How to use the Audit Program Manager

1 First thing! Save a backup copy in case a formula gets accidentally changed.

2 List the processes/functional areas

Enter the process/functional area names (yellow cells B4 to B33). Leave the top cell blank.

3 Make the long range plan

The standard has no requirement to audit all processes every year. Based on risk, critical
processes should be audited every year. Forecast audits with an X in the cells.

4 Record changes
One simple way to show when audit forecasts are adjusted is through notes in the Plan.
Enter descriptions in the Changes section.

5 Plan the audit scope

There is an expectation to use the process audit method. Audit Planner suggests which
clauses should be covered in each process. Use the Data filter function to select only those
clauses indicated with "X."

6 Perform the process audit

The clause-by-clause approach might work for the first round in preparation for
transition certification, but organizations are expected from there to use the
process approachwhen auditing. The turtle diagram provides a popular format,
but it matters less how the data are arranged than that the process is audited:
inputs, risks, controls, activities, equipment and materials, personnel and their
preparation, measurement and how success is recognized, and of course
outputs and how unfavorable results are dealt with. The format shown here is
a modified "turtle" with lines for easier note taking. The format you use matters
less than using the process approach, and that the entire standard gets covered
in the certification cycle.
###

How to use the Nonconformance Tracking Log

1

4
 How to use the Nonconformance Tracking Log
First thing! Save a backup copy in case a formula gets accidentally changed.

Prepare the dropdown menus

The process/functional areas are populated when listed in the Long Range Plan (yellow cells B4 to B33). Leave the top cell bla
Enter name of problem types in Subclassificaton table (orange cells AT145 to AT176). Leave the top cell blank.
Enter name of problem types in Root Cause table (blue cells AV144 to AV154).

Define the risk rankings

In the green cells at top of page, identify your three risk/hazard qualifiers: what is required to make this a serious problem?

Rules of the road to use the Log effectively

No NOT change or delete cells A1 to AQ176. This area contains the database that counts the findings automatically.
The graphs will automatically generate from the database in A1:AQ176.
Use the drop down menus for Functional Area, Root Cause and Subclassification (problem type). This is because these cells M
spelled correctly to be graphed.
Use the dropdown menus to enter Y or N in each of the hazard qualifier columns.

If no Ys or Ns are entered in the hazard qualifier columns, the Log assumes the finding is only an Opportunity for Improvement
Entering in Ys or Ns results in a recommended action, ranging from a 3W (Who, What, When action plan) to an 8D. For this to
Description of Findings entry is required.
OFIs do NOT get counted in the stacked bar graphs - only nonconformances get counted there. The pie chart compares the nu
OFIs to the nonconformances in the three risk levels.
OFIs DO get counted in the breakdown of root causes.

If you want to count more than 20 problem types, the data range will need to be increased in the Problem Type by Area bar cha
If you want to change the required responses to the four risk levels, enter your required responses in the pink Response cells.
 Long Range Plan
Processes 2015 2016 2017 2018 2019 2020 2021 2022
Business Planning, Top Management X X X X X X X X
Customer Service, Customer Complaints X X X X X X X X
Production Planning X X X X
Production 1 X X X X X X X X
Production 2 X 2 X X
Production 3 X X X X X X X X
Production 4 X X X X X X X X
Production 5 X X X X X X X X
Production 6 X X X X X X X X
Production 7 X X X X X X X X
Production 8 X X X X X X X X
Production 9 X X X X X X X X
Production 10 X 1 X X X
Inspection/QC Laboratory, Calibration X X X X X
Procurement X X X X X X X X
Maintenance X X X X X X X X
Internal Audit/Corrective Action X X X X X X X X
Change Management X X X X X
Human resources X X X X X X
Document Control X X X X X
Information Technology X X X X X X
Other
Other
Other
Other
Other
Other
Other
Other
Other
Changes
1 Added due to findings in previous audit
2 All processes to be audited for transition to 2015 standard
 s
int
Co nt
pla
e
om gem
m
a
er
an
pM
Audit planner - process based

t
us
To
C
n 1 ning
r S i ng ,
,
ce
la n
n
rvi
sto Plan

e
P

2
3
n4
n

ion

n
tio
tio

tio
tio
s
me
es

t
uc
uc
uc
uc
uc
sin

od
od
od
od
od
Cu
Bu

Pr
Pr
Pr
Pr
Pr
Clause Description
4 Context of the organization
4.1 Understanding the organization and its context X
4.2 Understanding the needs and expectations of interested parties X
4.3 Determining the scope of the quality management system X
4.4 Quality management system and its processes X X X X X X
5 Leadership
5.1 Leadership and commitment
5.1.1 General X X X X X X
5.1.2 Customer focus X X X X X X
5.2 Policy
5.2.1 Establishing the quality policy X
5.2.2 Communicating the quality policy X X X X X X
5.3 Organizational roles, responsibilities and authorities X X X X X X
6 Planning
6.1 Actions to address risks and opportunities X X X X X X
6.2 Quality objectives and planning to achieve them X X X X X X
6.3 Planning of changes X X X
7 Support
7.1 Resources
7.1.1 General X X
7.1.2 People X X
7.1.3 Infrastructure X X X X X
7.1.4 Environment for the operation of processes X X X X
7.1.5 Monitoring and measuring resources X X X X
7.1.6 Organizational knowledge X X
7.2 Competence X X X X X
7.3 Awareness X X X X X
7.4 Communication X X X X X
7.5 Documented information
7.5.1 General X X X X X X
7.5.2 Creating and updating
7.5.3 Control of documented information X X X X X X
8 Operation
8.1 Operational planning and control X X X X X X
8.2 Requirements for products and services
8.2.1 Customer communication X
8.2.2 Determining the requirements for products and services X X
8.2.3 Review of the requirements for products and services X X
8.2.4 Changes to requirements for products and services X X X X X X
8.3 Design and development of products and services
8.3.1 General X
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision X X X
8.5.2 Identification and traceability X X X
8.5.3 Property belonging to customers or external providers X X X
8.5.4 Preservation X X X
8.5.5 Post-delivery activities X X X
8.5.6 Control of changes X X X
8.6 Release of products and services X X X
8.7 Control of nonconforming outputs X X X
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General X X X
9.1.2 Customer satisfaction X X
9.1.3 Analysis and evaluation X X
9.2 Internal audit
9.3 Management review X
9.3.1 General X
9.3.2 Management review inputs X
9.3.3 Management review outputs X
10 Improvement
10.1 General X
10.2 Nonconformity and corrective action X X X X
10.3 Continual improvement X X X X
 Pr
od
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
P ro tio
n3
du

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ctio
Pr n4
od
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Pr tio
od n5
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
P ro tio
n6
du

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ctio
Pr n7
od
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Pr tio
od n8
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Pr tio
od n9
uc

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
I ns tio
pe n1
0

X
X
X
X
X
X
X
X
X
X
cti
Pr o n
oc /Q
ur

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CL
Ma eme ab
in t nt ora

X
X
X
X
X
X
X
X
X
X
X
en to r
I nt a y,
ern nce Ca

X
X
X
X
X
X
X
X
X
X
X
X
X
X
al libr
Ch Au a ti
on
an dit
/C

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ge orr
Hu Ma ec
ma na t iv

X
X
X
X
X
X
X
X
X
X
X
X
nr ge
Do es me e Ac
tio
cu ou n

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
me rce nt
I nf nt s
orm C

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ati ontro
Ot
he o nT l
r ec
Ot hn
he olo
r gy
Ot
he
r
Ot
he
r
Ot
he
r
Ot
he
r
Ot
he
r
Ot
he
r
Ot
he
r
 X
X
X
X X X X X X X X X X X X X X X X

X
X
X
X
X
X

X
X
X

X X X X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X X X X
X X X X X X X X
X X X X X X X X

X X X X X X X X X X X X
X X X X X X X X X X X
Process Auditor: Date
9001:2015
Process owner Shift

Inputs 4.4.1 Outputs 4.4.1

Risks & Opportunities 6.1 Objectives 6.2.1 Documented Information 7.5 Revision

Operational controls, Resources 6.2.2, 7.1, 8.1, 8.4 Measurements 9.1.1 Instruments 7.1.5.2 Date due

Identification & traceability 8.5.2

Responsibility & competency 7.1, 7.2, 7.3 Policy 5.2.2 Analysis & evaluation 9.1.3

Results/Improvements 10.3
Communication 7.4

Nonconformity 8.7.1, 10.2 Preservation and Environment 8.5.4, 7.1.4

 Hazard 3W
Tracking Immediate Regulatory Repeat of Date Closed
number
Functional Area/Process Description of Findings Problem Type Root cause hazard? breach? earler action?
Risk 5Y Owner Status of Corrective Action Due Date
Out
Ranking or 8D
###

###
###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###
###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###

###
###
 C
B
u
su
ts
i
o
n
m
e
rs
s
S P
er
P
rlo
ob
va
inlP
Id PPPPPPPPPPPPPPPPPP
cerrrrrrrrrrrrrrrrrrr
n
u
sP
im
ce ooooooooooooooooooo Functional Areas Sub Classification Count of Root cause Response
###
###
###
###
###
###
###
### rt,nbbbbbbbbbbb
P
p ###
###
b###
b###
b###
b###
b###
b###
b###
###
###
b###
### causes Y
ro
P Not following specs Non conformance root causes
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### e
i###
g t###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### . 0 Procedures/SOPs OFI N
d
o
ro
cP y### or SOP's 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### ,###
C ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Business Planning, Top Management Problem type #1 0 were inadequate/ 3W
ItP
u
d
ro
u p Customer Service, Customer Failure to Comply
nonexistant
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### n ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Problem type #2 0 5Y
n
cP
u
d
io
rsT e Complaints with Regulations Not following specs or SOP's
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### to ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production Planning Problem type #3 0 Equipment Failure
Improper 8D
ct
u
rd
P
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### e
in ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 1 Problem type #4 0 Equipment
Improper
ctp
u
d
o
rl###
P # Installation Procedures/SOPs were inadequate/ nonexistant
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### rio ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 2 Problem type #5 0 tools/equipment
Equipment
cta
/P u
d
m
ro 1 used for thefor
task
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### n ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 3 Problem type #6 0 inadequate
ctio
P
Q M
u
e
d
n
o
r### needs Failure to Comply with Regulations
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### a
n
rio
C ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 4 Problem type #7 0 Other
ctn
ra
u
d
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### lo
1
o ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 5 Problem type #8
ctin
n u
d Equipment Failure
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### 2
d
L
n
P
o
a
iC ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 6 Problem type #9 OFI 0
ctn
u
A
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### u
3
Ia
rctio
n
M ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 7 Problem type #10 Risk level 2 0
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
g
h
u ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 8 Problem type #11
Nonconformances
Risk level 3
by 0 Improper Equipment Installation
c4
in
b
o
e
m
a
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
H
t
d fD
tic5o ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 9 Problem type #12 risklevel
Risk level4 0
m
p
n
io
u
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### io
rio
u
le
n
6 ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Production 10 Problem type #13 Improper tools/equipment used for the task
g
m
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### rctta
o n
7
e
a
n ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Inspection/QC Laboratory, Calibration Problem type #14
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### /m
u
tn
i###
e ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Procurement Problem type #15 Equipment inadequate for needs
8
n
C
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### m
a
o
n
M
9 ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Maintenance Problem type #16
o
te
r1
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### rra ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Internal Audit/Corrective Action Problem type #17 Other
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### in
y0
s###
n
e ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Change Management Problem type #18
ro
tc,sa
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### O
e ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Human resources Problem type #19
n
e
g
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### to
O
cC ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Document Control Problem type #20
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### e
u
th
O
o
T
a
rm
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Information Technology Problem type by area
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### e
th
iO
n
e
lce ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other
rcvi###
e 0 1
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### th
O ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other
n
re
e
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### th
O
rb
h ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other
ste
rn Problem type #1
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### r###
th
o
O ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### lA
ro
e ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Business Planning, Top
th
a
O Other
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### cth
rl###
e ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other
Management
ti###
ro Problem type #2
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### e
h ###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other Customer Service, Customer
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### ie
rg
o
# ###
###
###
###
###
##
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Other OFI Risk level 2 Risk level 3 Complaints
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### ryo
n #
###
###
###
###
###
##
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### Risk level 4 Problem type #3
n Production Planning
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
### #
###
###
###
###
###
##
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
###
Production 1
Problem type #4
Production 2

Root cause by area Problem type #5

Production 3
0 1 Production 4
Business Planning, Top Management Problem type #6 Production 5
Customer Service, Customer Complaints Production 6
Production Planning
Problem type #7 Production 7
Production 1 Not following specs or SOP's
Production 2 Production 8
Problem type #8 Production 9
Production 3
Production 4 Procedures/SOPs were in- Production 10
Production 5 adequate/ nonexistant Problem type #9
Inspection/QC Laboratory, Cal-
Production 6 ibration
Production 7 Problem type #10 Procurement
Production 8
Failure to Comply with Regu-
lations Maintenance
Production 9 Problem type #11
Production 10 Internal Audit/Corrective Action
Inspection/QC Laboratory, Calibration Change Management
Equipment Failure Problem type #12
Procurement Human resources
Maintenance
Problem type #13 Document Control
Internal Audit/Corrective Action Improper Equipment Installa- Information Technology
Change Management tion
Human resources Problem type #14 Other
Document Control Other
Information Technology Improper tools/equipment Problem type #15 Other
Other used for the task
Other
Other Problem type #16
Other Other
Other Equipment inadequate for Problem type #17 Other
Other needs
Other
Other
Problem type #18 Other
Other
Other 0
Other
Problem type #19 0
0
Problem type #20
 Information Technology Improper tools/equipment Problem type #15 Other
Other used for the task
Other
Other Problem type #16
Other Other
Other Equipment inadequate for Problem type #17 Other
Other needs
Other
Other
Problem type #18 Other
Other
Other 0
Other
Problem type #19 0
0
Problem type #20

Safety PSM/RMP
CA #___________________ Date: _______________ Owner: ______________________

1- Risk level: enter an X to the right of the most appropriate category

¨ Product failure risk or liability risk

¨ Process gap or dysfunction between departments
¨ Human performance/not following procedures
¨ Document or instruction gap: revision needed
¨ Audit readiness issue

2- Cause or contributing factors (enter an X to the right of any that apply)

a) Human Describe how you plan to address each factor.
¨ Knowledge or training not adequate for the task Human Estimated completion date:____________
¨ Physically unable perform the task
¨ Did not follow procedures: a one-time lapse
¨ Understands, but did not follow procedure(s)
¨ Supervisor did not find the error
¨ Other __________________________________
b) Materials
¨ Not appropriate for the task Materials Estimated completion date:____________
¨ Not available for the task or in needed quantities
¨ Expired or obsolete
¨ Confusing
¨ Other __________________________________
c) Machinery
¨ Malfunctioning, out of service or unavailable Machinery Estimated completion date:____________
¨ Inadequate for the situation or need
¨ Obsolete
¨ Confusing
¨ Other __________________________________
d) Environment e.g., temperature
¨ _____________________________________ Environment Estimated completion date:____________
¨ _____________________________________
¨ _____________________________________
e) System / procedures
¨ Communication systems or delivery failed System/procedures Estimated completion date:_________
¨ Procedure obsolete or did not address the need
¨ Procedure was contradictory or confusing
¨ Standard practice does not follow procedure
¨ Other __________________________________
CA closure: Auditor describe the reaudit or reassessment. Date of reaudit___________ Auditor:___________