DEFINING THE PRODUCT-BASED NON-CONFORMANCE

CLASSIFICATION
ROSLAN JAMALUDIN
School of Technology Management and Logistics
Universiti Utara Malaysia
06010 UUM Sintok, Kedah
Malaysia
Email: [email protected]
ABSTRACT
This paper focuses on the identification of non-conformances to facilitate improved
product validation and aids the pre-production team in product assessment. The
manifestation of mistakes which results in non-conformances and their relationship
with the characteristics of the product under validation is explained. A new nonconformance classification has been defined based on the manifestation of mistakes
and product characteristics. The classification has been evaluated by experts on
consumer electronic products from multinational manufacturing companies through
closed and open ended questionnaires. The respondents described the classification
to be feasible and applicable in pre-production. The proposed classification
contributes to the understanding of mistakes and product quality deficiencies which
can be minimised by addressing non-conformances during product validation.

Keywords: non-conformance, mistakes proofing, product design and development,

pre-production, quality, validation

INTRODUCTION
In the Product Development Process (PDP), products which are found to be outside
specification are said to be non-conforming and can be a major cost to manufacturing
industry. Non-conformances contribute to unreliable product quality, which shows up,
for example, as functional failure (Almgren, 2000) and poor appearance. Whilst most
non-conformances are manifested and identified at the later stages of product
development, they often escape into production and into the hands of users (Booker,
2003). Hence, the later non-conformances identified, especially late in development,
the higher the cost incurred to rectify a product (Milne, 1994, cited in de Castro and
Fernandes, 2004).
The reasons for pre-production are validation and verification of products prior to
production to ensure product conformance with specification and quality
requirements (Jamaludin and Young, 2005). Companies describe non-conformances
in a distinctive manner, for example by colour coding, numerical, or the simple no/nogo. The decision on how to assess non-conformances depends on the perception and
experience of the senior staff in the company. This results in inconsistency in dealing
with non-conformances when different people and circumstances exist. Therefore,
without a consistent understanding of non-conformances, it is difficult to address non-

conformances comprehensively and, hence, to conduct an effective product validation

process.
Product non-conformances are known to arise from three sources: complexity,
variation, and mistakes (Hinckley, 2001). Excessive complexity and uncontrolled
variation result in increasingly difficult to understand about products and production
processes, and whilst mistakes are seen as the major source of non-conformances
(Hinckley, 1997; 2001; 2003), the consequences are significant. A study has found
that of 23,000 production defects, 82% originated from mistakes (Hinckley and
Barkan, 1995; Hinckley, 1997), and most of the mistakes are human-generated
(Nikkan Kogyo Shimbun, 1988).
There has been a lack of empirical studies on the understanding of non-conformances,
and the methodological principles of how to improve product validation in preproduction (Almgren, 2000; Nagasaka, 2000; Liu and Cheraghi, 2006). Most research
describes non-conformances either from a broad or narrow aspect. The broad aspect
describes non-conformances in the context of the overall product development
process with cost as the main focus of discussion (Crosby, 1979; Deming, 1986; Juran
and Godfrey, 1999), while the narrow aspect presents mathematical and statistical
analysis in problem solving on a specific non-conformance issue. The lack of
academic works and industry inadequacy in addressing product non-conformance has
been reflected in failure in understanding of non-conformances extensively. Hence,
there is a need for a holistic understanding of non-conformances, by understanding
the manifestation of non-conformances and the product under validation.
The focus of the research is on product non-conformance in pre-production, with the
aim of improving methods for delivering high quality products. The formulation and
development of the research ideas had evolved from the understanding of product
non-conformance and validation process in pre-production. The proposed method
have been evaluated by experts from six multinational manufacturing companies who
have authority in the product development process and involved in product validation.
The study reported in this paper contributes to the domain of product quality within
the Product Development Process.

PRODUCT VALIDATION PROCESS

A typical product validation process is illustrated using the IDEF0 activity modelling
method (Bal, 1998; Cheung and Bal, 1998; Dorador and Young, 2000), as depicted in
Figure 1 (non-conformances are identified and classified based on the new
classification, the Product-based Non-conformance Classification.). The validation
process consists of five elements; Input, Output, Controls, Mechanism and Process.
The input represents the product to be validated on either a new or improved product.
The output is the product which completes validation in two conditions: (i) the
product is in conformance and qualifies for production, and (ii) the product is nonconforming and requires further scrutiny. The controls represent the validation
consideration i.e. specification and quality requirements. The mechanism for checking
product conformance and non-conformances is by means of inspection. The process
is the conduct of the validation and relates to all four elements described earlier. The

model is adopted as it represents the validation process, the associated elements and
their relationship in an easy to understand model which non-experts can view and
understand (Dorador and Young, 2000).
Controls
(Specification/Quality)

Input

Output
(Validate product)

Process
(Product)

(Conforming product)
(Inspection)

Mechanism

(Non-conforming product)

Product-based Non-conformance
Classification (PNC)

Figure 1
Typical product validation model.
The research has identified three interrelated characteristics of product under
validation i.e. Information, Process and Parts/Components, as shown in Figure 2. The
arrows pointing towards the product represent the products characteristics, while the
dotted arrows are the relationship between these characteristics. For example, when
inspecting one aspect, it is necessary to counter-inspect with the other aspects. As
such products are validated for integrity among the characteristics, as dictated by the
specification and quality requirements.
INFORMATION
Standards
Specifications
Instruction
Bill of Materials (BOM)
Drawings

PROCESS
PCB assemblies
Sub-assemblies
Final assemblies
Packaging

PARTS/COMPONENTS
Packaging
Accessories
Mechanical parts
Electronic parts
Electrical parts

Figure 2
Three interrelated product characteristics in pre-production.

The pre-production of typical consumer electronic product is accompanied with a

complete set of control documents or information. These are technical documentation
pertaining to the product and its assembly process. The documents are specification,
drawings, Bill-of-Materials (BOM), standard procedures and instruction, and
Engineering Change Orders (ECO). In the trial-run, the whole assembly process is
looked into according to assembly information such as the work instruction and
assembly drawings. The assembly lines typically consist of printed circuit board
assembly lines, sub and final assembly lines, and packaging lines. Then, all parts and
components listed in the BOM are delivered to the assembly lines and assembled
according to the assembly drawings and work instruction. The parts and components
are grouped into packaging materials, accessories, and functional parts (mechanical,
electronic and electrical).

VALIDATION ASPECTS DURING PRE-PRODUCTION

Product validation focuses on the items within this three product characteristics, i.e.
information, process and parts/components, thus the identification of nonconformances should be directed on these items. The details of the validation
considerations are listed in Tables 1, 2 and 3. Any deviation from specification and
quality requirement identified in the products characteristics during validation
represents the manifestation of non-conformances. Therefore, non-conformances are
classified based on their manifestation on these three characteristics.
Table 1
List of validation considerations related to Information.
Particulars

Information Description

Drawings

Complete set of the most recently approved assembly, detail and working drawings.
Information on drawings identification, for example drawing number, title, page number,
dimensions, notes, amendments, symbols, conventions, etc.

Most recent approved documents with complete list of mechanical and electronic parts
and components, and sub-assemblies.
Printed identifiable product information, for example labels, graphics, colour, languages,
instructions, messages, numbers, characters on the carton boxes, plastic/paper
wrappers and polystyrene-foams, bar-coded product information, etc.
Safety information on carton boxes, plastic wrappers, and polystyrene foams, for
example weight, size, handling orientation, stacking guides, safety messages and
instructions, etc.
Complete set of accessories printed materials.
Instructions, manuals, booklets, warranty card, reply cards, for example for all
accessories, with part name and part numbers, labelled, correct languages on printed
materials.

Bill-of-materials

Packaging

Product safety

External and internal

features

Assembled, sub-assembled parts, mechanical and electronic components are clearly

labelled or imprinted with safety messages, warnings and instructions in compliance
with safety standards and specifications.

Brand logo, model identification (name of model and unique number on stickers or
imprinted); labelling for functions and features (for example power on-off, volume,
left/right, etc.).
Dismantling instructions, messages, warnings and instructions all around and inside the
product.

Parts and
components

Testing and
measurement

To tally with detail and assembly drawings, for example dimensions, type of material,
colour, etc.

Testing and measuring the electronic and electrical values as per specification and
safety requirements.
Quality and reliability testing and measurement, including information for packaging
specification.

Table 2
List of validation considerations related to Process.
Aspects

Process Description

Both automated and manual insertions, for example new and additional components,
components to be removed or replaced.

Sub-assemblies

Sub-assembled parts, for example product modules, CD/cassette drivers, PCBs.

Fitting of loose parts, for example bolts/nuts, plastic fasteners, joints, brackets,
housings, washers, wiring, lids, bases, etc.

Final assemblies

Fitting all sub-assembled parts and modules according to procedures, with special care.

Packing of items with packaging materials using appropriate methods, sequence and
orientation of packaging.
Instruments, tools, equipment, and handling. Attention will focus on the type of tools
needed to assemble the product. Where necessary, jigs, gauges and fixtures will have
to be supplied. Special requirements for tools, equipment, handling methods or even
testing instruments are avoided as much as possible.

PCB assemblies

Packaging

Table 3
List of validation considerations related to Parts/Components.
Particulars

Parts/Components Description

Packaging
configuration

Carton boxes.
Plastic wrappings for product and accessories.
Polystyrene foam (protecting product).
Packing seals and cushioning (bubble packs).

Complete set of printed materials, for example warranty cards, reply cards, manuals,
instructions booklets.
Complete set of accompanying items, for example remote controls, cables, loudspeakers, batteries, antenna, and other related items.

Accessories

Product

Functionality
Safety

Physical and appearance.

Casings (front panel, rear panel, base, lids, and battery lids), colour, materials, stickers,
etc.
Moving mechanism, for example buttons, CD trays, sliders, cassette decks, antenna,
handles, knobs, and other parts.
Cables and fittings, for example power supply, external antenna, speakers, microphone
and headphones.
Mechanical and electronic assemblies.
Fittings, housings, brackets, fasteners, joints.
PCBs (main board, tuner board, AV boards), LEDs, miniature components, wire
harnesses, displays, motors, cables and wiring connections, etc.

Conditions and features as per requirement and working together with accessories.

Visual, audible and tactile check on mechanical parts, for example sharp and pointed
edges, loose assemblies, breakages, foreign materials, etc.
Visual and audible inspection, and testing on wiring and cables insulations, labels,
colour codes, warning signs, jacks and insertion, LEDs, etc.

DEFINING PRODUCT NON-CONFORMANCES

The research has identified those product non-conformances in pre-production as
having two distinctive aspects,
(1) Non-conforming items are the results of mistakes. These mistakes have
been identified in the products characteristics, as shown in Figure 3, and

(2) The Outcome-based Classification by Hinckley (2001) describes mistakes

identified in production into five groups: defective material, information
errors, misses, selection errors, and omission/commission errors. In preproduction, similar mistakes which result in non-conformances are manifested
in the products characteristics.
INFORMATION
Standards/Specifications
Drawings
Bill-of-Materials (BOM)
Procedures/Instruction
Engineering Change
Orders (ECO)

Wrong material
Wrong operation
Wrong orientation
Wrong destination
Wrong location
Wrong part
Inadequate material
entering
Omitted operations
Prohibited actions
Omitted part
Added material/part
Misadjustment
Misaligned parts

PROCESS
PCB assemblies
Sub-assemblies
Final assemblies
Packaging

Ambiguous
Incorrect
Mismeasure
Omitted information
Inadequate warning

PARTS/COMPONENTS
Packaging materials
Accessories
Mechanical parts
Defective
Electronic parts
Electrical parts

material

Figure 3
Relationship between product characteristic and type of mistakes.
Thus, a generic classification of non-conformances which relates to mistakes and
product characteristics is introduced. The classification is called the Product-based
Non-conformances Classification or PNC (Jamaludin, 2008) As shown in Table 4, the
classification consists of three types of non-conformances corresponding to the
products mistakes and characteristics:

Information Non-conformances,
Process Non-conformances, and
Parts/Components Non-conformances.

The potential of the PNC is that the approach should be able to aid in identifying nonconformances with the following important features:

Each product characteristics has a known type of mistakes, likewise any

mistakes can be tangibly identified with the corresponding characteristics.
Mistakes in one product characteristic correlate with other characteristics, as
shown in Table 5. This shows that one mistake is related to other mistakes;
hence one class of non-conformance is correlated with other classes of nonconformance. For example, wrong operation (process non-conformance) is
strongly correlated with defective material (parts/components nonconformance), incorrect information (information non-conformance), and

omitted operation. This ensures that potential non-conformances are not

ignored or overlooked. The table depicts holistically how mistakes, product
characteristics and non-conformances are correlated. Therefore it is important
to identify other potential non-conformances within the three product
characteristics.
Table 4
Classes and location of non-conformances, and potential mistakes.
Class of nonconformance

Locality of nonconformances

INFORMATION

Technical
specifications
Work Instructions
Bill-of-Materials
Drawings
Checklist
Engineering-changeorder

PROCESS

PARTS/
COMPONENTS

PCB assemblies
Sub-assemblies
Final assemblies
Packaging

Packaging Materials
Accessories
Mechanical Parts
Electronic Parts
Electrical Parts

Type of mistakes

Description of mistakes

Ambiguous Information

Information can be interpreted many

ways, some interpretations may be
incorrect.

Incorrect Information

Information provided is incorrect.

Misread, Mis-Measure,
Misinterpret

Gauge-reading errors, errors in

measuring, or errors in understanding
correct information.

Omitted Operations

Failure to perform the required

operation.

Wrong Part

Part selected, but wrong part.

Wrong Orientation

Part inserted in correct location, but the

part has wrong orientation.

Wrong Operation

Operation executed, but wrong

operation.

Wrong Location

Part insertion or process execution in

incorrect location that is not the result
of incorrectly orienting parts.

Wrong Destination

After completing operation, product

sent to wrong address or destination.

Defective Materials

Material entering process is defective

or inadequate for the intended function,
process, or purpose.

Subsequently, identifying non-conformances as the result of mistakes on the

individual items of the products characteristics is much simpler. Once nonconformances are identified, it is easier rectify and to learn from mistakes
(Gillingham et al., 1997).

CASES SUPPORTING THE PRODUCT-BASED NON-CONFORMANCE

CLASSIFICATION
The following paragraphs exhibit typical non-conformances, as a result of mistakes,
manifested on product under validation in a multinational manufacturing company
which designs and produces consumer audio and video products. The exhibition
represent evidence of non-conformances classified according to the PNC.
Evidence of Information Non-conformance - Information essential for the correct
execution of a process or operation is not available or has never been prepared.
Part names for assembling a component were not shown in the assembly drawings
but only part number, as shown in Exhibit 4. As operators are used to identifying

Mismeasure, interpret

Omitted Information
Inadequate Warning
Misalign

Misadjust

Mistimed or Rushed

PROCESS

Omitted Operation

Omitted Parts

Concept or Material

Wrong Location

Wrong Parts

Wrong Orientation

O
O

O
O

O
O

O
O

Wrong Destination

Wrong Location

Omitted Parts

O
O

Commit Prohibited

Wrong Destination

Omitted Operation

Wrong Material

Prohibited Act

Added Parts

Wrong Operation

Added Parts

Misalign

Wrong Orientation

Incorrect

Wrong Parts

Wrong Operation

Ambiguous

Mistimed or Rushed

INFORMATION

P/C - Defective Material

Misadjust

PROCESS

Inadequate Warning

Omitted Information

Mismeasure, interpret

Incorrect

Connection
Blank Weak/No Connection

INFORMATION

Ambiguous

Strong Connection

Defective Material

P/C

parts by names, parts and components were mixed or assembled with the wrong part
during trial-run assembly.
Table 5
Classes of non-conformance and their related mistakes.

Source: Adapted from Hinckley (2001).

Exhibit 4
Omitted part name in assembly drawing.

O
O

Evidence of Process Non-conformnce - A missing part resulting from failure to

comply with correct product requirement. Often recurring non-conformances are of
this nature due to the similarity of many product versions. For example, a label on
the rear panel of a product was found missing during inspection, as shown in Exhibit
5. Most products use the same panel but with a different label requirement.

Missing label on back panel

Exhibit 5
Missing label.
Evidence
of
Parts/Components
Non-conformance
Non-conforming
parts/components are manifested when material entering a process is defective, or
inadequate for the intended function, process, or purpose. This section describes in
detail the third classification of non-conformances and its connection with other
classes. As shown in Exhibit 6, the two cassette lids did not open simultaneously
when both eject buttons were pressed.

Exhibit 6
Two cassette lids open at different pace
One of the lids was suspected to be out of dimension because the lid touched the
opening frame, leaving no gap. Other variables such as foreign material, gear,
spring, cassette player lids, lid frame, inspection check list, and assembly
methods are elements where non-conformances could occur, as shown in Exhibit
7.

Foreign material
Check list

Gear fitting
Spring

Gear
Product X
Non-conformance

Cassette Lids
Faulty
Spring
Cassette lids

Exhibit 7
Elements contributing to non-conformances
There are also mistakes, such as mis-adjustment, defective material, omitted
information, wrong parts, and wrong operation, which cause non-conformances.
How are these two aspects linked? A cause and effect diagram in Exhibit 8
presents the connection between the elements and mistakes which contribute to
non-conformances. For example, the gear was misadjusted when tightening
screws with tight torque or not fitting the gear according to the pre-determined
sequence (wrong operation) are the most likely causes of the faulty lid. Misadjustment and wrong operation in fitting the gear have high probability or
strong connection for causing the faulty lid. The connection between the two
aspects is presented in the connection matrix, as shown in Table 6.

Defective Material
Omitted information
Gear

Mis-adjustment

Design requirement

Lid frame
Spring
Gear fitting

Cassette lids

Checklist
Cassette Lids
Faulty

Cassette lid
Spring

Gear fitting

Foreign material

Gear
Wrong operation

Omission/
Commission Errors

Wrong parts

Exhibit 8
Elements and mistakes causing faulty cassette lid.
In summary, any deviation from specification and loss of quality identified in the
product characteristics during validation represents the manifestation of nonconformances. For this reason, non-conformances can be classed based on the product
characteristics.

10

Table 6
Connection between elements and mistakes.
Mistakes
Strong Connection
Connection

Defective Omitted
Prohibited Wrong
Misadjust
Act
Operation
material Information

Cassette Lids Faulty

Elements
Gear fitting

Wrong
Parts

Foreign material

Gear
Spring
Cassette lids
Lid frame

Check list
Requirement

EVALUATION RESULTS
The PNC has been evaluated through interviews and questionnaires with experts who
are vastly experienced in wide range of consumer electronic product, having authority
and involved in designing, in pre-production and production activities. The validity of
the concept of the PNC is viewed from the practical and actual design and
manufacturing environment.
Experts, or evaluators, from six manufacturing companies (companies name are
remained anonymous) were invited to assess the PNC. The profile of evaluators, by
designation, length of service, and their companys range of product are shown in
Table 7. Evaluators were identified as A, B, C, D, E and F. A semi structured
questionnaires was used to assess:
i.
ii.
iii.

the product characteristics,

mistakes as the source of non-conformance, and
the PNC.
Table 7
Profile of evaluators and companies.

Company

Evaluator Designation

Years in
company

Product

Senior Engineer
(NPI Division)

Hard disk drives for computers, mobile

devices and enterprise storage.

Assistant Manager
(R&D Department)

11

CRT TV, LCD TV, projector and computer

monitors

Senior Manager
(R&D Division)

13

CRT & electron devices

Senior Engineer
(R&D Centre)

7.5

Hi-fi, radio cassette recorders & hometheatre

Executive
(NPI Department)

Car air conditioners, radiators, and engine

electrical control units.

Senior Manager
(NPI Division)

20

2-way radio, mobile phone

11

The questions required evaluators assessment on the aspects of relevance,

comprehensiveness, coherence, practicality and recommendation; where evaluators
provide opinions, comments and additional information.
Evaluators confirmed the three product characteristics as representing the components
of the product under validation. The response establishes the relevance of the product
characteristics as the basis for the new non-conformance classification. Evaluator B
claimed to have an almost similar approach in describing product characteristics
which are known as the three components or triangle, which represents (i) actual
part, (ii) drawings, and (iii) part number. Nonetheless, he recommended the three key
product components be put forward in the new classification. Evaluator F suggests
each item of product characteristics be validated also for its reliability. Since this
research focuses on the quality inspection only, reliability testing is not related to the
subject being addressed.
Evaluators agreed that this is a coherent and practical classification in identifying
non-conformances resulting from mistakes. Evaluator A claimed about 70% of nonconformances are originated from mistakes, while evaluator B admitted that mistakes
are a major source of non-conformances. Evaluator C now had a positive perception
on non-conformances rather than hating them, and suggests to his subordinates to
look into them seriously during design stage. Evaluator F agreed that mistakes cause
non-conformances, but perceived other elements also contribute, such as process
variation and capabilities which is beyond the scope of this report.
Although evaluator A is sceptical of the practicality of the PNC, which have not been
tested in an actual pre-production setting, however evaluator A understands that it is
somewhat difficult to test new ideas in sensitive and critical areas in any well
established companies. Evaluator C admitted to realising the importance of
addressing non-conformances during development, and suggested that the PNC is
about risk management. Evaluator D recommends the concept be used beyond preproduction, especially during design stage. Overall, evaluators perceived the PNC as
relevant and recommended for used in pre-production.
In general, evaluators claimed that the new classification is categorically correct in
defining non-conformance and it is simple to understand. The illustration and
description of the classification is agreed, and provides a broader view and clearer
picture of non-conformances. All six evaluators agreed that overall the PNC in
product validation process were relevant, comprehensive, coherent and practical
classification, and recommended in pre-production.

DISCUSSION AND CONCLUSION

This paper has addressed non-conformances in pre-production stage of product design
and development. Three aspects have been identified to facilitate product validation
and aid the pre-production team in product assessment i.e. mistakes as a major source
of non-conformances, the characteristics of product under validation, and the
classification of three types of non-conformances. A new classification of nonconformances based on the manifestation of mistakes related to the product
characteristic has been presented. The classification has been demonstrated in the

12

actual industrial cases of non-conformances of consumer electronic product. The

evaluations have proven to be feasible in defining and identifying non-conformances.
It has been shown that it is possible to build a comprehensive understanding of nonconformances by linking the source of non-conformances and product characteristics.
Understanding this relationship enable to control and prevents non-conformances
from leaving the pre-production. Using a structured procedure, guidelines and
appropriate tool, the implementation of the PNC has the potential to provide
improved validation practices and rapid rectification of non-conformances.

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