The Easy and Cost Effective Way to AS9100 Certification

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1 The Easy and Cost Effective Way to AS9100 Certification Presented by John Graham June 26,

2 Seminar Sponsors Fulcrum Associates John Graham Det Norske Veritas (DNV) Sidney Vianna Performance Review Institute (PRI) Scott Burkholder ex

3 Seminar Objective To give participants an overview of the AS9100 requirements and identify an easy and effective method to achieve certification To explore how to implement a cost effective AS9100 system that will provide a return on your investment 3

4 International Aerospace Quality Group 4

5 Subjects to Address AS What it is and what it is not How to adapt the standard to fit your company What some of the most common misinterpretations of the standard are How to use computerized templates to ease the pain & improve effectiveness What to do to prepare for the Certification process How to select a Registrar that provides ongoing value How to get started and how long you can expect the project to take 5

6 Historical Developments Six European Countries Form Common Market (EEC) ISO 9000 TC 176 Formed ISO 9000:1987 Adopted By Fourteen Countries ISO 9000:1994 Second Revision Released Ninety Countries Adopt ISO 9000 as National Standard Jan D1-9000:1997 Rev A Released AS9000:1998 Released Nov AS9100:1999 Released Dec ISO 9000:2000 Third Revision Release July AS9100 Rev A Update to ISO 9000:2000 Ver. 6

7 AS9100 Process Focused Model Quality Management System Continual Improvement C U S T O M E R R e q u i r e m e n t s Resource management Input Management responsibility Product (and/or service) realization Measurement, analysis, improvement Output Product/ Service S a t i s f a c t i o n C U S T O M E R 7

8 ISO 9000 Management Principles 1. Customer focus Understand current and future customer needs and strive to exceed their expectations 2. Leadership Create environment where people can be fully involved 3. Involvement of people Full involvement enables people s abilities to be used 4. Process approach Manage processes to achieve desired results more efficiently 5. System approach to management Understanding interaction contributes to organizational effectiveness and efficiency 6. Continual improvement Should be embedded as permanent organizational objective 7. Factual approach to decision making Analysis of data improves effectiveness of decisions 8. Mutually beneficial supplier relationships Interdependent and mutually beneficial relationship creates value 8

9 Process Based Systems Desirable Characteristics of a Process Based Organizational System Roles and responsibilities are clearly defined Organizational mission processes are identified Processes are linked and effectively integrated Process ownership and accountability are clear Processes are documented in an understandable and user friendly fashion The process objective fulfills a portion of the organizational mission The non-value added activities within a process become apparent Process redundancies and duplications are identified and eliminated 9

10 Defining the Process Model Processes Create Products Process Definition set of interrelated or interacting activities which transforms inputs into outputs Product Definition results of a set of interrelated or interacting activities which transforms inputs into outputs ISO9000:

11 Determine Organizational Processes Activities or Operations are Processes The products or services delivered to our customers are the results of processes. The degree to which we control these processes determines the customer satisfaction with the product/service. 11

12 True or False Questions 1. When documenting processes it is best to minimize the documentation 2. The best way to start implementing AS9100 is with a gap analysis 3. Avoid documenting anything beyond the AS9100 requirements to prevent unnecessary audit nonconformities 4. Only list and keep the records required by the standard 5. You can achieve certification by documenting only six ISO processes and four AS processes 6. You must have a quality manager who is ultimately responsible for the product quality 7. You can not produce top quality products without AS9100 Certification 8. Once you achieve Certification the customers will beat a path to your doorstep 9. All registrars and auditors are equally capable 12

13 Common Misinterpretations 1. A documented configuration management process is not needed if you only do contract manufacturing 2. You can exclude some of the requirements of section 7 by subcontracting work to a supplier 3. If you don t use raw material test reports to accept material you do not need to periodically validate the test reports 4. The requirements of 7.6 Control of Monitoring and Measuring Devices do not apply if you do not calibrate your own measurement devices 5. The entire QMS must be audited annually 6. Nonconforming material must be in a locked cage or room 13

14 Business/Organizational Processes Typical Manufacturing Company Processes Establish & Maintain Contracts Plan and Monitor Production Select, Qualify, & Monitor Suppliers Purchase Materials & Services Manage Nonconforming Products Inspect Products Identify, Package, & Ship Products 14

15 Process Flowcharting Start Responsibility Reference Document Process Document or Record On or Off Page Connector B Decision Diamond Apply KISS Principle End 15

16 Visual Impact Flowcharts Structure for Expansion and Linkage Select, Qualify, and Monitor Suppliers Quality 4. Assess Supplier's capability No 5. Does Supplier meet requirements? No Start Purchasing 1. Identify requirements for Suppliers Purchasing 2. Research & select potential Suppliers 3. Is Supplier currently qualified? Yes Qualified Supplier List Supplier catalogs 1. Identify a Supplier requirement based on the need to satisfy a customer product or service requirement. 2. Conduct research to determine the capability of the Supplier to satisfy the identified requirement. For customer specified suppliers, purchase parts and materials from only those suppliers when specified by drawing or contract. Customer specified suppliers must still be qualified and monitored for capability and performance. 4. Conduct a survey of the Supplier per Qualify Supplier, to assess their capability to provide quality products and/or services. Use the Supplier Survey Form, to collect Supplier information. Yes 16

17 Eliminate Non-value Added Processes Results of Good System Planning HR Facilities Accounting Design & Development Manufacturing Quality Material Management Marketing & Sales 17

18 Eliminate Gaps and Redundancies Results of No/Poor System Planning?? Design & Development Manufacturing Quality Facilities Accounting HR Material Management Marketing & Sales 18

19 Identify Business Processes Establish & Maintain Contracts Administer Order Entry Plan, Monitor, & Expedite Production Select, Qualify, & Monitor Suppliers Purchase Materials & Services Receive & Verify Materials Handle, Store, & Issue Materials Manage Nonconforming Products Manufacture Products Inspect Products Identify, Package, & Ship Products Develop & Control Documents & Data Control Quality Records Administer Communications System Control Inspection, Test, & Measuring Equip. Maintain Facilities & Equipment Control Tools & Software Develop & Train Personnel Administer Human Resources Conduct Internal Audits Perform Corrective & Preventive Action Review Quality System 19

20 Business/Organizational Functions Customer Order Entry Production Planning Purchasing Core Functions Receiving Material Manufacturing Shipping Customer Administrative Support Quality Assurance Human Resources Facilities & Equipment Support Functions 20

21 Linking and Integrating Processes Business Functions Customer Business Processes Order Entry Establish & Maintain Contracts Administer Order Entry Production Planning Plan, Monitor, & Expedite Production Purchasing Select, Qualify, & Monitor Suppliers Purchase Materials & Services Receiving Receive & Verify Materials Material Handle, Store, & Issue Product Manage Nonconforming Product Manufacturing Manufacture Products Inspect Products Administrative Support Shipping Customer Identify, Package, & Ship Products Quality Assurance Control Quality Records Develop & Control Documents & Data Administer Communications System Manage Projects Human Resources Conduct Internal Audits Perform Corrective & Preventive Action Review Quality System Establish & Apply Statistical Techniques Facilities & Equipment Develop & Train Personnel Administer Human Resources Control Inspection, Test, & Measuring Equip. Maintain Facilities & Equipment Control Tools & Software 21

22 Identify Business Records Receiving Records Purchase Orders Qualified Supplier List Supplier Corrective Action Request Product Specifications Nonconforming Material Reports Rework Instructions In-process Inspection Reports Final Inspection Reports Work Orders Production Plans Internal Audit Nonconformities Internal Audit Schedule Internal Audit Report Corrective Action Reports Calibrated Equipment Recall List Software Validation Report Personnel Training Records Personnel Competency Assessments Management Review Minutes 22

23 Process Based Communication System Use Common Tools and Technology to Improve Communication Document and communicate process ownership Use appropriate tools to enhance user friendly communication Use technology to show linkage throughout organizational system Enable open information storage for all team members Organize information to enhance locating and use Protect and maintain information integrity Establish clear information source accountability Eliminate redundant data storage to minimize confusion Eliminate non-mission critical information 23

24 BMS 2000 Business Management System Business Function Model Customer Order Entry Production Planning CORE FUNCTIONS Purchasing Receiving Material Manufacturing Shipping Customer Administrative Support Facilities & Equipment Quality Assurance Executive & Finance Human Resources SUPPORT FUNCTIONS 24

25 BMS 2000 Business Management System Model Business Process Model Business Functions Business Processes Customer 01 Order Entry Establish & Maintain Contracts Administer Order Entry Coordinate Customer Service 02 Production Planning Plan, Monitor, & Expedite Production 03 Purchasing Select, Qualify, & Monitor Suppliers Purchase Materials & Services 04 Receiving Receive & Verify Materials 05 Material Handle, Store, & Issue Materials Manage Nonconforming Product & Materials 06 Manufacturing Manufacture Products Inspect Products Identify & Package Products 07 Shipping Prepare & Ship Products 08 Administrative Support Customer 09 Facilities & Equipment Control Business Management System Records Develop & Control Documents & Data Define & Manage Communication System Plan & Manage Projects Control Monitoring & Measuring Equipment Maintain Facilities & Equipment Control Tools & Software 10 Quality Assurance 12 Executive & Finance 11 Human Resources Conduct Business Management System Audits Perform Corrective & Preventive Action Establish Monitoring & Measuring Controls Develop & Update Business Plan Review & Update Business Management Syst. Develop & Train Employees Administer Human Resources 25

26 Documentation System Structure Manual (Mission, Policy, & Business Functions) Procedures (Business Processes) Work Instructions & Specifications Forms, Templates, Logs (Detailed, single-user or department instructions) Records (Results of carrying out processes) 26

27 BMS 2000 Business Management System Information Center Tier 1: Business Functions Information Center 01 Order Entry 02 Production Planning 03 Purchasing 04 Receiving 05 Materials 06 Manufacturing 07 Shipping 08 Admin Support 09 Facilities & Equipment 10 Quality A ssurance 11 Human Resources 12 Executive & Finance 27

28 28

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