Audit Project
Background
Objectives:
Impact:
Assumptions:
To develop and implement Quality Audit within The XYZ
Company
Effective execution of our requirements through the consistent
execution of quality audits throughout manufacturing
The Quality of our products and processes is a critical component of
the XYZ Company
Compliance to our performance requirements will deliver products
meeting our customer and consumers needs
Audit Project
DMADV Storyboard
Audit Project
D
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Auditing Project – Objective
To develop and implement processes for Quality
Audits of:
 All facilities and operations on an annual basis
 Suppliers – Major Product Suppliers
Auditing Project – Opportunity Statement
Monitoring and refining our quality assurance processes are critical elements to
maintaining the quality standards of our products as expected by our customers and
consumers.
There is an opportunity to achieve greater consistency in our governance
responsibilities through an audit program addressing the basics of the
manufacturing processes.
Audit Project
D
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Preliminary Project Objective:
By January 1, 2005, To develop and implement processes for:
 Quality audits of Manufacturing facilities
 Environmental and Occupational Health and Safety Audits for manufacturing
facilities
Audit Project
D
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Audit Program –Process Macro Flow
Processes
Core
Level 1
Level 2
Req./
New Product
Planning
Contract
Introduction
Business
Environmental
Data
Determine
Audit
Needs
Distributio
Marketing Production
n
Develop
Plans
Communicate
Business
Plans
Secure
Resources
Logistics
Execute
Plans
Execute
Audit
Plan
Sales
Customer
Service
Evaluate
Performance
Report
Audit
Performance
Audit Project
D
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Audit Level 2 Process: Project Scope
BU/QD
Operating Division
Supplier
Identify Facilities
Prepare
Collect information and
protocols
Conduct
Schedule Audits
Conduct on-site evaluation
including audit close-out
Report
Schedule
Auditors
Issue Audit Reports to
Facility and Division
Complete Logistics
Confirm findings
Issue Audit Summaries
CAP
Develop and submit CAP
Review CAP
Project Scope
Execute CAP
Audit Close-out: Confirming the status of the corrective actions
taken against the findings of previous audits.
Audit Project
D
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Audit Project – Interview Questions
1. For our team to get a common understanding, please tell us
how you interpret the term “Quality Auditing”?
2. What do you see as the attributes of a successful Quality
Audit program?
3. What are the top 3 attributes in order of importance?
4. How would you measure whether a Quality Audit program
meets your expectations on these top 3 attributes?
Identified
key attributes
of the program
5. What are your top 3 issues related to Manufactured Quality in
your organization today?
6. Do you see a Quality Audit program helping to resolve these
issues?
7. If so, how do you see a Quality Audit program helping to
resolve these issues?
Identified needs
arising from current
challenges
8. What information should a Quality Audit program generate for
your organization?
9. How will this information be used within your organization?
Identified
informational needs
and attributes
10. Is there anything else you would like to share with us?
“Catch all”
Audit Project
DM A D V
Audit Project – VOC Analysis

Extracted solutions, issues and needs from interviews

253 need statements transcribed to Post-it notes

Post-it notes color coded by customer segment

Top needs from each customer highlighted

Needs affinitized and sorted using tree diagrams
All customers needs and priorities were similar
Audit Project
DM A D V
Audit Program – Project Track
Tracks
Design
Method
PMIS
Criteria
Project
Size
small
Cost
Discovery
Potential
Process
Knowledge
Gap to
Be
Closed
least
least
highest
Small
moderate
QFD
medium
moderate
large
moderate
moderate
moderate
large
Benchmarking
medium
high
large
moderate
high
low
large
QFD (Quality Function Deployment) Track selected
for current project
Audit Project
DM A D V
Audit Project – New Process Objective
To develop and implement a program for Quality
Audits of all Manufacturing facilities and
operations on an annual basis that:

Is reliable

Audits the right things in the right places

Has actionable outputs
Audit Project
DM A D V
Audit Project – Design Ideas
CTQ
Design Ideas
Clearly identify where the
current and potential risks and
problems
 In-depth standardized audit modular protocols for systems and compliance
 Determine audit schedule, type, content and team appropriate for the auditee in
collaboration with local BU/Division
Independent Audits
 Internal validation process
 Use external auditors only
 Interdivisional audit teams
Locally Relevant




Fair audits
 Auditor certification
Verification of completeness of
Corrective Action
 System for reporting status of findings and corrective actions
 Corrective action escalation procedure
Consistent audits
 Decision criteria and process for consistent ratings of individual findings and overall
facility performance
Externally accepted audits
 Audit program certified by recognized 3rd party - Mechanism for benchmarking against
other companies to establish competitive advantage
Complete Communication
 Audit reporting roll-up process
Incorporation of Division Quality representative in audit team
Audit expertise at BU level to implement and adopt locally
Audit budget is owned at BU level to enable local initiative and adoption
Linked to ISO certification where appropriate
Audit Project
D M A D V
Audit Program – QFD
Importance
How Much
9
213
219
1422
16
9
3
9
9
9
9
9 1
3 9
9 1071
1422
9
9
9
3
3
9
9
1
3
9
9
1
9
13
987
9
1071
January 2003 100 % of 25 - 30
100% lead auditors
Compliance
are iso lead
modules by January
assessor certified; 1, 2004;100% of the
50% of auditors 15 System modules
certified to TCCC
by June 1, 2004
Our
certified auditor
program
requirements by
end of 2004
(transition). 80%
thereafter as steady
state in system.
9
9
9
9
3
9
1
Global audit reporting roll-up
process for BOD & Executive
Comm.
Use External Auditors only
13
93
9
9
Audit expertise at SBU level to
implement global audit & adopt
locally
1
9
9
Global audit program certified by
recognized 3rd party to ISO 19011
9
Global audit reporting roll-up
process for BOD & Executive
Comm.
99
1
Decision criteria and process for
consistent ratings of individual
findings and overall facility
performance
Decision criteria and process for
consistent
ratings
of individual
Determine
audit
& audit team
findings and overall facility
appropriate for the auditee in
performance
489
39
363
309
249
TCCC Certified auditors
Rating
TCCC Certified auditors
Rating
Needs (Whats)
Needs (Whats)
Clearly Identifying current and potential risk
Clearly Identifying current and potential risk
and problems
and problems
48
Independent
Audits
Independent
Audits
39
The
Program
is locally
relevant
TheGlobal
Global
Program
is locally
relevant 36
Fair
30
FairAudits
Audits
Consistent Audits
24
Consistent
Audits
Verification of completeness of corrective
Verification of completeness of corrective
action
21
action accepted audits
Externally
21
Complete
communication
16
Externally
accepted audits
Importance
Complete communication
Global audit program certified by
recognized 3rd party to ISO 19011
Determine
audit
& audit team audit
In-depth
standardised
appropriate
the auditee
modularfor
protocols
forin systems
collaboration with local
compliance
SBU/division
9
1
Hows (Design Requirements)
collaboration with local
SBU/division
In-depth standardised audit
modular protocols for systems &
compliance
&
Hows (Design Requirements)
9
9
1
1
1
9
3
966
3
987
900
39
3
966
9
765
3
1
514
900
80% of time match An accuracy rate of All elements of ISO
audit type to
100% for critical
19011 will be
auditee; 100%
findings and 80%
incorporated into
match of audit team accuracy for nonthe Global Audit
on process
critical findings and Program design by
knowledge; In 2004 overall plant ratings
January, 2004.
at least 50% of
for each audit by
audits conducted
December 2003
with fully certified
auditors; 2005 on
80% of audits
conducted with fully
certified auditors
504
9
765
Provide bi-monthly
reports for BOD
meetings; provide
monthly reports to
Exec. Com.,Quality
Division and SBU
heads by February
5, 2004
Audit Project
D M A D V
Audit Project – Trade-offs
Top 6 design
elements have no
conflicts and are
synergistic
“Inclusion of Division QA
in audit team” and
“Convertible Rating
System” conflict with
other design elements
Potential
synergies and
conflicts between
design ideas
identified
Audit Project
D M A D V
6
TCCC Certified auditors
Insufficient number of auditors Insufficient resources to meet
certified
audit objectives
8
Transfer of
Division auditors
who are not
capable
4
TCCC Certified auditors
Insufficient number of auditors Insufficient resources to meet
certified
audit objectives
8 Division
auditors auditors
4
Mix of Internal and
External
not available for
enables annualtransfer
audits of all
manufacturing operations
RPN
Variaton in
requests
Detection
6
6 Lost or
7
Routine for considering
the
mishandled
requests
incorporation of local
needs into Audit
program
Occurrenc
e
Inability to capture local ideas / Local levels start performing
request that could be
audit activities for local issues
globalized
and the GAP is unable to
detect local risks.
7
Severity
Determine audit & audit team
appropriate for the auditee in
collaboration with local
SBU/division
8
Current
Controls
8
4
4
128
10 420 Create a procedure for
reviewing, sharing learnings
across geographies, and for
validation and tracking of
solutions with originator within
an agreed timeframe.
10 360 Routine for considering the
incorporation of local needs
into global audit program (and
TCCQS) that includes criteria
for review and evaluation
against TCCC standards and
applicability for globalization.
6
4
5
120
6
4
1
24
10 320 Develop and apply auditor
selection criteria during
transition. Use auditor pool
across SBU's while building
SBU capability.Identify multiple
external certification bodies in
design phase.
10 320 Use auditor pool across SBU's
while building SBU
capability.Identify multiple
external certification bodies in
design phase.
8
1
1
8
8
4
1
32
RPN
Determine audit & audit team
appropriate for the auditee in
collaboration with local
SBU/division
Potential Effect(s) of Failure
Over estimation of current
performance leading to false
sense of security and/or misrepresentation of risk & Under
estimation of current
performance leading to unfair
audits
Inability to capture local ideas / Local levels start performing
request that could be
audit activities for local issues
globalized
and the GAP is unable to
detect local risks.
Detection
Potential Failure Mode
Incorrect individual findings
leading to incorrect overall
facility performance rating
Potential
Cause(s) of
Failure
Auditor does not
follow process
Occurrenc
e
Design Requirement
Decision criteria and process
for consistent ratings of
individual findings and overall
facility performance
Severity
Audit Program – FMEA
Recommended Actions
10 560 Auditor calibration and training.
Also, include evidence in
working papers that process
was followed. Incoporate
review of audit ratings prior to
closing meeting.
Top design requirements tested for failure and countermeasures incorporated in design
Audit Project
Audit planning
designed in
accordance
Level
2 19011
with
ISO
D M A D V
Audit Program – Process Flow
Determine
Audit
Needs
Establish
Current Status
Level 3
IT Enablers:
• Searchable
Auditor and
Operation
Databases
• Scheduling
Software
Secure
Resources
Identify Audit
Type
• Identify number of
plants to be audited
and location
• Determine audit type
required based on facility
maturity
• Establish maturity of
facility and rank
operations based on
potential risk. (Based
on Division
assessment against
established criteria)
• Determine additional
auditing needs (obtained
by use of the collaborative
routine established in the
GAP)
• Determine the preferred
audit timing from the
Divisions
Execute
Audit
Plan
Report
Audit
Performance
Identify Audit
Team Required
Schedule Audits
Select the audit team
Develop audit schedule:
based on:
 Schedule systems audits based
on auditee’s readiness and auditor
availability
• Qualification
• Right process knowledge
• Language ability
 Firm scheduling of compliance
audits (prioritized based on risk
profile)
• Availability
Draft Schedule indicates:
• Lead Auditor
 Availability of auditee
• Location of auditor
 Duration and type of audit
 Timing of audit & team who will
conduct audit
Confirmation of schedule
Communication of final schedule
How Much:
80% of time match audit type to auditee; 100% match of audit team on process knowledge; In 2004 at least 50% of audits
conducted with fully certified auditors; 2005 onwards 80% of audits conducted with fully certified auditors
Firm scheduling routines to have the right team at the right location
conducting the right audit
Audit Project
Selection,
training and
evaluation
of auditors
consistent
with
Level
2
ISO-19011
Level 3
D M A D V
Audit Program – Process Flow
Determine
Audit
Needs
Selection
Secure
Resources
Execute
Audit
Plan
Report
Audit
Performance
Certification
Maintenance
Training
Certification
Select using criteria for:
• Personal Attributes
• Education
• Related experience
Train auditors in:
• Audit principles
• Audit execution
• ISO Lead Assessor
• Process Technologies
• Business Processes
• Quality Management
System (ISO-9000)
• Laws and regulations
Certify auditors Certification
criteria
Periodic re-training and
evaluation
How much:
By 31 January, 2004
• 80 % of internal auditors
recruited/transitioned
• 100% of external audit
service providers identified
How much:
• 80% of auditors trained by
end of June 2004;
• 100% of auditors certified
to ISO Lead Assessor by
31 January 2005
How much:
• 80% of auditors and 100%
of lead auditors certified
• Certification criteria by 31
December 2004
How much:
Maintain steady state of
80% of auditors and 100%
of lead auditors certified
Auditor Certification Program - Internal and external auditors have the
right skills and competences
Audit Project
D M A D V
Audit Program – Process Flow
Level 2
Determine
Audit
Needs
Secure
Resources
Level 3
Plan Plant Audit
IT Enabler:
• Electronic
Protocol
Distribution
Standardized protocol
module for planning,
execution and reporting of
individual audit outcomes
Execute
Audit
Plan
Report
Audit
Performance
Perform Plant Audit
Standardized modules to
evaluate compliance of
processes and systems
during individual audits
How Much:
• 100% of 25-30 Compliance modules completed
by January 1, 2004
• 100% of 14 Systems modules completed by
June 1, 2004
• 100% of Manufacturing Operations audited by
31 December, 2004
Audit execution
designed to meet
ISO-19011
guidelines
Includes
Decision
criteria and
process for
consistent
ratings.
Sub-Team with geographic
representation, to compile, review
and standardize modules.
In-depth protocols and decision criteria deliver consistent and fair audits
Audit Project
D M A D V
Audit Program – Process Flow
Determine
Audit
Needs
Level 2
Communicate Detailed
Audit Findings
Level 3
• Detailed Audit report issued to
Auditee that identifies critical and
systemic risks
• Auditee uses report information to
drive program improvement
IT Enabler:
• Searchable
Audit report
Database
• Formalized communication of high
risk findings to appropriate
management levels.
Secure
Resources
Execute
Audit
Plan
Summarize
Audit Data
• Gather, analyze and trend data to
create a summary report that
includes identification of high risk
issues, status of corrective action,
successful practices and
learnings.
• Audit summary to provide
comparative data of Division / BU
performance against our
performance.
Report
Audit
Performance
Audit reporting
activities
designed to
meet ISO-19011
Communicate
Summarized Information
• Incorporate reporting of audit
information into established
management routines for Quality
performance at the BU level.
Information can be used to drive
resource allocation at the BU
and Division level.
• Audit summary provided to
BOD. Information will be used as
input to resource allocation, and
greater understanding of the
risks in the organization.
How Much:
Provide bi-monthly reports for BOD meetings; provide monthly reports to Executive Committee,
Quality Division and BU/Vision heads by February 5, 2004
Actionable audit information available - Auditee to BOD
Audit Project
D M A D V
Audit Program – Detailed Design Ideas
Detailed design ideas related to the process flow generated through:
 High level design review with extended team
 Surveys Quality Managers)
 Idea generation within the Core Team
QUALITY AND TECHNICAL Audit SURVEY
As you are aware, a team under the sponsorship of Jim Power is working to design a Quality Audit program for implementation beginning January 2004. The immediate
focus is the program design for audits of Manufacturing Operations.
Early on in the project, SBU heads, Division Presidents and other senior leaders were surveyed. Their expectations for the program are:
It is reliable
Audits the right things in the right places
The program design requirements to meet these high level needs are:
Certified auditors
Match audit type and audit team appropriate for the auditee’s facility status, in collaboration with local BU/Division
Standardized, modular, protocols and work aids for Systems and Compliance audits
Decision criteria and process for consistent ratings of individual findings and overall facility performance
Audit program certified by recognized third party to ISO 19011
Combination of external/internal audit teams
Audit Project
D M A D V
Audit Project - Determine Audit Needs
QFD #1
High Level
Design
Elements
9
3
9
9
1
9
21
21
16
9
3
9
1422
9
1
9
1071
9
Global audit reporting roll-up
process for BOD & Executive
Comm.
9
9
1
Global audit program certified by
recognized 3rd party to ISO 19011
Decision criteria and process for
consistent ratings of individual
findings and overall facility
performance
48
39
36
30
24
Determine audit & audit team
appropriate for the auditee in
collaboration with local
SBU/division
TCCC Certified auditors
Rating
Needs (Whats)
Clearly Identifying current and potential risk
and problems
Independent Audits
The Global Program is locally relevant
Fair Audits
Consistent Audits
Verification of completeness of corrective
action
Externally accepted audits
Complete communication
Importance
In-depth standardized audit
modular protocols for systems &
compliance
Hows (Design Requirements)
Detailed
Design
Options
9
9
9
3
3
9
9
9
9
3
966
900
1
QFD #2
9
3
3
987
9
765
Options
Final Flowchart
Error Proofing
Critical Risk Flow Process
PVP
Hub Q.A.
Audit Group
Lead Auditor
Division
Auditee
ID of critical/high
risk (1)
Communicate
finding to auditee
(2)
Confirmation of
finding (4)
Agree
(8)
No
Continue audit
(6)
Yes
Telephonic
discussion
with auditor
(7)
Discussion and
confirmation of
evidence (3)
Confirm with
audit manager
(5)
No
S Potential Causes
E
V What causes the Key
E Input to go wrong?
R
I
T
Y
Yes
Telephonic
discussion
with audit
manager (10)
Agree
(11)
Confirm with
Hub Q.A. (9)
No
Continue audit based on
audit manager comment
(13)
Yes
Telephonic
discussion with
division to get a
plan for action
(15)
Confirmation
with audit
manager (14)
D
Current Controls
E
T
What are the existing
E R
controls and procedures
C P
(inspection and test) that
T N
prevent either the cause
I
or the Failure Mode?
O
N
no current controls
10 400
Actions Recommended
What are the actions for reducing the
occurrence of the cause, or improving
detection?
Establish routines to quarterly for divisions to review
current status against current EMS content
Resp. Actions Taken S
E
What are the V
completed actions E
taken with the R
recalculated I
RPN?
T
Y
GAP
Mngr
9
Planning of resources
ineffective
4
no current controls
Define a procedure for rigorous planning. Use auditor
pool across SBU's while building SBU capability.
GAP
10 360 Identify multiple external certification bodies in design
Mngr
phase.
8
Process for updating is
not followed
4
no current controls
10 320
Discussion with
bottler &
preparation of
CAP (16)
No
Agree with
content of CAP
(18)
O
C
C
U
R
R
E
N
C
E
Did not provide the
10 information or update the 4
EMS
Inform auditor
(12)
Decision criteria and process for consistent
ratings of individual findings and overall facility
performance
Global audit program certified by recognized 3rd
party to ISO 19011
Global audit reporting roll-up process for BOD &
Executive Committee
Importance
Forward plan by
email to audit
manager (17)
Determined by
Previous Audit result
Determined by Audit
Manager
Determined by
Auditee
Determined by
Division QA Manager
Hub Audit Manager
Select Team
Lead Auditor Selects
Team
Div QA Mgr Selects
Team
Decentralised
Scheduling
Centralised
Scheudling Process
3
1
3
1
3
3
9
3
1
9
1
1422
1071
987
O
C
C
U
R
R
E
N
C
E
900
Audit the updating process at a local level
GAP
Mngr
9
9
1
3
3
765
2961
987
2961
987
2961
2961 16983 11061 1887 11583 3687
Value-Added Analysis
PRODUCTIVITY ANALYSIS
D
E
T
E R
C P
T N
I
O
N
10 2 5 100
9 2 4 72
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
STEP
Update of EMS with new plant information
Determine number of plants to be audited (EMS)
Request information on plant maturity, risk and audit timing
Evaluate every plant against agreed criteria (DIVISION)
Prioritize based on risk and audit timing (DIVISION)
Comunicate prioritized plant list to audit group (DIVISION)
Collect prioritized list from divisions
Any new process identified in the prioritized list?
Request information regarding new process
Provide information regarding new process
Development and inclusion of the new module
Update prioritized list
Compare mandays required with mandays available
Are sufficient auditors available within SBU?
Are there auditors available in other SBU´that can be used?
Re-evaluate prioritized list to focus on risk priority
P
R
I
M
E
D
X
O
T
S
Actions
Quarterly review and update plant information on EMS
X
Ask for required information in advance and frequent follow up.
X
Quarterly survey with Division to identify new processes.
X
X
Identify and prepare an external pool of auditors
Get access to information on auditors in other SBU´s
Ensure there are sufficient trained auditors available with the required skills
17 Do auditors have required process knowledge?
18 Do auditors have required language skill?
X
X
Ensure there are sufficient trained auditors available with the required skills
Ensure there are sufficient trained auditors available with the required skills
19 Is location of auditors suitable for conducting audits?
20 Can audit be re-scheduled?
21 Is there a lead auditor available?
22 Allocate resources to the prioritized list
23 Prepare/Review Draft Schedule
X
Ensure there are sufficient trained auditors available with the required skills in yours
SBU
Ensure there are sufficient trained auditors available with the required skills in yours
SBU
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process.
24 Communicate Draft Schedule to Divisions
25 Agree with draft schedule? (DIVISION)
26 Communicate proposed changes (DIVISION)
Inform Hub
Q.A.and copy
division
technical
director (19)
Preliminary Flowchart
966
Productivity Analysis
Yes
Voice mail to SBU
Pres. Copy PVP, Div.
Pres, SBU QA, SBU
Tech, Div Tech
detailing critical status
(20)
SCHEDULING
Determined by
Quality Indicator only
Needs (Whats)
TCCC Certified auditors
In-depth standardised audit modular protocols
for systems & compliance
Determine audit & audit team appropriate for the
auditee in collaboration with local SBU/division
High Level
Design
Elements
Weight
CTQs
TEAM SELECTION
Determined using
TCCQS Maturity
continiuum only
AUDIT TYPE
8 2 4 64
27 Are changes feasible?
28 Communicate to Divison that changes are not possible
29 Prepare final schedule
30 Communicate final schedule
X
X
X
X
X
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process. Alternately commit the Division to respond within
an agreed timeframe or the schedule would be accepted as it is.
9
10
11
12
13
14
15
16
STEP
Update of EMS with new plant information
Determine number of plants to be audited (EMS)
Request information on plant maturity, risk and audit timing
Evaluate every plant against agreed criteria (DIVISION)
Prioritize based on risk and audit timing (DIVISION)
Comunicate prioritized plant list to audit group (DIVISION)
Collect prioritized list from divisions
Any new process identified in the prioritized list?
YES (10), NO(12)
Request information regarding new process
Provide information regarding new process
Development and inclusion of the new module
Update prioritized list
Compare mandays required with mandays available
Are sufficient auditors available within SBU?
Are there auditors available in other SBU´that can be used?
Re-evaluate prioritized list to focus on risk priority
17
18
19
20
21
22
23
Do auditors have required process knowledge?
Do auditors have required language skill?
Is location of auditors suitable for conducting audits?
Can audit be re-scheduled?
Is there a lead auditor available?
Allocate resources to the prioritized list
Prepare/Review Draft Schedule
1
2
3
4
5
6
7
8
24 Communicate Draft Schedule to Divisions
25 Agree with draft schedule? (DIVISION)
VALUE CATEGORY
VA
BVA
NVA
X
X
X
X
X
X
X
X
X
X
X
X
Perform updating of EMS each quarter and detec new processes
X
Define sufficient number of auditors, based on process knowledge, language skill,
location, leading. Reduce number of audits based on risk evaluation
X
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process.
X
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process.
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process.
X
X
X
X
X
X
X
X
X
X
26 Communicate proposed changes (DIVISION)
X
27 Are changes feasible?
28 Communicate to Divison that changes are not possible
29 Prepare final schedule
30 Communicate final schedule
ACTION
X
X
Note: Minimize this loop with more active involvement with the Divisons in the early
stage of the scheduling process.
X
X
Detailed design options selected, flowcharted and measures identified
Audit Project
D M A D V
Audit Program – Features of Electronic Management System
Document Management
Audit program, management of procedures and modules, incorporating:
• Document creation
• Document revision
• Document review
• Document approval
• Document distribution
• Document control
• Document archiving
(Above done with electronic workflow)
Recordkeeping
Auditor Capability
Plant maturity and operational data
Audit reports
• Field for high risk, corrective action
status and successful practices
• Status of corrective action receipt
• Audit schedule status
• Search of reports by:
• Risk
• BU
• Division
• Personnel information:
• Education
• Work Experience
• Auditor training
• Auditor experience
• Auditor qualifications (incl. Auditor
Certification status)
• Auditor internal/external
• Languages, nationality, location
• Course and skill profiles
• Filter/search capability
This functionality is available with current solutions and/or off-the-shelf software
Audit Project
D M A D V
Individual Ratings - Revalidation Exercise
Conclusions:
 Improved consistency in applying the definitions
 Auditors did not have a good understanding of the findings
used (and/or lack of context or different context)
 Most auditors did well with the audit format
Next Steps:
 Incorporate above into development of ongoing Auditor
Training and Calibration exercises (already built into
Auditor Development and Certification)
Audit Project
Process Name:
Primary Customer
of Process: Plant
Audit
Management
Process Map
Determine Global
Mfg. Audit Needs
ID Audit Team
Determine Current Status and Audit Type
Hub Audit Group
SBU/Divison
Manufacturer
Bottler
Outcome
Indicators
(Ys)
Upstream
Indicators
(Xs)
-Name
-Numerator &
Denominator
- Specification
-Name
-Numerator &
Denominator
or Description
X1.1 = % of
Audits
Scheduled with
incomplete
knowledge on
team
(# of audit
knowledge
requirements
not met in
schedule / total
number of audit
knowledge
requirements
scheduled in 1
wk)
2
Prioritize Risk & Timing
of Audit
3
Identify Audit Type
4
Do Existing Audit
Modules Cover Content
Needed ?
No
6
Are there
Qualified Auditors
Available
Yes
No
Outcome Indicators (Ys):
Y1= % of Reportable Incidents That Were Preventable
Y2=% of Survey Scores Indicating Dissatisfaction
Misc.
Information
Capturing Data
Indicator
Chart
Type
P Chart
“Physical”
Item to
Check
Audit Plan
When to
Check
Weekly
Who
Performs
Check
Hub Audit
Mgr
-Indicator Formula
-Procedures
-Abbreviations
-Comments
Recovery
Action
HUB Mgr
adjusts to
get a
qualified
audit team
prior to
audit
execution
The team must
collectively cover all
the process
knowledge and local
knowledge required.
All team members
must have been
trained in behavioral
skills. Each audit will
have 3 defect
opportunities ( (1)
process knowledge
required, (2) local
knowledge (culture,
language, gov’t, etc.,
(3) behavioral skills.)
7
Re-Evaluate List
and Prioritize to
Focus on Risk
Yes
8
Allocate
Auditors
X1.1
9
Draft Schedule and
Communicate
Schedule Audits
Customer’s CTQs: Clearly ID Current &
Potential Risk & Problems
Fair Audits
1
Evaluate Plants using
Previous Audit Performance
and Maturity
5
Contact TCCQS to
Create Module
DM A D V
Process Management Control System
11
Are Changes
Feasible
No
10
Agree With
Schedule ?
No
12
Adjusted Schedule
13
Communicate
Final Schedule
Yes
Rev #
Date
1
12/30/03
Change Log – Describe Revisions
By
B. Cappad
Apppr
Audit Project
Summary
• The Design was completed on schedule and full
scale implementation began January 5, 2005
• Preliminary results indicate all CTQs will be met
• An estimated $2.0 million in cost saving from
improved productivity and global contracting
• Audit process design can be created and
implemented in 4 months
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Quality Audits for Manufacturing