16431 Quality Assurance

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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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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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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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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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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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depart-

ment

Line

depart-

ment

Upper

depart-

ment


Draft of polices, procedures and other rules to be

followed

in in -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -

Final approval - - In

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -


Scheduling of audits In In -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -



Conduct of audits In - -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -




Verification - In -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -




Verification - In -Publication of reports with facts In - -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -





Discussion on reports In In In

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

in in -






Discussion on action to be taken - In -

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depart-

ment

Line

depart-

ment

Upper

depart-

ment



followed

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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quality

Stated objectives in the budgets, programs,

contracts, etc.

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quality


contracts, etc. Customer and companyquality specifications

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quality



Government specifications

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quality




Otherquality standards on products, processes

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quality




Otherquality standards on products, processes Published guides for conduct ofquality audits

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quality





Quality department instructions

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quality





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

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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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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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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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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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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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Details of audit plan (including audit personnel,

dates, activities)

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dates, activities)

Standards, checklist, or other referencedocuments that were used in auditing

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dates, activities)


Recommendations for improvement

opportunities

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dates, activities)



opportunities

Recommendations for follow-up on the corrective

plans

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dates, activities)



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

16431 Quality Assurance

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