The Process-Based Approach:

Going Beyond Auditing to Assessing

Presenter: Ron Sedlock 880 State Road 26 Melrose, Florida 32666 Phone: (352) 473-6095 E-mail: [email protected] www.thequalitycatalyst.com

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Select One Obsessed with Sex and Booze! Excellent Decision Maker Uses System’s Thinking Good Management Skills 2

Presentation Outline •

The Element Approach

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Process and Systems Models

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Process-Based Techniques

“In Conclusion…”

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What do all of the following have in common? 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

Activity-based Costing MBO Concurrent Engineering JIT Quality Circles MRP MRP II Kaizen CIP TQM TQL Hoshin Kempner-Tregoe ZD VA/VE

Answer: Cross-Functional Teamwork

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“Quality is the result of the system.”

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ISO 9000 Series Quality Elements (1987) Requirements

9001

9002

9003

1. Management Responsibility

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2. Quality System

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3. Contract Review

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4. Design Control

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5. Document and Data Control

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6. Purchasing

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7. Control of Customer-Supplied Product

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8. Product Identification and Traceability

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9. Process Control

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10. Inspection and Testing

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11. Control of Inspection, Measuring, and Test Equipment

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12. Inspection and Test Status

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13. Control of Nonconforming Product

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14. Corrective Action

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15. Handling, Storage, Packaging, Preservation, and Delivery

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16. Control of Quality Records

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17. Internal Quality Audits

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18. Training

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19. Servicing

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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 Standard

Audit Actual

Yes

Compliance

Audit Completed

No

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Scope and Depth Scope

Depth

Task Documentation Compliance

Dept.

Traditional Audits

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Scope and Depth Scope Task

Depth

Documentation Compliance Effective Improve

Dept.

Links

System

Traditional Audits

Process-Based Assessments 10

Deming’s System Model Design and redesign

Consumer research

Suppliers of materials and equipment A B C D

Consumers

Receipt and test of materials

Distribution Production, assembly,

inspection

Tests of processes, machines, methods, costs

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Updated System Model Management Responsibility

Benchmarking

Resources Design

Customer Focus

Purchasing Product Realization

Measurement/ Analysis/ Improvement

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Model of a Process-Based Quality Management System (QMS) Continual improvement of the quality management system

Management responsibility Customers

Resource

Measurement,

Customers

management

analysis and

Satisfaction

improvement Requirements

Input

Product realization

Product

Output

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ISO9001:2000 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 14

ISO 9001:2000 and Baldrige Continual improvement of the quality management system 1 3

Leadership

Customer and Market Focus

Management 2

responsibility

Strategic

Customers

Planning 5

Resource

Input

Business

Customer and Market Focus

Customers

Measurement, analysis and improvement

Resource Requirements

3

Results

management Human Focus

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4

Satisfaction

Information and Analysis

Product realization 6 Process Management

Product

Output

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ISO 9001 Nonconformance Audit

Malcolm Baldrige Strengths & Weaknesses Assessment

An assessment of the effectiveness of the Quality Management System (QMS) 16

Traditional Quality Problem solving Root Cause Analysis

Appreciative Inquiry Quality Existing solution searching What-is-working amplification

What do we need to do less of?

What do we need to do more of?

Weaknesses

Strengths 17

Fishbone Process Model Person

Material

Process Machine

Method

S.I.P.O.C. Process Model Suppliers

Input

Process

Output

Customers

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IPO Spider Process Model™ Who

Incoming Material

Process

Input

Environment

Equipment

Decision Making

Workplace

Information

Output

Measurement

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Model of a Process-Based Quality Management System (QMS) Continual improvement of the quality management system

Management responsibility Customers

Resource

Measurement,

Customers

management

analysis and

Satisfaction

improvement Requirements

Input

Product realization

Product

Output

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I

P

O

Customer Initiate Processes

Your Organization

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Business Processes Customer Oriented Processes (COP’s) 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 22

Process Linkages

I

P

O

Customer Customer Initiated InitiatedProcess Process

Internal Customer Initiated Process Management Process

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IPO Spider Web Model

Design

Purchasing

Prod

Assy

Doc

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Linkage Strength

Process

Output

Input

Process

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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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Ship

Prod

Eng

Purch

HR

Sales

Scheduled Audit

Design

Process-Based Audit Schedule

Management Responsibility Resource Management Product Realization Measurement 28

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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h t t i d u A

s d on m a i d e

Was the decision based on facts? Who made the decision? How timely? How many yes’s vs. no’s? Where are they located?

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Audit Report Content SECTION I: Audit Identification •Auditee’s 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 team’s 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 General Manager

Manager

Super

Worker1 Worker2 Worker3 Worker4 Worker5

Super

Worker1 Worker2 Worker3

Super

Worker1 Worker2 Worker3 Worker4 Worker5 Worker6

Manager

Manager

Super

Super

Worker1 Worker2 Worker3 Worker4 Worker5

Worker1 Worker2 Worker3 Worker4 Worker5

Manager

Super

Worker1 Worker2 Worker3

Super

Worker1 Worker2 Worker3 Worker4 Worker5 Worker6 Worker7

Manager

Super

Worker1 Worker2 Worker3 Worker4 Worker5 Worker6 Worker7

Super

Worker1 Worker2 Worker3 Worker4 Worker5

Super

Worker1 Worker2 Worker3 Worker4 Worker5 Worker6

Super

Worker1 Worker2 Worker3 Worker4 Worker5

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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 35

au di tor (ô'di-ter) n. 1. One who hears; a listener.

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Thanks for listening!

The End There will be a meeting of the immediately after in the tavern. 37