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ISO 9001: 2000 Quality System Training Rev N/C Mar 04
Some Facts That Are Always True ä All Companies Go Though The Same Basic Stages Of Development And Growth ï Same patterns in Growth ÷Engineering Management Concepts, Inc. ÷MCA Engineers, Inc. ÷SBAR, Inc. ä How Effectively The Stages Are Handled Determine How A Company Will Survive And Continue to Grow.
Stages of Organizational Growth Approximate Organization Size (millions in sales) Stage Description Critical Development Areas I New Venture Markets and products Less than $1 II Expansion Resources and operational systems $1 thru $10 III Professionalization Management Systems $10 thru $100 IV Consolidation Corporate Culture $100 thru $500
Developmental Phases by Stages IV III II We Are here Develop Corporate Culture Develop Management Systems Values Beliefs Norms Develop Operational Systems Acquire Resources Define Products and Services I Identify and Define a Market Niche Planning Organization Development Management Development Controls (EVM) Accounting Financial Policies & Procedures Resource Management
Practical Reasons for ISO 9001 ä Need To Establish Sound Policies And Procedures ï Policies/Procedures Are Operating Baseline ä Need To Measure Company Performance ï Metrics – How Are We Doing? ï Is Customer Satisfied? ï How Do We Improve? ä Position Company For “Controlled Growth”
Closed Loop System Document Processes (Work Instructions) Document Issues And Improvements Train Staff to Use Work Instructions Collect Metrics and Customer Feedback Audit Compliance & Effectiveness Of WI
Implementing the ISO Process Perform Task per Work Instruction Complete Task Documents Problem Occur ? Work Instructions Developed and Released Scheduling System Task Conduct Training No MDRL PAR Process Yes Problems Identified ? CP-00 -9013 -14 NCAR Procedure SBAR Internal Quality Audits CP-00 -9017 Internal Audits Task could be– Work Order, Delivery Order, Task Assignment Leads to ISO 9001 Registration Close Task Records
ISO Registrar l EAQA-USA, Huntington Beach, CA is Our ISO Registrar l After Reviewing Our QMS Documentation and Records and Conducting an Audit, EAQA Registered MCA to the ISO 9001 Standard in June 2001 l EAQA Continues to Conduct Six Month Surveillance Audits of MCA Operations to Verify Continued Compliance with ISO 9001 l Will Begin SBAR Audits in 2004
ISO 9001 Is ……. . v Say What You Do = Documentation v Do What You Say = Implementation v Record/prove It! = Objective Evidence (Records /Audits) v Improve It = Continuous Improvement Ongoing Top Management Commitment ÷ Adequate Resources (People to Sustain the System) ÷ Continuous Improvement of the System. ÷
ISO DOCUMENTS • Quality Management Systems-Requirements (ISO 9001, Third Edition 2000 -12 -15) • Quality Management Systems-Fundamental and Vocabulary (ISO 9000, Second Edition 2000 -12 -15)
ISO 9001 Quality System Requirements • • • Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis, and Improvement
4. 0 Quality Management System (QMS) SBAR Quality Manual (QAP 2000) CP-00 -9005, Document and Data Control Procedure CP-00 -9016, Control of Quality Records Procedure • General Requirements • Implement Actions and Continual Improvement • Documentation Requirements • Quality Manual • Control of Documents • Control of Records • Record all facets of QMS!
Quality Manual, Procedures and WI Locations Contract/Office Specific Work Instructions (WIs) Corporate/Division Procedures Quality Manual MCA Web Site (http: /www. mca. eng. com) Pathway: Customer Service; Policies & Procedures; User Name: Contact Web Master Usually on Local Server Controlled Paper Copies (When Authorized) Contact Your Quality Assurance Office (QAO) for Access
5. 0 Management Responsibility SBAR Quality Manual (QAP 2000) CP-00 -9019, Servicing Procedure • Management Commitment • Establish the Quality Policy/Quality Objectives • Customer Focus/Customer Satisfaction • Quality Policy • Planning • Quality Objectives • Responsibility, Authority, and Communication • Top Management Appoints a Quality Manager • Management Review • Audit Results, Customer Feedback, Nonconformances • QMS Effectiveness, Resource Needs
SBAR is Committed to Quality!
What Does Our Quality Statement Mean ? v Our Customers Are the Final Judge of the Quality of SBAR’s Products and Services. v Everyone Is Responsible for Quality! v If Something Is Not Right, Let Your Supervisor Know Immediately. v If You Are a Manager/Supervisor Fix the Problem Before the Product Reaches the Customer. v Find Out and Give the Customer What They Want. v Keep the Customer Informed. v Make Suggestions for Quality Improvement.
Duties and Responsibilities SBAR Quality Manual QAP 2000 Who President, Executive Vice President, and Corporate Managers Responsibility and Authority 1. Maintain the Quality Management System (QMS) 2. Develop and implement plans for improving the quality management system 3. Communicate and ensure the visibility and understanding of SBAR’s quality policy throughout SBAR 4. Chair/attend QSC meetings 5. Ensure customer requirements are identified and achieved to enhance customer satisfaction 6. Establish communication processes to ensure that there is feedback regarding the effectiveness of the QMS
Duties and Responsibilities SBAR Quality Manual QAP 2000 Who Responsibility and Authority • Ensure that the QMS is established, Corporate Quality (QA) Manager implemented, and maintained in accordance with ISO standards throughout SBAR • Ensures QSC meetings recorded • Report QMS performance to Top Management/QSC and make recommendations for improvement • Ensure the promotion of customer requirements throughout SBAR
Duties and Responsibilities SBAR Quality Manual QAP 2000 Who Responsibility and Authority • Obtain and communicate customer Functional Area Managers (division, branch, contract etc. ) and supervisory personnel requirements to the appropriate management level • Ensure that qualified, skilled, and trained personnel, as well as other resources, are used to implement the QMS
Duties and Responsibilities SBAR Quality Manual QAP 2000 Who All Employees Responsibility and Authority Ensure that products/services satisfy customer requirements, including quality, safety, cost, timeliness, performance, reliability, durability, maintainability, etc. Comply with applicable specifications, and documented procedures/work instructions Understand the quality process Perform quality work Comply with SBAR Quality Manual Stop work in-progress and notify the FAM when quality is in doubt or compromised
6. 0 Resource Management SBAR Quality Manual (QAP 2000) CP-00 -9018, Training Procedure CP-00 -9009, Process Control Procedure • Provision of Resources Enhance Customer Satisfaction • • Human Resources • Train, Evaluate Training, or Make Other Provisions • Infrastructure • Buildings, • Workspace, • Equipment, etc. • Work Environment (i. e. , manage and maintain)
Training Program ä PHILOSOPHY - SBAR Will Employ Qualified Personnel Who Can Perform Specific Tasks (Of Their Job) Based On Appropriate Education, Training, And/Or Experience. ï To The Maximum Extent, We Hire Only Qualified Personnel. ï Our Training Program Provides Mechanism To Ensure That Personnel With The Appropriate Experience, Qualifications, And Training And Are Kept Current With Technology As Required.
Supplemental Training ä Supplemental Training May Be Required By An Approved Training Plan. Examples Are: SBAR Operating Procedures And Mode Of Operation “Train The Trainer” Training Proficiency Training To Apply For A Specific License/Certification (E. G. , Crane Certification, Certified Welder) ï Continuing Training/Education Mandated By Federal, State, Or Local Regulatory Agencies (E. G. , Educational Requirements For Professional Engineers Required By The California Board Of Registration For Professional Engineers) ï Customer Mandated Training ï ISO Auditor Training ï ï ï
Annual Training Cycle Charters And Individual Position Descriptions Define Mission of Employee Training Assessment Identifies Annual Training Plan Assessments Consolidated into Plan Individual Areas Where Training Will Enhance Employee Performance Annual Appraisal Focuses Employee Objectives Based On PDs And/Or Charter
7. 0 Product Realization CP-00 -9009, Process Control Procedure CP-00 -9003, Contract Review Procedure • Planning and Product Realization • Determine Product Quality Objectives/Requirements • Customer-Related Process • Customer/Statutory/Regulatory Requirements • Review of Requirements Related to The Product • Define All Product Requirements • Ability to Fulfill All Contract Requirements • Customer Communication • Customer Feedback, Including Customer Complaints
7. 0 Product Realization (Cont) CP-00 -9004, Design & Development Control Procedure • Design and Development Planning • Design and Development Inputs • Statutory, Regulatory, and Customer Inputs • Design and Development Outputs • Product Acceptance Criteria • Design and Development Reviews • Identify Problems and Implement Solutions • Design and Development Verification • Design and Development Validation • Control of Design and Development Changes
7. 0 Product Realization (Cont) CP-00 -4000, Purchasing Procedure • Purchasing Process • Approved Vendor List • Purchasing Information • Identify Product Approval, Procedures, Processes, and Equipment Requirements • Personnel Requirements • Verification of Purchased Product • Inspect Purchased Goods and Services • SBAR/Customer Verification at Supplier’s Premises (When Required)
7. 0 Product Realization (Cont) CP-00 -9009, Process Control Procedure CP-00 -9019, Servicing Procedure CP-00 -9008, Product ID and Traceability Procedure CP-00 -9010, Inspection and Testing Procedure CP-00 -9012, Inspection and Test Status Procedure CP-00 -9007, Customer Property Procedure CP-00 -9015, HSSP Procedure • Production and Service Provision • Control of Production and Service Provision • Validation of Processes • Identification and Traceability • Customer Property (Includes Intellectual Property) • Preservation of Product
7. 0 Product Realization (Cont) CP-00 -9011, Control of IMTE Procedure • Control of Monitoring and Measuring Devices (i. e. , Inspection, Measuring, and Test Equipment or IMTE. ) • What IMTE Processes and Equipment is Needed? • IMTE Requirements Include: • Calibrated at Specified Intervals • Calibrated Against National Standards • Protected Against Damage or Deterioration • Calibration Status Identifiable • Safeguarded Against Adjustments that Could Invalidate A Measurement
8. 0 Measurement, Analysis, & Improvement CP-00 -9019, Servicing Procedure CP-00 -9017, Internal Quality Audits Procedure • Monitoring and Measurement • Customer Satisfaction • Internal Audit • Identified Nonconformances • Monitoring and Measurement of Processes • Monitoring and Measurement of Product • Monitor and Measure Product Characteristics • Do Not Release Nonconforming Product Without Proper Authorization (e. g. , Customer approval)
Internal Quality Audits ä CP-00 -9017, Internal Audit Procedure ä Quality Audits Are: Systematic, Independent Examination To Verify That We Comply With Our Quality System Requirements ä Audits Are Intended To: ï Evaluate OUR SYSTEM, Not OUR PEOPLE ï Identify Problems And Potential Improvements ä We Are Looking For “Continuous Improvement” Of The System And All Of Our Processes.
Who Audits What? ä Trained ISO Auditors – Conduct All Audits And Document The Audit Results ä Each Of The Key ISO Elements Must Be Audited At Least Once A Year. ä If There Are Problems Audits May Be More Frequent. ä Problems Are Documented And Tracked Through Our Corrective Action Program.
8. 0 Measurement, Analysis, and Improvement (Cont) CP-00 -9013/14, N/CAR Procedure • Control of Nonconforming Product • Deal with Nonconforming Product by: • Eliminating the Detected Nonconformity, or • Authorizing Its Use, But ONLY Under Controlled and Planned Provisions, Supervised by Relevant Authority (i. e. A Supervisor, Manager, Customer), and/or • Precluding the Use of the Nonconforming Product (e. g. Segregate, Rework, Scrap)
8. 0 Measurement, Analysis, and Improvement (Cont) CP-00 -9020, Measurement and Analysis Procedure CP-00 -9019, Servicing Procedure • Analysis of Data • Collect and Analyze Data that Relates to: • Customer Satisfaction • Process Trends and Possible Preventive Actions • Suppliers/Vendors • Conformity to Product Requirements • Continuous Improvement
Performance Measurement ä Regular and Systematic Feedback from Customers, both Senior Managers and “Working Level” Customer Employees ï Assign Specific Personnel/Positions to Interact with Their Customer Counterparts ï If Possible, Make this Feedback Electronic/Web Based ï At Least on A Quarterly Basis ä Review and Act Upon All Customer “Report Cards, ” E. G. , CPAR Reports, Award Fee Determination Letters, Customer Survey Forms
Customer Feedback System
Collecting Performance Metrics ä Collect and Track All Customer Metrics, E. G. , Statements of Work, Service Delivery Summaries, Industry Recognized Metrics/Standards ä Identify Functional Area Manager (FAM) Responsible for Each Metric—Give that FAM Authority to Take Prompt Action if Metric Achievement is In Doubt ä Automate Metric Collection System-Identify A FAM Who is Responsible for Collecting Metrics (NOTE: Person collecting the metric should not be the person responsible for that metric. )
8. 0 Measurement, Analysis, and Improvement (Cont) CP-00 -9013/14, N/CAR Procedure • Corrective Action • Review Nonconformities (Including Customer Complaints) • Determine the Cause of Nonconformities • Take Action to Preclude Recurrence • Review Corrective Action Taken • Preventive Action • Determine Potential Nonconformities and Causes • Take Action to Prevent Nonconformances • Review Preventive Action Taken
Corrective Action Program ä Corrective Or Preventive Actions, Product Or Service Non-conformances And Possible Improvements Are Documented On A PAR Form And Tracked Through Analysis And Final Implementation (See CP-00 -90013/14) ä We Implemented A Web-based System To Allow Us To Document And Route Corrective Action Reports Through The Organization.
In Conclusion ä Everyone at SBAR Is Responsible for Quality! ISO 9001 Requires That You: Say What You Do Do What You Say Record Improve It!
QUESTIONS AND ANSWERS Did you understand that? Now I got it!