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ISO 9001:2000 Implementation – Increasing Value and Reducing Lead Time
- Removing Implementation Roadblocks
San Jose, CaliforniaChad Kymal
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Agenda
• ISO 9001:2000 Requirements and Deadlines• ISO 9001:2000 Roadblocks and Prevention• Transitioning from ISO 9001:1994 – Key
Differences• Creating Value from ISO 9001:2000
Implementations• Creating the culture change and the savings
quickly
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ISO 9001:2000 Requirements and Deadlines
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ISO 9001:2000 Process Model
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ISO 9000 Series of Standards
Terms and Definitions
Guidance
QMS Requirements
ISO 9000:2000
ISO 9001:2000
ISO 9004:2000
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ISO 9001:2000 Registration Process
• Documentation Review
• Onsite Audit
• Corrective Action
• Certificate Issuance
• Surveillance
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Steps to ISO 9001:2000 Implementation
Activity Jan Feb Mar Apr
Conduct Discovery Analysis and Assessment
Develop Plan and Strategy Present Executive OverviewForm Team and Initiate ProjectTrain TeamCreate Documentation Plan and Facilitate RolloutFormulate Implementation PlanTrain Internal AuditorsConduct Internal Audit
Conduct Corrective ActionConduct Registeration Audit
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ISO 9001:2000 Deadlines
• Organizations need to get registered by Dec.31, 2003 to retain their ISO Certification
• Organizations not upgraded to ISO 9001:2000 will lose their ISO certification
• ANSI/RAB and registrars will not continue to support ISO 9001:1994 past the deadline
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ISO 9001:2000 Roadblocks and Prevention
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Roadblocks and Problems
• Top Management commitment and involvement• ISO 9001:2000 Implementation seen as a Quality Department
effort• Goal of Implementation is passing the audit• No Plan or leadership for the implementation. • Providing Customer Focus/Measuring Customer Satisfaction• Over documentation• Understanding steps for Process Focus• Implementing a process for continual improvement• Objectives deployment and Business Review• Poor internal audits
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Transitioning from ISO 9001:1994 - Key Differences
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Transitioning from ISO 9001:1994 - Key Differences
• Process Focus and business process measurement
• Documentation of Procedures
• Customer Focus
• Objectives Deployment
• Management Review
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Transitioning from ISO 9001:1994 - Key Differences (cont’d)
• Resources Planning and including Competency
• Customer Satisfaction
• Analysis of Data
• Continual Improvement
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Providing Value In ISO 9001:2000 Implementations
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Getting Value from Your Implementation
• Set Objectives for your ISO/TS 16949:2002 Implementations– Find crucial senior management problems to work
on – SAVE Money with the implementation
• For example:– Setting business objectives and a management process– Implement Six Sigma or Lean as a part of the continual
improvement process – Save Money– Process and documentation Commonization– Improved Problem solving with lead time and cost savings
target
• Become Process focused –process map, process list, BMS control plans, and alignment charts
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Getting Value from Your Implementation (cont’d)
• Use the alignment methodology to become customer focused
• Train your implementation team and Auditors– Use the idea of a BMS and not a QMS
• Use software which has prescribed Best In Class Methods. Use it to optimize the implementation and make it easy. Use web based software– Documentation– Customer Focus and Continual Improvement– New Product Development (FMEAs?)– Process Mapping and Process Flows
• Get your top management involved in the implementation
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Creating the culture change and the savings quickly
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ISO 9001:2000 Implementation Plan
• Form Overall Objectives and Strategy • Form Team and Train Team • Form ISO and Software Implementation Plan• Develop Documentation• Implement Software Modules – Documentation,
Process Focus, Customer Focus• Train Auditors and Conduct Audit –implement Audit Pro
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ISO 9001:2000 Implementation Plan
• Form Overall Objectives and Strategy – Month 1 • Form Team and Train Team – Month 1• Form ISO and Software Implementation Plan – Month 1• Develop Documentation – Month 2• Implement Software Modules – Documentation,
Process Focus, Customer Focus – Month 2 to 4• Train Auditors and Conduct Audit –implement Audit Pro
– Month 5
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Month 1
• Conduct Discovery Analysis and formulate overall objectives and strategy for ISO 9001:2000
• Form ISO and Software Implementation Plan • Conduct Executive Overview for Senior Management• Form Team and Train Team
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Month 2 – Develop Documentation
• Required Procedures – Most can be reused from ISO 9001:1994 system– Document Control– Records Control– Internal Audit– Non Conforming Product– Corrective Action– Preventive Action
• Review documentation from current system and decide which to keep
• Identify additional value added documentation
Keep documentation to a minimum. Use softwareTo implement and provide evidence of a process
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Month 2 to 4 – Implement Software Modules
4.1, 4.2 building the process model, review of process metrics
and managing process variation.
4.2 document management.
5.1 - 5.4, 6.1 managing customer expectations, customer satisfaction,
continual improvement, and data analysis. 5.5 6.2, 6.4 human performance management functions, competency,
training management and satisfaction surveys 6.3 preventive and reactive maintenance. 7.1 project management. 7.1, 7.3 APQP, PPAP processes
7.4, 7.5 document management.
7.5 preventive and reactive maintenance.
7.4, 8.2.2 internal and external audit function with a focus on
process improvement. 7.6, 8.4 calibration and measurement systems analyses. 8.2.1 human performance management functions, competency, training management and satisfaction surveys
8.2.3, 8.4, 8.5 managing customer expectations, customer satisfaction,
continual improvement, and data analysis. 8.5.2, 8.5.3 document management.
Process Pro
Document ProBOSS
HR Pro
TPM Pro Project Planner AQuA Pr Document ProTPM Pro Audit Pro
MSA Pro HR Pro
BOSS
Document Pro
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Process Focus - Process Pro
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The process flow shows the linkages between each step within the process. You can then click to see the processflow definition.
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Business Management System Control Plan – Example A
Business Management System Control Plan
Organization_______________________________________ Product Description ______________________________________
General Manager___________________________________ Issue/Rev Date __________________________________________
Process ActivityCustomer Req/Expectation
Key Process? Measurement Responsibility
Acceptance Criteria 2002
Review Frequency Control Methods
Comments/ Reaction
Q1,Q2,Q3,Q4
EXAMPLES
Business Fulfillment On time delivery Yes % On-time in FAB Logistics 94,95,96,96% 4/yrPareto chart, Cont Imp Targets
Corrective action after 3 consecutive
% On-time to customer
Production Control 100% 4/yr Pareto chart
C/A is more than 15% off target
Complaint Response Quality 10 days 4/yr Pareto chart Continue to monitorValid Complaints Quality 10 per qtr 4/yr Pareto chart Continue to monitor
Competitive No Time to market Design/Dev 52 weeks Weekly Proj Rev minutes R, Y, G reactionBusiness Creation Innovation No Patents Filed Design 20 per year Monthly Line item Continue to monitor
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Customer Focus and Continual Improvement -
BOSS
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It all starts with the customer
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Quality is what the customer says it is!
Multiple customers and multiple expectations categories.
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You can then align customer quality expectations with company driven process improvement activities.
EwQMS helps you measure key processes.
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OFI’s can trigger improvement proposals so the team can make adjustments to the process.
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If results indicate further analysis, team meetings can be held to determine OFI’s.
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Data for process measurables is kept within the EwQMSsystem for analysis and continuous improvement activities.
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Excel data can also be imported using Data Exchanger, an EwQMS tool giving you total flexibility in data collection.
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You can then use the EwQMS report generator to report detailed information on a variety of process metrics.
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EwQMS drill down functionality allows management to quickly find the root cause of process variation.
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Again, EwQMS visual management tools allow easy interpretation of metrics data.
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Improvement proposals can be documented and tracked against results.
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Documentation – Document Pro
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CustomerDocumentation
SupplierDocumentation
1
2
3
BMS Manual
Common
Specific
Common
Specific
4Common
Specific
Additional Levels- Reference Documents- Marketing Information- Uncontrolled documents- CAD Drawings- Business Metrics- PPAP- Customer Specific Information- Measurement Systems- Audit Information
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The Document Management Process
Spans multiple sites, groups and levels.
No limited file types; graphics, audio, video
Action items with email support
Automated routing and escalation
Records management
Document draft functionality
User defined login default
On line revision history and reference documents
EwQMS module hot links
Customer complaint and concern management
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Month 5 – Train Auditors and Conduct Audit
• Train Internal Auditors• Conduct Internal Audit using Audit Pro• Use Audit Pro to follow up on Corrective Actions
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Audit Pro
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The Auditing Process
Scheduling of Audits
Auditor selection criteria ( i.e. qualifications)
Auditor calendar and date verification
Managing Audits
Visual audit status
Audit query and report capability
Visual CAR status
Reminders and escalation functionality
Custom email messages
Sharing across the Enterprise
Audit information
Auditee information
Auditors
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Conduct Registration Audit
• Conduct Registration Audit• Track and record – overall objectives accomplished• Provide Senior Management Presentation