This document provides an overview of quality and quality management. It discusses the quality function in organizations and how it focuses on ensuring product and process quality. It also describes key aspects of a quality management system, including a quality plan, quality management standards like ISO 9001, handling non-conformances, corrective and preventive actions, the seven basic quality control tools, and generating management reports and analyses. The goal is to help students and professionals better understand quality practices in manufacturing organizations.

1. The Essentials - Quality
HASH MANAGEMENT SERVICES LLP
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2. Overview
 ‘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.
 You can subscribe to our bi-weekly newsletter here.
 Follow us:
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3. 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
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4. 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
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5. Organization Structure
 Head of Quality Assurance reports to the
CEO of the company
 Normally there would be In-Charges for
CEO
the three focus areas of Quality:
 Incoming Inspection
 In-process or online inspection and Head - Quality
Assurance
 Final Inspection or Finished Goods Testing or Batch
Release Testing – previously done as QC
In-Charge In-charge
 In Manufacturing Industries, Testing In-Charge
Incoming In-process
Inspection Final Inspection
Inspection
Laboratories comes under the QA.
 We have explained a typical functional hierarchy. It may
vary according to each organization
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6. Responsibilities of an Engineer in the Quality
Function
•Ensuring the Raw Materials used in production are as expected
Incoming Inspection
In-Charge and fit for use.
Incoming
Inspection •Asserting the suppliers of their ability to supply consistently
Supplier Development good quality and improve them
In-Charge •Identify the parameters of the machines and/or intermediates
In-Process In-process Inspection which are critical to quality of the Final Product and help
production to avoid problems in those parameters
Inspection
•Check the conformance of final products to the customers’
Final Inspection requirements and ensure that the customer who is going to
In-Charge receive them get satisfied with the products.
Final
Inspection Customer Feedback •Get the feeling of customers upon using our products and develop
our internal product specifications
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7. 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.
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8. 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
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9. Drawing based on the customer requirement
252 +/- 2 mm
62 +/- 1 mm
126 +/- 2 mm
2 mm dia
10 mm
Color Code : Green (abcd)
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10. 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
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11. 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
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12. 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
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13. 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.
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14. 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“.
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15. Quality Management System – ISO 9001
 ISO 9001 is an international quality certification that defines
minimum requirements for a company's Quality Management
System (QMS) Level 1
Quality
 Applies to the processes that create and control the products Manual
and services an organisation supplies
Level 2
 Prescribes systematic control of activities to ensure that the Processes
needs and expectations of customers are met
Level 3
 Is designed and intended to apply to virtually any product or Work Instructions
service, made by any process anywhere in the world.
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16. 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
Plan
 1.2 Application
 Clause 2 - Normative Reference
 Clause 3 – Terms and Definitions Act Do
 The clauses 1, 2 and 3 explain about the aim of this
standard, where this standard is applicable (Clause 1), Check
reference to the standard ISO 9000 : 2005, Quality
Management System – Fundamentals and Vocabulary
(Clause 2) and Terms and Definitions (Clause 3)
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17. ISO 9001 – in a nutshell
ISO
9001:2008 Clause Title Explanation
Clause
QMS (Quality Management Define your working system as a series of processes and identify the criteria to
4.1
System) measure the effectiveness of each process. (E.g. Timely delivery etc)
QMS (Quality Management Proper controls like supervision, inspection, training, documentation etc. should be
4.1
System) exercised on outsourced (Subcontracted) processes to ensure acceptable results.
Say what you do – in your documents. (E.g. methodology, Procedures, Drawings,
4.2 Documentation Requirements
Specifications)
4.2 Documentation requirements Document your working system as quality manual, procedures and work instructions.
Only approved current documents should be made available for work. (E.g..
Drawings, Specification, Procedures etc.)This includes external standards also. The
4.2.3 Document Control
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
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18. 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
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19. 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
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20. 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
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21. 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
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22. 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
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23. 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...
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24. 7 QC Tools – Check Sheet
Weight (Kg.) Check Sheet Total
 Example: A company wants to check the 98 0
98.25 II 2
weight of bags of sugar that are supposed to 98.5 IIII 4
98.75 IIIII III 8
weigh 100 kg. The resulting checklist is 99 IIIII IIII 9
99.25 IIIII 5
99.5 IIIII III 8
shown in the following Table. The checklist 99.75 IIIII IIIII IIIII II 17
100 IIIII IIIII IIIII IIIII III 23
indicates that the machine is not filling all the 100.25 IIIII IIII II 12
100.5 IIIII III 8
bags within the specification. 100.75 IIIII IIII 9
101 IIII 4
101.25 III 3
 Sugar Bag Weight Check Sheet -
101.5 IIII 4
101.75 II 2
(Specification : 100kg. ± 2 Kg.) 102 I 1
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25. 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
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26. 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:
Copyright of Hash Management Services LLP www.businessense.in