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
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Other
Other
Changes
1 Added due to findings in previous audit
2 All processes to be audited for transition to 2015 standard
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4.4 Quality management system and its processes X X X X X X
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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
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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
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7.1.2 People X X
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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
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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
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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
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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
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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
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Production 1
Problem type #4 Production 2
Production 3
Root cause by area Problem type #5
0 1 Production 4
Business Planning, Top Management Production 5
Problem type #6
Customer Service, Customer Complaints Production 6
Production Planning Production 7
Problem type #7
Production 1 Not following specs or
SOP's Production 8
Production 2
Problem type #8 Production 9
Production 3
Production 4 Production 10
Procedures/SOPs were Problem type #9
Production 5 inadequate/ nonexistant Inspection/QC Laboratory,
Production 6 Calibration
Production 7 Problem type #10 Procurement
Production 8 Failure to Comply with Maintenance
Production 9 Regulations Problem type #11 Internal Audit/Corrective
Production 10 Action
Inspection/QC Laboratory, Calibration Change Management
Problem type #12
Procurement Equipment Failure
Human resources
Maintenance
Problem type #13 Document Control
Internal Audit/Corrective Action
Change Management Improper Equipment Information Technology
Installation Problem type #14
Human resources Other
Document Control Other
Information Technology Problem type #15
Improper tools/equipment 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 Other 0
Problem type #19 0
0
Problem type #20
 Information Technology Problem type #15
Improper tools/equipment 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 Other 0
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:___________