TQM:UNIT-5

PPT No.: PPT_TQM_Unit 5_1_2019-20

by

Dr. P. K. Chaudhary
AMIE(I), FIE (I), Chartered Engg. (IEI)
M. Tech. in Industrial Engg., IT-BHU
Ph. D. in Mech. Engg., IIT-BHU
Professor & Dean
Department of Mech. Engg.
Buddha Institute of Technology
Gorakhpur (UP)
Objective
To have a foundation of purpose of Quality
system
 Outcome
Students will be able to describe the following:
1. Concepts of different Quality system
 Introduction
• ISO- International Organization for Standardization
• Founded in 1946, in Geneva, Switzerland
• Main function is to promote the development of standardization of
goods and services, to better accommodate a world wide market.
• ANSI- American National Standards Institute
• ANSI represents U.S. in the ISO
 ISO Registration
• Companies can become registered as an ISO company
• This involves the registrar giving an assessment of the operations a
company, and then making periodic surveillance audits
• Primary Reason: To give your customer the comfort of knowing that
you have a quality plan in place, and it is being monitored by an
objective third party
 Internal Reasons for Becoming ISO
Registered
• 100 Italian manufacturing firms were surveyed to find out what
improved after certification.
• Internal quality: less scrap, rework, nonconformities
• Production reliability: less breakdowns, less time with emergencies,
downtime
• Time performance: time to market, punctual deliveries
Externally: less nonconformities
 Negatives
• Prevention and appraisal costs increased
• Only one negative shown in 100 surveys.
• Positives outweigh negatives
• Takes time to implement, but worth it in the long run
 ISO 9000
• The ISO 9000 series of standards is generic
• It is designed to adapt to fit any industry type
• Three standards of the 9000 series:

• ISO 9000:2000- Fundamentals and vocabulary

• ISO 9001:2000- Requirements
• ISO 9004:2000- Guidelines for performance improvements
 Sector-specific Standards
• Some industries require special set of ISO rules; not operated the
same as most
• Three other quality systems:

• AS9100-
• ISO/TS 16949
• TL9000
 AS9100
• This standard is specifically for the aerospace industry
• Attempt at unifying the requirements of NASA, DOD, and FAA
• At the same time satisfying the industry’s needs
 ISO/TS 16949
• Standard specifically for automotive suppliers
• Merges supplier quality requirements of U.S. with German, French,
and Italian automakers
• Goal- provide continuous improvement, defect prevention, reduce
variation and waste
• Is assumed that this standard will show 85% improvement rate in first
5 years
 TL9000
• Telecommunications Industry
• Consolidate various quality systems requirements
• Defines design, development, production, delivery, installation and
maintenance of telecommunications
• Customers receive benefits , worldwide competition, benchmarks,
improvement initiatives
 TL 9000 continued-
• This standard focused on:

• Hardware Specific Requirements and Measures

• Software Specific Requirements and Measures
• Services Specific Requirements and Measures
 ISO 9001 REQUIREMENTS
• The standard has 8 clauses

1)Scope
2)Normative Reference
3)Terms and Definitions
4)Quality Management Systems
5)Management Responsibility
6)Resource Management
7)Product Realization
8)Measurement Analysis and Improvement
 1. Scope

To provide a product that meets

a) Customer Requirement

b) Regulatory Requirements

c) Customers Satisfaction
 2. Normative Reference:
Fundamentals and vocabulary

3. Terms and Definitions:

Supplier Organization Customers
4. Quality Management System:
a) General Requirements
b) Documentation
* General Documentation
* Quality Manual
* Control of Documents
* Control of Records
5) Management Responsibility:
a) Management commitment
b) Customer Focus

c) Quality policy
d)Planning
* Quality Objectives
* Quality Management System
Planning
e) Responsibility, Authority, And Communication
* Responsibility and Authority
* Management Representative
* Internal Communication
f) Management Review
* General Management
* Review Input
* Review Output
6) Resource Management :

a) Provision of Resources
b) Human Resources
* General
* Competence, Awareness and Training
c) Infrastructure
d) Work Environment
7) Product Realization
a) Planning of product Realization
b) Customer Related Processes
* Determination Of Requirement Related to the Product
* Review Of Requirement Related to the Product
*Customer Communication
c) Design And Development
* Design And Development Planning
* Design And Development Inputs
* Design And Development Outputs
* Design And Development Review
* Design And Development Verification
* Design And Development Validation
* Control of Design And Development Changes
d) Purchasing
* Purchasing Process
* Purchasing Information
* Verification Of Purchased Product
e)Production And service Provision
* Control Of Production And service Provision
* Validation Of Processes For Production and service Provision
*Identification And Traceability
* Customer Property
* Preservation of Product
f) Control Of Monitoring And Measuring Devices
8) Measurement , Analysis, And Improvement
a) General
b) Monitoring And Measurement
* Customer Satisfaction
* Internal Audit
* Monitoring And Measurement Of Processes
* Monitoring And Measurement of Product and Service
c) Control Of Nonconforming Product
d) Analysis Of Data
e) Improvement
* continual improvement
* corrective Action
* preventive Action
 IMPLEMENTATION

1) Top Management Commitment

2) Appoint the Management Representative
3) Awareness
4) Appoint an Implementation Team
5) Training
6) Time Schedule
7) Select Element Owners
8) Review the Present System
9) Write the Documents
10) Install the New System
11) Internal Audit
12) Management Review
13) Pre-assessment
14) Registration
 POLICY:

• This is a document that defines what will be done and why.

• A quality policy manual should be written so it is clear, precise,
practical, and easy to understand.
 PROCEDURE:

• The procedures define

1) who should perform specific tasks
2) when the task should be done
3) Where documentation will be made
showing that the task was performed.
 WORK INSTRUCTIONS:

• Work instructions are usually department, machine, task, or product

oriented and spell out how a job will be done.
• The writing of a work instruction is best carried out by the employee
who performs the task.
 RECORDS:

• Records are a way of documenting that the polices, procedures, and

work instructions have been followed.
• Records provide data for corrective action and a way of recalling
products.
 DOCUMENT DEVELOPMENT:

• To begin creating the documentation system, the implementation team

should gather all the existing policies, procedures, work instructions,
and forms that are presently in use.

• When the documents have been completed, they should be formatted

in a manner that will allow for simple and effective document control.
 WRITING THE DOCUMENTS

• When writing the document it should be simple rather than complex.

• Use flow chart and check sheets where ever possible wherever
possible rather than lengthy verbiage.
 INTERNAL AUDITS
Objectives:
1) Determine that actual performance conforms to the documented
QMS.
2) Initiate corrective action activities in response deficiencies.
3) Follow up on noncompliance items from previous audits.
4) Provide continued improvement in the system through feedback to
management.
5) Cause the auditee to think about the process, thereby encouraging
possible improvement.
 AUDITOR:

A qualified individual who have received training in auditing

principles and procedures should perform audits.
 TECHNIQUES:

During the audit the auditor should employee three methods:

1) Examination of documents
2) Observation of activates
3) Interviews
 Examination of Documents:

The auditor should examine the documents in a systematic manner

1) Documents are identified with a title, revision date, and responsible
owner.
2) Documents are readily available to users
3) A master list by departments or function for procedures, work
instructions, and records is appropriately located.
4) There are no obsolete documents at workstations.
5) Changes follow a prescribed procedure.
Observation Activity:
It requires an aptitude for details.

Interviews:
1) Place the auditee in a non-threathing environment
2) Encourage employees to talk about the process.
3) Focus on the system not on the auditee.
4) Discuss the major issues informally with the auditee first.
5) Use the appropriate type of questions.
 PROCEDURE:

• Before the audit takes place an audit plan and check list should be
prepared.

• The audit itself has three parts

1) The pre-audit meeting
2) The audit
3) A closing meeting
 REGISTRATION

It is the assessment and audit of a quality system by a third party,

known as a registrar.

Two parts:
1) Selecting a registrar.
2) The registration process.
 SELECTING A REGISTRAR

• Qualifications And Experience

• Certificate Recognition
• The Registration Process
• Time And Cost Constraints
• Auditor Qualifications
 REGISTRATION PROCESS

The process has six basic steps:

1) Application for registration.
2) Document review.
3) Pre-assessment
4) Assessment
5) Registration
6) Follow-up surveillance
 CLOSING COMMENTS

• The standards are written for contractual compliance to the standard.

• Before entering into a contract for registration, management must be
able to justify the cost versus the potential gains in continued or
increased business.
 THANK YOU
And
Your Quarries, if any