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In d iv id u a l Fa ilu re C o st Tre n d s

Cost of Poo

Distribution of Failure Costs Overtime


$140.00

$120.00

$100.00

$80.00

$60.00

$40.00

$20.00

$-
Jan Feb Mar Apr May Jun Jul Aug Sep
Year 1

Summary and Conclusion:

Action Items and Target Dates:

Challenges:
ost of Poor Quality (CoPQ) Manageme

COPQ as % of Revenues

e Costs Overtime
10
50 60
40 70
30 80
20 90
10 100

Summary and Conclusion:


Jul Aug Sep Oct Nov Dec

Action Items and Target Dates:

Challenges:
anagement

% of Revenues % Change From Last Period

Starting Point

10
50 60 50 60
70 40 70
80 30 80
90 20
28% 90
100 10 100

Summary and Conclusion:

Action Items and Target Dates:

Challenges:
Cost of Poor Quality (COPQ) Management
In d ivid u al Failu re C o st Tre n d s (m illio n s)

Total Failure Cost by Month Failure Cost Breakdown by Percentage of Total 3 Year Costs Total Internal Failure Costs by Site by Month Total Internal Failure Costs by Site by Product and by Month
$120.00

Plant 5 Plant 4 Plant 3 Plant 2 Plant 1


$100.00

Controversial Costs
Distribution of Individual Failure Costs Overtime 2.32% $80.00
$140 .0 0

$120 .0 0

External Failure Cost $60.00


$100 .0 0 42.23% Internal Failure Cost
55.45%
$80 .0 0
$40.00
$60 .0 0

$40 .0 0
$20.00

$20 .0 0

$- $-
Ja n Feb Ma r Apr May Jun Jul Aug Sep Oct Nov Dec Ja n Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oc t Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Year 1 Year 2 Year 3
Year 1
Conclusion: Conclusion: Conclusion: Conclusion:

$300.00
Distribution of Total Failure Costs Overtime $300.00
Total Failure Costs

$250.00 $250.00

$200.00 $200.00

$150.00 $150.00

$100.00 $100.00

$50.00 $50.00

$- $-
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Year 1 Year 2 Year 3

Conclusion:
Cost of
Cost Category
Q1
Controversial Costs $ 9.8
Inclusion of overhead on top of direct costs $ 9.80
Internal Failure Costs $ 327.7
Remediation $ 164.85
Rework $ 117.43
Scrap/ Spoilage $ 26.40
Nonconformances (NCR, CAPA, SCAR) $ 19.00
External Failure Costs $ 235.8
Post Market Surveillance (Complaints) $ 186.02
Field Corrective Actions (FCA) $ 3.01
Holds $ 1.50
Recalls $ 0.74
External Inspections/Audits $ -
Agency Observations / WL $ 38.10
Liability $ 5.00
FDA/MOH Communications $ 1.48
Opportunity Costs $ -
Cost of regaining lost customers (measureable campaigns) $ -
Lost sales what could be regained $ -

Controversial Costs $ 9.80


Internal Failure Cost $ 327.69
External Failure Cost $ 235.84
Opportunity Costs $ -
Total Cost of Poor Quality (VOPQ) $ 573.3

Revenues $ 20,000.0
COPQ as % of Revenues 2.9%

Change from Last Period


% Change from Last Period
Cost of Poor Quality (COPQ) Manag
Year 1 Year 2

Q2 Q3 Q4 Total - Year 1 Q1 Q2
$ 12.3 $ 10.0 $ 9.4 $ 41.4 $ 9.8 $ 12.3
$ 12.25 $ 9.95 $ 9.40 $ 41.40 $ 9.80 $ 12.25
$ 262.1 $ 217.7 $ 198.7 $ 1,006.2 $ 278.9 $ 262.1
$ 124.27 $ 71.47 $ 68.38 $ 428.97 $ 146.85 $ 124.27
$ 105.15 $ 103.54 $ 97.65 $ 423.79 $ 98.73 $ 105.15
$ 15.90 $ 22.20 $ 15.90 $ 80.40 $ 15.60 $ 15.90
$ 16.80 $ 20.44 $ 16.80 $ 73.04 $ 17.70 $ 16.80
$ 167.3 $ 199.7 $ 167.0 $ 769.7 $ 188.3 $ 167.3
$ 165.72 $ 180.72 $ 165.72 $ 698.17 $ 155.02 $ 165.72
$ 0.00 $ 8.00 $ 0.00 $ 11.02 $ 3.01 $ 0.00
$ - $ 9.00 $ - $ 10.50 $ - $ -
$ 0.34 $ 0.34 $ 0.34 $ 1.77 $ 0.05 $ 0.34
$ - $ - $ - $ - $ - $ -
$ 0.30 $ 0.20 $ - $ 38.60 $ 29.20 $ 0.30
$ - $ - $ - $ 5.00 $ - $ -
$ 0.90 $ 1.39 $ 0.90 $ 4.67 $ 1.08 $ 0.90
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -

$ 12.25 $ 9.95 $ 9.40 $ 41.40 $ 9.80 $ 12.25


$ 262.13 $ 217.66 $ 198.74 $ 1,006.20 $ 278.89 $ 262.13
$ 167.26 $ 199.65 $ 166.96 $ 769.73 $ 188.35 $ 167.26
$ - $ - $ - $ - $ - $ -
$ 441.6 $ 427.3 $ 375.1 $ 1,817.3 $ 477.0 $ 441.6

$ 24,000.0 $ 21,000.0 $ 23,000.0 $ 88,000.0 $ 20,000.0 $ 30,000.0


1.8% 2.0% 1.6% 2.1% 2.4% 1.5%

$ 131.7 $ 14.4 $ 52.2 $ 198.2 $ 35.4


23% 25% 35% 11% 7%
PQ) Management
Year 2 Year 3

Q3 Q4 Total - Year 2 Q1 Q2 Q3
$ 10.0 $ 9.4 $ 41.4 $ 9.8 $ 12.3 $ 10.0
$ 9.95 $ 9.40 $ 41.40 $ 9.80 $ 12.25 $ 9.95
$ 217.7 $ 198.7 $ 957.4 $ 327.7 $ 262.1 $ 217.7
$ 71.47 $ 68.38 $ 410.97 $ 164.85 $ 124.27 $ 71.47
$ 103.54 $ 97.65 $ 405.09 $ 117.43 $ 105.15 $ 103.54
$ 22.20 $ 15.90 $ 69.60 $ 26.40 $ 15.90 $ 22.20
$ 20.44 $ 16.80 $ 71.74 $ 19.00 $ 16.80 $ 20.44
$ 199.7 $ 167.0 $ 722.2 $ 235.8 $ 167.3 $ 199.7
$ 180.72 $ 165.72 $ 667.17 $ 186.02 $ 165.72 $ 180.72
$ 8.00 $ 0.00 $ 11.02 $ 3.01 $ 0.00 $ 8.00
$ 9.00 $ - $ 9.00 $ 1.50 $ - $ 9.00
$ 0.34 $ 0.34 $ 1.07 $ 0.74 $ 0.34 $ 0.34
$ - $ - $ - $ - $ - $ -
$ 0.20 $ - $ 29.70 $ 38.10 $ 0.30 $ 0.20
$ - $ - $ - $ 5.00 $ - $ -
$ 1.39 $ 0.90 $ 4.27 $ 1.48 $ 0.90 $ 1.39
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -

$ 9.95 $ 9.40 $ 41.40 $ 9.80 $ 12.25 $ 9.95


$ 217.66 $ 198.74 $ 957.40 $ 327.69 $ 262.13 $ 217.66
$ 199.65 $ 166.96 $ 722.23 $ 235.84 $ 167.26 $ 199.65
$ - $ - $ - $ - $ - $ -
$ 427.3 $ 375.1 $ 1,721.0 $ 573.3 $ 441.6 $ 427.3

$ 21,000.0 $ 25,000.0 $ 96,000.0 $ 20,000.0 $ 19,000.0 $ 21,000.0


2.0% 1.5% 1.8% 2.9% 2.3% 2.0%

$ 14.4 $ 52.2 $ 101.9 $ 131.7 $ 14.4


10% 21% 6% 23% 25%
Year 3
Total -
3 Year Summary
Q4 Total - Year 3
$ 9.4 $ 41.4 $ 124.2
$ 9.40 $ 41.40 $ 124.20
$ 198.7 $ 1,006.2 $ 2,969.8
$ 68.38 $ 428.97 $ 1,268.92
$ 97.65 $ 423.79 $ 1,252.67
$ 15.90 $ 80.40 $ 230.40
$ 16.80 $ 73.04 $ 217.83
$ 167.0 $ 769.7 $ 2,261.7
$ 165.72 $ 698.17 $ 2,063.51
$ 0.00 $ 11.02 $ 33.06
$ - $ 10.50 $ 30.00
$ 0.34 $ 1.77 $ 4.61
$ - $ - $ -
$ - $ 38.60 $ 106.90
$ - $ 5.00 $ 10.00
$ 0.90 $ 4.67 $ 13.61
$ - $ - $ -
$ - $ - $ -
$ - $ - $ -

$ 9.40 $ 41.40 $ 124.20


$ 198.74 $ 1,006.20 $ 2,969.81
$ 166.96 $ 769.73 $ 2,261.68
$ - $ - $ -
$ 375.1 $ 1,817.3 $ 5,355.7

$ 18,000.0 $ 78,000.0 $ 262,000.00


2.1% 2.3% 2.0%

$ 52.2 $ 198.2 $ 498.40


35% 11% 28%
Cost

Cost Category Q1
Appraisal Costs $ 36.0
Quality / Service internal audits $ 36.00
Supplier Audits/Evaluations $ -
Depreciation $ -
Calibration $ -
Inspection $ -
Field Servicing $ -
Prevention Costs $ -
Preventive Maintenance $ -
Process Planning/ Control $ -
Training $ -
Supplier Development Management $ -
Improvement Costs $ -
New software, tools, and/or technology implemented $ -
Coaching/Mentoring $ -
Improvement Projects $ -

Apraisal Costs $ 36.00


Preventive Costs $ -
Improvement Costs $ -
Total Investment in Good Quality $ 36.00
Cost of Good Quality (COGQ) M
Year 1 Ye

Q2 Q3 Q4 Total - Year 1 Q1
$ 36.0 $ 36.0 $ 36.0 $ 144.0 $ 36.0
$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -

$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00


$ - $ - $ - $ - $ -
$ - $ - $ - $ - $ -
$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00
(COGQ) Management
Year 2 Yea

Q2 Q3 Q4 Total - Year 2 Q1 Q2
$ 36.0 $ 36.0 $ 36.0 $ 144.0 $ 36.0 $ 36.0
$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00 $ 36.00
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -

$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00 $ 36.00


$ - $ - $ - $ - $ - $ -
$ - $ - $ - $ - $ - $ -
$ 36.00 $ 36.00 $ 36.00 $ 144.00 $ 36.00 $ 36.00
Year 3
Total -
3 Year Summary
Q3 Q4 Total - Year 3
$ 36.0 $ 36.0 $ 144.0 $ 432.0
$ 36.00 $ 36.00 $ 144.00 $ 432.00
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -
$ - $ - $ - $ -

$ 36.00 $ 36.00 $ 144.00 $ 432.00


$ - $ - $ - $ -
$ - $ - $ - $ -
$ 36.00 $ 36.00 $ 144.00 $ 216.00
Value of Quality (VOQ) Management

Cost Category Action Superset Category

Value of Poor Quality Reactive Controversial Costs Controversial Costs

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap/ Spoilage

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/ Fa

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/


Failure Analysis
Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints


Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs Holds

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Inspections/Audits

Value of Poor Quality Reactive External Failure Costs Agency Observations

Value of Poor Quality Reactive External Failure Costs Liability / Lawsuits

Value of Poor Quality Reactive External Failure Costs FDA/MOH Communica

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Procurement

Value of Good Quality Proactive Appraisal Costs Maintenance

Value of Good Quality Proactive Appraisal Costs Calibration

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Field Servicing

Value of Good Quality Proactive Prevention Costs Maintenance

Value of Good Quality Proactive Prevention Costs Planning

Value of Good Quality Proactive Prevention Costs Process Control

Value of Good Quality Proactive Prevention Costs Remediation

Value of Good Quality Proactive Prevention Costs Process

Value of Good Quality Proactive Improvement Costs Process


Value of Good Quality Proactive Improvement Costs Coaching/Mentoring

Value of Good Quality Proactive Improvement Costs Improvement Project


y (VOQ) Management - Year 1

Cost Name Cost Description Sites Product Jan Feb

Inclusion of overhead on top of di Inclusion of overhead on Plant(s) Product(s)


top of direct costs 3.30 3.10
Consulting costs Cost of consulting services, Plant(s) Product(s)
contingent labor, etc. 34.60 37.00

Reinspection, retest, 100% sortingCosts of inspectors labor, Plant(s) Product(s)


cost of supplies used in 19.80 22.87
retesting and reinspection
Rework and Sorting at the company Cost of rework and sorting Plant(s) Product(s) 37.44 33.54
related to product holds or
of defects identified during
identified
Product Holds production
Cost run or quality
of production holds Plant(s) Product(s)
nonconformances. This 2.10 1.70
inspections.
due to rework Capture
of defective
cost element does not
Retraining expense reworked
products
Costs material
at supplier cost
site.that
includeofreworkretraining the
or scrap Plant(s) Product(s)
2.10 1.50
includes
Other
internal the
costs labor.
may This
include cost
costs of stakeholders.
the rejected goods.
element inventory
product does not fees. include The
Scrap of expired materials/producCost of scrap of expired Plant(s) Product(s) 0.00 0.00
scrap of
costs costSCARof the and rejected
non-
materials/products. Does
goods.
conformance investigations
Scrap of obsolete materials not include
Scrap FCA related
are
scrap. notofincluded.
obsolete materials.
The costs Plant(s) Product(s)
0.00 0.00
Obsolete material
of Field Action holds due areto not
Scrap of defective materials order
Cost
included cancelation.
of any scrap
in this cost of thecost
This Plant(s) Product(s)
does
defective not include cost ofcost 9.20 5.30
category. material. This
expired
does materials
include labor FCA
notdefective and cost,
Scrap at supplier Cost
related of scrap. Plant(s) Product(s)
production
materials/parts rejectedtoat
delays due 6.30 0.20
high scrap siterate,
andand FCA
Disposal of scraped materials/go supplier
Cost
related of scrap.
disposal thescraped
of Plant(s) Product(s)
disposal
materials/ofgoods. rejected goods. 0.00 0.00
Although this costs will be
Downgrading Downgrading
consumed by is reducing
a supplier, Plant(s) Product(s)
the 0.00 0.00
however, collecting of
quality or status thisa
CAPAs, NCRs material
cost at theor piece
Root Cause Analysis ofmay
buyer of
level, Plant(s) Product(s)
equipment
help assessthat
production themay
defects qualityimpact
(CAPAs,of 7.70 5.70
its flexibility
goods received
NCRs). Cost and
of from in the
use
failure
SCARs Root
process.
supplier.Cause Analysis of Plant(s) Product(s)
analysis
defects atand re-designing
supplier site
0.00 0.00
activities
(SCARs) as part of the
Complaint adjustment and Any rebateand
corrective in price to
preventive Plant(s) Product(s)
allowances resolve quality issues. 26.60 24.70
actions. The costs of
Cost of handling complaints Reduction
complaints
Cost of handling in
are thenot invoice
included Plant(s) Product(s)
amount
complaints. The costcredit).
in this (could
cost be
category. a should 45.44 28.54
be estimated for reportable
Warranty charges Warranty charges are any Plant(s) Product(s)
(MDRs/MDVs) and non-
costs related to product 0.00 0.00
reportable complaints.
quality issues, product
Product returned from field Cost of acceptable returned Plant(s) Product(s)
serviceability, for products
goods from the field, 5.40 0.10
returned under warranty.
example: customer does
Courtesy costs are included
not like the product, but no
in the cost category.
product defects were found.
FCA Technical Assessments Cost of preparation of FCA Plant(s) Product(s)
and Review Board Technical Assessments to 3.00 0.00
determine
FCA Customer Communications (i.e if field action
Cost of executing is
the field Plant(s) Product(s)
required. 0.00 0.00
action and preparation of
Holds ( Labor and Freight ) the
CostCustomer
of issuing product Plant(s) Product(s)
Communications 1.50 0.00
Holds (Labor and (i.e. Freight).
Non-plant Recall Costs Important
Other costs
Non-plant Information
may include
Recall Costs is Plant(s) Product(s)
Letters,
any
Plants to provide the recalled product costetc.)
fees
anything associated
that
information
happens with
at 0.00 0.00
holding
the plantthe product
level, suchat the
as:
Plant Recall Costs (Plant mfg. re Plant Recalllocation.
Costs (Plant Plant(s) Product(s)
warehouse
Field-related recall costs, 0.51 0.11
mfg. related Recalls)
Customer service Recall
External Inspections/Audits (outsiExternal Agency Audits
Costs, restucking inventory, Plant(s) Product(s) 0.00 0.00
(outside of routine
transportation, investigation
Warning Letters / 483s inspections).
at theofcustomer
Cost Other
responding site,costs
toetc. Plant(s) Product(s)
may include
Warning any fees to
Letters/483s the
and
28.00 10.00
externalobservations,
agency agencies for and
Lawsuits Product liability is the area Plant(s) Product(s)
conducting
meeting
of law in with
the
whichthe audits.
Health
those who
5.00 0.00
Authority
make agencies,
products i.e. to
available
FDA/MOH Communications FDA/MOH
travels, meetings, Plant(s) Product(s)
the public
Communications.are heldOther 0.88 0.30
accommodation
responsible for thecosts, etc.
injuries
costs
This may
cost include
element mailing
Cost of regaining lost customer Cost
those
and
of regaining
products
WebEx cause. not
costs.
does
lost Plant(s) Product(s)
0.00 0.00
include
customers. the cost of FCAs,
Examples:
Example: lawsuits, breach
recalls,
focus
Lost sales what could be regaine of
Lost holds,
groups,
sales related
warranty, etc. to any
and various Plant(s) Product(s)
advertisement campaigns, 0.00 0.00
quality
consumer events such
protection as:
claims.
training,
delays inetc.
production, delays
Quality / Service internal audits Cost of routine Internal Plant(s) Product(s)
in new product
Quality audits launches, 12.00 12.00
customer dissatisfaction,
Supplier Cost of routine
etc. that can beQuality
regained Plant(s) Product(s)
supplier auditsan at supplier 0.00 0.00
and represent
site
Supplier Performance Evaluation opportunity for savings
Cost of evaluating and
suppliers Plant(s) Product(s) 0.00 0.00
revenue
and increase.
preparation of
Depreciation of test equipment scorecards
Cost of depreciated test Plant(s) Product(s)
equipment 0.00 0.00
Calibration of measuring and tes Cost of calibration of Plant(s) Product(s)
parts/equipment/tools 0.00 0.00
Receiving inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
routine receiving inspection.
In-process inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
Final finished goods inspection routine
Cost of in-process
inspecting of Plant(s) Product(s)
inspection. 0.00 0.00
incoming goods at the
Field testing and appraisal at cus routine
Cost of final
field inspection.
testing and Plant(s) Product(s)
appraisal at customer site.
0.00 0.00
Preventive Maintenance The
Costcost of goods disposal
of supervision of Plant(s) Product(s)
and investigation
preventive maintenance is -
0.00 0.00
captured
maintain in the Complaint
accuracy of test
Process planning Any
cost operations
category. process Plant(s) Product(s)
equipment.
planning, such Thisas:cost
VIPdoes
0.00 0.00
not include
-Value calibration costs
Process control Cost
as ofImprovement
this routine
cost is process
captured Plant(s) Product(s)
Project,
controls etc.
(i.e. Cost of revising
statistical
0.00 0.00
under Calibration
QMS procedures costother
and
Training process
category.
Costs controls).
of retraining Other
the Plant(s) Product(s)
planning
costs may activities, such as:
include software 0.00 0.00
internal
integrationstakeholders
and acquisition,
fees. to not following
Supplier Development Managem related
transfers,
Cost etc.
of Supplier Plant(s) Product(s)
procedures.
developmentThe cost of
management.
0.00 0.00
routine trainings are
New software, tools, and/or tec Example:
captured
supplier training,
Cost of purchasing
in6the new
individual Plant(s) Product(s)
supporting
softwares, sigma
tools and/or 0.00 0.00
costs categories.
initiatives
implementing a new
technology.
Coaching/Mentoring Coaching/Mentoring costs Plant(s) Product(s)
are associated with
0.00 0.00
Improvement Projects Continuous Improvements, Plant(s)
Cost of Improvement Product(s)
such as: company 0.00 0.00
Projects undertaken by the
Talks/Town
company toHalls,
improve
coaching / mentoring
product quality of
and quality
individual
systems. employees as
part of their development
process, etc.
Mar Q1 Total Apr May Jun Q2 Total Jul Aug Sep Q3 Total

3.40 9.80 4.50 3.70 4.05 12.25 3.35 3.90 2.70 9.95

32.90 104.50 27.80 31.30 16.10 75.20 10.60 6.40 5.90 22.90

17.68 60.35 16.69 16.19 16.19 49.07 16.19 16.19 16.19 48.57

33.45 104.43 33.45 33.45 33.45 100.35 34.14 30.45 30.45 95.04

4.10 7.90 0.10 0.10 0.10 0.30 2.60 0.10 0.10 2.80

1.50 5.10 1.50 1.50 1.50 4.50 2.70 1.50 1.50 5.70

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.30 19.80 5.30 5.30 5.30 15.90 11.10 5.30 5.30 21.70

0.10 6.60 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.50 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.60 19.00 5.60 5.60 5.60 16.80 9.24 5.60 5.60 20.44

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

24.70 76.00 24.70 24.70 24.70 74.10 28.70 29.70 27.70 86.10

30.54 104.52 30.54 30.54 30.54 91.62 33.54 30.54 30.54 94.62

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 5.50 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 3.01 0.00 0.00 0.00 0.00 1.00 0.00 0.00 1.00

0.00 0.00 0.00 0.00 0.00 0.00 7.00 0.00 0.00 7.00

0.00 1.50 0.00 0.00 0.00 0.00 9.00 0.00 0.00 9.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.11 0.74 0.11 0.11 0.11 0.34 0.11 0.11 0.11 0.34

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.10 38.10 0.10 0.10 0.10 0.30 0.10 0.10 0.00 0.20

0.00 5.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.30 1.48 0.30 0.30 0.30 0.90 0.79 0.30 0.30 1.39

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

12.00 36.00 12.00 12.00 12.00 36.00 12.00 12.00 12.00 36.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Oct Nov Dec Q4 Total Total Annual Costs

3.35 3.45 2.60 9.40 41.40

3.91 3.99 3.91 11.81 214.41

20.19 18.19 18.19 56.57 214.56

30.45 30.45 30.45 91.35 391.19

1.60 0.10 0.10 1.80 12.80

1.50 1.50 1.50 4.50 19.80

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

5.30 5.30 5.30 15.90 73.30

0.00 0.00 0.00 0.00 6.60

0.00 0.00 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00

5.60 5.60 5.60 16.80 73.04

0.00 0.00 0.00 0.00 0.00

24.70 24.70 24.70 74.10 310.30

30.54 30.54 30.54 91.62 382.37

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 5.50


0.00 0.00 0.00 0.00 4.02

0.00 0.00 0.00 0.00 7.00

0.00 0.00 0.00 0.00 10.50

0.00 0.00 0.00 0.00 0.00

0.11 0.11 0.11 0.34 1.77

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 38.60

0.00 0.00 0.00 0.00 5.00

0.30 0.30 0.30 0.90 4.67

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

12.00 12.00 12.00 36.00 144.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


Value of Quality (VOQ) Management

Cost Category Action Superset Category

Value of Poor Quality Reactive Controversial Costs Controversial Costs

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap/ Spoilage

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/ Fa

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/


Failure Analysis
Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints


Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs Holds

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Inspections/Audits

Value of Poor Quality Reactive External Failure Costs Agency Observations

Value of Poor Quality Reactive External Failure Costs Liability / Lawsuits

Value of Poor Quality Reactive External Failure Costs FDA/MOH Communica

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Procurement

Value of Good Quality Proactive Appraisal Costs Maintenance

Value of Good Quality Proactive Appraisal Costs Calibration

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Field Servicing

Value of Good Quality Proactive Prevention Costs Maintenance

Value of Good Quality Proactive Prevention Costs Planning

Value of Good Quality Proactive Prevention Costs Process Control

Value of Good Quality Proactive Prevention Costs Remediation

Value of Good Quality Proactive Prevention Costs Process

Value of Good Quality Proactive Improvement Costs Process


Value of Good Quality Proactive Improvement Costs Coaching/Mentoring

Value of Good Quality Proactive Improvement Costs Improvement Project


y (VOQ) Management - Year 2

Cost Name Cost Description Sites Product Jan Feb

Inclusion of overhead on top of di Inclusion of overhead on Plant(s) Product(s)


top of direct costs 3.30 3.10
Consulting costs Cost of consulting services, Plant(s) Product(s)
contingent labor, etc. 28.60 31.00

Reinspection, retest, 100% sortingCosts of inspectors labor, Plant(s) Product(s)


cost of supplies used in 17.80 19.87
retesting and reinspection
Rework and Sorting at the company Cost of rework and sorting Plant(s) Product(s) 27.74 29.54
related to product holds or
of defects identified during
identified
Product Holds production
Cost run or quality
of production holds Plant(s) Product(s)
nonconformances. This 1.70 1.70
inspections.
due to rework Capture
of defective
cost element does not
Retraining expense reworked
products
Costs material
at supplier cost
site.that
includeofreworkretraining the
or scrap Plant(s) Product(s)
1.50 1.50
includes
Other
internal the
costs labor.
may This
include cost
costs of stakeholders.
the rejected goods.
element inventory
product does not fees. include The
Scrap of expired materials/producCost of scrap of expired Plant(s) Product(s) 0.00 0.00
scrap of
costs costSCARof the and rejected
non-
materials/products. Does
goods.
conformance investigations
Scrap of obsolete materials not include
Scrap FCA related
are
scrap. notofincluded.
obsolete materials.
The costs Plant(s) Product(s)
0.00 0.00
Obsolete material
of Field Action holds due areto not
Scrap of defective materials order
Cost
included cancelation.
of any scrap
in this cost of thecost
This Plant(s) Product(s)
does
defective not include cost ofcost 4.40 5.30
category. material. This
expired
does materials
include labor FCA
notdefective and cost,
Scrap at supplier Cost
related of scrap. Plant(s) Product(s)
production
materials/parts rejectedtoat
delays due 0.30 0.20
high scrap siterate,
andand FCA
Disposal of scraped materials/go supplier
Cost
related of scrap.
disposal thescraped
of Plant(s) Product(s)
disposal
materials/ofgoods. rejected goods. 0.00 0.00
Although this costs will be
Downgrading Downgrading
consumed by is reducing
a supplier, Plant(s) Product(s)
the 0.00 0.00
however, collecting of
quality or status thisa
CAPAs, NCRs material
cost at theor piece
Root Cause Analysis ofmay
buyer of
level, Plant(s) Product(s)
equipment
help assessthat
production themay
defects qualityimpact
(CAPAs,of 6.40 5.70
its flexibility
goods received
NCRs). Cost and
of from in the
use
failure
SCARs Root
process.
supplier.Cause Analysis of Plant(s) Product(s)
analysis
defects atand re-designing
supplier site
0.00 0.00
activities
(SCARs) as part of the
Complaint adjustment and Any rebateand
corrective in price to
preventive Plant(s) Product(s)
allowances resolve quality issues. 23.60 22.70
actions. The costs of
Cost of handling complaints Reduction
complaints
Cost of handling in
are thenot invoice
included Plant(s) Product(s)
amount
complaints. The costcredit).
in this (could
cost be
category. a should 28.44 25.54
be estimated for reportable
Warranty charges Warranty charges are any Plant(s) Product(s)
(MDRs/MDVs) and non-
costs related to product 0.00 0.00
reportable complaints.
quality issues, product
Product returned from field Cost of acceptable returned Plant(s) Product(s)
serviceability, for products
goods from the field, 5.40 0.10
returned under warranty.
example: customer does
Courtesy costs are included
not like the product, but no
in the cost category.
product defects were found.
FCA Technical Assessments Cost of preparation of FCA Plant(s) Product(s)
and Review Board Technical Assessments to 3.00 0.00
determine
FCA Customer Communications (i.e if field action
Cost of executing is
the field Plant(s) Product(s)
required. 0.00 0.00
action and preparation of
Holds ( Labor and Freight ) the
CostCustomer
of issuing product Plant(s) Product(s)
Communications 0.00 0.00
Holds (Labor and (i.e. Freight).
Non-plant Recall Costs Important
Other costs
Non-plant Information
may include
Recall Costs is Plant(s) Product(s)
Letters,
any
Plants to provide the recalled product costetc.)
fees
anything associated
that
information
happens with
at 0.00 0.00
holding
the plantthe product
level, suchat the
as:
Plant Recall Costs (Plant mfg. re Plant Recalllocation.
Costs (Plant Plant(s) Product(s)
warehouse
Field-related recall costs, 0.02 0.02
mfg. related Recalls)
Customer service Recall
External Inspections/Audits (outsiExternal Agency Audits
Costs, restucking inventory, Plant(s) Product(s) 0.00 0.00
(outside of routine
transportation, investigation
Warning Letters / 483s inspections).
at theofcustomer
Cost Other
responding site,costs
toetc. Plant(s) Product(s)
may include
Warning any fees to
Letters/483s the
and
21.00 8.10
externalobservations,
agency agencies for and
Lawsuits Product liability is the area Plant(s) Product(s)
conducting
meeting
of law in with
the
whichthe audits.
Health
those who
0.00 0.00
Authority
make agencies,
products i.e. to
available
FDA/MOH Communications FDA/MOH
travels, meetings, Plant(s) Product(s)
the public
Communications.are heldOther 0.48 0.30
accommodation
responsible for thecosts, etc.
injuries
costs
This may
cost include
element mailing
Cost of regaining lost customer Cost
those
and
of regaining
products
WebEx cause. not
costs.
does
lost Plant(s) Product(s)
0.00 0.00
include
customers. the cost of FCAs,
Examples:
Example: lawsuits, breach
recalls,
focus
Lost sales what could be regaine of
Lost holds,
groups,
sales related
warranty, etc. to any
and various Plant(s) Product(s)
advertisement campaigns, 0.00 0.00
quality
consumer events such
protection as:
claims.
training,
delays inetc.
production, delays
Quality / Service internal audits Cost of routine Internal Plant(s) Product(s)
in new product
Quality audits launches, 12.00 12.00
customer dissatisfaction,
Supplier Cost of routine
etc. that can beQuality
regained Plant(s) Product(s)
supplier auditsan at supplier 0.00 0.00
and represent
site
Supplier Performance Evaluation opportunity for savings
Cost of evaluating and
suppliers Plant(s) Product(s) 0.00 0.00
revenue
and increase.
preparation of
Depreciation of test equipment scorecards
Cost of depreciated test Plant(s) Product(s)
equipment 0.00 0.00
Calibration of measuring and tes Cost of calibration of Plant(s) Product(s)
parts/equipment/tools 0.00 0.00
Receiving inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
routine receiving inspection.
In-process inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
Final finished goods inspection routine
Cost of in-process
inspecting of Plant(s) Product(s)
inspection. 0.00 0.00
incoming goods at the
Field testing and appraisal at cus routine
Cost of final
field inspection.
testing and Plant(s) Product(s)
appraisal at customer site.
0.00 0.00
Preventive Maintenance The
Costcost of goods disposal
of supervision of Plant(s) Product(s)
and investigation
preventive maintenance is -
0.00 0.00
captured
maintain in the Complaint
accuracy of test
Process planning Any
cost operations
category. process Plant(s) Product(s)
equipment.
planning, such Thisas:cost
VIPdoes
0.00 0.00
not include
-Value calibration costs
Process control Cost
as ofImprovement
this routine
cost is process
captured Plant(s) Product(s)
Project,
controls etc.
(i.e. Cost of revising
statistical
0.00 0.00
under Calibration
QMS procedures costother
and
Training process
category.
Costs controls).
of retraining Other
the Plant(s) Product(s)
planning
costs may activities, such as:
include software 0.00 0.00
internal
integrationstakeholders
and acquisition,
fees. to not following
Supplier Development Managem related
transfers,
Cost etc.
of Supplier Plant(s) Product(s)
procedures.
developmentThe cost of
management.
0.00 0.00
routine trainings are
New software, tools, and/or tec Example:
captured
supplier training,
Cost of purchasing
in6the new
individual Plant(s) Product(s)
supporting
softwares, sigma
tools and/or 0.00 0.00
costs categories.
initiatives
implementing a new
technology.
Coaching/Mentoring Coaching/Mentoring costs Plant(s) Product(s)
are associated with
0.00 0.00
Improvement Projects Continuous Improvements, Plant(s)
Cost of Improvement Product(s)
such as: company 0.00 0.00
Projects undertaken by the
Talks/Town
company toHalls,
improve
coaching / mentoring
product quality of
and quality
individual
systems. employees as
part of their development
process, etc.
Mar Q1 Total Apr May Jun Q2 Total Jul Aug Sep Q3 Total

3.40 9.80 4.50 3.70 4.05 12.25 3.35 3.90 2.70 9.95

32.90 92.50 27.80 31.30 16.10 75.20 10.60 6.40 5.90 22.90

16.68 54.35 16.69 16.19 16.19 49.07 16.19 16.19 16.19 48.57

29.45 86.73 33.45 33.45 33.45 100.35 34.14 30.45 30.45 95.04

4.10 7.50 0.10 0.10 0.10 0.30 2.60 0.10 0.10 2.80

1.50 4.50 1.50 1.50 1.50 4.50 2.70 1.50 1.50 5.70

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.30 15.00 5.30 5.30 5.30 15.90 11.10 5.30 5.30 21.70

0.10 0.60 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.50 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.60 17.70 5.60 5.60 5.60 16.80 9.24 5.60 5.60 20.44

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

24.70 71.00 24.70 24.70 24.70 74.10 28.70 29.70 27.70 86.10

24.54 78.52 30.54 30.54 30.54 91.62 33.54 30.54 30.54 94.62

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 5.50 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 3.01 0.00 0.00 0.00 0.00 1.00 0.00 0.00 1.00

0.00 0.00 0.00 0.00 0.00 0.00 7.00 0.00 0.00 7.00

0.00 0.00 0.00 0.00 0.00 0.00 9.00 0.00 0.00 9.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.02 0.05 0.11 0.11 0.11 0.34 0.11 0.11 0.11 0.34

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.10 29.20 0.10 0.10 0.10 0.30 0.10 0.10 0.00 0.20

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.30 1.08 0.30 0.30 0.30 0.90 0.79 0.30 0.30 1.39

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

12.00 36.00 12.00 12.00 12.00 36.00 12.00 12.00 12.00 36.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Oct Nov Dec Q4 Total Total Annual Costs

3.35 3.45 2.60 9.40 41.40

3.91 3.99 3.91 11.81 202.41

20.19 18.19 18.19 56.57 208.56

30.45 30.45 30.45 91.35 373.49

1.60 0.10 0.10 1.80 12.40

1.50 1.50 1.50 4.50 19.20

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

5.30 5.30 5.30 15.90 68.50

0.00 0.00 0.00 0.00 0.60

0.00 0.00 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00

5.60 5.60 5.60 16.80 71.74

0.00 0.00 0.00 0.00 0.00

24.70 24.70 24.70 74.10 305.30

30.54 30.54 30.54 91.62 356.37

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 5.50


0.00 0.00 0.00 0.00 4.02

0.00 0.00 0.00 0.00 7.00

0.00 0.00 0.00 0.00 9.00

0.00 0.00 0.00 0.00 0.00

0.11 0.11 0.11 0.34 1.07

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 29.70

0.00 0.00 0.00 0.00 0.00

0.30 0.30 0.30 0.90 4.27

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

12.00 12.00 12.00 36.00 144.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


Value of Quality (VOQ) Management

Cost Category Action Superset Category

Value of Poor Quality Reactive Controversial Costs Controversial Costs

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Remediation

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Rework

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Scrap/ Spoilage

Value of Poor Quality Reactive Internal Failure Costs Scrap

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/ Fa

Value of Poor Quality Reactive Internal Failure Costs Nonconformances/


Failure Analysis
Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints

Value of Poor Quality Reactive External Failure Costs Complaints


Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs FCA

Value of Poor Quality Reactive External Failure Costs Holds

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Recalls

Value of Poor Quality Reactive External Failure Costs Inspections/Audits

Value of Poor Quality Reactive External Failure Costs Agency Observations

Value of Poor Quality Reactive External Failure Costs Liability / Lawsuits

Value of Poor Quality Reactive External Failure Costs FDA/MOH Communica

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Poor Quality Proactive Opportunity Costs Opportunity Costs

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Audit/inspection

Value of Good Quality Proactive Appraisal Costs Procurement

Value of Good Quality Proactive Appraisal Costs Maintenance

Value of Good Quality Proactive Appraisal Costs Calibration

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Quality Controls

Value of Good Quality Proactive Appraisal Costs Field Servicing

Value of Good Quality Proactive Prevention Costs Maintenance

Value of Good Quality Proactive Prevention Costs Planning

Value of Good Quality Proactive Prevention Costs Process Control

Value of Good Quality Proactive Prevention Costs Remediation

Value of Good Quality Proactive Prevention Costs Process

Value of Good Quality Proactive Improvement Costs Process


Value of Good Quality Proactive Improvement Costs Coaching/Mentoring

Value of Good Quality Proactive Improvement Costs Improvement Project


y (VOQ) Management - Year 3

Cost Name Cost Description Sites Product Jan Feb

Inclusion of overhead on top of di Inclusion of overhead on Plant(s) Product(s)


top of direct costs 3.30 3.10
Consulting costs Cost of consulting services, Plant(s) Product(s)
contingent labor, etc. 34.60 37.00

Reinspection, retest, 100% sortingCosts of inspectors labor, Plant(s) Product(s)


cost of supplies used in 19.80 22.87
retesting and reinspection
Rework and Sorting at the company Cost of rework and sorting Plant(s) Product(s) 37.44 33.54
related to product holds or
of defects identified during
identified
Product Holds production
Cost run or quality
of production holds Plant(s) Product(s)
nonconformances. This 2.10 1.70
inspections.
due to rework Capture
of defective
cost element does not
Retraining expense reworked
products
Costs material
at supplier cost
site.that
includeofreworkretraining the
or scrap Plant(s) Product(s)
2.10 1.50
includes
Other
internal the
costs labor.
may This
include cost
costs of stakeholders.
the rejected goods.
element inventory
product does not fees. include The
Scrap of expired materials/producCost of scrap of expired Plant(s) Product(s) 0.00 0.00
scrap of
costs costSCARof the and rejected
non-
materials/products. Does
goods.
conformance investigations
Scrap of obsolete materials not include
Scrap FCA related
are
scrap. notofincluded.
obsolete materials.
The costs Plant(s) Product(s)
0.00 0.00
Obsolete material
of Field Action holds due areto not
Scrap of defective materials order
Cost
included cancelation.
of any scrap
in this cost of thecost
This Plant(s) Product(s)
does
defective not include cost ofcost 9.20 5.30
category. material. This
expired
does materials
include labor FCA
notdefective and cost,
Scrap at supplier Cost
related of scrap. Plant(s) Product(s)
production
materials/parts rejectedtoat
delays due 6.30 0.20
high scrap siterate,
andand FCA
Disposal of scraped materials/go supplier
Cost
related of scrap.
disposal thescraped
of Plant(s) Product(s)
disposal
materials/ofgoods. rejected goods. 0.00 0.00
Although this costs will be
Downgrading Downgrading
consumed by is reducing
a supplier, Plant(s) Product(s)
the 0.00 0.00
however, collecting of
quality or status thisa
CAPAs, NCRs material
cost at theor piece
Root Cause Analysis ofmay
buyer of
level, Plant(s) Product(s)
equipment
help assessthat
production themay
defects qualityimpact
(CAPAs,of 7.70 5.70
its flexibility
goods received
NCRs). Cost and
of from in the
use
failure
SCARs Root
process.
supplier.Cause Analysis of Plant(s) Product(s)
analysis
defects atand re-designing
supplier site
0.00 0.00
activities
(SCARs) as part of the
Complaint adjustment and Any rebateand
corrective in price to
preventive Plant(s) Product(s)
allowances resolve quality issues. 26.60 24.70
actions. The costs of
Cost of handling complaints Reduction
complaints
Cost of handling in
are thenot invoice
included Plant(s) Product(s)
amount
complaints. The costcredit).
in this (could
cost be
category. a should 45.44 28.54
be estimated for reportable
Warranty charges Warranty charges are any Plant(s) Product(s)
(MDRs/MDVs) and non-
costs related to product 0.00 0.00
reportable complaints.
quality issues, product
Product returned from field Cost of acceptable returned Plant(s) Product(s)
serviceability, for products
goods from the field, 5.40 0.10
returned under warranty.
example: customer does
Courtesy costs are included
not like the product, but no
in the cost category.
product defects were found.
FCA Technical Assessments Cost of preparation of FCA Plant(s) Product(s)
and Review Board Technical Assessments to 3.00 0.00
determine
FCA Customer Communications (i.e if field action
Cost of executing is
the field Plant(s) Product(s)
required. 0.00 0.00
action and preparation of
Holds ( Labor and Freight ) the
CostCustomer
of issuing product Plant(s) Product(s)
Communications 1.50 0.00
Holds (Labor and (i.e. Freight).
Non-plant Recall Costs Important
Other costs
Non-plant Information
may include
Recall Costs is Plant(s) Product(s)
Letters,
any
Plants to provide the recalled product costetc.)
fees
anything associated
that
information
happens with
at 0.00 0.00
holding
the plantthe product
level, suchat the
as:
Plant Recall Costs (Plant mfg. re Plant Recalllocation.
Costs (Plant Plant(s) Product(s)
warehouse
Field-related recall costs, 0.51 0.11
mfg. related Recalls)
Customer service Recall
External Inspections/Audits (outsiExternal Agency Audits
Costs, restucking inventory, Plant(s) Product(s) 0.00 0.00
(outside of routine
transportation, investigation
Warning Letters / 483s inspections).
at theofcustomer
Cost Other
responding site,costs
toetc. Plant(s) Product(s)
may include
Warning any fees to
Letters/483s the
and
28.00 10.00
externalobservations,
agency agencies for and
Lawsuits Product liability is the area Plant(s) Product(s)
conducting
meeting
of law in with
the
whichthe audits.
Health
those who
5.00 0.00
Authority
make agencies,
products i.e. to
available
FDA/MOH Communications FDA/MOH
travels, meetings, Plant(s) Product(s)
the public
Communications.are heldOther 0.88 0.30
accommodation
responsible for thecosts, etc.
injuries
costs
This may
cost include
element mailing
Cost of regaining lost customer Cost
those
and
of regaining
products
WebEx cause. not
costs.
does
lost Plant(s) Product(s)
0.00 0.00
include
customers. the cost of FCAs,
Examples:
Example: lawsuits, breach
recalls,
focus
Lost sales what could be regaine of
Lost holds,
groups,
sales related
warranty, etc. to any
and various Plant(s) Product(s)
advertisement campaigns, 0.00 0.00
quality
consumer events such
protection as:
claims.
training,
delays inetc.
production, delays
Quality / Service internal audits Cost of routine Internal Plant(s) Product(s)
in new product
Quality audits launches, 12.00 12.00
customer dissatisfaction,
Supplier Cost of routine
etc. that can beQuality
regained Plant(s) Product(s)
supplier auditsan at supplier 0.00 0.00
and represent
site
Supplier Performance Evaluation opportunity for savings
Cost of evaluating and
suppliers Plant(s) Product(s) 0.00 0.00
revenue
and increase.
preparation of
Depreciation of test equipment scorecards
Cost of depreciated test Plant(s) Product(s)
equipment 0.00 0.00
Calibration of measuring and tes Cost of calibration of Plant(s) Product(s)
parts/equipment/tools 0.00 0.00
Receiving inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
routine receiving inspection.
In-process inspection Cost of inspecting of Plant(s) Product(s)
incoming goods at the 0.00 0.00
Final finished goods inspection routine
Cost of in-process
inspecting of Plant(s) Product(s)
inspection. 0.00 0.00
incoming goods at the
Field testing and appraisal at cus routine
Cost of final
field inspection.
testing and Plant(s) Product(s)
appraisal at customer site.
0.00 0.00
Preventive Maintenance The
Costcost of goods disposal
of supervision of Plant(s) Product(s)
and investigation
preventive maintenance is -
0.00 0.00
captured
maintain in the Complaint
accuracy of test
Process planning Any
cost operations
category. process Plant(s) Product(s)
equipment.
planning, such Thisas:cost
VIPdoes
0.00 0.00
not include
-Value calibration costs
Process control Cost
as ofImprovement
this routine
cost is process
captured Plant(s) Product(s)
Project,
controls etc.
(i.e. Cost of revising
statistical
0.00 0.00
under Calibration
QMS procedures costother
and
Training process
category.
Costs controls).
of retraining Other
the Plant(s) Product(s)
planning
costs may activities, such as:
include software 0.00 0.00
internal
integrationstakeholders
and acquisition,
fees. to not following
Supplier Development Managem related
transfers,
Cost etc.
of Supplier Plant(s) Product(s)
procedures.
developmentThe cost of
management.
0.00 0.00
routine trainings are
New software, tools, and/or tec Example:
captured
supplier training,
Cost of purchasing
in6the new
individual Plant(s) Product(s)
supporting
softwares, sigma
tools and/or 0.00 0.00
costs categories.
initiatives
implementing a new
technology.
Coaching/Mentoring Coaching/Mentoring costs Plant(s) Product(s)
are associated with
0.00 0.00
Improvement Projects Continuous Improvements, Plant(s)
Cost of Improvement Product(s)
such as: company 0.00 0.00
Projects undertaken by the
Talks/Town
company toHalls,
improve
coaching / mentoring
product quality of
and quality
individual
systems. employees as
part of their development
process, etc.
Mar Q1 Total Apr May Jun Q2 Total Jul Aug Sep Q3 Total

3.40 9.80 4.50 3.70 4.05 12.25 3.35 3.90 2.70 9.95

32.90 104.50 27.80 31.30 16.10 75.20 10.60 6.40 5.90 22.90

17.68 60.35 16.69 16.19 16.19 49.07 16.19 16.19 16.19 48.57

33.45 104.43 33.45 33.45 33.45 100.35 34.14 30.45 30.45 95.04

4.10 7.90 0.10 0.10 0.10 0.30 2.60 0.10 0.10 2.80

1.50 5.10 1.50 1.50 1.50 4.50 2.70 1.50 1.50 5.70

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.30 19.80 5.30 5.30 5.30 15.90 11.10 5.30 5.30 21.70

0.10 6.60 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.50 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

5.60 19.00 5.60 5.60 5.60 16.80 9.24 5.60 5.60 20.44

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

24.70 76.00 24.70 24.70 24.70 74.10 28.70 29.70 27.70 86.10

30.54 104.52 30.54 30.54 30.54 91.62 33.54 30.54 30.54 94.62

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 5.50 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 3.01 0.00 0.00 0.00 0.00 1.00 0.00 0.00 1.00

0.00 0.00 0.00 0.00 0.00 0.00 7.00 0.00 0.00 7.00

0.00 1.50 0.00 0.00 0.00 0.00 9.00 0.00 0.00 9.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.11 0.74 0.11 0.11 0.11 0.34 0.11 0.11 0.11 0.34

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.10 38.10 0.10 0.10 0.10 0.30 0.10 0.10 0.00 0.20

0.00 5.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.30 1.48 0.30 0.30 0.30 0.90 0.79 0.30 0.30 1.39

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

12.00 36.00 12.00 12.00 12.00 36.00 12.00 12.00 12.00 36.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Oct Nov Dec Q4 Total Total Annual Costs

3.35 3.45 2.60 9.40 41.40

3.91 3.99 3.91 11.81 214.41

20.19 18.19 18.19 56.57 214.56

30.45 30.45 30.45 91.35 391.19

1.60 0.10 0.10 1.80 12.80

1.50 1.50 1.50 4.50 19.80

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

5.30 5.30 5.30 15.90 73.30

0.00 0.00 0.00 0.00 6.60

0.00 0.00 0.00 0.00 0.50

0.00 0.00 0.00 0.00 0.00

5.60 5.60 5.60 16.80 73.04

0.00 0.00 0.00 0.00 0.00

24.70 24.70 24.70 74.10 310.30

30.54 30.54 30.54 91.62 382.37

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 5.50


0.00 0.00 0.00 0.00 4.02

0.00 0.00 0.00 0.00 7.00

0.00 0.00 0.00 0.00 10.50

0.00 0.00 0.00 0.00 0.00

0.11 0.11 0.11 0.34 1.77

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 38.60

0.00 0.00 0.00 0.00 5.00

0.30 0.30 0.30 0.90 4.67

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

12.00 12.00 12.00 36.00 144.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


0.00 0.00 0.00 0.00 0.00

0.00 0.00 0.00 0.00 0.00


Direct Labor
Finance

Overhead
Finance

Equipment
Operations

Part(s)
Operations

Reworked Material
Operations

Expired Material
Operations

Obsolete Material
Operations

Disposal
Finance

Finance Travel Accomodations

Compliance Agency Observations

Testing
Finance
Equipment/Parts
Calibration
Operations

Fee charges
Functions responsible for obtaining cost information

Finance

Lawsuits
Legal
Value of Quality (VOQ) Management

Office Supplies
Finance

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