Professional Documents
Culture Documents
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observations
Audit #
#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
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Corrective Action
completion date:
completed (date)
Correction Action
Date
reassed
Date
closed
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response (in
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Overdue
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Time DIS
were open
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comments
auditees
auditor
Only a doc
update?
QAR #
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Open DIS
Audit discrepancy
Root cause
code
CA Proj?
Who?
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On track:
#DIV/0!
What?
When?
On track?
Over-due?
(days)
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Point Value
Parameters
Severity (Maximum
PROBABLE Loss)
(A)
Frequency of Task
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)
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
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
Owner
Target
date
Date CA
Complete
Tsmith
2/19/11
2/18/11
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
On track:
#DIV/0!
When?
On track?
Contact
n/a
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00000
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00000
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00000
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00000
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n/a
00000
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00000
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00000
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00000
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n/a
00000
n/a
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n/a
n/a
n/a
00000
n/a
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n/a
00000
n/a
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n/a
00000
n/a
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00000
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00000
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QAR #
Issued
Functional Areas
CA Proj?
Who?
00000
n/a
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n/a
00000
00000
n/a
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00000
n/a
n/a
n/a
00000
n/a
n/a
n/a
00000
n/a
n/a
n/a
00000
n/a
n/a
00000
n/a
00000
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
n/a
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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
0
0
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
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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
0
0
0
0
0
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
0
0
0
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
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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
Days
open
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
Count
20%
40%
60%
80% 100%
Quality Assuran
Procurement
Process Enginee
Plant Engineerin
Manufacturing
Information Syst
Human Resourc
Design
Administration
12 months
5
Quality Assurance
Procurement
Process Engineering
Plant Engineering & Maint
Manufacturing
Information Systems
Design & Test Engineering
Human Resources
Breakdown of causes (total)
Design
Not following specs or SOP's
Procedures /SOPs were inadequate/ nonexistant
Failure to Comply with Regulations
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
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
Design & Test Engineering
Information Systems
Manufacturing
Plant Engineering & Maint
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
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
Plant Engineering & Maint
Manufacturing
Information Systems
Design & Test Engineering
Human Resources
Design
Administration
1
0.8
0.6
0.4
0.2
0
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
5.4.2
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
0.1
0.2
0.3
Count
0.4
0.5
0.6
0.7
7.3.3.1
0.8
0.9
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
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
Initiatives
Targets
Title
Measures
Mission:
Objectives
Financial
Internal Busin
Processes
Mission:
Initiatives
Title
Targets
Mission:
Measures
Objectives
Vision
and
Strategy
Title
Initiatives
Targets
Measures
Objectives
ernal Business
Processes