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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)

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Page 1: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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)

Page 2: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 3: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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.

Page 4: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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 …

Page 5: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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!

Page 6: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 7: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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.

Page 8: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 9: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 10: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 11: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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!

Page 12: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 13: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 14: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 15: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 16: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 17: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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.

Page 18: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 19: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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.

Page 20: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 21: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 22: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 23: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 24: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 25: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 26: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

J. L. Romeu. Copyright 2010

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

Page 27: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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

Page 28: Quality Assessments of Systems and Productsweb.cortland.edu/matresearch/QAssessOverview.pdf · •The first “Q” activity performed –When arriving to an organization –We investigate

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