Quality assurance

Introduction
Quality assurance (QA) is a broad concept that focuses on the entire quality system including suppliers and ultimate consumers of the product or service. It includes all activities designed to produce products and services of appropriate quality QA includes all those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given needs
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Quality assurance
It is an enhancement to the traditional way of doing business It is a proven technique to guarantee survival in the world class competition. Only change in action of the management will change the culture and actions of an entire organization
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DIFFERENCE IN TRADITIONAL AND QUALITY APPROACH

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 activity of 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 development

Product evaluation Product monitoring

Designing Manufacturing analysis Inspection analysis Maintainability analysis
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Examples of departmental quality assurance activities

Production Process capability analysis Failure mode analysis for process Audits of production quality Inter-laboratory test Measurement Audit of packing, transportation and storage Evaluation of maintenance services

Inspection Customer service

Quality assurance
Quality assurance is similar to the concept of financial audit, which provide assurance of financial problems

Quality audit
Quality audit is an independent review conducted to compare quality performance with standard Quality audit is an independent evaluation to determine whether the quality activities are suitable for achieving objectives or not

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 is taken 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 of quality 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
Specific Activity Engineering documentation Machines and tools Calibration Production and inspection Examples Use of latest specifications Time required for design Use of specific machines and tools for minimum maintenance To do accurate measurements Certification programs for critical skills and training

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Subject matter of audits

Specific Activity Production facilities Inspection instruments Documentation of inspection results Examples Cleanliness and Control of critical environment Existence of instruments Proper Working of required instruments 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 program

Activities Audit department in Line Upper depart- department ment in in Discussion of purpose to be achieved by audits

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Steps in constructing an audit program

Activities Audit department in in Line Upper depart- department ment in in in Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed

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Steps in constructing an audit program

Activities Audit department in in Line Upper depart- department ment in in in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval

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Steps in constructing an audit program

Activities Audit department in in In Line Upper depart- department ment in in In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits

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Steps in constructing an audit program

Activities Audit department in in In In Line Upper depart- department ment in in In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits

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Steps in constructing an audit program

Activities Audit department in in In In Line Upper depart- department ment in in In In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits Verification

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Steps in constructing an audit program

Activities Audit department in in In In In Line Upper depart- department ment in in In In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits Verification Publication of reports with facts

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Steps in constructing an audit program

Activities Audit department in in In In In Line Upper depart- department ment in in In In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits Verification Publication of reports with facts

Discussion on reports

In

In

In

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Steps in constructing an audit program

Activities Audit department in in In In In Line Upper depart- department ment in in In In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits Verification Publication of reports with facts

Discussion on reports Discussion on action to be taken

In -

In In

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Steps in constructing an audit program

Activities Audit department in in In In In Line Upper depart- department ment in in In In in In Discussion of purpose to be achieved by audits Draft of polices, procedures and other rules to be followed Final approval Scheduling of audits Conduct of audits Verification Publication of reports with facts

Discussion on reports Discussion on action to be taken

Subsequent follow-up

In In

In In
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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 company quality 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 company quality 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 company quality specifications Government specifications Other quality 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 company quality specifications Government specifications Other quality standards on products, processes Published guides for conduct of quality 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 company quality specifications Government specifications Other quality standards on products, processes Published guides for conduct of quality 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 company quality specifications Government specifications Other quality standards on products, processes Published guides for conduct of quality audits Quality department instructions General literature on auditing

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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 make recommendations 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 the recommendation 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 can ruin 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

we need human relationships

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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)
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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 rather than person-oriented

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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 upper management These things should avoid
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How to maintain the human relations

Depersonalize the reports and recommendations Real recommendations should be in the form of facts rather than the opinion Auditor has a right and a duty to add his /her opinion as an input to the decision-making process

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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 manager can point out any mistake w.r.t. facts

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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 reference documents 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 reference documents 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 reference documents 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 reference documents that were used in auditing Recommendations for improvement opportunities Recommendations for follow-up on the corrective plans Distribution list for audit reports
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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 of overall 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 of discrepancies/defects/inadequacies as:
Critical Major minor

Discrepancies may be found in:

planning, procedures, decision-making data-recording and so on

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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

Traditionally photo-copies of the reports are sent to the upper management for notification, review, and possible follow-ups If discrepancies are there, they will not happy with audit report So audit report is sent to auditing head(line management) and a follow-up audit is scheduled to correct maximum discrepancies
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