Putting ISO 9001 2000 to Work for You

Putting ISO 9001: 2000 to Work for You Center for Professional Management September 16, 2003 9/16/2003 Center for Professional Management

Outline • ISO 9001: 2000 – The WIIFM Factor • Overview • Details – Transition – Implementation – Use 9/16/2003 Center for Professional Management

Overview 9/16/2003 Center for Professional Management

Background • There are several standards organizations – SAE, ASTM, ANSI, DIN, BSI – ISO • The International Organization for Standardization • From the Greek isos – equal or standard • ISO 9001: 2000 Quality Management Systems - one of many ISO standards • Aggregation of Mil and Industry Req’s 9/16/2003 Center for Professional Management

Definition ISO 9001: 2000 is A series of standards to insure that necessary processes are in place, that the processes identified as necessary are appropriately coordinated, that they are being performed consistently and effectively and that there is objective evidence of same. 9/16/2003 Center for Professional Management

8 Quality Principles 1. 2. 3. 4. 5. 6. 7. 8. Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision-Making Mutually Beneficial Supplier Relationships 9/16/2003 Center for Professional Management

5 Core Elements (Clauses) • • • Clause 4 – Quality Management System Clause 5 – Management Responsibility Clause 6 – Resource Management Clause 7 – Product Realization Clause 8 – Measurement Analysis and Improvement 9/16/2003 Center for Professional Management

The “Big 6” • • • Required Procedures 4. 2. 3 Control of Documents 4. 2. 4 Control of Records 8. 2. 2 Internal Audit 8. 3 Control of Non Conforming Product 8. 5. 2 Corrective Action 8. 5. 3 Preventive Action 9/16/2003 Center for Professional Management

Transition From 1994 Standard ISO 9001: 2000 • 5 Core Elements • 6 Req’d Procedures • Business System 9/16/2003 ISO 9000: 1994 • 20 Core Elements • 18 Req’d Procedures • Shop Floor Control System Center for Professional Management

90% + Fall Into 1 0 f 4 Groups – Not ISO Registered – Registered to the 1994 Standard – ISO 9001: 2000 or QS • Customer Requirement • Foundation for CE stamp – “Did what we had to do to get ISO in on time” 9/16/2003 Center for Professional Management

Considerations Beyond ISO As Example – • Lean Manufacturing – Error proofing – 5 Ss • • • Sort Shine Set in Order Standardize Sustain – – – Employees properly trained Use Visual Management techniques Managers are committed to the program’s success Workplace is well ordered & adheres to procedures New procedures become a habit • How do you keep these initiatives alive and well? 9/16/2003 Center for Professional Management

. . . who wish to know about the world must learn about it in its particular details. -- Heraclitus c. 500 B. C. 9/16/2003 Center for Professional Management

The Details 9/16/2003 Center for Professional Management

TLAs • ABC • BPI • BPM • BRP • CIT • CMM • CPM • CQI 9/16/2003 • CRM • CRP • DRP • ERP • FBA • GMP • HMT • JAD • JIT • KPI • MBO • MRP • MES • OEE • QFD • QIT • QMS • QRP Center for Professional Management • SCM • SPC • TCO • TOC • TQM • TPP • TPM • WCM

TLAs • ABC • BPI • BPM • BRP • CIT • CMM • CPM • CQI 9/16/2003 • CRM • CRP • DRP • ERP • FBA • GMP • HMT • JAD • JIT • KPI • MBO • MRP • MES • OEE • QFD • QIT • QMS • QRP Center for Professional Management • SCM • SPC • TCO • TOC • TQM • TPP • TPM • WCM

? ? ? • CMMS • SCADA • CFPR 9/16/2003 Center for Professional Management

9/16/2003 ISO Center for Professional Management

ISO 9001: 2000 9/16/2003 Center for Professional Management

Additional Definition ISO 9001: 2000 is also • • Model Framework Structure Backbone 9/16/2003 Center for Professional Management

ISO as ‘Backbone’ Model People Methods Mgt. Initiatives Morale Communications Performance Measure Quality Mgt. Coaching&Mentoring ERP System Training&Devlpmnt Company Objectives Company Mission ISO 9001 Direction Tooling Production Lines Vendor Certification Computer Network Chemicals Components Equipment 9/16/2003 Company Material Center for Professional Management

Further Definition ISO 9001: 2000 as Business System outlines the following: • A Management System – A Process Control System – A Document Control System 9/16/2003 Center for Professional Management

Characteristics ISO 9001: 2000 • • • Completeness/Encompassing “Closed Loop” System Linked Inputs and Outputs Internal Audits Externally Audited Global Recognition 9/16/2003 Center for Professional Management

Model of a Process Based QMS Continual Improvement of the Quality Management System Management Responsibility Customers Measurement, Analysis & Improvement Resource Management Requirements 9/16/2003 Input Customers Product Realization Key Value -adding activity Information flow Center for Professional Management Product Satisfaction Output Source: ANSI/ASQ/ISO

ISO 9001: 2000 -- Not a Silver Bullet 9/16/2003 Center for Professional Management

“All good tools can be used poorly… and often are. A lot of companies that have to do ISO misuse ISO. They cause more instead of less work, paperwork, training, meetings, etc. ” -- Lestie Carey 9/16/2003 Center for Professional Management

Resource versus Requirement • “ISO tells what to do to run a good company – To improve your business you have to fill-in the how. ” • “They should be business requirements – if they are not business requirements, they should not be ISO requirements” 9/16/2003 Center for Professional Management

Terms • Quality – the degree to which a set of inherent characteristics fulfills requirements. • Effective – Plan-to-Actual performance • Efficiency – amount of resources ut takes to complete a task • Conformance – fulfillment of a requirement. • Customer Satisfaction – the customer’s perception of the degree to which the customer’s requirements have been fulfilled. 9/16/2003 Center for Professional Management

Please Note • It should be Conformance versus Compliance to standards • ISO 9001: 2000 is a Registration as opposed to being a Certification 9/16/2003 Center for Professional Management

Transition ISO 9001: 2000 is Less Prescriptive • Focus Shifted From Documentation to Objective Evidence • From Shop Floor Control to Mgt System – with Emphasis on: – – – Planning Process Being Effective Visibility to Management Customer Perspective Causing Success & Insuring Success 9/16/2003 Center for Professional Management

Changing Doctrines • 1994 Dogma “Document What You Do and Do What You Document” • 2000 Dogma “A Failure to Plan is a Plan to Fail” 9/16/2003 Center for Professional Management

Implementation Implement ISO using the ISO conforming processes 9/16/2003 Center for Professional Management

Project Mgt 101 • Identify Major Tasks & Activities • Categorize Work Content • Calculate Effort & Duration – Effort = Unit of work by category X the volume required X the periodicity X the frequency – Duration accounts for availability of resources – Forecast variability using MVIs • Plan Backward from Finish Date 9/16/2003 Center for Professional Management

Implementation Build Nucleus of Support “Recruit’” Senior Sponsor ID Peers Open Develop Resource Estimates Cost Effort Staff Requirments Pre Establish Implementation Project Management Select/Appoint Implementation Project Manager Weeks 1 - 6 Draft Project Outline Establish Project Timeline ID Registrar/Prime Resource 6 wks Gap Analysis Week 7 Presentation to Sr. Mgt. Prelium timeline Resource Req’s Major content Features and Benefits- What will be different Week 8 Establish Terminology Open a Glossary of Terms Review Terms in Standards Review & Training Week 9 9/16/2003 Center for Professional Management

Selecting the audit firm • • References Bench Audit Pricing Gap Analysis as ‘Test Drive” 9/16/2003 Center for Professional Management

Implementation Review CAP Review Corrective Action Procedure 8. 5. 2 Design Implementation Efforts to Insure that CAP is Used Week 9 Define Individual Roles ID probable cast Week 9 Week 10 SR Mgt Approval Schedule Dates Gap analysis Interim Final Audit Registration audit Week 12 Lock-in timeline Develop Promotions Promotional Campaign Materials Negotiate Assignments Recruit identified ‘volunteers’ Clear ‘volunteer’ participation with area sprv/mgt Review understanding of commitment (roles & responsibilities) w/’volunteers’ Kick-off 9/16/2003 Week 11 Center for Professional Management

Implementation Prelim Internal Audit Activities ID ‘Lead” Internal Auditor(s) Schedule Certification Classes ID Resource to Assist Initial Internal Audit Efforts Institute Document Control Appoint administrator Enter into vendor selection – Resource/Software Define Controlled Document & Protocol Establish Quality Record Listing Format Mark Non cntrl’d process maps “for reference only” Schedule Standards Review Publish Resource Names Draft Quality Policy Statement Draft Quality Objectives Identify Key Processes Develop Process Formats 9/16/2003 Establish Map Design Develop Process Database Center for Professional Management

Process Map Design C U S T O M E R Requirements 9/16/2003 Quality Mrkting R & D Mgt Ops Sales Finance MIS Center for Professional Management C U S T O M E R Satisfaction / Fulfillment

Process Map Document Example 9/16/2003 Center for Professional Management

9/16/2003 Center for Professional Management

Implementation Process Map Process Gap Analysis Impanel Mgt Board Select/Appoint Mgt Rep Devlelop Mgt Review Protocols Big 6 Procedures Draft Quality Manual Quality Record Database Develop Training Program Develop Training modules Create Handouts Determine Time Requirements Schedule Training/Set Training Timeline Review Work Instructions Initiate Training 9/16/2003 Center for Professional Management

Training Material Example Stress Linkage with Organizational Objectives Corporate Quality Mission Policy Statement 9/16/2003 Dept Mission Statement Area Mission Statement Center for Professional Management Functional Quality Objectives

Implementation Initiate Internal Audits “Initialize” System First Interim External Audit Make Necessary Adjustments Communications Process 5. 5. 3 Draft Letters Introduction letter ID all communications Have communication meetins post minutes Use System Continue audits, Training, Promotions Second Interim Audit Fill-in Gaps Registration Audit Celebrate 9/16/2003 Center for Professional Management

Audit Schedule/Layout – Bad Example 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 4 - QUALITY MANAGEMENT SYSTEM 4. 1 General requirements X X 4. 2 Documentation requirements 4. 2. 1 General X X 4. 2. 2 Quality manual X X 4. 2. 3 Control of documents X X 4. 2. 4 Control of records X X 5 - MANAGEMENT RESPONSIBILITY 5. 1 Management commitment X 5. 2 Customer focus X 5. 3 Quality policy X 5. 4 Planning 5. 4. 1 Quality objectives X 5. 4. 2 Quality management system planning X 5. 5. 1 Responsibility and authority X 5. 5. 2 Management representative X 5. 5. 3 Internal communication X 9/16/2003 Center for Professional Management

Audit Schedule/Layout – Good Example 4. 1 4. 2. 2 4. 2. 1 4. 2. 3 4. 2. 4 5. 1 5. 2 5. 3 5. 4. 1 MANAGEMENT Strategic Planning X Operating Committee X QUALITY SYSTEMS Quality Systems Management X X Quality Control Management - Line Inpection - Receiving Inspection - Analytical Lab Quality Assurance X Regulatory Affairs OPERATIONS Manufacturing Management X X Production Management - Production Line Operation - Maintenance - Material Handling 9/16/2003 Center for Professional Management

Using the System 9/16/2003 Center for Professional Management

ISO’s Approach Familiar PDCA Cycle Plan Act Do Check 9/16/2003 Center for Professional Management

Juran Approach Conforming Product / Service Requirement Yes Plan Do Check Conforms? No Corrective Action 9/16/2003 Remedial Action Feedback Loop Center for Professional Management

ISO Overlay Conforming Product / Service Requirement (1. 1, 4. 1, 7. 2. 2) Yes Plan (5. 4, 7. 1, 7. 3. 1, 8. 5. 3) Corrective Action (8. 5. 2) 9/16/2003 Do (5. 5. 1, 5. 6, 6, 7. 2, 7. 3. 2 -7, 7. 4, 7. 5) Remedial Action (8. 3) Check (7. 6, 8. 2) Feedback Loop Center for Professional Management Conforms? (8. 1) No

Signs ISO IS Sub Optimized • “ISO requires us to do this. ” • People with ISO in their job titles • Activities that were ‘done for ISO’ (e. g. , flowcharts, work instructions, etc. ) but are not referred to or used otherwise 9/16/2003 Center for Professional Management

Good Practice • Good Companies use Major Events to Provide Improvement in Specific, Usually Predefined, Areas of the Business 9/16/2003 Center for Professional Management

Best Practice • Great Companies Use Major Events as a Place Marker from which to Examine Thinking 9/16/2003 Center for Professional Management

Selling ISO to Senior Management – ISO as a Resource NOT a Requirement – Major part of ROI comes from all the other projects working as they should – Sarbanes - Oxley 9/16/2003 Center for Professional Management

Near Flawless Execution Requires Robust Policy, Procedures and Practices 9/16/2003 Center for Professional Management

Process Map with Board C U S T O M E R Requirements 9/16/2003 Quality Mrkting R & D Board Mgt Ops Sales Finance MIS Center for Professional Management C U S T O M E R Satisfaction / Fulfillment

Maturation ISO 9001: 2000 Evolves 9/16/2003 Center for Professional Management

Role of the Individual • • Desire to have a positive impact Effort to get ISO up and running Diligence Change of mindset 9/16/2003 Center for Professional Management

Critical Success Factors • • Link Inputs and Outputs Include Everyone Design Ongoing Involvement Promote Institutional Memory 9/16/2003 Center for Professional Management

ISO ‘Take-Aways’ • Structured Management • Major Constituents Addressed – Customers – Employees – Suppliers • • • Common Understandings Enforced Functions Linked Process Reinforcement Communications Integrated Participation at All Levels 9/16/2003 Center for Professional Management

Resources - Pocket Guides • Goal/QPC Memory Joggers – – 9000: 2000 Memory Jogger Project Management Creativity Tools • ASQ/J. P. Russell – Process Auditing Techniques – Internal Auditing Pocket Guide – ISO 2000 Lesson Guide 9/16/2003 • An Audit of the System, not the People – Quality Pursuit, Inc. • Cracking the Case of ISO 9001: 2000 for Service – Cianfrani, West • Cracking the Case of ISO 9001: 2000 for Manufacturing - Cianfrani, West • ISO 9001: 2000 Revision Highlights - Graebig Center for Professional Management

Resources - Books • American National Standard Quality Management Systems-Requirements – ANSI/ISO/ASQ Q 9001 -2000 - ASQ • Demystifying ISO 9001: 2000 – Paradis, Trubiano • The Route to Registration – BSI, CEEM • ISO 9000 Requirements – Kanholm • ISO 9001: 2000 Standard Paraphrased – Peach, Wilson 9/16/2003 • The Management Review Handbook – Robitalle • The Painless ISO 9001: 2000 Transition – Robitalle • Quality Audits for ISO 9001: 2000 – O’Hanlon • How to Audit the Process. Based QMS – Arter, Cianfrani, West • ISO 9001: 2000 Explained – Cianfrani, Tsiakals, West • ISO 9000 - Johnson Center for Professional Management

Resources - Web Sites • ISO - http: //www. iso. ch/iso/en/ISOOnline. frontpage – Magical Demystifying tour - http: //www. iso. ch/iso/en/iso 900014000/tour/magical. html • ASQ - http: //www. asq. org/ – Standards - http: //standardsgroup. asq. org/ • BSI - http: //www. bsi-global. com/index. xalter 9/16/2003 Center for Professional Management

ISO as Resource ISO 9001: 2000 is a business management system that can be used by managers: • As a robust outline of ‘good practice’ coordinated procedures • As a means for insuring consistent interdepartmental cross-functional support • As a way to maintain management oversight and participation – at ALL levels 9/16/2003 Center for Professional Management

Use ISO 9001: 2000 As A Resource 9/16/2003 Center for Professional Management

Success does not just happen – Success is caused 9/16/2003 Center for Professional Management

Cause Success Thank You APICS Center for Professional Management 9/16/2003 Center for Professional Management