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Quality assurance
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Introduction
Quality assurance (QA) is a broad conceptthat focuses on the entire quality system
including suppliers and ultimate consumers of
the product or service. It includes allactivities designed to produce
products and services of appropriate quality
QA includes all those planned or systematicactions necessary to provide adequate
confidence that a product or service will
satisfy given needs2
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Quality assurance
It is an enhancement to the traditional way ofdoing business
It is a proven technique to guarantee survivalin the world class competition.
Only change in action of the management willchange the culture and actions of an entire
organization
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DIFFERENCE IN TRADITIONAL AND
QUALITY APPROACH
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Quality assurance
It is a philosophy and a set of guiding
principles that represents the foundation of a
continuously improving organization
Quality assurance is the activityof providing
the evidence needed to establish confidence
that quality related activities are being
performed affectively
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Quality assurance
Provide protection against quality problems
Examples of departmental quality assurance
activities:-
Marketing Product evaluation
Product monitoring
Productdevelopment DesigningManufacturing analysis
Inspection analysis
Maintainability analysis6
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Examples of departmental quality
assurance activities
Production Process capability analysis
Failure mode analysis for process
Audits of production quality
Inspection Inter-laboratory test
Measurement
Customer
service
Audit of packing, transportation and
storage
Evaluation of maintenance services
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Quality assurance
Quality assurance is similar to the concept of
financial audit, which provide assurance of
financial problems
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Quality audit
Quality audit is an independent review
conducted to comparequality performance
with standard
Quality audit is an independent evaluation to
determine whether the quality activities are
suitable for achieving objectives or not
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Purpose of quality audits
Purpose of quality audits is to provide
assurance that:-
If we follow the plans we will attain the quality
level
Products are useful and safe for customers
Procedures are adequate for manufacturing
Deficiencies are identified and corrective action istaken
Opportunities for improvement are identified
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Subject matter of audits
What we should to do assure the quality?
In large companies, the program of audit use
one or more of the following approaches for
dividing up the subject matter:-
Organizational unit: in large companies
multiple teams ofquality auditors are there
to do their specific work/job
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Subject matter of audits
Product lines: here the audits evaluates
quality aspects of specific product lines(eg.
Pump) all the way from design through field
performance
Quality systems: they can review any system
such as design, manufacturing, supplier
quality, etc
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Subject matter of audits
Specific activities: audits may also be
designed to do a single job which has special
significance to the quality mission:
documentation, instrument calibration, etc
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Specific Activity Examples
Engineering documentation Use of latest specifications
Time required for design
Machines and tools Use of specific machines and tools for
minimum maintenance
Calibration To do accurate measurements
Production and inspection Certification programs for critical skills
and training
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Subject matter of audits
Specific Activity Examples
Production facilities Cleanliness and
Control of critical environment
Inspection instruments Existence of instruments
Proper Working of required instruments
Documentation of inspection results Required details
Feedback from production personals
Material status Material storage
Inspection report
Material handling
Segregation of defective products
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Subject matter of audits
Identifying opportunities for improvement
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Structuring the audit program
To do auditing programs we need a
structure/collaboration
It include:
The heads of the activities
The heads of auditing department(s)
The upper management, which presides over both
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Structuring the audit program
audit program will fail without such
collaborations
Because one cant improve the quality
failure mode may be due to: Abrasive relationship b/w auditor and line
manager
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
Verification - In -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
Verification - In -Publication of reports with facts In - -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
Verification - In -Publication of reports with facts In - -
Discussion on reports In In In
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
Verification - In -Publication of reports with facts In - -
Discussion on reports In In In
Discussion on action to be taken - In -
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Steps in constructing an audit
programActivities Audit
depart-
ment
Line
depart-
ment
Upper
depart-
ment
Discussion of purpose to be achieved by audits in in in
Draft of polices, procedures and other rules to be
followed
in in -
Final approval - - In
Scheduling of audits In In -
Conduct of audits In - -
Verification - In -Publication of reports with facts In - -
Discussion on reports In In In
Discussion on action to be taken - In -
Subsequent follow-up In - -27
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Planning and performing audits on
activities
Now we want to conduct audits which has
been approved by upper management
Most of the auditing is done on a scheduled
basis, no surprises, no secrets
They organize(divide) the work-loads and do
accordingly
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Use of reference standards and
checklists
Auditor compare the activities with objective
standard
Comparison is done to keep the difference
minimum b/w actual and reference standard
values
For continuous improvement
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Reference standards include:
Written policies of the company as they apply to
quality
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc.
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
Government specifications
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
Government specifications
Otherquality standards on products, processes
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
Government specifications
Otherquality standards on products, processes Published guides for conduct ofquality audits
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
Government specifications
Otherquality standards on products, processes Published guides for conduct ofquality audits
Quality department instructions
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Reference standards include:
Written policies of the company as they apply to
quality
Stated objectives in the budgets, programs,
contracts, etc. Customer and companyquality specifications
Government specifications
Otherquality standards on products, processes Published guides for conduct ofquality audits
Quality department instructions
Generalliterature on auditing37
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checklist
Checklist identifies the areas of subject
matter which are to be checked
Eg:
Maintenance of
machines,
tools, or
control of engineering change order(process)
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Verification of facts
Line department verify the facts(symptoms)
of any deficiencies discovered during the
audit
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Discovery of causes
In many companies, the Auditor is expected
to investigate major deficiencies and their
causes
In other companies, Auditor is expected to
leave such investigations to the line
department
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Recommendations and remedies
Auditors are expected to makerecommendations with a view to reducing
deficiencies and improving performance
Auditors are expected to follow up
recommendations to ensure that something
specific is done i.e. , that therecommendation is accepted or rejected
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Flow chat for quality audit
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Human relations in auditing
Human relations are very important in quality
auditing
To improve quality standards or
To ensure the quality
Because
Single person canruin the quality but
Single person cant improve/ensure the quality
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Human relations in auditing
And to achieve the quality standards
we need team work
and for team work
weneed human relationships
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H t i t i th h
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How to maintain the human
relations
The reason behind the audits:
It is not enough to explain that upper
management wants audit done
Must explain the reasons why we are doing these
things
Must explain the benefits they derive from audits
(because all the employees are customers,
consumers and concerned citizens)48
H t i t i th h
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How to maintain the human
relations
Avoiding an atmosphere of blame:
Dont try to blame someone
Try to find out the possible ways to achieve
improvement
Audit report should be problem-oriented ratherthan person-oriented
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H t i t i th h
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How to maintain the human
relations
Balance in reporting:
means report must include opportunities with
deficiencies
Depersonalizing the report:
In many companies, auditors want that their
report should be reviewed by the uppermanagement
These things should avoid
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H t i t i th h
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How to maintain the human
relations Depersonalize the reports and recommendations
Real recommendations shouldbein the form of
factsrather than the opinion
Auditor has a right and a duty to add his /her
opinion as an input to the decision-makingprocess
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H t i t i th h
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How to maintain the human
relations
Post-audit meeting:
Meeting with audit manager/line manager
At this meeting, auditors observations are
presented to take a corrective action
In addition, the managercan point out anymistake w.r.t. facts
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Ho to maintain the h man
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How to maintain the human
relations
Self-audit and independent audit:
build an atmosphere of trust based on prior
reputation of auditor
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Audit reporting
Audit results should be documented in a
report, and a draft should be reviewed with
the management of the activity(head)
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Report should include
Purpose and scope of the audit
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Report should include
Purpose and scope of the audit
Details of audit plan (including audit personnel,
dates, activities)
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Report should include
Purpose and scope of the audit
Details of audit plan (including audit personnel,
dates, activities)
Standards, checklist, or other referencedocuments that were used in auditing
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Report should include
Purpose and scope of the audit
Details of audit plan (including audit personnel,
dates, activities)
Standards, checklist, or other referencedocuments that were used in auditing
Recommendations for improvement
opportunities
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Report should include
Purpose and scope of the audit
Details of audit plan (including audit personnel,
dates, activities)
Standards, checklist, or other referencedocuments that were used in auditing
Recommendations for improvement
opportunities
Recommendations for follow-up on the corrective
plans
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Report should include
Purpose and scope of the audit
Details of audit plan (including audit personnel,
dates, activities)
Standards, checklist, or other referencedocuments that were used in auditing
Recommendations for improvement
opportunities
Recommendations for follow-up on the corrective
plans
Distribution list for audit reports60
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Summarizing audit data
Summarize the report by finding the facts and
the discrepancies
It include:
Reports of each discrepancy to secure the
corrective actions
Performance of individual team
A report ofoverall status of subject matter
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Summarizing audit data
Evaluate overall quality performance by
answering following questions
Is the product safe?
Is the product fit for use? Is the product marketable?
Are we complying with legal requirements?
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Seriousness classification
In include the classification ofdiscrepancies/defects/inadequacies as:
Critical
Major minor
Discrepancies may be found in:
planning, procedures,
decision-making
data-recording and so on63
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Units of measure
Compare the inadequacies found against
some estimate of the opportunities for
inadequacies
Means comparison b/w actual no. of defects
and expected no. of defects
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Distribution of audit reports
Traditionallyphoto-copies of the reports are
sent to the upper management for
notification, review, and possible follow-ups
If discrepancies are there, they will not happywith audit report
So audit report is sent to auditing head(line
management) and a follow-up audit isscheduled to correct maximum discrepancies