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AN IMPLEMENTATION
45 words RISK
54 words RISK
16 words RISK
In various words
Various words : risk due to inadequate safety, quality and efficacy,
risk to quality, risk of error, risk of mix-up, risk of cross
contamination, risk of microbial contamination, risk of manipulations,
risk to the product, etc
Regulatory Requirements
Product Life Cycle Risk - Patient
US
Sister Friends
Patients
Brother Parents
Basic Principles
The evaluation of the risk to quality
should be based on scientific knowledge
and ultimately link to the protection of
the patient; and
The level of effort, formality and
documentation of the quality risk
management process should be
commensurate with the level of risk.
Advantages as Process
Risk:
The combination of the probability of
occurrence of harm and the severity of
that harm (ISO/IEC Guide 51).
Harm:
Damage to health, including the damage
that can occur from loss of product
quality or availability (ICH Q9).
What is (QUALITY) RISK MANAGEMENT ?
10 | Q-Risk
Management | April
SEVERITY
S 5
e
4
v
e Risk Control
3
r
i 2 Accept w/ Risk Control
t
y 1 Accept w/ Risk Control based on Priority
1 2 3 4 5 6 7 8 9 10
Occurrence : Probability + Detectability
RISK EVALUATION EXAMPLE B
BE AWARE OF .(1)
16 | Q-Risk
Management | April
BE AWARE OF .(2)
17 | Q-Risk
Management | April
Implementation Approach
Quality Risk
Management
Existing (QRM)
internal
Documentation Where
to be in
System future?
(Mission, Policy)
What to do?
(e.g. Directives)
How to do?
(e.g. Guidelines)
Detailed instructions
(e.g. Standard Operating Procedures) Records
Scope
Any events where there is conditions or process
parameter or product that DOES NOT MEET the
approved requirement and specification
INTEGRATE RISK MANAGEMENT
1 Deviation
Originator
FR-C4.0554, PT-C4.0093
Process Owner
DRF, PT-C4.0093
Apakah kategori
penyimpangan major atau Tidak 1
kritikal?
Ya 3
Process Owner
PT-I2.0007, PT-C4.0200
01
20
01 Deviation
3 6
5 4
02
Implementasi correction Change Control
Compliance Mgr/QM
21 2
CLASSIFICATION IN DEVIATION
RECORD
CRITICAL INCIDENT
DEVIATION
CLASSIFICAT
ION
MAJOR MINOR
22
23
PROACTIVE RISK MANAGEMENT
Risk Evaluation 24
Risk Reduction
Risk Control 25
Risk Acceptance
Risk Control 26
Risk Review 27
Implement Deviation Record/Incident
Simplifying Minor Deviation Handling
One Day Root Cause Analysis & Finalized
Reduce Lead Time
Strengthen QA Inspector Role
Analyzed Reoccured Deviation
Finalized CAPA from deviation
Risk Analysis (Accept residual risk or not)
HOWS RISK MANAGEMENT GIVE
MEANING IN CALIBRATION
2500
2000
1500
Measuring Devices
Calibration Activities
1000
500
0
2014 2015 2016
BACKGROUND AND PURPOSE
BACKGROUND
An organization which is not unlimited resources, so
it needs to optimize the resources for calibration
activities with improving quality risk management on
calibration policy
PURPOSE
This document describes an assessment approach
that should be applied to evaluate measuring
device criticality and define required calibration
intervals or frequencies.
RISK EVALUATION-STAGE 1
5 4 4 4 5 5
Risk Evaluation Score :
4 3 3 4 4 5 3 : Low
3 2 3 3 4 4 4 : Medium
2 1 2 3 3 3 5 : High
1 1 1 2 3 3
1 2 3 4 5
Needs to be calibrated
No needs to calibrated
RISK EVALUATION-STAGE 2
3
stability calibration result extended calibration
period
4th calibration pass 2 period calibration
1 2 3 4 5
3rd calibration pass 1 period calibration
Man Hour
6800 6685.5
6700
6600
6500
6400
6300 6183.5 Reduce 6%
6200 man hour/year
6100
6000
5900
w/o RA with RA
HOWS RISK MANAGEMENT GIVE
VALUE IN TRAINING MANAGEMENT