product and process measures drive continuous product quality and business improvement angelo g....
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Product and Process Measures
Drive Continuous Product Quality and Business Improvement
Angelo G. Scangas, President
Quality Support Group, Inc.
978-430-7611
www.qualitysupportgroup.comQSGQSGQuality Support Group, Inc.
What is on your mind?
Do you have any questions?
What have you tried?
• Worked or not? Why?
Your feedback and engagement
QSGQSGQuality Support Group, Inc.
Continuous Improvement is the relentless effort of top management to seek out and eliminate waste at all levels of the organization. This is achieved through a sustained, results oriented process to instill this culture changing mindset into all levels of the organization through leadership, tools and training.
Continuous Improvement Vision / Definition
QSGQSGQuality Support Group, Inc.
Align your QMS with the achievement of organizational and business success.
Continuous Improvement Vision / Definition
QSGQSGQuality Support Group, Inc.
Cost Of Poor Quality
Revenues
- (Cost of Operations)
- (Cost of Poor Quality)
- (Cost Recovery)Profits
• Scrap
• Rework
• Supplier Scrap/Rework
• Audits
• Equipment Maintenance
• Inspection
• Testing
• Customer Cost
• Warranty Cost
• Returned Material
• Customer Service/Complaints
• Quality Planning
• Training
• Process Control
• Process Planning
Internal Failure (IF) Appraisal (AP)
External Failure (EF) Prevention (PC)
COQ = IF + AP + PC + EF
TMC
COQ = Cost of Quality
IF = Internal Failure
AP = Appraisal
PC = Prevention Cost
EF = External Failure
TMC = Total Mfg. CostCost of Quality - Definition
We have only hit the tip of the iceberg,
There is much more to capture !!
Inspection
Rework
Premium Freight
ECNs
Lost clients
Floor Space
Warranty
Morale
Excess Inventory
Business Excellence Model
QSGQSGQuality Support Group, Inc.
Business Excellence Model
SUPPLIER &PARTNERSHIP
PERFORMANCE
PEOPLESATISFACTION
CUSTOMERSATISFACTION
IMPACT ONSOCIETY
ENABLERS RESULTS
LE
AD
ER
SH
IPL
EA
DE
RS
HIP
PR
OC
ES
SE
SP
RO
CE
SS
ES
OR
GA
NIZ
AT
ION
AL
O
RG
AN
IZA
TIO
NA
L
RE
SU
LT
SR
ES
UL
TS
Policy & Strategy
Customer & Market Focus
PeopleManagement
Resource & Info Management
The ISO ModelContinual Improvement of the Quality Management System
Resource Management
Measurement, Analysis,
Improvement
Management Responsibilit
y
Product Realization Product
Inputs Outputs
The new ISO 9001:2008 requirements demand that a company:
understand its operations as a series of linked, interactive processes
manage each process by allocating resources, defining methods and criteria for monitoring and improvement
taking action when a process fails to meet expectations.
QSGQSGQuality Support Group, Inc.
Effectiveness
Extent to which planned activities are realized and planned results achieved.
ISO 9000:2000 3.2.14
Improvement and Effectiveness
Top Management shall ensure that the quality policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system.
ISO 9001: 2008 5.3
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
ISO 9001: 2008 8.5
Process Flow ChartC
ust
om
er-o
rie
nte
dP
roce
sses
Su
pp
ort
Man
agem
ent
Management
Review
Internal
Audit
Quality
Records
Continual Improvement
Corrective Actions
Preventive Actions
Customer
Property
Calibration
Yes
Inquiry & Quote
(Design Feasibility)PurchasingDesign
Supplies
Development
NDA?
Customer
Review
Ship to
Customer
No
Document
Control
Assembly,
Inspection,
and Test
Training
Production Process (Major Elements & Boundaries)
*Start- 1. Production schedule2. Verify Work Instructions3. Perform machine set-up(s)4. Material Prep5. Build and verify first piece6. Build lot7. Final product audit *End- 8. Transact to Non-netable
LimboProcess Owners: Cell Administrators
Inputs/Materials(With what?)
DemandParts
EquipmentComputers
Facility
Suppliers(By whom?)
Cell AdministratorCell Leader
M. Q. EngineerMaterial Handler
AsemblersSet-Up Technician
Customers(For whom?)
ShippingCustomer Service
External Customers
OutputsProducts
Transactions
Measures(Trend Charts)
Defect Per MillionProductivity
OTD to Customers
Methods (How?)
Work InstructionsTraining
Non-conforming MaterialPreventive Maintenance
CalibrationDocumentation ControlRecords (test results)
PROCESS MAP FOR PRODUCTION
Skills/Training & Competency
(Of whom?)Qualifications (Job Descriptions)
PFP for SalariedSkills matrix for direct labor
Ergonomic/Safety Policies and Procedures
Prepared By: M. Cushing Date: 10/4/2004
Approved By: N. Royce Date: 1/18/2005
Approved by ISO Authority: M. Cushing Date: 1/18/2005
Disposition:
Document Number: M7.1.Production Effectivity Date: 12/15/2004
Pane 2 – Why are we here?
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Pane 1 – Where are we?
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6.00%
Septe
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r FY05
Octobe
r FY05
Novem
ber F
Y05
Decem
ber F
Y05
Janu
ary F
Y05
Febru
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Y05
Mar
ch F
Y05
April F
Y06
May
FY06
June
FY06
July
FY06
Aug F
Y06
Month
Per
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Sh
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wit
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Run Chart Data Exceptions by Month
Month Paid shipments # Exceptions Exceptions Goal
September FY05 886 43 4.85% 2.50%October FY05 1139 32 2.81% 2.50%November FY05 1103 45 4.08% 2.50%December FY05 1346 48 3.57% 2.50%January FY05 993 38 3.83% 2.50%February FY05 856 36 4.21% 2.50%March FY05 1056 44 4.17% 2.50%April FY06 923 33 3.58% 2.50%May FY06 877 13 1.48% 2.50%June FY06 891 14 1.57% 2.50%July FY06 779 9 1.16% 2.50%Aug FY06 923 7 0.76% 2.50%
Pane 3 – How did we get here? Pane 4 – What do we do now?
Action Plan
Action Resp Date Comment
4 Panel Report - Example
The QSG Model
In the following example, an organization has identified several quality objectives and has collected data on the results of these objectives. Using a gap analysis technique, the results are compared to the objectives and the degree of effectiveness of the QMS is established for a given time period.
Examples of results recorded
by the Organization
Analysis of Data
OrganizationalResults
Customer satisfaction
Statutory & regulatory compliance
Quality system metrics
Inspection and test
Supplier performance
OrganizationalObjectivesCustomer
requirements
Statutory & regulatory
requirements
Defect rate and customer returns
QMS controls
Purchasing
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
0 0
100 100
The gap measures the lack of effectiveness of the quality management system.
The narrower the gap, the more effective the QMS.
Things are looking good!
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
0 0
100 100
Management should get a wake up warning!
The gap measures the lack of effectiveness of the quality management system.
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
0 0
100 100
The Organization is in trouble!
The gap measures the lack of effectiveness of the quality management system.
Improvement in the QMS
OrganizationalObjectives
OrganizationalResults
% 100 75 50 25 0
Improvement in the QMS
Improvement in the QMS
OrganizationalObjectives
OrganizationalResults
Customer Focus
Corrective Action
Procurement
Improvement Initiatives
These actions may cause the organization to revise its objectives.
What actions are taken when gaps are identified?
In this example, the organization identified three key areas for improvement.
Management Review
OrganizationalObjectives
OrganizationalResults
0 0
100 100
Customer Focus
Corrective Action
Procurement
Improvement Initiatives
Management Review
The improvement processes are also evaluated during management review meetings and appropriate action taken.
Which may cause the organization to again revise its objectives.
Conclusion
The effectiveness of the quality management system in meeting both quality and/or business objectives is likely to be the key attribute that
ensures the on-going support and resource allocation to maintain the quality management
system within the corporate environment.
The overall result of using the QSG model is an enhanced pro-active approach to
meet QMS objectives and more importantly their related corporate
business and/or financial objectives.
THANK YOU!
Angelo G. Scangas
President
Quality Support Group, Inc.
978-430-7611
WWW.QUALITYSUPPORTGROUP.COM
QSGQSGQuality Support Group, Inc.