Global Tracking Audit Log

Period
Area audited
DIS number OBS number
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observations
Audit #
Last Updated on: September 15, 2010

Discrepancies
#DIV/0!
Items checked
Auditor
On track:
% Def
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Date
assessed
Closing meeting
Date
published
Response Due
date
Functional Areas
Element
number
Repeat NC? If so,

Risk Ranking
which element?
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Corrective Action
completion date:
completed (date)
Correction Action
Date
reassed
Date
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Time DIS
were open
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comments
auditees
auditor
Only a doc
update?
QAR #
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Corrective Action Summary
Open DIS
Audit discrepancy
Root cause
code
CA Proj?
Who?
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#DIV/0!
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(days)
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Point Value
Parameters
Severity (Maximum
PROBABLE Loss)
(A)
Frequency of Task
Disruption less than 1

hour; no product loss
Disruption between one

and four hours; no
product loss
Quarterly or less
Monthly
Extremely Unlikely
Unlikely
2-Jan
7-Mar
(B)
Likelihood of the error
(C)
# of Persons performing
the operation per shift
(D)
Disruption between and

1 day; rework is required
Disruption over 1 day.

Rework is required.
Loss of product or missed

delivery
Weekly
Daily
Hourly / Continuously
Possible
Probable
Certain
15-Aug
16 - 50
> 50
Date of
review
Functional
Area
Process
Operation
PR
12/29/10
Design
NTPRS
SP-12345,
8.4.2
Tom Smith
Ris
Description
Trial material brought into

process without a Purchase
Order.
Impacts and Measures
Incoming Inspections are not planned or carried

out. As a result, discrepant material may enter
the manufacturing processes.
Measure: cost of rework or lots scrapped
Severity
"A"
Risk Rankings
Frequency
"B"
# of Persons
performing the Calculated
Likelihood
operation per Ranking
"C"
shift
(AxBxCxD)
"D"
18
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Action
Action for resolution
1-Make a flow chart of the material qual process.

2-Put in hyperlinks to forms and procedures.
3-Email the flowsheet to all affected personnel.
4-Train all affected personnel to follow the flowchart
pcocess.
5-Evaluate results.
Owner
Target
date
Date CA
Complete
Tsmith
2/19/11
2/18/11
New Risk Rankings

# of Persons
performing the Calculated
Severity Frequency Likelihood
operation per Ranking
"A"
"B"
"C"
shift
(AxBxCxD)
"D"
12
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Corrective Action Details

Updated: September 15, 2010
On track:
#DIV/0!
When?
On track?
Contact
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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00000
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QAR #
Issued
Functional Areas
CA Proj?
Who?
00000
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00000
00000
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00000
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00000
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00000
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00000
n/a
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00000
n/a
00000
Open DIS Audit discrepancy
What?
DO NOT enter any data in this worksheet! The cells are program
QAR #
DIS #
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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Pub
Date
% Def
Funct
Area
Element
number
REPEAT
Element
number
Risk
Ranking
Root
Cause
Days
response
overdue
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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0
0
0
0
0
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0
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0
0
0
0
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
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0
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n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
n/a
n/a
n/a
n/a
n/a
n/a
n/a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
ls are programmed to automatically draw data from the worksheets an

Days
overdue
close
Days
open
Trends of root causes by group - last 12 months

0
Not following specs or SOP's

Procedures/SOPs were inadequate/ nonexistant
Failure to Comply with Regulations
Equipment Failure
Improper Equipment Installation
Improper tools/equipment used for the task
Equipment inadequate for needs
Proce
Impro Other
Not dures/ Failur
Impro per Equip
followi SOPs e to Equip per tools/ ment
Total
ng were Compl ment Equip equip inade
Nonconf
Other
Administ specs inade y with Failur ment ment quate
0 quate/
0
0
0
0
0
0
0
0
ration
or
Regul
e
Install
used
for
Design
0
0
0
0
0
0
0
0
0
ation for the needs
Human SOP's nonex ations
Resourc
Design &
0
0
0
0
0
0
0
0
0
istant
task
es
Test
0
0
0
0
0
0
0
0
0
Engineer
Informati
ing
on
0
0
0
0
0
0
0
0
0
Systems
Manufact
Plant
0
0
0
0
0
0
0
0
0
uring
Engineer
0
0
0
0
0
0
0
0
0
ing &
Process
Maint
Engineer
0
0
0
0
0
0
0
0
0
Desig
Plant
ing
Procure
0 Huma
0 n &0 Inform
0
0 Engin
0 Proce
0
0 Qualit
0
ment
Quality
Assuran
0 n 0 Test
0 ation
0 Manuf
0 eering
0 ss 0 Procu
0 y
0
Admin
ce
Sum
0
0
0
0
0
0
0
0
Percent
istrati
Desig
Resou
Engin
Syste
acturi
&
Engin
remen
Assur
Docum
4.2
of total on
n
rces eering ms
ng
Maint eering t
ance Documenta
entatio
Manag
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
n
tion
ement
require
Requireme
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
5.1
Custom
commit
ments
Respon
nts
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
er
5.2
ment
Plannin
5.4
sibility,
focus
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
g
Planning
authorit
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
5.5
Manag
y and
Provisi
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
ement
5.6
commu
on
of
review
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
6.1
Human
nication
resourc
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
Resour
6.2
es
Infrastr
ces
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
6.3
Work
Plannin
ucture
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
environ
6.4
g
of
Custom
ment
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
product
7.1
er
Design
realizati
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
related
7.2
and
on
process
Control
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
7.3
Product
develop
Purcha
es
of
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
7.4
ion
and
ment
Statistic
sing
monitor
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
service
7.5
al
tools
ing
and
provisio
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
7.6
identific
measur
Monitor
n
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
ation
8.1
Control
ing
ing
and
and
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
8.2
of
equipm
measur
knowle
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
noncon
8.3
ent
ement
dge
forming
product
Analysi
s of
Improv
data
ement
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
8.4
8.5
Percent of nonconformances by group, 12 month

0%
Documentation requirements
Management commitment
Customer focus
Planning
Responsibility, authority and communication
Management review
Provision of resources
Human Resources
Infrastructure
Work environment
Planning of product realization
Customer related processes
Design and development
Purchasing
Production and service provision
Control of monitoring and measuring equipment
Statistical tools identification and knowledge
Monitoring and measurement
Control of nonconforming product
Analysis of data
Improvement
Count
20%
40%
60%
80% 100%
Quality Assuran
Procurement
Process Enginee
Plant Engineerin
Manufacturing
Information Syst
Design & Test En
Human Resourc
Design
Administration
AdminisDesignHumanDesignInformaManufaPlant EProcesProcur Quality Assurance

0
0
0
0
0
0
0
0
0
0
orksheets and present in charts.
12 months
5
Quality Assurance
Procurement
Process Engineering
Plant Engineering & Maint
Manufacturing
Information Systems
Design & Test Engineering
Human Resources
Breakdown of causes (total)
Design
Procedures /SOPs were inadequate/ nonexistant
Equipment Failure
Im proper Equipm ent Ins tallati on
Im proper tools /equipm ent used for the task
Equipment i nadequate for needs
Other
Administration
Functional Areas
Avg days late Avg days late

response
close
Avg days
open
Code
Number
1
2
3
4
5
6
7
8
Risk Avg
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Max Risk
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Administration
Design
Human Resources
Information Systems
Manufacturing
Process Engineering
Procurement
Quality Assurance
Documentation requirements
Management commitment
Customer focus
Planning
Responsibility, authority and communication
Management review
Provision of resources
Human Resources
Infrastructure
Work environment
Planning of product realization
Customer related processes
Design and development
Purchasing
Production and service provision
Control of monitoring and measuring equipmen
Statistical tools identification and knowledge
Monitoring and measurement
Control of nonconforming product
Count
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Repeat
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Analysis of data
Improvement
0
0
0
0
0
0
0
0
Audit results by elem ent, 12 m onth
group, 12 months
Risk Avg
100%
Repeat
0.1
0.2
0.3
Count
0.4
0.5
0.6
Quality Assurance
Procurement
Process Engineering
Manufacturing
Information Systems
Human Resources
Design
Administration
1
0.8
0.6
0.4
0.2
0
Count of nonconformances by group, 12 m
Element
number
4.1 & 4.1.1
4.2 & 4.2.1
4.2.2
4.2.3
4.2.3.1
4.2.4
5.1
5.1.1
5.2
5.3
5.4
5.4.1
Breakdown of causes (total)
5.4.2

Procedures /SOPs were inadequate/ nonexistant
Failure to Com ply w ith Regulations
Equipment Failure
Improper Equipment Ins tallation
Improper tools /equipment used for the task
Equipment i nadequate for needs
Other
5.5 & 5.5.1

5.5.1.1
Root Cause Codes

Procedures/SOPs were inadequate/ nonexistant
Equipment Failure
Improper Equipment Installation
Improper tools/equipment used for the task
Equipment inadequate for needs

Other
Count of
causes
0
0
0
0
0
0
0
0
5.5.2
5.5.2.1
5.5.3
5.6
5.6 & 5.6.1.1
5.6.2
5.6.3
6.1
6.2 & 6.2.1
6.2.2
6.2.2.1
6.2.2.2
6.2.2.3
6.2.2.4
6.3
6.3.1
6.3.2
6.4
6.4.1
6.4.2
7.1
7.1 & 7.1.1
7.1.2
7.1.3
7.1.4
7.2
7.2.1 & 7.2.1.1
7.2.2 & 7.2.2.1
7.2.2.2
7.2.3 & 7.2.3.1
7.3.1
7.3.1.1
7.3.2
Administration
Design
Human Resources
7.3.2.1
7.3.2.2
7.3.2.3
7.3.3
ts by elem ent, 12 m onths

Repeat
0.1
0.2
0.3
Count
0.4
0.5
0.6
0.7
7.3.3.1
0.8
0.9
ormances by group, 12 months
7.3.3.2
7.3.4 & 7.3.4.1
7.3.5
7.3.6 & 7.6.3.1
7.3.6.2
7.3.6.3
7.3.7
7.4.1
7.4.1.1
7.4.1.2
7.4.1.3
7.4.2
7.4.3
7.4.3.1
7.4.3.2
7.5.1
7.5.1.1
7.5.1.2
7.5.1.3
7.5.1.4
7.5.1.5
7.5.1.6
7.5.1.7
7.5.2
7.5.3
7.5.4
7.5.5
7.5.5.1
7.6
7.6.1
7.6.2
7.6.3
8.1
8.1.1
8.1.2
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3.1
8.3.2
8.3.3
8.3.4
8.4.1
8.5.1
8.5.1.2
8.5.2
8.5.3
Design & Test

Engineering
Information
Systems
Manufacturing
Plant Engineering
& Maint
Process
Engineering
Procurement
Quality Assurance
REPEAT
Element
number
Risk Ranking
Totals
Suggested measures
# findings/OFIs
# of CARs
# of audit reports
RPN or risk value
Regulatory problem avoidance
Adequacy of CA follow through
Scoring
Milestone met
Success metric: $, time, error rate, etc
Initiatives
Targets
Title
Measures
Mission:
Objectives
Customer
Numerical: Use formulas or rubric scoring

Thumbs up or down: pass/fail
Stop light: Color scoring
Initiatives
Targets
Title
Measures
Mission:
Objectives
Financial
Internal Busin
Processes
Mission:
Initiatives
Title
Targets
Mission:
Measures
Learning and Growth
Objectives
Vision
and
Strategy
Title
Initiatives
Targets
Measures
Objectives
ernal Business
Processes

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Period

DIS number OBS number

Last Updated on: September 15, 2010

Repeat NC? If so,

Management Action Date of Response to

Other input (describe)

Corrective Action Summary

Disruption less than 1

Disruption between one

Disruption between and

Disruption over 1 day.

Loss of product or missed

Trial material brought into

Impacts and Measures

Incoming Inspections are not planned or carried

Action for resolution

1-Make a flow chart of the material qual process.

New Risk Rankings

Corrective Action Details

Open DIS Audit discrepancy

ls are programmed to automatically draw data from the worksheets an

Trends of root causes by group - last 12 months

Not following specs or SOP's

Percent of nonconformances by group, 12 month

Design & Test En

AdminisDesignHumanDesignInformaManufaPlant EProcesProcur Quality Assurance

orksheets and present in charts.

Avg days late Avg days late

Audit results by elem ent, 12 m onth

Count of nonconformances by group, 12 m

Breakdown of causes (total)

Not following specs or SOP's

5.5 & 5.5.1

Root Cause Codes

Equipment inadequate for needs

ts by elem ent, 12 m onths

ormances by group, 12 months

Design & Test

Numerical: Use formulas or rubric scoring

Learning and Growth

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