The document discusses quality assurance in production processes. It defines key concepts like quality management systems, quality assurance, and quality control. It explains how the 5Ms (man, machine, material, methods, measurement) and environment influence production quality. Effective maintenance of machines is important for quality, and there are different maintenance strategies like preventative, condition-based, and risk-based maintenance. Quality assurance professionals should understand maintenance approaches and monitor critical equipment to help ensure product quality.

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Understanding Quality Assurance in
Production Industry
(Part 1)
Sunday E. Elkana
For Neogreen Integrated Resources Ltd

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Learning Points:
 Quality assurance – what does it mean?
 How the 5Ms & 1E (man, methods, materials, machine, measurement, and
environment) influence the production process

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Quality assurance – what does it mean?
Practical explanations of some important concepts:
Quality management system (QMS) resides at the highest
organisational level to establish and implement an overall quality
policy. It is a high level strategy. In other words, a QMS gives
DIRECTION, i.e., WHAT need to achieve.
Quality assurance (QA) provides the management tools for the
achievement of the quality policy/strategy spelt out in the QMS.
In other words, QA is the HOW to achieve the QMS.
Quality control (QC) is basically the RESULTS of the QMS,
in terms of the product parameters.

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Let us use another scenario to throw more light on these concepts:
Quality, Process and Product Parameters:
For any product, quality is subject to consumers’ perception of
taste, feel, colour, smell, and how audible (for products that make
sound). In other words, the quality of a product is what the
consumers say it is.
Quality parameters are basically the quality objectives of the
organisation. They embody the characteristics of the product and
the processes that lead to the realisation of those characteristics.
It is safe to say that quality parameters combine both process and
product parameters. This is where QMS resides – give direction by
setting the quality parameters.

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With respect to production, process parameters
are the influencers of the production process, i.e.,
the characteristics of machines, materials,
methods, manpower, measurements and even the
environment. All of these have direct or indirect
impact on the final product quality. If these
parameters are not adequately monitored and
controlled during production, they will negatively
impact on the final product. This is where QA
resides – monitor and correct the characteristics of
the 5Ms & 1E to ensure the product parameters
are achieved.

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Product parameters are the characteristics that
describe a finished product. These are the
attributes consumers see or feel before making
making the buying decision. In other words,
product parameters are the attributes of the
product that interact with the consumers.
Though consumers cannot measure product
parameters, however, they use their senses of
sight, taste, smell and touch to pass their
judgement on the product quality. This is
where QC resides – confirm the final product
parameters before they are released to trade.

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How the 5Ms & 1E (machine, materials, methods, measurement, man and environment) influence
the production process
Let us zero in on quality assurance and see how the 5Ms and 1E are managed during production towards
achieving the desired product quality.
The Fish Bone (Ishikawa) diagram,
establishes that a production process uses
machinery, methods and human resources
to transform measured raw materials into a
finished product, and not forgetting the
impact of the operational environment.
Quality assurance is the fundamental process that determines the company’s position on the market and
that influences its competitiveness.

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A machine is any piece of plant, machinery,
instrument or tool, which is used for carrying
out a specific activity or operation, eg, mixers,
millers, fillers, pumps etc.
Production process depends upon the good
performance of these machines. A machine
maybe,
• a single system, or
• an integrated system
Machine (Equipment)
How do you achieve product quality with machines?
 Machine maintenance
 Machine quality points

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Effective machine maintenance has a great role in achieving the desired product
quality. A machine that is not in basic condition can be likened to a sick
employee. Such machine cannot deliver the expected outcome. Manufacturers
should pay adequate attention to equipment maintenance to keep them in
good condition always.
1. Planned maintenance
2. Autonomous maintenance
There are two major categories of machine maintenance.
 Machine/Equipment Maintenance

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1. Planned Maintenance
• In the TPM methodology, planned
maintenance is the third (3rd) of the pillar
• It is a maintenance approach to achieve zero
breakdown
• There are four basic planned maintenance
philosophies:
• It is carried out by the maintenance team
(non-machine operators)
 Corrective maintenance
 Preventive maintenance
 risk-based maintenance
 condition-based maintenance

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1. Corrective Maintenance (CM):
 Also known as Breakdown Maintenance. The machine
runs and breaks down before it is looked into.
 It is a reactive approach and less expensive.
How does this impact realisation of quality product?
• In most cases, equipment failure is not instantaneous
but a gradual process.
• Components must have been failing before final break
down.
• For instance, a pack weigher, before breaking down,
must have been allowing product packs of lesser
weight pass through to final packing, due to some
faulty components that where not attended to before
the eventual breakdown. Products with lesser weights
are likely to pass to trade in that instance.
2. Preventive Maintenance (PM):
 This type is carried out at planned intervals aimed at
reducing the failure risk or performance degradation
of the equipment.
 Machine components need not go bad before
replacement.
 Most manufacturers avoid preventive maintenance
due to cost.
How does this impact realisation of product quality?
• The equipment manufacturer could recommend that
the pack weigher, in our earlier example, be
inspected and serviced every six months or after a
certain number of hours of operation. If this
recommendation is judiciously followed, one can be
sure of the integrity of the pack weigher to deliver
packs of the right weight at all times.

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3. Risk-based Maintenance (RBM):
 RBM places emphasis on equipment that carry the
most risk to safety or quality or productivity, if they
were to break down.
 That means in this approach, machines are
categorised according to how critical they are –
Criticality Assessment.
How does this impact on realisation of quality product?
• It depends on the organisation’s priority. If
productivity is higher on the priority list, it means the
machine will not receive attention for quality issues,
so long as it keeps running and producing.
4. Condition-based Maintenance (CBM):
 CBM is a strategy that monitors the actual condition
of an equipment to decide what maintenance needs
to be done.
 CBM dictates that maintenance should only be
performed when certain indicators show signs of
decreasing performance or upcoming failure.
 Condition-based maintenance can also be termed
Predictive Maintenance.
How does this impact realisation of quality product?
• It can lead to a break down of the machine, if the
machine condition is not properly predicted.
• The same challenge with corrective maintenance
may happen.

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• In reality, it is difficult for manufacturers to stick to one of these strategies to achieve their maintenance objectives.
• One approach cannot fit for all equipment in all situations.
• The better option is to apply the strategies where and when appropriate.
• This introduces a more robust maintenance approach called Reliability Centered Maintenance (RCM).
• RCM tends to combine the preventive, risk-based and/or predictive strategies in view of scarce resources towards
achieving a balance in quality and productivity objectives of the organisation.
Which of the above maintenance methods is your organisation using?
It is important that quality assurance professionals understand these approaches and follow
through on maintenance of critical quality equipment instead of leaving all in the hands of the
maintenance team.

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• Autonomous maintenance is the
first (1st) of the pillars of TPM.
• AM is the concept of giving machine
operators the responsibility of
carrying out basic maintenance
tasks on the equipment they
operate instead of relying always on
the maintenance technicians.
• By this, the maintenance technicians
can focus on more complex
maintenance activities.
2. Autonomous Maintenance (AM):

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• Cleaning – Operators have the responsibility to clean their machines at defined intervals. They are
to escalate difficult to clean (DTC) areas of the machine for attention.
• Inspecting – After cleaning, the operators should inspect the machine for work-loosed parts, rusted
parts, etc., so that they can be handled before failure occurs. They are to escalate difficult to inspect
inspect (DTI) areas of the machine for attention.
• Lubricating – After inspection, the operators lubricate parts of the machine that require greasing
and oiling. Some machines have automatic lubrication system, the operators are to ensure this is
working adequately.
• Tightening – The operators tighten any work-loosed parts on the machine. They are given basic
tools for this activity.
At the end, these activities are documented.
The basic maintenance activities for the operators in AM are cleaning, inspecting, lubricating and
tightening (CILT).

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 Machine Quality Points (Q-Points)
Machine quality points is one of the quality maintenance tools in TPM.
In simple terms, machine quality points determination involves linking quality defects to the machine sub-
assembly responsible for that defect in the product.
There are three (3) steps involved:
1. QA Matrix:
The first step is the formation of the QA
matrix. This is simply matching the
observed quality defects to the process
inputs, categorised into the 5M & 1E (man,
method, material, machine, measurement
and environment), to determine the most
causative factor. QA Matrix can be
presented in a Pareto chart.

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The next step is to create the QX matrix. This shows the influence of process characteristics, machine
parts and settings on the particular quality defect.
2. QX Matrix:

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This is an impact assessment. It determines the
impact of the process characteristics for a given
machine part settings that is creating the
quality defect. The impact assessment is given
in 3-point scale, eg, low impact – 2; moderate
impact – 5; high impact - 8. Factors with the
highest ratings are given the status of machine
quality points. Meaning that the machine
component has the highest likelihood to
generate the particular quality defects.
3. QM Matrix:
The operatives are trained to monitor these
machine components. If it is a component that
generates figures, the figures can be plotted on
an SPC chart. This can be included in the
condition-based maintenance schedule to
prevent total failure of the component.

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A typical Quality Points for a
filling machine:

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 Assuming further that there are three components of the mixer that could be
responsible for the defect; QM matrix then attempts to find which of the
components has the highest impact on the defect. Low impact = 2, moderate
impact = 5, high impact = 8. The component with the high impact becomes the
Quality Point of the machine to be monitored to prevent such complaint in the
future. That component is then assigned a Quality Point number.
Q-Points summary and example:
 A customer complained of non-uniformity of colour and texture in a package flour
product. The company will analyse the quality defect to determine what was
responsible for the colour and texture variations – was it man, method, material or
machine? This analysis falls under QA Matrix.
 Assuming it was caused by machine, eg, the mixer, QX matrix will attempt to trace
the defect to the components and sub-components of the mixer that could be
responsible.

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