documentation? 5.C. List of approved suppliers. How are suppliers approved and is this approval process included in the Quality Manual? How do you keep a quality history of each supplier? 8.I. Scrap procedure and records. What records need to be maintained? 9.A. Shelf life procedure. What is the change in Rev. 3.6 and what does it mean for keeping track of shelf life data. 11 July ASA

22 11 July ASA

23 The purpose of an organization 23

24 The purpose of an organization Identify and meet the needs/expectations of its customers and other interested parties people in the organization suppliers owners society Achieve competitive advantage in an effective and efficient manner 24

25 The purpose of an organization Achieve, maintain, and improve overall organizational performance and capabilities. Manage costs and risks. 25

26 Overall performance may impact: customer loyalty repeat business revenue and market share response time to market costs & cycle times through use of resources 26

27 The application of QMS principles aligns processes to achieve desired results provides competitive advantage through improved organizational capabilities motivates people towards organization's goals and objectives increases customer confidence creates value to the organization 27

28 Traditional Approach System Approach Fire Fighting Quick Fix Not taking enough time for analysis Going from one crisis to another Look for the guilty party - Who did that? Generate laundry list of solutions to firefight the symptoms Narrow-focus results in suboptimization of system Focus on $ metrics alone and hope processes improve. Many factors making up a complex situation Fully understanding the problem. Address the systemic root cause(s) Permanently fix and improve performance Seek total understanding of the process: How did that happen? Take time to understand the big picture Elicit dialogue, diverse perspectives, to apply the solution Optimize the whole enterprise Focus on improving processes that actually effect performance metrics 28

29 The Fundamentals of a Quality Management System and ISO

30 What is the Purpose of the ISO 9000 Standards? To provide a common framework for doing business and managing quality. To allow diverse companies to exchange products and services with greater confidence. To enhance customer satisfaction by meeting customer requirements. 30

31 What are the Objectives of the ISO 9000 Standards? Achieve, sustain, and improve product/service quality by managing the processes that create them Give organizations confidence that customer requirements are being met Give the customer confidence that products and services are consistent Provide or sustain market entry 31

32 What ISO 9000 Isn t... A Panacea. It alone won t solve all problems related to quality. Prescriptive. It tells you What, not How. All we need to do. It only specifies minimum requirements for an effective quality system. The Ultimate Goal. Our competitive edge depends on our ability to constantly improve and strive for excellence. Sufficient. It requires supplementation with more specific and detailed customer and/or sector specific requirements. 32

33 ISO 9000 s roots are in US Military Standards Developed from existing Quality Documents within the ISO Community, primarily MIL Q-9858, a US Military Standard Major Additions to MIL Q-9858 Training Requirements must be documented Internal Audits must be conducted 3rd Party certification required Major Departures from MIL Q-9858 ISO 9000 is less prescriptive Cost of Quality is not required in ISO

34 ISO 9000 Status Today 400,000+ Companies Registered in over 150 countries 35,000+ Companies Registered in the U.S. 20,000+ U.S. Companies pursuing Registration DoD & many other sectors or industries have adopted ISO 9000 based standards 34

35 ISO 9001 Eight Based on QMS Principles 1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. System Approach 6. Continual Improvement 7. Factual Approach to Decision Making 8. Mutually Beneficial Supplier Relationships 35

36 ISO 9001 is comprised of the following 8 clauses: 1. Scope 2. Normative references (part of the requirements) 3. Terms and definitions 4. Quality management system 5. Management responsibility 6. Resource management 7. Product (and/or service) realization 8. Measurement, analysis & improvement 11 July ASA

37 ISO9001 Model of a process based QMS Continual Improvement of the Quality Management System CUSTOMER Management Responsibility CUSTOMER Management Responsibility Management Responsibility Satisfaction Requirements input Product Realization Product output Value added activities Information Flow 37

38 ISO 9001 Implements the PDCA process Plan Clause 5. Management responsibility Clause 6. Resource management Do Clause 7. Product realization Check Clause 8. Product Measurement, analysis & improvement Clause 8. Process Measurement, analysis & improvement Act Clause 8. Continual improvement; corrective action; preventive action 11 July ASA

39 It is everyone s role to continually improve the company... Improve Process through PDCA Cycle Plan Do Results Act Check QMS Improvement Objective Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results Baseline Performance 39

40 AS9000 International Aerospace Quality Standard Founded in

41 AS 9000 is An international aerospace QMS Maintained by SAE Written & revised by IAQG 41

42 AS 9000 is a family of standards AS9000 Aerospace Basic Standard AS9004 Direct-Ship Practices AS9003 Inspection & Test Quality Systems AS9006 Deliverable Aerospace Software AS9100 QS Design, Development, Production, Installation & Services AS9101 Checklist Quality Systems Assessment AS9102 First Article Inspection Requirements AS9103 Variation Management of Key Characteristics AS9110 QMS Requirements for Maintenance Organizations AS9120 QMS Requirements for Stockists Distributors AS9131 QS for Non-conformance Documentation AS9132 Data Matrix Coding Quality Requirements for Parts Markings AS9133 Qualification Procedures for Aerospace Standard Parts

43 Aerospace Quality Standards Numbering System International Standards - 91xx Are planned for harmonization across all 3 aerospace sectors and are recognized globally Americas Standards - 90xx Are published for use by AAQG, may become a 91XX standard at a later date AS Standards - Americas Published by Society of Automotive Engineers EN Standards - Europe published in Europe by AECMA JIS Q or SJAC is the Japan / Asia Equivalent 43

44 Why the Need for AS9000? To standardize Aerospace 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 44

45 AS9000 conforms to ISO9001 Model of a process based QMS Continual Improvement of the Quality Management System CUSTOMER Management Responsibility CUSTOMER Management Responsibility Management Responsibility Satisfaction Requirements input Product Realization Product output Value added activities Information Flow 45

46 ISO9001 versus AS9100 AS9100 version is formatted to match ISO 9001:2000 and added requirements that provide for: Regulatory interfaces Configuration Management Design and Development Control of changes in Production Process Control of production equipment, tools, NC machines Control of work in outside facilities Control of service operations First Article Inspection Inspection documentation These added requirements enable a standardized approach to supplier flow down requirements 46

47 ASACB ASA s Certification Body ASACB ANAB accredited to perform ISO 9001:2008 CB under the ICOP program for AS9100 and AS9120 (ANAB conducted the accreditation) Will be applying for AS9110 Reviewing the new counterfeit parts standards (ex. AS 5553) 11 July ASA

48 Are you a new company to ISO or AS? Determine which standard is best for your company Develop an implementation plan Implement the QMS or AQMS Sign contract with CB Get audited Address the NCRs Steps for Certification can be found at: Certification 11 July ASA

49 Already ISO or AS Certified? Interested in transferring? Process is not difficult but there are specific rules and timelines that must be followed Different rules for ISO v. AS Different rules for transferring during surveillance time period rather than last 12 months 11 July ASA

50 Already ISO or AS Certified? Interested in adding ASA-100 or AC 00-56? Can be done all at the same time - Planning is critical If new to ASA-100, must have a full ASA-100 audit and then incorporate the surveillance audit elements AC can almost be incorporated in ISO 9001 but for AS need additional time 11 July ASA

51 Looking Ahead ISO and AS world is changing rapidly Revision to 17021, which is the CB operating document Revision to aerospace document 9101, which details how the auditor conducts the audit Change to ISO 9001 Addition of Counterfeit Parts Standards Prediction Big increase in audit fees! 11 July ASA

52 Trademark for ASACB 11 July ASA

53 QUESTIONS 53