Description
Manufacturing process audit is one of the many quality tools to assess the effectiveness of manufacturing process and quality performance. They are commonly used in the effort to diagnose, maintain and improve quality management system.
World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
MAN_21
MANUFACTURING AUDIT TO IMPROVE QUALITY
PERFORMANCE – A CONCEPTUAL FRAMEWORK
Edly Ferdin Ramly
1
, Sha’ri Mohd Yusof
2
and J afri Mohd Rohani
2
1
EFR Management Consultant, 398 J alan Kempas 4,
Bandar Putra, 81000, Kulai, J ohor Malaysia
2
Department of Industrial Engineering, Faculty of Mechanical Engineering,
Universiti Teknologi Malaysia, Skudai, J ohor, Malaysia.
[email protected]
ABSTRACT
Manufacturing process audit is one of the many quality tools to assess the effectiveness of
manufacturing process and quality performance. They are commonly used in the effort to diagnose,
maintain and improve quality management system. It is made compulsory for the organization to
maintain their quality management system based on ISO9001 standard to conduct an internal audit.
However, similarly to any other physical or conceptual system, they may fail to achieve the objectives
set forth, to assess effectiveness and at the same time fail to recognized area for improvement. Based
on an extensive literature review, the issues relevant to manufacturing audit and quality performance
are examine, and discussed the several issues to identify the conceptual framework of manufacturing
audit.
Keywords: Auditing, Quality audit, Manufacturing industries, Performance improvement.
INTRODUCTION
The need to improve quality performance has been a major discussion issues due to competitive
pressure in manufacturing industries. In order to achieve the higher competitiveness level, these
organizations must be able to identify the current quality performance and realign their strategies,
operations and processes to improve the quality performance.
Audit is one of the many tools that have been found useful to identify the current quality performance
by diagnosing the opportunities for improvement and plan for improvement action. Audit is a tool with
wide spread use throughout business in the area of financial, quality, technical, safety, project
management, human resources and purchasing (Askey and Dale, 1994). Many organizations, have
conducted the audit or been audited in order to comply with certain requirements for example financial
requirements and quality management system requirements. But an audit has been traditionally
regarded as an “added cost” activity (Hepner, Wilcock and Aung, 2004). In order to change that
perception on audit, audit should focus toward improving the organization performance such as product
quality, reduction of waste, improve service and delivery and cost reduction (Williamson and
Rogerson, 1996).
The objective of this research is to identify the manufacturing process audit framework that should
result quality performance improvement. The suggestion for future research is highlighted to validate
the conceptual framework.
METHODOLOGY
The main goal is to identify the related issues either directly or indirectly with regard in manufacturing
industries related audit. An exhaustive search on the literature related to auditing was conducted in the
time frame from 1987 to end of 2006. The literature that was published before 1987 is also reviewed
but is limited to cross checking the evolution of audit. The financial audit is ruled out from the review
due to the different audit methodology, and qualification of an auditor. Summary from quality
management system auditing trainings are also used to develop the audit framework.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
25
World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
DEFINITION AND PURPOSE OF MANUFACTURING AUDIT
Manufacturing process is defined as a process of making and fabricating by converting the raw material
(input) to finished goods (output) (ISO/TS, 2002). The definitions of audit in table 1 can be associated
with examination, verification, evaluation, assessment, and check activities. Hence, manufacturing
process audit can be defined as a process to evaluate the process and making and fabricating
effectiveness and efficiency.
It is also important to understand the definition of audit before any audit is initiated to avoid confusion
on how the audit should be conducted (or audit method) and the process of auditor selection. ANSI and
ISO defined audit shall be conducted independently while others are not defined. For manufacturing
process audit to improve quality performance, it is recommended to be conducted either by
independently (ISO, 2002), internally (ISO, 2002) or self-assessment (Karapetrovic and Willborn,
2002) since the goal is to improve quality performance. We cannot limit on how to conduct the audit
for manufacturing performance improvement since independent, internal or self-audit have the
advantages.
Table 1: Definitions of audit
Source Definition Comments
ANSI/ASQC (1986)
Systematic examination of the acts and decisions by
people with respect to quality in order to independently
verify or evaluate and report degree of compliance to
operational requirements of the quality program, or the
specifications or contract requirements of the product or
service
Used termverify and evaluate –
degree of compliance to:
- Operational requirement
of quality program
- Specifications
- Contract requirements
IEEE 1028 (1988)
An independent evaluation of software products or
processes to ascertain compliance to standards,
guidelines, specifications, and procedures based on
objective criteria that include documents that specify the
form or content of the products to be produced; the
process by which the products shall be produced; and
how compliance to standards or guidelines shall be
measured
The definition emphasize on
evaluation of compliance to:
- Audit criteria
Oxford Advanced
Learner’s dictionary
(1990)
An examination of accounts to see that they are in order The definition used the term
examination
ISO 12207 (1995)
Conducted by an authorized person for the purpose of
providing an independent assessment of software
products and processes in order to assess compliance
with requirements
Used the termassessment
Audit by authorized personnel
ISO 19011 (2002) Audit is systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria
are fulfilled
Used termevaluate
Purpose of the audit can be divided into compliance audit and management audit (Arter, 1994).
Compliance audit look for conformance to the audit criteria, while management audit look for
conformance to the audit criteria and the effectiveness of the process and opportunities for
improvement in achieving organization goals. ISO (2002) used the term of audit criteria, which is refer
to specification, guideline, and requirements. Example of conformance audit includes financial audit,
tax audit, and regulatory audit. The management audits include manufacturing audit, product and
process audit, and improvement audit. Both of compliance audit and management audit can be
integrated but normally the organizations adapt the compliance audit based on audit criteria (i.e.
compliance to ISO9001) before the auditor can suggest area for improvements, which is outside the
audit criteria. Barthelemy and Zairi (1994) suggested the audit should evolve from compliance audit to
continual improvement, thriving, ultimate and total audit. It can evolve from compliance to total audit
that will cover more than quality performance. Russel and Regel (1996) suggested compliance audit is
conducted during infancy stage and improvement audit is conducted during steady state stage due to
the fact that it requires time to develop the auditor to suggest the opportunities for improvement.
The areas covered in manufacturing audit (see table 2) included manufacturing strategy, new product
introduction, process optimization, flexible manufacturing, production system, performance
measurement system, and technology audit. All of these areas interact with manufacturing process.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
Before any organization specified the area need to be audited i.e. the need for technology audit or
process optimization, the organization shall identify the weaknesses point before detail audit can be
conducted to improve the specific area. The manufacturing audit should able to diagnose each process
elements that directly or indirectly contribute toward improvement of manufacturing process
effectiveness and efficiency.
Table 2: Purpose of manufacturing audit from literature 1987 - 2007
Author Purpose of audit Research
method,
sample size
Type of Industry Significant contribution
Bobbit, 1989 Supplier Quality Audit Nil Nil 2 types of supplier audit. 8
categories for area to be audited
Askey and Dale, 1994
Internal Quality Management
Audit
Conceptual All Proposed structured approach to
efficient and effective audits.
Humand Leow, 1994 Manufacturing strategy Empirical, 55 Electronic in Singapore Framework empirical studies of
Hayes and Wheelwright, 1984
Martino, 1994 Technology Nil Nil Framework for technology audit
Gardiner and Gregory,
1996
New Product Introduction Action, 2 Telecommunication Framework of NPI audit
Bitichi, 1997 Integrity of performance
measure
Case study, 1 Small Engineering
manufacturing firm
Workbook to conduct audit
Branney, 1999 Process Optimization Action, 1 Fertilizer 3 phased of analysis. 86
improvements ideas. Potential
hard saving of USD 2 millions
Das S. K.., Patel P 2002 An audit tools for determining
flexibility requirements in a
manufacturing facilities
Case Study, 1 Electronics Audit tools for flexible facilities
Hepner,Wilcock and
Aung, 2004
Use of auditing as a tool for
continual improvement
Case study, 4 Meat industries Application of audit
Gordon, 2005 Supplier performance measure Nil Nil 7 steps to measure supplier
performance
Menda, 2004 The role of a manufacturing
audit in crafting the production
system
Case Study 1 Strategy to develop the
production system
Meybodi, 2006 Benchmarking Survey, 500 Variety large
manufacturing firm
Benchmarking competitive
priorities.
Internal auditing guideline
MANUFACTURING AUDIT FRAMEWORK
Typical manufacturing audit problems or failures are due to lack of audit preparation, audit criteria
elements or checklist driven, auditor skills and knowledge, commitment from the management, and
bureaucratic reporting (Askey, Dale, Karapetrovic, Barthelemy).
Systematic approach to the auditing is the first element for successful manufacturing process audit. The
audit activities framework in figure1 based on ISO19011 (2002) and VDA6.3 audit process is useful to
provide guideline for the systematic approached to auditing. Karapetrovic and Willborn (2000a and
2002) develop the generic and self audit program framework that is useful for performance
improvement related audit. The systematic audit program includes initiating the audit, preparing for on-
site audit, conducting on site audit, report preparation and follow-up activities. The follow-up activities
in this context are the improvements activities result from the audit finding.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
Audit Planning
Conducting Audit
Audit Follow up
Audit Initiation
Collecting and verifying information Completing the audit
Conducting documents review Audit Reporting Conducting audit follow up
Preparing on-site audit activities
Figure 1: Audit program management
The second element for manufacturing process audit, the audit shall cover more than the manufacturing
process, which shall include all supporting process in order the manufacturing to be effective. Series of
interrelated audit outweigh the single performance audit (Willborn and Cheng, 1994). Karapetrovic and
Willburn (2000b) and award based model (NIST and EFQM) suggest the audit shall cover the overall
system that include policy making, product design, process management and all issues related to the
manufacturing. The audit will loses it focus on manufacturing process improvement if the audit covers
too much on overall management system and strategic management. The strategic management should
derived based on weaknesses identified during the audit. Specific areas need to investigate in
manufacturing audit so that the audit will focus on quality performance.
Table 3: Comments on audit framework
# Source Comments
1. VDA 6.3, 1998 The most comprehensive framework for manufacturing
process audit. Clearly define the audit process and
manufacturing process structures. But the framework is too
complicated.
2. NIST, 1999 and EFQM, 1999 The framework covers overall organization performance.
Difficult to adopt for manufacturing process because the
criteria are general for overall organization.
3. ISO 19011, 2002 Audit process framework for quality and environment. Useful
to organize audit program.
4. Karapetrovic and Willborn
2002
Expand from the framework from the ISO19011 to suit the
performance improvement purposes. Guideline on
developing the audit criteria was not discussed.
5. Russel, 2006 Describe the process approached audit in detail. Adapt the
turtle diagram for ISO/TS16949 process approached auditing
from sanction training. The first papers sighted describe the
turtle diagram.
The process approached auditing techniques is introduced to the ISO/TS 16949 auditor through
sanction training and the process model adapt from ISO9001. Process audit are highly focus, but their
effective techniques not always understood (Russel, 2006). Seminal work on process audit was done by
VDA 6.3 and developed the most comprehensive audit framework, which considers all elements of the
processes and audit steps. Major automotive manufacturing firms have been utilized the VDA 6.3 audit
questionnaire to evaluate the manufacturing process quality performance either for internal or for
supplier. The VDA framework is comprehensive and focuses on compliance audit. The need to develop
the simple and easy to understand framework that can evolve from compliance audit to continual
improvement audit is vital to avoid the manufacturing audit failures.
The conceptual framework for manufacturing process audit in figure 3 is developed from audit program
management (figure1) and process approach audit (figure 2). The process approach model is simplified
for manufacturing process adapted from process definition, structure and interface as per figure 2. The
focus will be on the sequence of manufacturing process and their interaction to other supporting
process and manufacturing process elements. The framework listed in table 2 agreed that the main
priority in manufacturing process should be the performance measure indicators. Without the proper
installation of quality performance indicators, the quality performance cannot be measured and
manufacturing process effectiveness and efficiency will be evaluated subjectively. Tools, techniques
and best practice can be shared in term of infrastructure used, locations, supplier management, logistic,
human resources, procedures, occupational health and safety, social responsibilities, and financial as
support either directly or indirectly towards effectiveness and efficiency of manufacturing process.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
Figure 2: Process definitions, structure and interface (Source VDA 6.3)
With What? – (Equipment)
Figure 3: Conceptual manufacturing audit framework
The suggested conceptual framework divided the manufacturing process into seven elements, which
are the effective supply (input), infrastructure (with what), personnel (who), operational control (how),
support process (management system) and performance measure indicator for the output and related
process. All this process elements can be benchmark and opportunities of improvement or weaknesses
(audit findings) can be identified.
CONCLUSIONS
This conceptual framework is the first step to plan an effective quality improvement program for
manufacturing process. The framework is combination of process approached auditing and audit
program management that covered the main manufacturing process elements. The framework can be
either used either by external or internal auditor, or self-assessment and assist the auditor or the
assessor to develop the audit checklist or what to look for during the audit.
Development of generic and specific audit checklist for specific improvement activities based on the
conceptual framework is suggested in order to assist the auditor to diagnose the current practice in
- Total Productive Maintenance
- Quick changeover
- Advance Technology
Input
(Raw
Material)
(Support Process)
- QA
- Business
Management
- Planning
- OSH
MANUFACTURING
PROCESS
Process sequence
Who? – (Competency)
- Skills, experience, training, education
- Motivation, communication
Output
(Finished Good)
How? – (Procedures/
Methods/ Info)
What Results? (Performance
Indicator)
- Data Collection and
analysis
- Best Practice
- Information - Achievement
AUDIT PROGRAM MANAGEMENT
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
manufacturing process and compare with the best practice. Empirical study should be conducted to
verify the audit checklist effectiveness and the action research is recommended to validate that quality
improvement.
ACKNOWLEDGEMENTS
k EFR Management Consultant and Ministry of Higher Education
OHE) VOT 78101 that provide the financial and resources support in this research. Thanks to Dr
QC (1986), “Q1 Generic Guidelines for Auditing of Quality Systems”, American
Society for Quality Control, Milwaukee, WI.
[3] uality Management Auditing: An Examination,
lume 9 · Number 1 · 1997 ·
[6]
[7] harles A., Walter P. Smith, J r., “Process Optimization Audit”, IEEE 0-7803-3297-
facturing facilities”, Integrated Manufacturing Systems 13/4 (2002), pp 264-274
w product introduction system’ Integrated Manufacturing
[11]
y in Canada”, British Food Journal Vol. 106 No. 7, 2004 pp. 553-568, Emerald
[13]
framework” International Journal of Operations & Production
[14]
ndardization, Geneva.
production and relevant service part
[19]
.
ic benchmarking” Benchmarking: An International Journal, Vol. 13 No. 5,
2006, pp. 580-595.
The author would like to than
(M
Sha’ri Mohd Yusof, Mr. J afri Rohani from Faculty of Mechanical Engineering and Pn Roziah from
OMNI Precision Sdn Bhd for consistent support and advice.
REFERENCES
[1] ANSI/AS
[2] Arter D.R. (1994). Quality Audit for Improved Performance. ASQC Quality Press
Askey, J M and Dale, B G (1994), Internal Q
Managerial Auditing Journal, Vol. 9 No. 4, 1994, pp. 3-10, MCB University Press
[4] Barthelemy, J L; Zairi, M (1994), “Making ISO 9000 Work: The Role of Auditing” The TQM
Magazine, Vol. 6 No. 3, 1994, pp. 44-47, MCB University Press,
[5] Bititci U.S., Carrie A.S. and McDevitt, L (1997), “Integrated performance measurement
systems:an audit and development guide”, The TQM Magazine Vo
pp. 46–53
Bobbit C.E., “Supplier Quality Audits” Quality; Sep 1989; 28, 9; pp. 58-60
Branney, C
0/96
[8] Das S. K.., Patel P (2002), “An audit tools for determining flexibility requirements in a
manu
[9] EFQM (European Foundation for Quality Management) (1999), The European Quality Award
Application Handbook, EFQM.
[10] Gardiner G.S., Gregory M.J. (1996), “An audit-based approach to the analysis, redesign and
continuing assessment of a ne
Systems 7/2 [1996] 52–59
Gordon, S (2005), “Seven Steps To Measure Supplier Performance”, Quality Progress; Aug
2005; 38, 8
[12] Hepner, I; Wilcock, A; and Aung, M (2004), “Auditing and continual improvement in the
meat industr
Group Publishing Limited
Hum, S.H. and Leow, L.H., “Strategic manufacturing Effectiveness. An empirical study based
on the Hayes-Wheelwright
Management, Vol. 16 No. 4, 1996 pp 4-18
IEEE 1028 (1988), ‘Standard for Software Reviews and Audits’, Institute of Electrical and
Electronics Engineers (IEEE), Washington.
[15] ISO 19011 (2002), “Guidelines for quality and/or environmental management systems
auditing”, International Organization for Sta
[16] ISO 9000 (2000), “Quality Management Systems Fundamentals and Vocabulary”,
International Organization for Standardization, Geneva.
[17] ISO 12207 (1995), ‘Information Technology Software Life Cycle Processes’,
InternationalOrganization for Standardization, Geneva.
[18] ISO/TS 16949 (2002), “Quality Management System Requirements - Particular requirements
for the application of ISO 9001:2000 for automotive
organizations” International Organization for Standardization, Geneva
Karapetrovic, S. and Willborn, W. (2000), ``Generic audit for management system:
fundamental'', Managerial AuditingJjournal, Vol. 15 No. 6, pp. 278-294
[20] Karapetrovic, S. and Willborn, W. (2002),``Self-audit of process performance'', International
journal for quality and reliability management, Vol. 19 No. 1.
[21] Martino J .P. (1994), “A Technology audit: Key to technology planning”, IEEE CH3431-
4/94/0000-1241.
[22] Mohammad Meybodi (2006), “Internal manufacturing strategy audit: the first step in
integrated strateg
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
[23] Menda R. (2004), “The role of a manufacturing audit in crafting the production system”,
International Journal of Operations &Production Management Vol. 24 No. 9, 2004 pp. 929-
943
[24] NIST (1999), ``Overview of the criteria for performance excellence'', National Institute for
Science and Technology, Washington, DC,
(http://www.nist.gov/public_affairs/stockstudy.htm .
[26]
rogress; J un 2006, pp. 71-
[28] nagement of Quality Assurance Systems’,
[29] liamson, A; Rogerson; J H and Vella A D (1996), “Quality system auditors’ attitudes and
ty Press.
[25] Oxford (1990), “Oxford Advanced Learner’s dictionary”, Oxford
Russell, J .P. and Regel, T. (1996), ``After the quality audit: closing the loop on the audit
process'', Quality Progress, Vol. 29 No. 6, pp. 65-7.
[27] Russell J P (2006), “Process Auditing and Techniques” Quality P
74
Willborn, W. and Cheng, T.C.E. (1994), ‘Global Ma
McGraw-Hill, New York, NY.
Wil
methods: a survey, International Journal of Quality & Reliability Management, Vol. 13 No. 8,
1996, pp. 39-52, MCB Universi
[30] Umit S. Bititci U.S., Carrie A. S. and McDevitt, A (1997), “Integrated performance
measurement systems: an audit and development guide”, The TQM Magazine, Volume 9 ·
Number 1 · 1997 · pp. 46–53.
[31] VDA (1998), “Quality Management in the automotive Industry: Process Audit”Part 3,
Verband der automobilindustrie, Franfurt.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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doc_583972167.pdf
Manufacturing process audit is one of the many quality tools to assess the effectiveness of manufacturing process and quality performance. They are commonly used in the effort to diagnose, maintain and improve quality management system.
World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
MAN_21
MANUFACTURING AUDIT TO IMPROVE QUALITY
PERFORMANCE – A CONCEPTUAL FRAMEWORK
Edly Ferdin Ramly
1
, Sha’ri Mohd Yusof
2
and J afri Mohd Rohani
2
1
EFR Management Consultant, 398 J alan Kempas 4,
Bandar Putra, 81000, Kulai, J ohor Malaysia
2
Department of Industrial Engineering, Faculty of Mechanical Engineering,
Universiti Teknologi Malaysia, Skudai, J ohor, Malaysia.
[email protected]
ABSTRACT
Manufacturing process audit is one of the many quality tools to assess the effectiveness of
manufacturing process and quality performance. They are commonly used in the effort to diagnose,
maintain and improve quality management system. It is made compulsory for the organization to
maintain their quality management system based on ISO9001 standard to conduct an internal audit.
However, similarly to any other physical or conceptual system, they may fail to achieve the objectives
set forth, to assess effectiveness and at the same time fail to recognized area for improvement. Based
on an extensive literature review, the issues relevant to manufacturing audit and quality performance
are examine, and discussed the several issues to identify the conceptual framework of manufacturing
audit.
Keywords: Auditing, Quality audit, Manufacturing industries, Performance improvement.
INTRODUCTION
The need to improve quality performance has been a major discussion issues due to competitive
pressure in manufacturing industries. In order to achieve the higher competitiveness level, these
organizations must be able to identify the current quality performance and realign their strategies,
operations and processes to improve the quality performance.
Audit is one of the many tools that have been found useful to identify the current quality performance
by diagnosing the opportunities for improvement and plan for improvement action. Audit is a tool with
wide spread use throughout business in the area of financial, quality, technical, safety, project
management, human resources and purchasing (Askey and Dale, 1994). Many organizations, have
conducted the audit or been audited in order to comply with certain requirements for example financial
requirements and quality management system requirements. But an audit has been traditionally
regarded as an “added cost” activity (Hepner, Wilcock and Aung, 2004). In order to change that
perception on audit, audit should focus toward improving the organization performance such as product
quality, reduction of waste, improve service and delivery and cost reduction (Williamson and
Rogerson, 1996).
The objective of this research is to identify the manufacturing process audit framework that should
result quality performance improvement. The suggestion for future research is highlighted to validate
the conceptual framework.
METHODOLOGY
The main goal is to identify the related issues either directly or indirectly with regard in manufacturing
industries related audit. An exhaustive search on the literature related to auditing was conducted in the
time frame from 1987 to end of 2006. The literature that was published before 1987 is also reviewed
but is limited to cross checking the evolution of audit. The financial audit is ruled out from the review
due to the different audit methodology, and qualification of an auditor. Summary from quality
management system auditing trainings are also used to develop the audit framework.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
25
World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
DEFINITION AND PURPOSE OF MANUFACTURING AUDIT
Manufacturing process is defined as a process of making and fabricating by converting the raw material
(input) to finished goods (output) (ISO/TS, 2002). The definitions of audit in table 1 can be associated
with examination, verification, evaluation, assessment, and check activities. Hence, manufacturing
process audit can be defined as a process to evaluate the process and making and fabricating
effectiveness and efficiency.
It is also important to understand the definition of audit before any audit is initiated to avoid confusion
on how the audit should be conducted (or audit method) and the process of auditor selection. ANSI and
ISO defined audit shall be conducted independently while others are not defined. For manufacturing
process audit to improve quality performance, it is recommended to be conducted either by
independently (ISO, 2002), internally (ISO, 2002) or self-assessment (Karapetrovic and Willborn,
2002) since the goal is to improve quality performance. We cannot limit on how to conduct the audit
for manufacturing performance improvement since independent, internal or self-audit have the
advantages.
Table 1: Definitions of audit
Source Definition Comments
ANSI/ASQC (1986)
Systematic examination of the acts and decisions by
people with respect to quality in order to independently
verify or evaluate and report degree of compliance to
operational requirements of the quality program, or the
specifications or contract requirements of the product or
service
Used termverify and evaluate –
degree of compliance to:
- Operational requirement
of quality program
- Specifications
- Contract requirements
IEEE 1028 (1988)
An independent evaluation of software products or
processes to ascertain compliance to standards,
guidelines, specifications, and procedures based on
objective criteria that include documents that specify the
form or content of the products to be produced; the
process by which the products shall be produced; and
how compliance to standards or guidelines shall be
measured
The definition emphasize on
evaluation of compliance to:
- Audit criteria
Oxford Advanced
Learner’s dictionary
(1990)
An examination of accounts to see that they are in order The definition used the term
examination
ISO 12207 (1995)
Conducted by an authorized person for the purpose of
providing an independent assessment of software
products and processes in order to assess compliance
with requirements
Used the termassessment
Audit by authorized personnel
ISO 19011 (2002) Audit is systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria
are fulfilled
Used termevaluate
Purpose of the audit can be divided into compliance audit and management audit (Arter, 1994).
Compliance audit look for conformance to the audit criteria, while management audit look for
conformance to the audit criteria and the effectiveness of the process and opportunities for
improvement in achieving organization goals. ISO (2002) used the term of audit criteria, which is refer
to specification, guideline, and requirements. Example of conformance audit includes financial audit,
tax audit, and regulatory audit. The management audits include manufacturing audit, product and
process audit, and improvement audit. Both of compliance audit and management audit can be
integrated but normally the organizations adapt the compliance audit based on audit criteria (i.e.
compliance to ISO9001) before the auditor can suggest area for improvements, which is outside the
audit criteria. Barthelemy and Zairi (1994) suggested the audit should evolve from compliance audit to
continual improvement, thriving, ultimate and total audit. It can evolve from compliance to total audit
that will cover more than quality performance. Russel and Regel (1996) suggested compliance audit is
conducted during infancy stage and improvement audit is conducted during steady state stage due to
the fact that it requires time to develop the auditor to suggest the opportunities for improvement.
The areas covered in manufacturing audit (see table 2) included manufacturing strategy, new product
introduction, process optimization, flexible manufacturing, production system, performance
measurement system, and technology audit. All of these areas interact with manufacturing process.
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
26
World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
Before any organization specified the area need to be audited i.e. the need for technology audit or
process optimization, the organization shall identify the weaknesses point before detail audit can be
conducted to improve the specific area. The manufacturing audit should able to diagnose each process
elements that directly or indirectly contribute toward improvement of manufacturing process
effectiveness and efficiency.
Table 2: Purpose of manufacturing audit from literature 1987 - 2007
Author Purpose of audit Research
method,
sample size
Type of Industry Significant contribution
Bobbit, 1989 Supplier Quality Audit Nil Nil 2 types of supplier audit. 8
categories for area to be audited
Askey and Dale, 1994
Internal Quality Management
Audit
Conceptual All Proposed structured approach to
efficient and effective audits.
Humand Leow, 1994 Manufacturing strategy Empirical, 55 Electronic in Singapore Framework empirical studies of
Hayes and Wheelwright, 1984
Martino, 1994 Technology Nil Nil Framework for technology audit
Gardiner and Gregory,
1996
New Product Introduction Action, 2 Telecommunication Framework of NPI audit
Bitichi, 1997 Integrity of performance
measure
Case study, 1 Small Engineering
manufacturing firm
Workbook to conduct audit
Branney, 1999 Process Optimization Action, 1 Fertilizer 3 phased of analysis. 86
improvements ideas. Potential
hard saving of USD 2 millions
Das S. K.., Patel P 2002 An audit tools for determining
flexibility requirements in a
manufacturing facilities
Case Study, 1 Electronics Audit tools for flexible facilities
Hepner,Wilcock and
Aung, 2004
Use of auditing as a tool for
continual improvement
Case study, 4 Meat industries Application of audit
Gordon, 2005 Supplier performance measure Nil Nil 7 steps to measure supplier
performance
Menda, 2004 The role of a manufacturing
audit in crafting the production
system
Case Study 1 Strategy to develop the
production system
Meybodi, 2006 Benchmarking Survey, 500 Variety large
manufacturing firm
Benchmarking competitive
priorities.
Internal auditing guideline
MANUFACTURING AUDIT FRAMEWORK
Typical manufacturing audit problems or failures are due to lack of audit preparation, audit criteria
elements or checklist driven, auditor skills and knowledge, commitment from the management, and
bureaucratic reporting (Askey, Dale, Karapetrovic, Barthelemy).
Systematic approach to the auditing is the first element for successful manufacturing process audit. The
audit activities framework in figure1 based on ISO19011 (2002) and VDA6.3 audit process is useful to
provide guideline for the systematic approached to auditing. Karapetrovic and Willborn (2000a and
2002) develop the generic and self audit program framework that is useful for performance
improvement related audit. The systematic audit program includes initiating the audit, preparing for on-
site audit, conducting on site audit, report preparation and follow-up activities. The follow-up activities
in this context are the improvements activities result from the audit finding.
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Audit Planning
Conducting Audit
Audit Follow up
Audit Initiation
Collecting and verifying information Completing the audit
Conducting documents review Audit Reporting Conducting audit follow up
Preparing on-site audit activities
Figure 1: Audit program management
The second element for manufacturing process audit, the audit shall cover more than the manufacturing
process, which shall include all supporting process in order the manufacturing to be effective. Series of
interrelated audit outweigh the single performance audit (Willborn and Cheng, 1994). Karapetrovic and
Willburn (2000b) and award based model (NIST and EFQM) suggest the audit shall cover the overall
system that include policy making, product design, process management and all issues related to the
manufacturing. The audit will loses it focus on manufacturing process improvement if the audit covers
too much on overall management system and strategic management. The strategic management should
derived based on weaknesses identified during the audit. Specific areas need to investigate in
manufacturing audit so that the audit will focus on quality performance.
Table 3: Comments on audit framework
# Source Comments
1. VDA 6.3, 1998 The most comprehensive framework for manufacturing
process audit. Clearly define the audit process and
manufacturing process structures. But the framework is too
complicated.
2. NIST, 1999 and EFQM, 1999 The framework covers overall organization performance.
Difficult to adopt for manufacturing process because the
criteria are general for overall organization.
3. ISO 19011, 2002 Audit process framework for quality and environment. Useful
to organize audit program.
4. Karapetrovic and Willborn
2002
Expand from the framework from the ISO19011 to suit the
performance improvement purposes. Guideline on
developing the audit criteria was not discussed.
5. Russel, 2006 Describe the process approached audit in detail. Adapt the
turtle diagram for ISO/TS16949 process approached auditing
from sanction training. The first papers sighted describe the
turtle diagram.
The process approached auditing techniques is introduced to the ISO/TS 16949 auditor through
sanction training and the process model adapt from ISO9001. Process audit are highly focus, but their
effective techniques not always understood (Russel, 2006). Seminal work on process audit was done by
VDA 6.3 and developed the most comprehensive audit framework, which considers all elements of the
processes and audit steps. Major automotive manufacturing firms have been utilized the VDA 6.3 audit
questionnaire to evaluate the manufacturing process quality performance either for internal or for
supplier. The VDA framework is comprehensive and focuses on compliance audit. The need to develop
the simple and easy to understand framework that can evolve from compliance audit to continual
improvement audit is vital to avoid the manufacturing audit failures.
The conceptual framework for manufacturing process audit in figure 3 is developed from audit program
management (figure1) and process approach audit (figure 2). The process approach model is simplified
for manufacturing process adapted from process definition, structure and interface as per figure 2. The
focus will be on the sequence of manufacturing process and their interaction to other supporting
process and manufacturing process elements. The framework listed in table 2 agreed that the main
priority in manufacturing process should be the performance measure indicators. Without the proper
installation of quality performance indicators, the quality performance cannot be measured and
manufacturing process effectiveness and efficiency will be evaluated subjectively. Tools, techniques
and best practice can be shared in term of infrastructure used, locations, supplier management, logistic,
human resources, procedures, occupational health and safety, social responsibilities, and financial as
support either directly or indirectly towards effectiveness and efficiency of manufacturing process.
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
Figure 2: Process definitions, structure and interface (Source VDA 6.3)
With What? – (Equipment)
Figure 3: Conceptual manufacturing audit framework
The suggested conceptual framework divided the manufacturing process into seven elements, which
are the effective supply (input), infrastructure (with what), personnel (who), operational control (how),
support process (management system) and performance measure indicator for the output and related
process. All this process elements can be benchmark and opportunities of improvement or weaknesses
(audit findings) can be identified.
CONCLUSIONS
This conceptual framework is the first step to plan an effective quality improvement program for
manufacturing process. The framework is combination of process approached auditing and audit
program management that covered the main manufacturing process elements. The framework can be
either used either by external or internal auditor, or self-assessment and assist the auditor or the
assessor to develop the audit checklist or what to look for during the audit.
Development of generic and specific audit checklist for specific improvement activities based on the
conceptual framework is suggested in order to assist the auditor to diagnose the current practice in
- Total Productive Maintenance
- Quick changeover
- Advance Technology
Input
(Raw
Material)
(Support Process)
- QA
- Business
Management
- Planning
- OSH
MANUFACTURING
PROCESS
Process sequence
Who? – (Competency)
- Skills, experience, training, education
- Motivation, communication
Output
(Finished Good)
How? – (Procedures/
Methods/ Info)
What Results? (Performance
Indicator)
- Data Collection and
analysis
- Best Practice
- Information - Achievement
AUDIT PROGRAM MANAGEMENT
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
manufacturing process and compare with the best practice. Empirical study should be conducted to
verify the audit checklist effectiveness and the action research is recommended to validate that quality
improvement.
ACKNOWLEDGEMENTS
k EFR Management Consultant and Ministry of Higher Education
OHE) VOT 78101 that provide the financial and resources support in this research. Thanks to Dr
QC (1986), “Q1 Generic Guidelines for Auditing of Quality Systems”, American
Society for Quality Control, Milwaukee, WI.
[3] uality Management Auditing: An Examination,
lume 9 · Number 1 · 1997 ·
[6]
[7] harles A., Walter P. Smith, J r., “Process Optimization Audit”, IEEE 0-7803-3297-
facturing facilities”, Integrated Manufacturing Systems 13/4 (2002), pp 264-274
w product introduction system’ Integrated Manufacturing
[11]
y in Canada”, British Food Journal Vol. 106 No. 7, 2004 pp. 553-568, Emerald
[13]
framework” International Journal of Operations & Production
[14]
ndardization, Geneva.
production and relevant service part
[19]
.
ic benchmarking” Benchmarking: An International Journal, Vol. 13 No. 5,
2006, pp. 580-595.
The author would like to than
(M
Sha’ri Mohd Yusof, Mr. J afri Rohani from Faculty of Mechanical Engineering and Pn Roziah from
OMNI Precision Sdn Bhd for consistent support and advice.
REFERENCES
[1] ANSI/AS
[2] Arter D.R. (1994). Quality Audit for Improved Performance. ASQC Quality Press
Askey, J M and Dale, B G (1994), Internal Q
Managerial Auditing Journal, Vol. 9 No. 4, 1994, pp. 3-10, MCB University Press
[4] Barthelemy, J L; Zairi, M (1994), “Making ISO 9000 Work: The Role of Auditing” The TQM
Magazine, Vol. 6 No. 3, 1994, pp. 44-47, MCB University Press,
[5] Bititci U.S., Carrie A.S. and McDevitt, L (1997), “Integrated performance measurement
systems:an audit and development guide”, The TQM Magazine Vo
pp. 46–53
Bobbit C.E., “Supplier Quality Audits” Quality; Sep 1989; 28, 9; pp. 58-60
Branney, C
0/96
[8] Das S. K.., Patel P (2002), “An audit tools for determining flexibility requirements in a
manu
[9] EFQM (European Foundation for Quality Management) (1999), The European Quality Award
Application Handbook, EFQM.
[10] Gardiner G.S., Gregory M.J. (1996), “An audit-based approach to the analysis, redesign and
continuing assessment of a ne
Systems 7/2 [1996] 52–59
Gordon, S (2005), “Seven Steps To Measure Supplier Performance”, Quality Progress; Aug
2005; 38, 8
[12] Hepner, I; Wilcock, A; and Aung, M (2004), “Auditing and continual improvement in the
meat industr
Group Publishing Limited
Hum, S.H. and Leow, L.H., “Strategic manufacturing Effectiveness. An empirical study based
on the Hayes-Wheelwright
Management, Vol. 16 No. 4, 1996 pp 4-18
IEEE 1028 (1988), ‘Standard for Software Reviews and Audits’, Institute of Electrical and
Electronics Engineers (IEEE), Washington.
[15] ISO 19011 (2002), “Guidelines for quality and/or environmental management systems
auditing”, International Organization for Sta
[16] ISO 9000 (2000), “Quality Management Systems Fundamentals and Vocabulary”,
International Organization for Standardization, Geneva.
[17] ISO 12207 (1995), ‘Information Technology Software Life Cycle Processes’,
InternationalOrganization for Standardization, Geneva.
[18] ISO/TS 16949 (2002), “Quality Management System Requirements - Particular requirements
for the application of ISO 9001:2000 for automotive
organizations” International Organization for Standardization, Geneva
Karapetrovic, S. and Willborn, W. (2000), ``Generic audit for management system:
fundamental'', Managerial AuditingJjournal, Vol. 15 No. 6, pp. 278-294
[20] Karapetrovic, S. and Willborn, W. (2002),``Self-audit of process performance'', International
journal for quality and reliability management, Vol. 19 No. 1.
[21] Martino J .P. (1994), “A Technology audit: Key to technology planning”, IEEE CH3431-
4/94/0000-1241.
[22] Mohammad Meybodi (2006), “Internal manufacturing strategy audit: the first step in
integrated strateg
ISBN 978 - 983 - 43571 - 0 - 8 ©2007 FEIIC
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World Engineering Congress 2007, Penang, Malaysia, 5 – 9 August 2007
[23] Menda R. (2004), “The role of a manufacturing audit in crafting the production system”,
International Journal of Operations &Production Management Vol. 24 No. 9, 2004 pp. 929-
943
[24] NIST (1999), ``Overview of the criteria for performance excellence'', National Institute for
Science and Technology, Washington, DC,
(http://www.nist.gov/public_affairs/stockstudy.htm .
[26]
rogress; J un 2006, pp. 71-
[28] nagement of Quality Assurance Systems’,
[29] liamson, A; Rogerson; J H and Vella A D (1996), “Quality system auditors’ attitudes and
ty Press.
[25] Oxford (1990), “Oxford Advanced Learner’s dictionary”, Oxford
Russell, J .P. and Regel, T. (1996), ``After the quality audit: closing the loop on the audit
process'', Quality Progress, Vol. 29 No. 6, pp. 65-7.
[27] Russell J P (2006), “Process Auditing and Techniques” Quality P
74
Willborn, W. and Cheng, T.C.E. (1994), ‘Global Ma
McGraw-Hill, New York, NY.
Wil
methods: a survey, International Journal of Quality & Reliability Management, Vol. 13 No. 8,
1996, pp. 39-52, MCB Universi
[30] Umit S. Bititci U.S., Carrie A. S. and McDevitt, A (1997), “Integrated performance
measurement systems: an audit and development guide”, The TQM Magazine, Volume 9 ·
Number 1 · 1997 · pp. 46–53.
[31] VDA (1998), “Quality Management in the automotive Industry: Process Audit”Part 3,
Verband der automobilindustrie, Franfurt.
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