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H A S H M A N A G E M E N T S E R V I C E S L L P

C H E N N A I

P H : 9 1 7 6 6 1 3 9 6 5

The Essentials - Quality

Overview

Copyright of Hash Management Services LLP www.businessense.in

‘The Essentials’ series from Business Sense is an initiative to empower the students(freshers) and

professionals in performing more efficiently and effectively in the organization

This document is a part of the “Certified Manufacturing Professional” course offered by Business Sense

This course is aimed at bridging the gap between the institutions and the industry by providing the

fundamentals of manufacturing management which are not offered by any of our

institutions/curriculum

This course would immensely benefit students and professionals who are joining manufacturing

organizations

For more details, please visit www.businessense.in

At Business Sense, we help clients through consulting engagements focusing on improving their

Operations through Lean Manufacturing Implementation covering 5S, SMED, Kaizen and other tools.

We also serve clients on Preparation of Detailed Project Reports, Market Assessments, and Supply

Chain Re-engineering.

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Contents


Section 1 – Introduction to Quality Function

Section 2 – QMS and ISO 9001 Standard

Section 3 – NC, Corrective and Preventive Actions

Section 4 – 7 QC tools

Section 5 – MIS Reports and Analyses Points

What is Quality?


“Quality is fitness for use” – Deming

In an organization, Quality function means the department which independently works

on attaining specified levels of product / process quality of the core business

Quality Department can either be a quality control department or a Quality Assurance

department

Quality Department is the final In-Charge of the quality at the customer’s end

Quality Control Quality Assurance

Focus on Product Focus on Processes

Analysis after Completion of work Prevention is better than cure

Operation specific Core value; Organisation-wide

Individual/department oriented Leads to team work

Organization Structure


Head of Quality Assurance reports to the

CEO of the company

Normally there would be In-Charges for

the three focus areas of Quality:

Incoming Inspection

In-process or online inspection and

Final Inspection or Finished Goods Testing or Batch

Release Testing – previously done as QC

In Manufacturing Industries, Testing

Laboratories comes under the QA.

We have explained a typical functional hierarchy. It may

vary according to each organization

Head - Quality Assurance

In-Charge Incoming Inspection

In-charge

In-process Inspection

In-Charge

Final Inspection

CEO

Responsibilities of an Engineer in the Quality Function


•Ensuring the Raw Materials used in production are as expected

and fit for use. Incoming Inspection

•Asserting the suppliers of their ability to supply consistently good quality and improve them Supplier Development

In-process Inspection

Final Inspection

•Identify the parameters of the machines and/or intermediates which are critical to quality of the Final Product and help production to avoid problems in those parameters

Customer Feedback

•Check the conformance of final products to the customers’ requirements and ensure that the customer who is going to receive them get satisfied with the products.

•Get the feeling of customers upon using our products and develop our internal product specifications

In-Charge Incoming Inspection

In-Charge Final

Inspection

In-Charge In-Process Inspection

Quality Plan


All the five major aspects are covered in the Quality plan Document in

the following manner:

Specification for Raw Materials and Parameter to be checked upon receipts

Critical To Quality (CTQ) parameters of machine settings or intermediate products and

checking or verification points

Final product specifications and parameters to be tested for the conformance to customers’

requirements.

Sampling and Testing methods along with the action to be taken in case of any deviation for

all the above

In a nutshell, the quality plan describes how the quality of product /

process is managed in an organization.

Quality Plan - Example


Let us assume the Customer requirement is metal sheets for fabrication which

measures 10 x 5 inch metal plate in Green color with two holes

Upon accepting the Purchase order from the customer, the company works on

defining the product requirements as per the internal understanding. This

becomes the product specification and the target output quality.

The customer requirement of 10 x 5 inch metal plate in Green color has

translated in to:

MS / SS / Aluminium sheet of

252 mm length,126 mm width and 0.4 mm thickness (not given in the product requirement and

developed internally based on factors such as strength, pricing, etc)

Powder coated with Green color of Standard Color (with code - abcd) with

Two holes of 2 mm diameter as per the drawing

Drawing based on the customer requirement


252 +/- 2 mm

126 +

/- 2

mm

2 mm dia

10 mm

62 +

/- 1

mm

Color Code : Green (abcd)

Internal Specification


This final requirement/drawing is worked backward - the internal requirements

needed are listed and those become our in-process specifications.

At Painting Section, Painting Color (abcd) and the coat thickness are internal

parameters.

At Cutting section, Size specifications are –

L : 256 +/- 2 mm

W : 130 +/- 2 mm (4 mm extension is made for bending)

The holes as per the drawing

For inward inspection, the sheet thickness, dimensions and paint color forms a

specification

Contents







Quality Management System - QMS


A quality management system is a set of co-ordinated

activities to direct and control an organisation ensuring

that the organisation is continually improving its

performance.

Quality Plan is an integrated component in the Quality Management System

A QMS enables an organisation to achieve the goals and objectives set out in

its policy and strategy.

It provides consistency and satisfaction in terms of methods, materials,

equipment, etc, and interacts with all activities of the organisation, beginning

with the identification of customer requirements and ending with their

satisfaction, at every transaction interface.

It can be envisaged as a “wedge” that both holds the gains achieved along the

quality journey, and prevents good practices from slipping

Quality Management System


Benefits of QMS Improved business planning

Enhanced awareness on quality throughout the organisation

Improved Customer Satisfaction

Reduced cost of poor quality

Above all, an effective QMS provides the confidence to both the organisation and its customers that the organisation can provide good quality of product / service consistently.

If the Quality Management System of a company is inline with the set requirements of ISO 9001, the company may be certified as a quality assured company by a certification agency and the company will be declared an ISO 9001 certified company.

Quality Management System – ISO 9001


What is ISO?

ISO (International Organization for Standardization) - a non-governmental organization

is the world's largest developer and publisher of International Standards.

ISO is a network of the national standards institutes of 162 countries, one member per

country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

According to ISO, "ISO" is not an abbreviation. It is a word, derived from the Greek isos,

meaning "equal“.

Quality Management System – ISO 9001


ISO 9001 is an international quality certification that defines

minimum requirements for a company's Quality Management

System (QMS)

Applies to the processes that create and control the products

and services an organisation supplies

Prescribes systematic control of activities to ensure that the

needs and expectations of customers are met

Is designed and intended to apply to virtually any product or

service, made by any process anywhere in the world.

Level 1

Quality Manual

Level 2

Processes

Level 3

Work Instructions

ISO 9001 – in a nutshell


The requirements of a Quality Management System are

defined in the Standard (ISO 9001: 2008) in 8 clauses.

Clause 1 – Scope

1.1 General Requirements

1.2 Application

Clause 2 - Normative Reference

Clause 3 – Terms and Definitions

The clauses 1, 2 and 3 explain about the aim of this

standard, where this standard is applicable (Clause 1),

reference to the standard ISO 9000 : 2005, Quality

Management System – Fundamentals and Vocabulary

(Clause 2) and Terms and Definitions (Clause 3)

Plan

Do

Check

Act

ISO 9001 – in a nutshell


ISO 9001:2008

Clause Clause Title Explanation

4.1 QMS (Quality Management

System) Define your working system as a series of processes and identify the criteria to measure the effectiveness of each process. (E.g. Timely delivery etc)

4.1 QMS (Quality Management

System) Proper controls like supervision, inspection, training, documentation etc. should be exercised on outsourced (Subcontracted) processes to ensure acceptable results.

4.2 Documentation Requirements Say what you do – in your documents. (E.g. methodology, Procedures, Drawings, Specifications)

4.2 Documentation requirements Document your working system as quality manual, procedures and work instructions.

4.2.3 Document Control

Only approved current documents should be made available for work. (E.g.. Drawings, Specification, Procedures etc.)This includes external standards also. The organisation will need to control other external origin documents necessary for planning and operation of QMS. This can even include excise regulations.

4.2.4 Control of records Prove that you are following the system by maintaining appropriate records.

Remaining clauses are covered in the “Certified Manufacturing Professional” course .To access login to www.businessense.in

Contents







Defects and Non-conformance


Defective

When an item fails to meet its specification and / or known to fail to meet its

intended use, the item is called a defective. E.g. A casting with a blowhole

Defect

The exact reason / cause for the problem is called the defect. i.e. the blowhole

Nonconformity

Any non fulfillment of requirement is called nonconformity. E.g. A casting with

out blowholes is required. But the process produced a casting with blowhole. This

is a non-conformity

Corrective and Preventive Actions


Correction

An action to eliminate a detected nonconformity is called a correction.

A correction can be a rework, reprocess, repair, degrade, replacement or rejection.

Corrective Action (CA)

Actions to eliminate the cause of detected nonconformities are called corrective actions. (Actions to

eliminate the recurrence of nonconformity).

Timely Solution – Can be one-time solution – reactive – after the problem has occurred

Preventive Action (PA)

Actions to eliminate the causes of a potential nonconformities or other undesirable potential situations are

called preventive actions. (Actions to eliminate the occurrence of nonconformity).

Proactive solution – before the problem has occurred

Quality tools can be used (Pareto charts, Fish bone analysis, etc. / 5 Why analysis /

other tools) for taking CA&PA

Contents







7 QC Tools


Seven QC tools are fundamental instruments to improve the quality of

the product

Seven QC tools are utilized to organize the collected data in a way that

is easy to understand and analyze

They are used to analyze the production process, identify the major

problems, control fluctuations of product quality, and provide solutions

to avoid future defects

7 QC Tools – Check Sheet


A check sheet is a pre-designed format for collection of data that encourages

organized collection and groups data into categories.

Categories are created in advance and may be added as needed. A check mark is

added for each example of a category. The marks are added to determine

subtotals.

When to use it? To keep track of the parameters of an on going process. It can

be used to track events by such factors as timeliness (on time, one day late, two

days late, etc.); reason for inspection failure (appearance, performance, etc.);

person accomplishing the task (sales calls per representative) etc...

7 QC Tools – Check Sheet


Example: A company wants to check the

weight of bags of sugar that are supposed to

weigh 100 kg. The resulting checklist is

shown in the following Table. The checklist

indicates that the machine is not filling all the

bags within the specification.

Sugar Bag Weight Check Sheet -

(Specification : 100kg. ± 2 Kg.)

Weight (Kg.) Check Sheet Total

98 0

98.25 II 2

98.5 IIII 4

98.75 IIIII III 8

99 IIIII IIII 9

99.25 IIIII 5

99.5 IIIII III 8

99.75 IIIII IIIII IIIII II 17

100 IIIII IIIII IIIII IIIII III 23

100.25 IIIII IIII II 12

100.5 IIIII III 8

100.75 IIIII IIII 9

101 IIII 4

101.25 III 3

101.5 IIII 4

101.75 II 2

102 I 1

7 QC Tools – Graphs


Graphs are used for the purpose of comparison of visual representation of data collected.

The most commonly used graphs are in the form of Bar charts, Line charts and Pie charts.

Bar charts can be used to compare revenue projections , growth in sales volume over a time period

Pie Charts can be used to represent the region-wise revenue share / category-wise contribution to the profits etc

Year-wise sales trend

Remaining quality tools are covered in the “Certified Manufacturing Professional” course. To access login to www.businessense.in

End of Free Content


Please visit our website www.businessense.in to access the full course – “Certified Manufacturing

Professional”

Our website also contains list of ready-to-use templates and report formats containing Charts and

pivot tables.

Templates and report formats are available for Purchase, Stores, Production, Quality, Maintenance and

HR functions

These templates come in excel /word and can be downloaded and used right away

At Business Sense, we help clients through consulting engagements focusing on improving

their Operations through Lean Manufacturing Implementation covering 5S, SMED, Kaizen and

other tools.

We also serve clients on Preparation of Detailed Project Reports, Market Assessments, and

Supply Chain Re-engineering.

You can subscribe to our bi-weekly newsletter here.

Follow us:

http://www.businessense.in/

http://eepurl.com/pgLJr





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