Unit-5 Quality Control

What Is Quality Control?

Quality control (QC) is a process by which entities review the quality of all factors involved in
production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality
requirements".
This approach places emphasis on three aspects (enshrined in standards such as ISO 9001):
1. Elements such as controls, job management, defined and well managed processes, performance and
integrity criteria, and identification of records
2. Competence, such as knowledge, skills, experience, and qualifications
3. Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team
spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end
results of a service are analyzed). Product inspectors will be provided with lists and descriptions of
unacceptable product defects such as cracks or surface blemishes for example.
Quality control (QC) is a process through which a business seeks to ensure that product quality is
maintained or improved. Quality control requires the business to create an environment in which both
management and employees strive for perfection. This is done by training personnel,
creating benchmarks for product quality and testing products to check for statistically significant variations.
A major aspect of quality control is the establishment of well-defined controls. These controls help
standardize both production and reactions to quality issues. Limiting room for error by specifying which
production activities are to be completed by which personnel reduces the chance that employees will be
involved in tasks for which they do not have adequate training.
Quality Control
KEY TAKEAWAYS

 Quality control (QC) is a process through which a business seeks to ensure that product quality is
maintained or improved.

 Quality control involves testing of units and determining if they are within the specifications for the
final product.

 The quality control used in a business is highly dependent on the product or industry, and several
techniques exist for measuring quality.
Understanding Quality Control
Quality control involves testing of units and determining if they are within the specifications for the final
product. The purpose of the testing is to determine any needs for corrective actions in the manufacturing
process. Good quality control helps companies meet consumer demands for better products.
Quality testing involves each step of the manufacturing process. Employees often begin with the testing
of raw materials, pull samples from along the manufacturing line and test the finished product. Testing at the
various stages of manufacturing helps identify where a production problem is occurring and the remedial
steps it requires to prevent it in the future.
The quality control used in a business is highly dependent on the product or industry. In food and drug
manufacturing, quality control includes ensuring the product does not make a consumer sick, so the
company performs chemical and microbiological testing of samples from the production line. Because the
appearance of prepared food affects consumer perception, the manufacturers may prepare the product
according to its package directions for visual inspection.
In automobile manufacturing, quality control focuses on the way that parts fit together and interact and
ensuring engines operate smoothly and efficiently. In electronics, testing might involve using meters that
measure the flow of electricity.
The Techniques of Quality Control
There are several methods of measuring the performance of quality control. A quality control chart is a
graphic that depicts whether sampled products or processes are meeting their intended specifications—and,
if not, the degree by which they vary from those specifications. When each chart analyzes a specific attribute
of the product it is called a univariate chart. When a chart measures variances in several product attributes, it
is called a multivariate chart.
Randomly selected products are tested for the given attribute or attributes the chart is tracking. A common
form of a quality control chart is the X-Bar Chart, where the y-axis on the chart tracks the degree to which
the variance of the tested attribute is acceptable. The x-axis tracks the samples tested. Analyzing the pattern
of variance depicted by a quality control chart can help determine if defects are occurring randomly or
systematically.
The Taguchi Method of quality control is another approach that emphasizes the roles of research and
development, product design, and product development in reducing the occurrence of defects and failures in
products. The Taguchi Method considers design to be more important than the manufacturing process in
quality control and tries to eliminate variances in production before they can occur.

Elements of quality and factors controlling quality of design and conformance:

Creation of any product involves two major stages – intellectual creation and physical creation. During
intellectual creation a product is conceived in the mind and a design is created and after that it is physically
produced.
The term quality involves two complementary aspects, quality of design and quality of conformance. So,
good quality can be attained only when both of them are controlled satisfactorily. Quality is designed into a
product as much as it is built in during its production or service processes.
Quality of design
Quality of design is the quality which the producer or supplier is intending to offer to the customer. When
the producer is making the quality of design of the product, he should take into consideration the customer's
requirements in order to satisfy them with fitness for use of the product.
 If the quality of design does not reflect the customer's requirements, the product which the producer offers
him would not probably satisfy the customer, even if it does sufficiently conform to the design. Quality of
design is usually indicated by completeness and correctness of specifications, drawings, catalogues, etc. and
is measured with fitness for use.
Quality of conformance
Quality of conformance is the level of the quality of product actually produced and delivered through the
production or service process of the organization as per the specifications or design. When the quality of a
product entirely conforms to the specification (design), the quality of conformance is deemed excellent.
 Specifications are targets and tolerances determined by the designer of a product. Targets are the ideal
values for which production is expected to strive; tolerances are acceptable deviations from these ideal
values recognizing that it is difficult to meet the exact targets all the time due to variability in material,
machine, men and process.
For example, if an engineering component manufacturer specifies the diameter of a steel pin as
2.525 + 0.005 mm, the value 2.525 is the target value and  + 0.005 is the tolerance. In a similar way, in case
of an Airline service, if on time arrival of a flight is specified as within 15 minutes of scheduled time, the
target is scheduled time and tolerance is + 15 minutes.
The measure most commonly used for expressing the quality of conformance is fraction defective.  A
fraction of defect of 0 % implies that the quality of a product wholly conforms to the quality of
design.  Even if the quality of a design is very good and quality of conformance is poor, the product cannot
give the intended service and is classified as poor quality product.
 For example, in case of a service product like maintenance of law and order by governmental agencies, the
quality of design is reflected in the relevant acts and rules, whereas quality of conformance depends upon
the extent to which these acts and rules are complied by the enforcement agencies. In spite of having
excellent rules and regulations, the quality of law and order of society cannot be rated as good, if these rules
and regulations are not adhered to properly.
Fitness for use (quality of design) and conformance to specification (quality of conformance) provide the
fundamental basis for managing the processes to produce quality products. Good quality can be attained
only when both, quality of design and quality of conformance are good.

Process Control:
Automatic process control in continuous production processes is a combination of control
engineering and chemical engineering disciplines that uses industrial control systems to achieve a
production level of consistency, economy and safety which could not be achieved purely by human manual
control. It is implemented widely in industries such as oil refining, pulp and paper manufacturing, chemical
processing and power generating plants.
There is a wide range of size, type and complexity, but it enables a small number of operators to manage
complex processes to a high degree of consistency. The development of large automatic process control
systems was instrumental in enabling the design of large high volume and complex processes, which could
not be otherwise economically or safely operated.
The applications can range from controlling the temperature and level of a single process vessel, to a
complete chemical processing plant with several thousand control loops.
The objectives of process control are generally either to maintain a process at a desired, constant operating
condition (temperature, pressure, composition, etc.) in the face of disturbances or, less typically in
conventional process applications, to force it to follow a desired trajectory with time. All process control
configurations, whether manual, automatic, or computer-based, have three essential elements:
a. a measurement (often several);
b. a control strategy (embedded in a controller);
 c. a final element for implementing the control action (a valve, heater or other variable input).
For example, in classical feedback control, one can correct for the effects of a disturbance by:
a. measuring some property of the system to be controlled (its temperature, for example):
b. comparing it with its desired value (set point) and calculating what changes, if any, are required as
inputs to the process;
c. making an appropriate adjustment to that/those inputs (a variable heater, for example).
Similarly, in feedforward control, one can anticipate and compensate for the effects of a major disturbance
to the process by first measuring the disturbance; this would then be followed by the other two steps
described above.

Inspection planning and scheduling:

To achieve world class performance, organizations must plan, schedule and track maintenance activities. In
the maintenance world, planning and scheduling are two different functions that work together to create a
maintenance program. Planning is the process of planning, while scheduling is the process of reconfiguring
workloads in a production/manufacturing process. Scheduling is used to allocate plant and machinery
resources, plan human resources, plan production processes, and purchase materials.
Some companies integrate the jobs and functions of planning and scheduling in a single position. There are
merits to this approach because a scheduler can't fully grasp when it's time to have personnel on the floor
without also having first-hand information about when the puzzle pieces are in place so the work can move
forward.
However, some aspects of planning and scheduling don't overlap. Elements of the planning process can
involve skills and expertise such as purchasing and research and development. On the scheduling side, there
are human resources and budget considerations such as which workers are available and when they begin to
incur overtime.
When the responsibilities of planning and scheduling are integrated into a single position, there should be
ongoing collaboration and communication between the planner and scheduling and co-workers who are
more closely involved in the day-to-day details that affect both the overall plan and the weekly and daily
schedules.
Planning and Scheduling Software
There are plenty of programs available to help you through the planning and scheduling processes, including
Microsoft Project and Google Calendar. These programs provide templates that help you lay out and
organize tasks and see timelines and schedules. However, planning and scheduling can't always be captured
with a program that takes a one-size-fits-all approach, so many companies use programs like Excel to design
custom work plans and schedules.
One potential difficulty with planning and scheduling software is that the details of a project may change
once it's underway, especially if a company uses a lean manufacturing approach that emphasizes ongoing
learning and adaptation. With such an approach, the strength of planning and scheduling software lies in its
capacity to reflect adjustments that are made while work is in progress and to carry through the
consequences of these changes for steps down the line.
Coordinating Planning and Scheduling
When planning and scheduling are seamlessly integrated, work flows as smoothly as possible, and everyone
knows what he is supposed to do and when he is supposed to do it. When these two processes aren't well
coordinated, individuals and equipment may be scheduled for double duty, or they may be scheduled in
theory when they don't have the parts or resources they need to proceed. To effectively coordinate planning
and scheduling:

 Make sure all parts and resources are in place before scheduling personnel and equipment. Workers
should have what they need to get the job done, or they should be scheduled to do something else.

 Avoid overlap and redundancies. If two departments need to use the same machines, some
employees will be standing around waiting for others to finish rather than doing work that will move
the job forward. If two departments are tasked with completing the same work, you may have more
than you need of some parts and not enough of others.

 Plan for contingencies. It's a pretty safe bet that something along the line won't go precisely as you
planned. The more flexible your plan and schedule, the better you'll be able to switch gears as
circumstances unfold.

 Communicate your work plan effectively. If your team knows what is expected of them, they'll be
able to complete work on schedule, and if they don't understand the timing and expectations, they'll
just be flying blind. Communicate both the initial plan and changes that are introduced along the
way.
Maintenance Planning Principle
Planning Principle #1
It is very important that the role of the planner/scheduler is identified to be independent of the other
activities going on within a plant or facility. Take the planners off the tools and behind a desk in terms of
the administration of the work to be done. Responsibilities of the planner/scheduler should not include:

 Planning emergency work

 Acting as a relief supervisor

 Becoming a material expeditor

 Working on tools

 Performing time-consuming clerical activities

 Becoming a “go-fer” for maintenance / operations supervisor

Planning Principle #2
A planner must focus on arranging current and future maintenance work, as well as allocating the
appropriate resources, parts, finances, costs, and reliability information for each project. The planners
must also emphasize constant improvement, and use the Deming model on continuous improvement for
planning, doing, checking, and acting/adjusting schedules:

 Problem

 Goal
 Point of cause

 Root causes

 Counter measures

 Follow-up

 Standardization

Planning Principle #3
When implementing different component levels within your CMMS, take advantage of International
Standards such as ISO 14224 for best practice tips and ease of compliance. Component levels are
“minifiles” on every piece of equipment. They include work order histories, equipment registry, parts
registry and more.
Planning Principle #4
Once tasks are identified, an important principle of maintenance planning is to ensure all instructions are
documented and standardized. The best planners have experience estimating time and comparing actuals
of work done in bite size chunks in order to bring efficiencies into the next iteration of carrying out
preventive maintenance.
Planning Principle #5
Sometimes it’s not best to reinvent the wheel for all pieces of equipment. Planners should take advantage
of standard plans and enhance them. Plans will also take into account and recognize the skills of craft
technicians.
Planning Principle #6
Take advantage of data from past work to properly estimate appropriate and accurate plans for the
future. This will make wrench time more available and the more wrench time available, the more
maintenance activity can be performed.

 Measuring how much time craft technicians actually spend on the job site versus other activities
determines the effectiveness of the maintenance planning program: (Obtaining parts or tools, etc.)

 Delays are not simply part of a technician’s job and should be avoided

 Sampling wrench time can be used to measure how effective planning can be

 Use this as a metric to determine how effective your maintenance team is and look for ways to
improve performance when gaps emerge
People Rules of Planning

 Rule 1: The planning program is not trying to give away the plant’s work to contractors

 Rule 2: Planners cannot do the perfect job

 Rule 3: Planning is not designed to take the brains out of the technicians

 Rule 4: The technician owns the job after the supervisor assigns it to them

 Rule 5: Planners cannot make the perfect time estimate

 Rule 6: Management cannot hold technicians accountable to time estimates for single jobs
 Rule 7: Showing what is not correct is often as important as showing what is correct

 Rule 8: Planners do not add value if they help jobs-in-progress

 Rule 9: Everyone is an adult

 Rule 10: Everyone should enjoy their work

 Rule 11: Everyone should go home at the end of each day knowing if they have won or lost

 Rule 12: Wrench time is not strictly under the control of the technicians

 Rule 13: Schedule compliance is not strictly under the control of the new supervisors

 Rule 14: It is better to train employees and lose them, than not to train them and keep them.

Maintenance Scheduling Principles

Scheduling Principle #1
To set realistic goals and schedules, the planner/scheduler must look at the appropriate resources for the
work to be performed and an estimate of the hours and effort it will require. To manage this process and
avoid roadblocks, try to plan to the lowest required skill level available and work upwards.
If you work the opposite way, organizations may end up in a situation where skills are available, but the
sort of work available is not appropriate for the priority level skill element. As a best practice, at the
beginning of a project, identify skills for:

 # Persons

 # Work hours

 Duration of work

Scheduling Principle #2
The most effective scheduling, identifying job priorities is important. The highest priority work (Priority
5) is the most urgent, and should be followed up on first. For example:
The ISO 14224 standard can help prioritize activities with the Failure-consequence Classification chart.
It is useful in terms of setting up asset information, analyzing reliability information, putting P&ID or
boundary drawings together, etc. It helps in terms of how to prioritize one work order over another.

Scheduling Principle #3
Scheduling from forecast of the highest skills available helps to increase productivity. If the work orders
are generated 10 days in advance, then more details can be put into the scheduling, resources,
availability of parts, and work to be done. Consider what jobs can be put together, what jobs can be
grouped, what condition monitoring work is outstanding and can it be bundled, and any proactive work
that can be done in advance.
Scheduling Principle #4
To help set up an organization’s maintenance team for success, scheduling work for every hour available
is a good rule of thumb, and allows for organizations to achieve practical goals.
In March 2015 on Maintenance Planner / Schedulers group on LinkedIn, a member asked: “Normally
scheduling is 100% of available resources. Due to several reasons assigned works are completed earlier
than the planned time. In order to increase craft utilization (wrench time) should we increase the
scheduling % of resources?”
An answer to this question comes from Doc Palmer, author of McGraw Hill Maintenance Planning and
Scheduling Handbook: “The purpose of the schedule is to help us complete more work than we would
normally do without the schedule. My experience is that crews that start out with a 100% loaded
schedule complete more work orders than crews that start out with only 80% loaded schedules. The
crews that start out with 100% loaded schedules do have lower schedule compliance. The schedule
compliance score is a management indication of how much is in the way of the crews trying to complete
expected work.”
Scheduling Principle #5
When it comes down to daily activities, the planner/scheduler should leave the granular detail of the
planning and scheduling to a crew leader or technician supervisor. With proper training, these crew
members can use a CMMS and take advantage of functionality to realign the resources based on their
priorities for the day. This should be easy enough if the planning and scheduling is proactive, but
knowing that potential emergencies and urgent activities might interrupt the day, there is still a chance
that it can be done if 80-90% of the day is planned out.
Scheduling Principle #6
In order to keep employees engaged, begin measuring performance by analysis of scheduled success.
This measure avoids supervisors feeling the calculation gives an unfair poorer-than-actual view of their
performance, and offers the crew any benefit of any doubt.

7 QC Tools:
The Seven Basic Tools of Quality (also known as 7 QC Tools) originated in Japan when the country was
undergoing major quality revolution and had become a mandatory topic as part of Japanese’s industrial
training program. These tools which comprised of simple graphical and statistical techniques were
helpful in solving critical quality related issues. These tools were often referred as Seven Basics Tools of
Quality because these tools could be implemented by any person with very basic training in statistics
and were simple to apply to solve quality-related complex issues.
7 QC tools can be applied across any industry starting from product development phase till delivery.
7QC tools even today owns the same popularity and is extensively used in various phases of Six
Sigma (DMAIC or DMADV), in continuous improvement process (PDCA cycle) and Lean management
(removing wastes from process).
The seven QC tools are:
1. Stratification (Divide and Conquer)
2. Histogram

3. Check Sheet (Tally Sheet)

4. Cause-and-effect diagram (“fishbone” or Ishikawa diagram)
5. Pareto chart (80/20 Rule)

6. Scatter diagram (Shewhart Chart)

7. Control chart

1. Stratification (Divide and Conquer)

Stratification is a method of dividing data into sub–categories and classify data based on group, division,
class or levels that helps in deriving meaningful information to understand an existing problem.
The very purpose of Stratification is to divide the data and conquer the meaning full Information to
solve a problem.
 Un–stratified data (An employee reached late to office on following dates)
5-Jan, 12-Jan,13-Jan, 19-Jan, 21-Jan, 26-Jan,27-Jan
 Stratified data: (Same data classified by day of the week )

(Frequency – Late in office day wise)

2. Histogram
Histogram introduced by Karl Pearson is a bar graph representing the frequency distribution on each
bars.
The very purpose of Histogram is to study the density of data in any given distribution and understand
the factors or data that repeat more often.
Histogram helps in prioritizing factors and identify which are the areas that needs utmost attention
immediately.

(Histogram: Defects day wise)

3. Check sheet (Tally Sheet)
A check sheet can be metrics, structured table or form for collecting data and analysing them. When the
information collected is quantitative in nature, the check sheet can also be called as tally sheet.
The very purpose of checklist is to list down the important checkpoints or events in a tabular/metrics
format and keep on updating or marking the status on their occurrence which helps in understanding the
progress, defect patterns and even causes for defects.

(Check Sheet: Defect types with their occurrence on day of the week)
4. Cause-and-effect diagram. (“Fishbone” or Ishikawa diagram)
Cause–and–effect diagram introduced by Kaoru Ishikawa helps in identifying the various causes (or
factors) leading to an effect (or problem) and also helps in deriving meaningful relationship between
them.
The very purpose of this diagram is to identify all root causes behind a problem.
Once a quality related problem is defined, the factors leading to the causal of the problem are identified.
We further keep identifying the sub factors leading to the causal of identified factors till we are able to
identify the root cause of the problem. As a result we get a diagram with branches and sub branches of
causal factors resembling to a fish bone diagram.
In manufacturing industry, to identify the source of variation the causes are usually grouped into below
major categories:
 People
 Methods
 Machines
 Material
 Measurements
 Environment
 (Fishbone Diagram: Missed deadline in manufacturing of product)
5. Pareto chart (80 – 20 Rule)
Pareto chart is named after Vilfredo Pareto. Pareto chart revolves around the concept of 80-20 rule
which underlines that in any process, 80% of problem or failure is just caused by 20% of few major
factors which are often referred as Vital Few, whereas remaining 20% of problem or failure is caused by
80% of many minor factors which are also referred as Trivial Many.
The very purpose of Pareto Chart is to highlight the most important factors that is the reason for major
cause of problem or failure.
Pareto chart is having bars graphs and line graphs where individual factors are represented by a bar
graph in descending order of their impact and the cumulative total is shown by a line graph.
Pareto charts help experts in following ways:
 Distinguish between vital few and trivial many.
 Displays relative importance of causes of a problem.
 Helps to focus on causes that will have the greatest impact when solved.
 (Pareto Chart: Causes for defects in supplied items)
6. Scatter diagram
Scatter diagram or scatter plot is basically a statistical tool that depicts dependent variables on Y – Axis
and Independent Variable on X – axis plotted as dots on their common intersection points. Joining these
dots can highlight any existing relationship among these variables or an equation in format Y = F(X) +
C, where is C is an arbitrary constant.
Very purpose of scatter Diagram is to establish a relationship between problem (overall effect) and
causes that are affecting.
The relationship can be linear, curvilinear, exponential, logarithmic, quadratic, polynomial etc. Stronger
the correlation, stronger the relationship will hold true. The variables can be positively or negatively
related defined by the slope of equation derived from the scatter diagram.
 (Scatter Diagram: Types of correlation in Scatter Plot)
7. Control Chart (Shewhart Chart)
Control chart is also called as Shewhart Chart named after Walter A. Shewhart is basically a
statistical chart which helps in determining if an industrial process is within control and capable to meet
the customer defined specification limits.
The very purpose of control chart is to determine if the process is stable and capable within current
conditions.
In Control Chart, data are plotted against time in X-axis. Control chart will always have a central line
(average or mean), an upper line for the upper control limit and a lower line for the lower control limit.
These lines are determined from historical data.
By comparing current data to these lines, experts can draw conclusions about whether the process
variation is consistent (in control, affected by common causes of variation) or is unpredictable (out of
control, affected by special causes of variation). It helps in differentiating common causes from special
cause of variation.
Control charts are very popular and vastly used in Quality Control Techniques, Six Sigma (Control
Phase) and also plays an important role in defining process capability and variations in productions. This
tool also helps in identifying how well any manufacturing process is in line with respect to customer’s
expectation.
Control chart helps in predicting process performance, understand the various production patterns and
study how a process changes or shifts from normally specified control limits over a period of time.

(Process Control Chart)

Vendor inspections:
 Vendor inspections are surveillance activities on testing carried out at supplier's premises, during
production. In Infrastructure market, where procurement assigns a massive number of items, with many
different manufacturers around the world, vendor inspections have several benefits as such as:

 assure the good development of the project

 check the right quality of equipment, products and components delivered by vendors

 verify the conformity with the requirements of applicable international standards or technical
specifications stated in the contract

 detect eventual defects at source

 check in advance the compliance with client expectations, in order to minimize or avoid the risk of
extra costs, due to subsequent failures at site.

Sampling plan:
A sampling plan allows an auditor or a researcher to study a group (e.g. a batch of products, a segment
of the population) by observing only a part of that group, and to reach conclusions with a pre-defined
level of certainty. A sampling plan is a detailed outline of which measurements will be taken at what
times, on which material, in what manner, and by whom. Sampling plans should be designed in such a
way that the resulting data will contain a representative sample of the parameters of interest and allow
for all questions, as stated in the goals, to be answered.
The steps involved in developing a sampling plan are:
1. identify the parameters to be measured, the range of possible values, and the required resolution

2. design a sampling scheme that details how and when samples will be taken

3. select sample sizes

4. design data storage formats

5. assign roles and responsibilities

Once the sampling plan has been developed, it can be verified and then passed on to the responsible parties
for execution.
What is random sampling?
In most cases, units from the group (or ‘population’) are picked at random.
In a random sample, all units/parts have the same likelihood of being selected for inspection.
Is it always necessary to inspect/test a sample in order to draw a conclusion about an entire batch?
No, it is not. If you check 50 watches costing 200 USD each, it might make more sense to check all 50 of
them, one by one.
In contrast, if you purchase 4 containers of Christmas balls costing 24 cents each, it makes no economic
sense to check 100% of them! You need to work on the basis of random sampling.
Statistical sampling plans
If an inspector controls the quality of your products in China, he probably checks only a portion of the whole
batch.
But how does he decide how many pieces to pick for his inspection? How does he decide what number of
defective units is “too many”? And how certain is he to make the right decision, since it is based on his
findings on a random sample?
Let’s say you decided to draw samples from a batch of products.
An unsophisticated approach to sampling often looks like this:
Take 10% randomly, and check these pieces.
We don’t suggest such a scheme for an activity your company will perform regularly. There are two reasons
for this:
1. How can you make the link between this plan and your risk as the buyer (of accepting a batch that is
worse than what you are willing to accept)?
2. Let’s say you find 3% of the samples you picked are defective. You are left negotiating with the
factory, with no previously-agreed rule to decide if they should take action (e.g. sort out the whole
batch and set aside the issues).
Quality audit system:
Quality audit is the process of systematic examination of a quality system carried out by an internal or
external quality auditor or an audit team. It is an important part of an organization's quality management
system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly
defined internal system monitoring procedures linked to effective action. This can help determine if the
organization complies with the defined quality system processes and can involve procedural or results-based
assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits
has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality
Management System (QMS) and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess
how successfully processes have been implemented, for judging the effectiveness of achieving any defined
target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of
the organization, quality auditing should not only report non-conformances and corrective actions, but also
highlight areas of good practice. In this way other departments may share information and amend their
working practices as a result, also contributing to continual improvement.
Quality audits can be an integral part of compliance or regulatory requirements. One example is the US
Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System
Regulation (QSR) for medical devices.
Several countries have adopted quality audits in their higher education system (New Zealand, Australia,
Sweden, Finland, Norway and USA) Initiated in the UK, the process of quality audit in the education system
focused primarily on procedural issues rather than on the results or the efficiency of a quality system
implementation.
Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most
powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly
deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness.
The processes and tasks that a quality audit involves can be managed using a wide variety of software and
self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and
conformance to standards, while others relate to Quality costs or, more accurately, to the Cost of poor
quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather than
just to conventional production or assembly processes.
A quality audit is a process by which you review and evaluate an element of your business to ensure that
you're meeting certain standards. The standards vary—you can set them or you can follow standards set by
your industry.
Types
A quality audit can apply to various aspects of a business, but a few types stand out. You can perform a
quality audit of your inventory or service to assure that it's acceptable for consumption by the public. This is
particularly important in the case of a product or service that could pose a threat to public safety. Some
business owners perform quality audits on employees, or rather the way employees perform. This is
particularly important in an atmosphere where workers must interact directly with customers. The business
may also perform quality audits on management, which would require a third-party evaluator in the case of a
small company managed by the owner. Finally, if the company has to maintain information in databases,
you can also perform data quality audits.
Significance
Performing quality audits are important for a few key reasons. For one, it ensures that the business is
offering a value to the public. For instance, selling a high-quality product or employing high-quality
customer service personnel can fuel future sales. It's also useful for advertising the business—informing the
public that the company is committed to quality standards and performs these regular audits may help
increase consumer confidence in the business. Finally, regular quality audits help protect the business from
issues that could arise from selling a poor quality product.
ISO
Some companies seek ISO 9001 certification, which requires a set of strict standards of quality established
by the International Organization for Standardization. Others seek Six Sigma training and certification to
help improve the business and ensure quality. The business must study and meet the standards set by the
organization to become certified. The specific requirements vary by industry and the certification can help
keep the business competitive.
At a high level, quality audits are conducted to obtain objective evidence of operational compliance. There
are several different types of audits that can be conducted to validate conformity. Audits can be performed
internally, externally by a supplier, or by an independent third party. Audits can encompass processes,
systems or products, but in all cases, they are measured against a defined set of standards.

The following is a list of 10 commonly performed quality audit types:

Internal Quality System Audit
This type of audit is an examination of the tool used to measure quality itself. An internal quality audit seeks
to evaluate an organization’s Electronic Quality Management System (EQMS). The quality documentation
and processes managed by the software solution are reviewed to ensure maximum efficiency and high-
quality product outcomes. The software manual is audited to ensure all critical areas of the solution are
covered and all key employees readily have access to the document. Work instructions are audited to ensure
conformity to standard operating procedures and to confirm quality processes are meeting targets.

Supplier Audit
Supplier audits allow an organization to collaborate in real-time directly with its suppliers. By auditing the
supply chain, companies can control the quality of its suppliers and sub-tier suppliers and introduce
accountability for poor performers. Key performance indicators (KPIs) quickly identify areas for
improvement. With this level of transparency, suppliers are able to view purchase order activity such as
receipt and inspection history in order to collaborate on nonconformances and corrective actions.

Production Team Audit

Production team members usually get an examination (audit) when Operator Acceptance or Certified
Operator programs are in place, or when skills management re-qualifications are required. Auditors evaluate
changes to processes, evidence of training, past activity for escapes, nonconformance, and conformity
inspections of operator accepted product as part of the re-qualification.

Safety Audit
A safety audit looks at the plans and procedures designed to protect the safety of company employees. This
type of audit can include a review of equipment operation or an examination of organizational procedures to
ensure routine safety. Successful safety policies prevent injuries and accidents from occurring and improve
overall employee well-being.

Facilities Audit
A facilities audit addresses quality concerns of a corporation’s assets. Components of a facilities audit can
include a review of building systems such as HVAC, manufacturing equipment or technology. Processes
associated with these facilities are reviewed to ensure safety and identify improvements that could affect
quality outcomes.

Environmental Audit
Environmental audits are designed to help companies create a safer work environment by helping to identify
areas of workplace risk with an actionable plan to meet OSHA and other standards. An audit is conducted to
ensure employees are adhering to regulatory standards and using appropriate personal protective equipment.

Risk Assessment Audit

A risk assessment is a process that identifies potential workplace hazards, then categorizes each risk so
preventative measures can be put into place. An audit of this type helps companies put an effective risk
mitigation strategy into action. When all risks have been identified, preventative measures can be prioritized,
preventing adverse workplace and economic consequences.

Design Control Audit

Design control audits are conducted within highly regulated industries to ensure that manufacturers follow a
formalized process that results in an end-product that meets acceptable quality and safety standards and
adequately serves user needs. The design plan and design inputs and outputs are reviewed for proper
acceptance criteria and a risk analysis is performed.

Regulatory Audit
Regulatory audits are conducted to verify compliance with a specific set of regulations or standards. Quality
practices are examined, and the data collection process is systematically reviewed to identify possible areas
of nonconformance. Examples of regulatory agencies include FAA, DARPA, DCMA, ISO, AS9100 as well
as many others.
Method Validation Audit
A method validation audit is used by the FDA or other regulatory authorities to ensure that the analytical test
methods used in the manufacturing process are standardized, reproducible and documented. This
methodology is applied to testing that requires consistency and accuracy, usually in cases of products
manufactured for human use.

An Electronic Quality Management System (EQMS) is key in helping a company build an effective audit
management strategy. The system provides the flexibility to manage customer specific audit processes. An
EQMS supports internal and external audits and allows auditors to get their job done more efficiently. With
an effective audit management strategy in place, companies can examine their audit process and better
predict where improvements can be made.