QUALITY MANAGEMENT SYSTEM

MOHAMMAD JUNAID IQBAL

A quality management system (QMS) is a system that documents the policies, business
processes, and procedures necessary for an organization to create and deliver its products or
services to its customers, and therefore increase customer satisfaction through high product quality.
QUALITY CONTROL VS QUALITY ASSURANCE

Quality System

Quality Assurance
Quality Control Quality Assurance
Corrective Approach Preventive Approach
Knee-jerk Approach Quality Control Proactive Approach
Product-based Process-based
Verify the Quality Manage the Quality
QUALITY CONTROL VS QUALITY ASSURANCE

Quality Control = Inspection + Corrective Actions

Quality Assurance = Quality Control + Preventive Actions + Customer Satisfaction

Modern world is focusing more on Quality Assurance rather than Quality Control
7 QUALITY CONTROL TOOLS

 Check Sheet
 Fishbone Diagram
 Histogram
 Pareto Chart
 Control Chart
 Scatter Diagram
 Stratification
FISHBONE/CAUSE AND EFFECT DIAGRAM

Man Machine

 Problem solving
technique
 Categorize potential
causes of a problem
Problem
 5M (Man, Machine,
Material, Method,
Mother Nature

Material Method Mother Nature

CONTROL CHART

 A graph used to study how a process changes over time

HAZARD AND RISK
Hazard Risk

Potential to cause harm Degree of likelihood of causing harm

e.g., Crossing a road e.g., Chance of an accident

Common Hazards at Workplace:

• Fall/Slip
• Fire
• Electrical
• Chemical
FALL/SLIP HAZARD
 Most of these hazards are due to poor housekeeping, spillages of any liquid/lubricant at floor, poor lighting & poor
safety practices during work at height.
ELECTRICAL HAZARD

 A dangerous condition where a worker could make electrical contact with energized equipment or a conductor.
FIRE HAZARD

 Fire hazards include all types of live flames, causes of sparks, hot objects, and chemicals that have potential for
ignition, or that can aggravate a fire to become large and uncontrolled.
CHEMICAL HAZARD

 A chemical hazard is a type of occupational hazard caused by exposure to chemicals in the workplace. Exposure

to chemicals in the workplace can cause acute or long-term detrimental health effects.
WORK PERMIT SYSTEM

A formal written system used to control certain types of work that are potentially hazardous.

Types of Work Permits:

 Cold Work Permit
 Hot Work Permit
 Electrical Work Permit
 Confined Space Entry Work Permit
 Excavation Work Permit
 Radiation Work Permit
 Road Closure Work Permit
5S SYSTEM

Step Name Japanese term Explanation

1. Sort Seiri (tidiness) Remove unnecessary items from each area

2. Set In Order Seiton (orderliness) Organize and identify storage for efficient use

3. Shine Seiso (cleanliness) Clean and inspect each area regularly

4. Standardize Seiketsu (standardization) Incorporate 5S into standard operating procedures

Assign responsibility, track progress, and continue

5. Sustain Shitsuke (discipline)
the cycle
DOCUMENTATION HIERARCHY

Quality Manual

Quality Procedure

Work Instructions

Forms & Records

DOCUMENTATION HIERARCHY
 Quality Manual
 Scope and boundaries
 Terms & Definitions
 Policy of the Organization, Objectives and targets

 Quality Procedures
 Operational Procedures
 Describes 6 major questions – Who, How, Where, When, What, Show me

 Work Instructions
 Written, drawings, photographs, machine care/operation
 What has to be done?
 Correct sequence

 Forms & Records

AUDIT
 Audit is the process of systematic examination of a system

1. Define Audit Objectives prior to the audit

2. Audit Announcement
3. Audit Entrance Meeting
4. Fieldwork/Site Visit
5. Reviewing and Communicating Results
6. Audit Exit Meeting
7. Audit Report
AUDIT CHECKLIST
Audit Checklist
Department   Location  

Auditor   Ref No.  

Date  
Observation
Sr. No. ITEM Remarks/Recommendations/Actions
OK NOT OK

1 Quality Policy      

2 Process Flowcharts      

3 Quality Plans      

 A quality audit checklist is a quality record that 4 Quality Objectives      

tracks the questions and responses during a

5 Records of Batch Cards      

6 Records of Hardness Testing      

quality audit. 7 Records of Housekeeping      

8 Records of Safety Inspection of area      

9 Compliance of Emergency Response Procedure      

10 Compliance of PPE      

11 Records of Inspection of Electrical Wiring      

12 Availability of Fire Extinguishers      

13 Safety precaution signs      

14 Emergency numbers posting      

15 Cleanliness of area      

16 Process Control Data      

17 Training & Efectiveness records      

18 Document control records      

19 Maintenance records      

20 Corrective & Preventive action records      

AUDIT REPORT

 Auditor
 Details of Non-conformance
 Good points observed

 Auditee
 Preparation of CAPA (Corrective Actions & Preventive Actions)

Corrective Preventive
Sr. No. Non-Conformance Root Cause Responsibility Deadline
Actions Actions
THANK YOU