A brief introductory overview of quality system components.

1. Quality Systems Overview
Some Key Elements

2. BASIC QUALITY FUNCTION
Ship to MODEL
Customer
Design of
Experiments,
R&D
Out of Y Immediate
Spec Corrections Y
(factual)
Root
Cause Complex Corrective
Analysis Problem? Action
Event Record
Inspections Failure costs
Audits Factors, risks Y
Customer Complaints Other Y
Processes Preventive
QMS Compliance Issues
Opportunity RISK? effected? Action
Safety Issues / HA, RA
Analysis COSTS?
Master Quality Record
Product History Record Y
Other event data
/consequence
Process Statistical Special
Capable Process Variation
Control
Y
Strategic
Planning

3. Costs of Quality
• Cost of poor quality
– Failure costs can be 15% to 30% of gross
sales.
– Most of these costs are not obvious, as they
are eventually accepted as business costs.
– Reducing these costs represent opportunitie$
– Pareto Principle: 80% of these cost may be
associated with only 20% of the causes.
– Costs of chronic events add up quickly.

4. Costs of Quality
“Principles of Quality Costs” by Jack Campanella
• Internal Failure Costs examples
– Rework or total Remake
– Re-inspection, re-grading
– Scrap
• External Failure Costs examples
– Fines and Suits
– Warranty
– Replacements, Allowances
– Expedite
– Good Will, intangible costs

5. Initial Data
Initial Commitment
Source Examples:
Audits
Final Inspection
In-Process Inspection
Safety Inspection
Hazard Analysis
Failure Mode and Effects Analysis
Customer Returns & Complaints
Maintenance & Repair Records
Adverse Event Reports
Employee Suggestions

6. Using Estimated Costs to Prioritize
Opportunities
Frequency per year of event X Unit Event Cost = Cost per year
Rework Direct Materials + Unit Cost + Re-Inspection Cost = Estimated
Unit Event Costs for product
Rework Direct Labor Hours X Rework Rate = Unit Labor Cost

7. Pareto Charts

8. Investments in Quality
P&A Costs
• Assessment Costs examples
– Inspections
– Testing
– Audits
– SPC
– RCA
• Preventive Costs examples
– Quality Training
– Preventive Actions
– Product and process quality planning

9. Balance of Quality Costs
Failure vs. Assessment & Preventive

10. Juran Trilogy
Plan, Control, Improve

11. Remove Root Causes
To Prevent Recurrence
Prioritize Projects for Resource Allocation
• ROOT CAUSE ANALYSES
• MONITORING Key Performance Indicators with SPC
• CORRECTIVE ACTIONS
• PREVENTIVE ACTIONS
• Follow Up Evaluation

12. Initial SPC AND RCA TEAMS
Human Resource Commitment
• Basic training
• Data Collection Planning and Measurements Development
– Placement in time and location
– Parts and physical samples
– People interview
– Paper and other records
– Paradigms effecting decisions leading to events
• Data Collection Assignments
• Analysis Assignments
• Charting Assignments
• Track and Facilitate Projects
• Interim Reporting

13. Root Cause Analysis Sequence
1. Definition of the real problem to be analyzed.
2. Understand the process, barriers, specifications
3. Identify the cause-effect relationships that combined to cause the
undesired outcome.
4. Decision to use Design Of Experiments for complex problems.
5. Collect data and objective evidence to support or reject cause-
effect relationships.
6. Analyze data to verify or eliminate cause-effect relationships
7. Record all verified physical, human and latent causes.
8. Assess risks, costs, calculate impact of event.
9. Decision to perform CAPA based on data.
10. Develop measures and process behavior charts.
11. Report findings and recommendations.

14. Process Behavior Charts
The best chart is the simplest that enables process improvement.
Percent defectives is a place to start
3. Count number of defective products each day
4. Count total number of products each day
5. Calculate %Defectives each day
6. Plot X and mR Chart using QIAnalyst
7. Monitor for special causes
8. Identify root causes
9. Eliminate or control root causes

15. Shewhart Chart Foundations
• Control limits which are set at a distance of 3
sigma on either side of the central line.
• Always use an average dispersion statistic to
calculate 3 sigma limits
• Rational sampling and sub-grouping of data.
• Rational, effective management and use of
knowledge from charts.

16. Selected References and Links
• Root Cause Analysis
– http://www.reliability.com/industry/rca_movies.html
– “Root Cause Analysis”; Latino et al; CRC Press
• Statistical Process Control
– http://www.SPCPress.com
– “Understanding Variation - the Key to Managing Chaos”; Donald J. Wheeler
• Quality Costs
– “Principles of Quality Costs: Principles, Implementation, and Use”; Jack Campanella

17. Quality Manager
• Establish quality subsystems • Direct and monitor change control
• Purchase tools • Document system
• Establish data collection • DMRs, DHRs
• Make assignments (jointly) • Direct and Monitor Quality Cost
• Conduct training Subsystem
• Direct and Track Analyses • Track and Report costs of internal
• OA, RCA, DOE, HA, Risk, Cost and external NC events, assessment
• Report results and make and prevention.
recommendations • Direct and monitor Quality
• Direct and Track CAPA projects Compliance
• Direct and Monitor SPC program • Direct and Monitor Calibration and
• Conduct Capability studies Reference Materials subsystem
• Plan, Lead, Report Internal Audits • Strategic Planning
• Quality Function SWOT
• Direct and monitor Inspections
• R&D proposals