The Process-Based Approach:

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The Process-Based Approach Going Beyond Auditing
to Assessing
Presenter Ron Sedlock the quality Catalyst 880
State Road 26 Melrose, Florida 32666 Phone
[phone] E-mail rsedlock_at_msn.com www.the
qualitycatalyst.com
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Select One

• Obsessed with Sex and Booze!
• Excellent Decision Maker
• Uses Systems Thinking
• Good Management Skills

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Presentation Outline

• The Element Approach
• Process and Systems Models
• Process-Based Techniques
• In Conclusion

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What do all of the following have in common?
Activity-based Costing MBO Concurrent
Engineering JIT Quality Circles MRP MRP II Kaizen
CIP TQM TQL Hoshin Kempner-Tregoe ZD VA/VE

• Process-Based
• Six Sigma
• DFSS
• Lean Manufacturing
• Balanced Scorecard
• SPC
• DOE
• QFD
• Benchmarking
• Reengineering
• 7 Habits
• The Learning Organization
• ISO 9001
• Baldrige
• Taguchi
• Poke Yoke

Answer Cross-Functional Teamwork
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Quality is the resultof the system.
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ISO 9000 Series Quality Elements (1987)
Requirements 9001 9002 9003
1. Management Responsibility ? ? ?
2. Quality System ? ? ?
3. Contract Review ? ? -
4. Design Control ? - -
5. Document and Data Control ? ? ?
6. Purchasing ? ? -
7. Control of Customer-Supplied Product ? ? -
8. Product Identification and Traceability ? ? ?
9. Process Control ? ? -
10. Inspection and Testing ? ? ?
11. Control of Inspection, Measuring, and Test Equipment ? ? ?
12. Inspection and Test Status ? ? ?
13. Control of Nonconforming Product ? ? ?
14. Corrective Action ? ? -
15. Handling, Storage, Packaging, Preservation, and Delivery ? ? ?
16. Control of Quality Records ? ? ?
17. Internal Quality Audits ? ? ?
18. Training ? ? ?
19. Servicing ? ? -
20. Statistical Techniques ? ? ?
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The Element Approach

• Not how a business really works
• Not easy for the user to interpret
• No connection to improvement
• No need for process linkages

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Traditional Compliance Audit
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Scope and Depth
Scope Scope Scope Scope Scope
Task Dept.
Documentation Traditional Audits Traditional Audits
Compliance Traditional Audits Traditional Audits
Depth
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Scope and Depth
Scope Scope Scope Scope Scope
Task Dept. Links System
Documentation
Compliance
Effective
Improve
Traditional Audits
Process-Based Assessments
Depth
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Demings System Model
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Updated System Model
Benchmarking
Management Responsibility
Resources
Design
Customer Focus
Purchasing
Product Realization
Measurement/Analysis/ Improvement
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Model of a Process-BasedQuality Management
System (QMS)
Continual improvement of the quality management
system
Customers
Customers
Management responsibility
Resource management
Measurement, analysis and improvement
Satisfaction
Product realization
Input
Output
Requirements
Product
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ISO90012000

• 0.2 Process approach
• The application of a system of processes within
  an organization, together with the identification
  and interactions of these processes, and their
  management, can be referred to as the process
  approach.
• An advantage of the process approach is the
  ongoing control that it provides over the linkage
  between the individual processes within the
  system of processes, as well as over their
  combination and interaction.

HR
Sales
Prod
Eng
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ISO 90012000 and Baldrige
Continual improvement of the quality management
system
1 Leadership
3 Customer and Market Focus
3 Customer and Market Focus
7 Business Results
2 Strategic Planning

• Human
• Resource
• Focus

4 Information and Analysis
Input
6 Process Management
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ISO 9001 Malcolm Baldrige
Nonconformance Strengths Weaknesses
Audit Assessment

An assessment of the effectiveness of the Quality Management System (QMS) An assessment of the effectiveness of the Quality Management System (QMS) An assessment of the effectiveness of the Quality Management System (QMS)
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Traditional Quality Appreciative Inquiry Quality
Problem solving Existing solution searching
Root Cause Analysis What-is-working amplification
What do we need to do less of? What do we need to do more of?
Weaknesses Strengths
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Fishbone Process Model
Material
Person
Process
Machine
Method
S.I.P.O.C. Process Model
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IPO Spider Process Model
Incoming Material
Equipment
Who
Information
Input
Output
Process
Measurement
Environment
Workplace
Decision Making
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Model of a Process-BasedQuality Management
System (QMS)
Continual improvement of the quality management
system
Customers
Customers
Management responsibility
Resource management
Measurement, analysis and improvement
Satisfaction
Input
Product realization
Output
Requirements
Product
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Customer Initiate Processes
O
P
I
Your Organization
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Business Processes
Customer Oriented Processes (COPs)
Market Analysis/Customer Requirements ? Bid/Tender ? Order/Request ? Product and Process Design ? Product and Process Verification/Validation ? Product Production/Realization Delivery ? Payment ? Warranty/Service ? Post Sales/Customer Feedback

Internal Customer Initiated (or core processes) Marketing ? Sales ? Design ? Purchasing ? Production ? Delivery ? Service ? Accounting

Management Initiated (or support processes)
Benchmarking ? Communication ? Contract Review ? Customer Property ? Data Analysis Human Resource ? Infrastructure ? Inspection ? Material Handling ? Metrology Product Identification ? Quality Policy ? Resource Management ? Training ? Management Review ? Customer Satisfaction and Measures ? Corrective and Preventive Action ? Records ? Document and Data Control ? Internal Audit Nonconforming Product Control ? Continual Improvement Records ? Auditing ? Management Review ? Maintenance
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Process Linkages
Customer Initiated Process
Customer Initiated Process
Customer Initiated Process
O
P
I
Internal Customer Initiated Process
Management Process
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IPO Spider Web Model
Prod
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Linkage Strength
Output
Input
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Process A Process B Process C Process D Process E
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7.1 Planning and product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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Process-Based Audit Schedule

Management Responsibility
Resource Management
Product Realization
Measurement
Ship
HR
Sales
Prod
Eng
Purch
Design
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Auditing Systems
Design Purchasing Engineering Production






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Audit the arrows
A hand-off from one operation to another? A
communication link from one department or company
to another? Transporting product from one
location to another? An input to the
process? Indicating off-line processes?
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Audit the diamonds
Was the decision based on facts? Who made the
decision? How timely? How many yess vs.
nos? Where are they located?
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Audit Report Content
SECTION I Audit Identification Auditees name, location, date, product identification Key personnel contacted (Cross-Functional) Audit team members Auditors qualifications Identification of checklist
SECTIN II Results of Audit Strengths Weaknesses Major Discrepancies Minor Discrepancies Recommendations Exit interview attendees (Cross-Functional)
SECTION III References Audit teams appreciation Distribution list List of attachments
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Why Process-Based?

• To provide input for management review.
• To assess the system effectiveness.
• To provide insight to process owners.

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Optimizing the System
Cross-Functional Improvement
Functional Control
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In conclusion

• Audit linkages.
• Report the good.
• Add value to process owners.
• Add value to management review.
• Bottom line Go from auditing to assessing

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au?di?tor (ô'di-ter) n. 1. One who hears a
listener.
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Thanks for listening!The End