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Chapter

1
1-A Awareness:
Introduction to ISO Series

Quality means the solution of customers problems. With the evaluation of civic sense, the
need for specific standards was identified. Also if we observe the creation of this world and
heavens, it is also structured on systematically documented grounds.

With the dramatic fall due to the Second World War, U.S. military starting working on the
standards and introduced U.S. MIL. SPEC. in 1954. Later on these standards were also
adopted by The British with some cultural and nomenclature changes like BS.EN:5750. Later
on a movement was started to establish a unanimously acceptable standard for all type of
organizations by ISO. ISO means International Organization for Standardization. The
organization published a process control standard named ISO 9001 in 1984. The standards
include procedures for planning, procurement, resource management, product and service
realization, handling and storage, Internal & external communication and customer
satisfaction. Quality Management Systems (QMS) have been an integral part of business
practices for many years. The implementation of a QMS is a decision made by the
organization, either as an internal improvement tool or in response to a customer requirement
or a combination of both. Conformance to the ISO 9000 family of standards is voluntary;
however in many industries it is a requirement of customers for their suppliers to have a
registered QMS in place.

ISO 9001:2000 is a generic set of guidelines that should form the framework for improvement
in any organization. The actual structure of the QMS will vary, depending on factors such as
organization objectives, type of product/service provided, the processes employed by the
organization and the size and structure.

The processes to draft, apply, implement and check the all above cited procedures is
comprised of following three levels of documentation;
System Manual

(Includes flow charted and descriptive procedures)

Job Instructions and Descriptions

(Include hiring and operational Limits)

Form

(Includes forms, cards, display signs, registers, boards and etc.)

Main essence is to implement whole of the document is through proper input, review and
monitoring of the three or five level of documents.

1-B Intro Contents:

Following contents should be explained to give the introduction of organization.
 Owners introduction

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 Organization history
 HR Strength
 Capacity
 Principal products
 Principal market
 General values

1-C General Terms:

Dept. Department
I/C In charge
Mktg. Marketing
QA Quality Assurance
QSM Quality System Manual
JID’s Job Instructions & Descriptions
CAP Corrective Action + Preventive
QMS Quality Management System

Conformity Fulfillment of specified requirements

Contract Review Systematic activities carried out by the supplier before

signing the contract to ensure that requirements for quality are adequately defined, free from
ambiguity, documented and can be realized by the supplier.

Defect Non-fulfillment of an intended usage requirement or

reasonable expectation, including one concerned with safety.

Inspection Activity such as measuring, examining, testing or gauging

one or more characteristics of an entity and comparing the results with specified requirements
in order to establish whether conformity is achieved for each characteristic.

Management Review Formal evaluation by top management of the status and

adequacy of the quality system in relation to the quality policy and objectives.

Objective Evidence Information, which can be proved true, based on facts

obtained through observation, measurement, test or other means.

Preventive Action Action taken to eliminate the causes of a potential non-

conformity, defect or other undesirable situation in order to prevent occurrence.

Procedure Specified way to perform an activity

Process Set of inter-related resources and activities which

transform inputs into outputs (resources may include personnel, finance, facilities, equipment,
techniques and methods)

Product Liability Generic terms used to describe the owns on a producer or

others to make restitution for loss related to personnel injury, property damage or other harm
caused by a product

Product Result of activities or process.

Qualification Process Process of demonstrating whether an entity is capable of

fulfilling specified requirements.

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Quality Assurance All the planned and systematic activities implemented
with in the quality system, and demonstrated as needed, to provide adequate confidence that
an entity will fulfil requirement for quality.

Quality Audit Systematic and independent examination to determine

whether quality activities and related results comply with planned arrangements and whether
these arrangements are implemented effectively and are suitable to achieve objectives.

Quality Control Operational techniques and activities that are used to

fulfill requirements for quality.

Quality Management All activities of the overall management function that

determine the quality policy, objectives and responsibilities, and implement them by means
such as quality planning, quality assurance, quality control and quality improvement within
the quality system.

QSM Document stating the quality policy and describing the

quality system of an organization.

Quality Plan Document setting out the specific quality practices,

resources and sequences of activities relevant to a particular product, project or contract.

Quality Planning Activities that establish the objectives and requirements

for quality and for the application of the quality system elements.

Quality Policy Overall intentions and direction of an organization with

regard to quality, as formally expressed by the top management

Quality System Organizational structure, procedures, process and

resources needed to implement quality management.

Quality Totality of characteristics of an entity (an activity , a

process, a product or/ and an organization) that bear on its ability to satisfy stated and implied
needs.

Record Document which furnishes objective evidence of activities

performed or results achieved.

Specification Document stating requirements.

Trace ability Ability to trace the history, application and location of an

entity (a product, process or an activity) by means of recorded identification.

Verification Confirmation by examination and provision of objective

evidence that specifies requirements has been fulfilled.

1-D Standard perquisites:

 Describe the introduction of the organization.
 Identify the normative references.
 Illustrate the terms and definitions used by the standard and organization.

1-E Approach:

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 Customer-focused organization - Organizations depend on their customers and
therefore should understand current and future customer needs, meet customer
requirements and strive to exceed customer expectations.
 Leadership - Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which people can
become fully involved in achieving the organization’s objectives.

 Involvement of people - People at all levels are the essence of an organization and
their full involvement enables their abilities to be used for the organization’s behalf.

 Process approach - A desired result is achieved more efficiently when related

resources and activities are managed as a process.

 System approach to management - Identifying, understanding and managing a

system of interrelated processes for a given objective improves the organization’s
effectiveness and efficiency.

 Continual improvement - Continual improvement should be a permanent objective

of the organization.

 Factual approach to decision making - Effective decisions are based on the

analysis of data and information.

 Mutually beneficial supplier relationship - An organization and its suppliers are

interdependent, and a mutually beneficial relationship enhances the ability of both to
create value.

Chapter

2
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Scope & Quality Management System

2-A Identification of Scope:
Scope means area of implementation, where the standards are planned to be applied. It
includes;
 Processes
 Departments
 Raw/Intermediate Services

2-B Documentation Level:

Quality
System
Manual

Job
Inst. &
Des.

Forms

2-C Parameters to Adopt:

 Plan your day effectively at least 1 day earlier.
 Categorize the tasks and involve your team.
 Be bold to present and publish any type of truthful data.
 Declare consequences on conclusions.

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 Say what you do, and do what u say.
 Walk the talk, and talk the walk.
 Express your opinions, suggestions and feelings on formal documents (forms) and
informal papers (what ever you like).
 Understand the procedures and make other propel understand.
 Act your procedures those are your believe system.
 Evaluate and monitor process, production and productivity on short term basis.

2-D Precautionary steps to be taken:

 Avoid misrepresentation.
 Avoid false statements.
 Avoid deterioration of display charts.
 Reduce corrective maintenance of your machine equipments, machinery and utensils.
 Discourage verbal actions and vocal slogans.
 Avoid contradiction of procedures in any form.
 Eliminate sense of fakeness in your sayings, writing and doings.
 Eradicate reoccurrence of observatory level nonconformance.
 Do not afraid to plan due to change in plan.
 Lessen unnecessary description and narration.

2-E Points to monitor:

 Follow and fill the generic information (like date, serial number, time, etc.) and
Check the efficacy of strategic data.
 Check the mobilization of copies to be distributed in due course.
 Inspect the registration of changes and amendments in Procedures, JID’s , Forms.
 Discuss and follow-up the reasons for duplication of minor level nonconformance.
 Arrange the true implementation of productive maintenance of machines.

2-F Continuous evaluation parameters:

 Inter bench mark production jobs, time base performances and sales.
 Review the strength of Internal communication regarding customer feedback.
 Appraise the record of management review meetings.
 Keep on considering the information changes being displayed in workshops(floor).
 Check the practical participation of human resource.

2-G Standard perquisites:

Establish your quality system
Identify the processes that make up your quality system.
Describe your quality management processes.

Implement your quality management system

Use quality system processes.
Manage process performance.

Improve your quality management system

Monitor process performance.
Improve process performance.
 

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Document your quality system
Develop documents to implement your quality system.
Develop documents that reflect what your organization does.

Prepare quality system manual

Document your procedures.
Describe how your processes interact.
Define the scope of your quality system.

Control quality system documents

Approve documents before you distribute them.
Provide the correct version of documents at points of use.
Review and re-approve documents whenever you update them.
Specify the current revision status of your documents.
Monitor documents that come from external sources.
Prevent the accidental use of obsolete documents.
Preserve the usability of your quality documents.

Maintain quality system records

Use your records to prove that requirements have been met.
Develop a procedure to control your records.
Ensure that your records are useable.

Chapter

3
3-A Identification of Resources:
Resource Management

Resources means factors required for producing a product or service. It includes;

 Men
 Machine
 Methodology
 Material

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It is also known as term of “4M”. Resource management may be defined as the integrated
activities performed to hire, purchase, arrange, shifting them from one stage of process to
the other.

3-B Parameters to Adopt:

 Identify the requirements.
 Check the available resources.
 Determine he gap between required and available.
 Define the track to procure.
 Hiring, operating & working limits for men (top, middle & bottom line)
 Search for machinery i.e. abreast with modern technology.
 Establish easily understandable procedures to perform the process.
 Prepare list of your potential suppliers.
 Adopt necessary and analytical documentation.
 Benchmark the efficacy of applied resources.

3-C Precautionary steps to be taken:

 Avoid over hiring utilizing the right man at right job concept.
 Discourage leg pulling by adopting direct communication.
 Avoid deterioration of equipments due to unauthorized use.
 Reduce corrective maintenance of your machine equipments, machinery and utensils.
 Don’t rely on trial & error to perform a procedure.
 Avoid contradiction of procedures in any form.
 Eliminate sense of fakeness in your described methods.
 Eradicate reoccurrence of observatory level nonconformance.
 Do not compromise acceptable criteria determined to pass / reject a raw material.
 Lessen unnecessary stocks.

3-D Points to monitor:

 Review you human resource for performance based appraisals.
 Consider the time study for particular jobs.
 Monitor the machine breakdown history records.
 Analyze whether the head provide job based training during his operations.
 Check the interaction of all “4M”.

3-E Continuous evaluation parameters:

 Short-term objectives on individual basis.
 Power consumption of your machines.
 Conversion of methodology towards simplicity.
 Handling and preservation of raw material.
 Check the practical participation of human resource.

3-F Standard perquisites:

Human Resource
Qualification and experience records.
Job descriptions.

Machinery
Operating manuals & work instructions.
Calibration and validation records.

Workplace & Buildings

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Healthier and work friendly environment.
Installation of necessary safety equipments.
 
Methodology
Documents to implement your quality process.
Kew process indicators of your work procedures.

Raw Material
List of approved suppliers.
Purchasing data documentation.
Verification of purchased product.
Issuance and consumption records.
Evaluation of approved suppliers.

Chapter

4
4-A Definition of Process Control:
Process Control

Methods adopted to review customer requirements, communicating them to design

department, application on proto of test service, producing in a bulk and present it to
customer, entertaining customer feedback and complaints.

4-B Parameters to Adopt:

 Document the customer requirements.
 Clearly understand the amendments if any.
 Plan your processes effectively.
 Declare ultimate responsibilities and authorities for every assignment needed to
complete process control.
 Determine the samples, prototypes or test services analysis checklists.

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 Calculate lead, cycle and takt time.
 Establish easily understandable procedures for sub-contractors.
 Prepare instructions for provision of product or service.
 Adopt necessary and analytical documentation.
 Prepare macro & micro level blockage controls.

4-C Precautionary steps to be taken:

 Avoid verbal changes in customer orders.
 Discourage verbal internal communication.
 Avoid deterioration of samples, product snaps, patterns, designs, formulae.
 Reduce wastage of time, material and power in any shape.
 Don’t rely on short cuts.
 Avoid contradiction of prescribed methods to produce a particular product or service
at any cost.
 Eliminate unnecessary accumulation of unwanted items around the machines.
 Eradicate root cause of problem not the problem itself.
 Do not transfer the fault to next stage with an intention to remove it there.
 Lessen your overtimes.

4-D Points to monitor:

 Contract Reviews
 Work Orders, Work Permits.
 Daily Production Reports, Task Management Reports.
 In process and Final Inspection Reports.
 Corrective Action Reports

4-E Continuous evaluation parameters:

 Time line or comparison between lead, cycle and takt time.
 Display stage wise contribution reports.
 Preventive actions.
 Primary, secondary and tertiary level protocols.
 Improvement in skills, technology and mechanism.

4-F Standard perquisites:

Contract Review
Document ordering & delivery time, quantity, specifications and other needs.
Scope of sub-contractors must be defined.
Design & development changes must be reviewed.

Determine & Review Requirement Related To Process

Process flow charts must be prepared and displayed at work environment.
Work instructions must be communicated to every individual.

Determine & Review Requirement Related To Product

Document the design development and approval techniques.
Provide or arrange basic information about a product i.e. Samples, Pictures,
Formulae.
Keep records or shelf life of products or guaranteed period of after sale services
 
Product & Service Provisions
Record forward & back ward tractability records.
Entertain customer feed back and complaint by virtue of record keeping as well.

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Control of Measuring & Test Equipment

Validation maintenance records of equipment.
Calibration records of equipment.

Control of Non Conforming Product

Prepare product inspection reports
Record faults and potential faults in a product or service.
Correct them and keep the records

Chapter

5 Monitoring, Measurement & Analysis

5-A Definition of Quality Control & Internal Auditing:
Iprovement actions adopted to demonstrate conformity and effectiveness of
 Product
 Quality Management System
 Customer Satisfaction

5-B Parameters to Adopt:

 Determine applicable statistical techniques and extent of their use.
 Determine methods for obtaining and using information.
 Set & select frequency, plans, program, criteria and independent auditors for internal
audits.
 Declare non-conformities in management review meetings.
 Take immediate actions to rectify the non-conformities.
 Apply suitable methods to monitor and measure processes to achieve planned results.
 Take effective corrective actions to ensure conformity of products if planned results
are not achieved.
 Ensure non-conforming product is identified and records are well kept to prevent
unintended use or delivery of such product.
 Determine actions to eliminate root causes of potential non-conformities.
 Improve the effectiveness of quality policy, objectives, audit results, data analysis,
corrective & preventive actions and management reviews.

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5-C Precautionary steps to be taken:

 Avoid chance of personal grudges while inspecting, monitoring or auditing.
 Don’t delay to eliminate non-conformities at any cost.
 Avoid un-authorized release of product.
 Don’t deny the non-conformities if raised by customer after release of product.
 Don’t ignore the role of suppliers.
 Avoid re-occurrence of non-conformities.
 Prevent the potential effects of the problem.
 Eradicate root cause of problem not the problem itself.
 Do adopt the constant objectives like slogans.
 Avoid complex statistical techniques.

5-D Points to monitor:

 Corrective Actions
 Preventive Actions.
 Internal and external audit results.
 Potential non-conformities.
 Status of action decide in management reviews

5-E Continuous evaluation parameters:

 Quality policy, objectives.
 Audit results.
 Data analysis.
 Corrective & preventive actions.
 Management reviews.

5-F Standard perquisites:

General
Prepare product inspection reports at in process and final stages.
Keep the records with unique identification no. .

Measurement Analysis & Improvement

Keep the records of customer perceptions/implied requirements.

Internal Audit
Internal Audit plan and program/scheme.
Internal audit checklists.
Internal audit reports and summaries.
 
Control of Non-conforming Product
Quality records of delivery..

Analysis of Data
Prepare graphs related to.
Customer satisfaction
Product requirement conformance
Process trends
Key Process Indicators of objectives
Suppliers

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Corrective & Preventive Actions

Prepare corrective and preventive action reports.

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