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J. L. Romeu. Copyright 2010
Quality Assessments of Systems and Products
Jorge Luis Romeu, Ph.D. Certified Quality & Reliability Engineer
Senior Member, Region II Director ASQ
https://www.linkedin.com/pub/jorge-luis-romeu/26/566/104
Email: [email protected]
January 2015 (C)
J. L. Romeu. Copyright 2010
Industrial Statistics Consulting Our Technical Expertise Includes:
Statistical analysis and design of experiments
Statistical process control/quality control/Six Sigma
System reliability modeling and analysis
System simulation, optimization & performance evaluation
Quality systems assessments, planning & control
Training in any of the above areas.
Our Analyses Procedures have been Implemented at:
AFOSR/Rome Laboratory: Advanced Design Experiments
AMPTIAC: Advanced Materials and Processes Anal. Ctr.
RAC: Reliability Analysis Center/SRC: Systems Rel. Ctr
DACS: Data and Analysis Center for Software
IITRI: IIT Research Institute/Alion Sciences
Our Professional Credentials Include:
Certified Quality and Reliability Engineer, ASQ
Senior Member, ASQ; Member ASA
Chartered Statistician Fellow, Royal Stat. Society
J. L. Romeu. Copyright 2010
Outline
• Systems, Quality and Costs
• What is Quality Assessment
• Types and Classifications
• Assessment and Planning
• Evaluation and Reporting
• A Roadmap for Assessment
• Gurus, Standards and Examples.
J. L. Romeu. Copyright 2010
What is Quality?
• In the eyes of the beholder …
– Fitness for use …
– Customer satisfaction and loyalty …
• What or who is a customer?
– Anyone affected by the product/service
– Internal and External customers
• Quality of what?
– Of products, processes, systems …
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Organizational Issues
• What is an Organization/System/Process?
• What is the Organization/System Mission?
• What are Core Competencies/Features?
• Who are the Organization Customers?
• What Customers consider Good Results?
• How is Q Assessment an important issue?
– Id Problems/Opportunities for Innovations!
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Two Dimensions of Quality
• Features (affect income/sales)
– Refers to Quality of Design
• Freedom from Deficiencies
– Affects production costs
– Refers to Quality of Conformance
• Identify problems & opportunities
– Propose How actions to address them
– Ways to develop quick and efficiently
J. L. Romeu. Copyright 2010
Three Quality Processes
• Quality Planning
– Product and Process development; DFSS
• Quality Control
– Define, Measure, Compare, Act; SPC
• Quality Improvement
– Continuous improvement process
– DOE, Lean, Six Sigma, etc.
• Need to assess all three of them.
J. L. Romeu. Copyright 2010
Quality Assessments
• The first “Q” activity performed
– When arriving to an organization
– We investigate the Status of “Q”
• It Reviews and Assesses
– At the Organization level
– The General “Q” procedures
– The 0rganization’s “Q” Culture
J. L. Romeu. Copyright 2010
What is Quality Assessment?
• An Independent review
– Not by the party, nor its supervisor
– But by someone unrelated to both
• Second or Third Party assessments
• To Compare
– The entity performance
– Versus an established standard
– Or with the Competition or Best One
J. L. Romeu. Copyright 2010
Quality Assessment Elements
• Cost of Poor Quality
– Appraisal, Scrap, Prevention, Warranties
• Standing in the Market Place
– Benchmarking, field studies
• Quality Culture of the Organization
• Operation of its Quality Systems
– ISO 9000; Baldrige
J. L. Romeu. Copyright 2010
Cost of Poor Quality
• COPC: monetary loss driven by
– Non-conformities
– Inefficient processes
– Lost opportunities
• We must differentiate between:
– Efficiency: do things right.
– Effectiveness: do the right things!
• We must address Both, not only one!
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Cost of Poor Quality (COPC)
• Difficult to notice and/or recognize
• Product non conformities (defects)
• Inefficient production processes
• Lost opportunities (sales/revenues)
• Appraisal and Prevention Costs
• As well as Hidden Quality Costs:
– Downtime, extra inventory, overtime
J. L. Romeu. Copyright 2010
COPC Categories (1)
• Internal Failure Costs
– Meet customer Requirements
• Scrap, materials, rework
• redesign, downgrading
• Re-inspection, re-testing
– Inefficient Processes or Systems
• Variability in performance
• Downtime, extra inventory
• Non-value added activities
J. L. Romeu. Copyright 2010
COPC Categories (2)
• External Failure Costs
– Fails to meet Customer Requirements
• warranty, adjustments, etc.
• returns, allowances, penalties, etc.
– Lost Opportunity Costs
• Customer defections
• Potential new customer loss
– Compliance (e.g. FDA, EPA etc.)
• Delays, court/paperwork costs
J. L. Romeu. Copyright 2010
COPC Categories (3)
• Appraisal Costs
– Acceptance, in-process and final testing
– Quality audits, equipment, etc.
– Internal disputes among departments
• Prevention Costs
– Quality planning, training, etc
– Process planning and control
• Non-value adding activities
– Minimize or eliminate
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Standing in the Marketplace
• How do We compare with:
– Peers or competitors?
– The Best in the field?
• How do we measure Standing?
– Market Surveys, Benchmarking
• How do we Improve Standing?
– Product Re-design
– Process Improvements
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Quality Culture?
• What is it?
• Does it actually Exist?
• How wide/deep is it?
• Supported from the Top?
• Implemented at the Bottom?
• Ways to create/improve it.
• Ways to maintain it, afterward.
Quality Audits
• Sometimes, equivalent to Assessments
• Other times, with a different function
– Assessing an existing/known entity
– Specifically, measuring its “Q” status
• Investigating its Progress or Decay
• Signaling deficiencies and areas
• Opportunities for Improvement
J. L. Romeu. Copyright 2010
J. L. Romeu. Copyright 2010
Principles of Quality Audits
• Emphasis on Conclusions, based on Facts
• Report purpose: to help corrective actions
• Identify Opportunities for Improvements
• Human Relations, as a Key issue
• Tech Competence of the Auditors
• Good Planning and Execution
• Support from upper management
• Support also from line managers.
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Planning the Audit
• Flowchart all Quality Audit activities
• Preparation of Audit questionnaires
• Preparation of the Audit Team
• Preparation/Acceptance of Audit Chart
• Preparation of potential interviewees
• Reporting of fact-based results
• Involvement with Corrective Action
• The Human Relations side
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The Process Audit
• This Audit concerns all process
– Activities that affect the final
– Product Quality (Big “Q”)
• Two types of Process Audits:
– Engineering: process steps, parameters, SPC
– Monitor: specifications, documentation, logs
• Think Process as more than just Production
– Also as Organization/System/Service
J. L. Romeu. Copyright 2010
Process Assessment Results
• Identify process improvements
– In the Assessment Report:
• Help achieve higher efficiency:
– By reducing time and waste
• Help raise worker productivity:
– By streamlining the process
• By Reducing or Eliminating
– Non-Value Added activities
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The Product Audit
• Concerns the process Final Output
• Is Justified by Field Complaints
• Takes place at Inspection Stations
• Involves Product Re-inspection
• Verifies adequacy of procedures
– And correctness of specifications
• Acceptance/Rejection decisions
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Conclusions
• Quality Audits and Assessments
– Initial Step in new Quality Efforts
– Evaluation of Status of Existing Effort
– Helps Establish the Need (via COPQ)
– Identify Areas of Current Poor Quality
– Identify Quality Improvement Directions
• Preparation/Implementation/Reporting
• A Human-Relations Intensive Activity
– Requires full support from above
– As well as full cooperation from base
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Key Ideas of Main Gurus
• Deming’s and Feigenbaum’s “points”
• Juran’s Quality Trilogy:
– Control, Planning and Improvement
• Shingo’s Zero Quality Control
– workers inspect 100% of their products
• Crosby’s Fourteen Steps to Quality
• Toyota Production System and Kaisen:
– Waste/non-value added activities
– Inconsistent use/excessive demands
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Quality Operation Documents
• ISO 9000 Standard
– Int’l Organization for Standardization
– Emphasizes Q Organizational Procedures
– Minimal requirements for Quality
• Baldrige Quality Award
– NIST (Nat. Institute for Standards)
– Emphasizes Customer-Focused Results
– Highest Quality Standards
J. L. Romeu. Copyright 2010
Additional Readings
• Auditing Practical Skills
• Ten Auditing Rules
• Process Auditing Techniques
• Different types of Audits
• Audit Practical Examples
• Main Ideas of the Gurus
• ISO 9000 Basics
• Baldrige Quality Award
Assessments Application HW: Develop an Organization Flowchart, and devise a Quality Audit
• Develop a List of Items of Concern, derived from the COPQ
• Develop a List of Individuals, in your organization, to interview
• Develop a List of Questions (questionnaire) for these individuals
• Succinctly, answer (yourselves) said list of Questions posed.
• Develop a Diagnostic of issues uncovered through such answers.
• Propose a Root-Cause analysis of possible reasons for problems
• Create Results of these Diagnostics and Root Cause Analyses.
• Propose/analyze, some solutions for fixing the Quality issues
• Propose some measures to assess the Improvements obtained
• Propose some measures to make such Improvements Sustainable.
J. L. Romeu. Copyright 2010