QUALITY MANAGEMENT
SYSTEM
SUBMITTED BY :- SUBMITTED TO:-
KUMARI SUPRIYA HARSHITA
MISHRA

CONTENT
1. INTRODUCTION
2. QUALITY RISK MANAGEMENT
3. RISK ASSESSMENT
4. RISK CONTROL
5. RISK REVIEW
6. RISK MANAGEMENT TOOLS
7. HACCP
8. RISK RANGING AND FILTERING
9. CHANGE CONTROL
10. DEVIATION(PLANNED AND
UNPLANNED)
11. CAPA

INTRODUCTION
A QUALITY MANAGEMENT SYSTEM IS :-
o System for managing the quality of an
organization
o Includes everything in the organization that relates to
quality :
a. Products and Services
b. Processes
c. Operations
d. Customer Satisfaction

Document
Manager
Risk
Manager
Training
Record
Manager
Audits
CAPA
Supplier
Manager
Asset
Manage
r TYPES OF QUALITY
MANAGEMENT SYSTEM

Quality Risk Management
The systemic application of quality management policies ,
procedures and practices to the tasks of assessing,
controlling, communicating and reviewing risk .

Principle
• The evaluation of the risk to quality should be based on
scientific knowledge and ultimately link to the protection of
the patient.
• The level of effort, formality and documentation of the
quality risk management process should be commensurate
with the level of risk.

Risk Assessment
A systemic process of organizing information to support a risk
decision to be made within a risk management process.
Three parts of risk assessment :-
I. Risk Identification(What might go wrong?)
II. Risk Analysis(What is the probability it will go wrong?)
III. Risk Evaluation(what are the consequences?)
(Severity)

RISK IDENTIFICATION
The systemic use of information to identify potential sources
of harm referring to the risk or problem.
RISK ANALYSIS
The estimation of the risk associated with the identified
hazards. It is the qualitative or quantitative process of
occurrence and severity of harm.

RISK EVALUATION
The comparison of the estimated risk to given risk criteria
using a qualitative or quantitative scale to determine the
significance of the risk.
RISK=PROBABILITY*SEVERITY*DETECTABILITY

Risk Control(DecisionMaking
Activity)
o Actions implementing risk management decisions.
o The purpose is to reduce the risk to an acceptable level.
o The amount of effort used in risk control should be
proportional to the significance of risk.
o Two parts of risk control :-
1. Risk Reduction
2. Risk Acceptance

Risk Reduction
• Actions taken to lesson the probability of occurrence severity
of the harm.
• Risk reduction measures might introduce new risks into the
system or increase the significance of other risks.
• Revisit risk assessment to identify and evaluate any possible
change

Risk Acceptance
• The decision to accept the risk
• The best quality risk management might not entirely
eliminate risk
• The quality risk is reduced to a specified acceptable level
which will decided on a case-by-case bass.

Risk Communication
• The sharing of information about risk and risk management
between the decision maker and other stakeholders.
• Parties communicate at any stage of process
• The output/result should be appropriately communicated and
documented

Risk Review
• Review or monitoring of output/results of the risk
management
• The process should be utilized for events (planned or
unplanned events)
• The frequency of any review should be based on the level of
risk
• Risk review might include reconsideration of risk acceptance
decisions

List Of Risk Management Tools
• Basic risk management facilitation methods
• Failure Mode Effects Analysis ( FMEA)
• Failure Mode, Effects and Critically Analysis (FMECA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk ranking and filtering

HACCP(SEVEN PRINCIPLE)

RISK RANKING AND FITERING
• It is a tool for comparing and ranking risks which requires the
evaluation of multiple qualitative and quantitative factors for
each risks.
• This tool involves in breaking down a basic risk question into as
many component as needed to capture factors involved in the
risk
• Potential Areas of Uses:-
1. Used to prioritize manufacturing sites for inspection/audits by
regulators or industry.
2. Useful when management needs to evaluate both
quantitatively-assessed risks and qualitatively-assessed risks
within the same organizational framework.

CHANGE CONTROL
CHANGE CONTROL CONTD.

CHANGE CONTROL CONTD.
• To make or become different from expected.
• Types of change :-
Project Change
Product Change
Potential impacts need to be considered when evaluating
a change request :
Scope,Schedule,Cost,Quality,Process and
Deliverable,Risk.

DEVIATION (PLANNED AND
UNPLANNED)
• Quality Risk Management was mainly designed to be used
prospectively when manufacturing operations are defined
and validated. Therefore, potential deviations are identified
and avoided by implementing risk control measures and
preventive actions.
Event Detection
Decision Making Process / Deviation Categorization
Deviation Treatment
Root cause investigation
CAPA

Permanent
Planned
Unplanned
Product Impacted
Minor or Major
Negligible Impact Impact
Request Corrections
Deviation Initiation
Investigation
Engineering
Approval
Production
Approval
QA Approval
Closed Approved/Rejected
Initiate Change
Control
Initiate
Nonconformance
Initiate CAPA

Implementing A CAPA System With
A Closed Loop

Corrective Action And Preventive
Action
The root cause investigation process is a key step in handling major and
critical deviations as it will provide objective evidence to implement
corrective and possibly preventive actions as part of the CAPA system.
Corrective Actions are taken to eliminate the root causes of deviations,
and should be based on good quality investigations. Corrective actions
should be QA approved before implemented and their efficacy verified in
a documented manner, activity that could require a significant period of
time. Corrective actions could be transferred to an independent CAPA
system to avoid unnecessary delay for deviation closure. This independent
CAPA system should include tracking of all actions required by a pre-
approved CAPA plan and effectiveness check.