Introduction on Quality Systems and

SOPs

Presentation By:
Ravi Chauhan
Quality Systems
 Objectives

 To introduce the quality management

process and key quality management
activities
 To explain the role of standards in quality
management
 Basic Idea regarding Standard Operating
Procedures
OVERVIEW
 Quality refers to all those features of a product (or service) which are
required by the customer.
 Quality management means what the organization does to
ensure that its products or services satisfy the customer's quality
requirements and
 comply with any regulations applicable to those products or services
 Quality management also means what the organization does to
◦ enhance customer satisfaction, and
◦ achieve continual improvement of its performance
 Management System Requirements
Customers
Policy
Shareholders
Employees
Procedures
Suppliers REQUIREMENTS PRODUCT SERVICE
SATISFIED
REQUIREMENTS
Society/Community
Financial Institutions Instructions

Government
Insurance Records/Results/Evidences
Organization
 How to Integrate Management
Systems PDCA Approach
PLAN DO
Develop Policies and Structures Implementation & Operations
Risk Assessment (Legal & Other) Responsibility & Training
Business Planning Communication
Setting Objectives & Targets Document & Record Control
Process Controls

ACT CHECK
Management Review Monitoring & Measuring
Corrective Action - Product
Preventive Action - Process
Non-conformances, Incidents
Auditing
 The DMAIC (Define, Measure, Analyze,
Improve, and Control) cycle
Define

Define Quality Objectives

At the commencement of each year the management shall prepare a quality
plan for the company. The quality plan defines:
•The quality objectives for the year
•The primary responsibility for achievement of each objective
•Criteria for monitoring and measurement of each objective
•Procedure for monitoring and measurement of each objective
The quality plan shall be prepared in the template for quality planning and
communicated to all personnel in the organization by the management.
The basis for defining the quality objectives shall include:
•A review of the previous year’s quality objectives and achievement of the
same
•Previous year’s performance and the business plan of the company for the
forthcoming year.
•Overall strategic initiatives that the organization wishes to take
 The DMAIC (Define, Measure, Analyze,
Improve, and Control) cycle
Measure
The quality objectives for each year shall be monitored during the course of the year
and measured at the end of a specified period for example:
Customer satisfaction – quarterly
Turnover achievement – annually
Personnel performance – quarterly etc.
the year.
The measure and the methodology for measurement for each objective shall be
defined in the quality plan itself.
Analyze
Analysis of achievement of the quality objectives
The Business Unit Director together with the management representative and the
respective function heads shall analyze the reasons for non-achievement of any of
the quality objectives.
The analysis shall include a task level drill down to identify the root cause of the
issue due to which the quality objective was not achieved.
This analysis shall reveal causes for non-achievement of the quality objective and
highlight areas of concern to be addressed.
 The DMAIC (Define, Measure, Analyze,
Improve, and Control) cycle
Improve
Areas for improvement shall be identified through the management review procedure
and an improvement plan shall be drawn up by the relevant function heads to address
the causes underlying the non-achievement of the quality objective.
Further Corrective and Preventive action shall be defined and documented in the
corrective and preventive action form as per the procedure for “Corrective and
Preventive action SOP_04”. This shall be submitted to the management for approval
prior to being implemented

Control
On achievement of the quality objective the business unit Director shall assign a time
frame for maintaining the achieved quality level. (E.g. Customer satisfaction of 8 on a
scale of 10) and maintain it for a defined period of time.
Once the desired level of the quality objective is achieved, the management shall
redefine the level of quality for each objective and aim for a higher rating on the same.
 ISO 9001

Management responsibility Quality system

Control of non-conforming Design control
products
Handling, storage, packaging Purchasing
and delivery
Purchaser-supplied products Product identification and traceability
Process control Inspection and testing
Inspection and test equipment Inspection and test status
Contract review Corrective action
Document control Quality records
Internal quality audits Training
Servicing Statistical techniques
MODEL OF PROCESS BASED QUALITY
MANAGEMENT SYSTEM
 ISO 9001 and quality management

ISO 9001
quality models

initiated as

documents
Organisation Organisation
quality man ual quality pr ocess

is used to de velop instantiated as

Project 1 Project 2 Project 3 Project quality

quality plan quality plan quality plan management

Supports
 Definition of Standard Operating
Procedures
A Standard Operating Procedure (SOP) is a set of written instructions that document a
routine or repetitive activity followed by an organization duly approved by persons in
charge of the function. The development and use of SOPs are an integral part of a
successful quality system as it provides individuals with the information to perform a
job properly, and facilitates consistency in the quality and integrity of a product or
end result.

SOPs under Quality Management System of KMC Constructions Ltd. accurately

reflect good information regarding management practices being followed by KMC
Constructions Limited. These are sufficiently practical and usable in various
departments/ sub- departments. The good KMC management practices relate to
general aspects of management functions including project operations, tendering,
Finance and Accounts, Mechanical, HR & Admin, Quality Systems.

SOPs are written by individuals knowledgeable with the activity and the
organization's internal structure. These are written with sufficient detail so that
someone with limited experience with or knowledge of the procedure, but with a
basic understanding, can successfully reproduce the procedure when unsupervised.
SOPs contd.
SOP for Project launch contains the formalized structures for:
•Project award notification
•Project Hand-over
•Contract Review
•Risk and Opportunity Management
•Bid Clarification and Technical Queries
•Project Kick off
•Project Quality Plan
•Environmental Plan
•Safety Plan

At KMC SOPs are systematically reviewed on a periodic basis to ensure that the
policies and procedures remain current and appropriate, or to determine whether SOPs
are even needed. The SOPs are updated and re-approved as and when a change is
noticed to some procedure so that SOP remain current and fit for implementation
 Standard operating procedures serve the
following purpose
•Detail the work processes
•Document the way activities are to be performed
facilitate consistent conformance
support data quality
•Intended to be specific to the organization
•Assist that organization to maintain their quality control and quality assurance
processes and ensure compliance

•Development and use of SOPs promotes quality through consistent implementation of

a process or procedure within the organization.
•Reduces work effort, along with improved data comparability, credibility, and legal
defensibility
•Standardize the approach of individuals within the company to specific procedures,
improving the quality and speed of decision making in key areas like – Project
operations, Project planning, Tendering, Contract Administration, Finance &
Accounts, Equipments Management etc.
 Standard operating procedures serve the
following purpose Contd.
•Act to disseminate best practice within the organization and can be updated as the
conditions and regulations require creating a knowledge rich enterprise.
•Serve to speed the integration of an individual into the organization during the
induction training phase by making available a library of company-wide best practice
and company operating procedures.
•Improve transparency within the organization by enabling all employees to see how
specific problems are handled in a standard and clear fashion which helps in the
creation of shared values.
Provide a clear audit trail in cases of dispute or external investigation where it can be
shown that correct procedures were followed and records maintained
THANK YOU