This presentation f=gives Overview of Quality Risk Management Process and presents case studies for application of QRM in Manufacturing Operations.
◦ Drug Substance Attributes
◦ Excipient Selection
◦ Process Selection
◦ Formulation Development & Optimisation
◦ “Manufacturing Process Development
Unit V - Hazard Indentification Techniques.pptxNarmatha D
Job Safety Analysis-Preliminary Hazard Analysis-Failure mode and Effects Analysis- Hazard and Operability- Fault Tree Analysis- Event Tree Analysis Qualitative and Quantitative Risk Assessment- Checklist Analysis- Root cause analysis- What-If Analysis- and Hazard Identification and Risk Assessment
This presentation presents how Quality Risk management can be applied in Commissioning & Qualification of Facility , System and Equipments in Pharmaceutical Facilities.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
This presentation f=gives Overview of Quality Risk Management Process and presents case studies for application of QRM in Manufacturing Operations.
◦ Drug Substance Attributes
◦ Excipient Selection
◦ Process Selection
◦ Formulation Development & Optimisation
◦ “Manufacturing Process Development
Unit V - Hazard Indentification Techniques.pptxNarmatha D
Job Safety Analysis-Preliminary Hazard Analysis-Failure mode and Effects Analysis- Hazard and Operability- Fault Tree Analysis- Event Tree Analysis Qualitative and Quantitative Risk Assessment- Checklist Analysis- Root cause analysis- What-If Analysis- and Hazard Identification and Risk Assessment
This presentation presents how Quality Risk management can be applied in Commissioning & Qualification of Facility , System and Equipments in Pharmaceutical Facilities.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
As Europe's leading economic powerhouse and the fourth-largest hashtag#economy globally, Germany stands at the forefront of innovation and industrial might. Renowned for its precision engineering and high-tech sectors, Germany's economic structure is heavily supported by a robust service industry, accounting for approximately 68% of its GDP. This economic clout and strategic geopolitical stance position Germany as a focal point in the global cyber threat landscape.
In the face of escalating global tensions, particularly those emanating from geopolitical disputes with nations like hashtag#Russia and hashtag#China, hashtag#Germany has witnessed a significant uptick in targeted cyber operations. Our analysis indicates a marked increase in hashtag#cyberattack sophistication aimed at critical infrastructure and key industrial sectors. These attacks range from ransomware campaigns to hashtag#AdvancedPersistentThreats (hashtag#APTs), threatening national security and business integrity.
🔑 Key findings include:
🔍 Increased frequency and complexity of cyber threats.
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Our comprehensive report delves into these challenges, using a blend of open-source and proprietary data collection techniques. By monitoring activity on critical networks and analyzing attack patterns, our team provides a detailed overview of the threats facing German entities.
This report aims to equip stakeholders across public and private sectors with the knowledge to enhance their defensive strategies, reduce exposure to cyber risks, and reinforce Germany's resilience against cyber threats.
Adjusting primitives for graph : SHORT REPORT / NOTESSubhajit Sahu
Graph algorithms, like PageRank Compressed Sparse Row (CSR) is an adjacency-list based graph representation that is
Multiply with different modes (map)
1. Performance of sequential execution based vs OpenMP based vector multiply.
2. Comparing various launch configs for CUDA based vector multiply.
Sum with different storage types (reduce)
1. Performance of vector element sum using float vs bfloat16 as the storage type.
Sum with different modes (reduce)
1. Performance of sequential execution based vs OpenMP based vector element sum.
2. Performance of memcpy vs in-place based CUDA based vector element sum.
3. Comparing various launch configs for CUDA based vector element sum (memcpy).
4. Comparing various launch configs for CUDA based vector element sum (in-place).
Sum with in-place strategies of CUDA mode (reduce)
1. Comparing various launch configs for CUDA based vector element sum (in-place).
Levelwise PageRank with Loop-Based Dead End Handling Strategy : SHORT REPORT ...Subhajit Sahu
Abstract — Levelwise PageRank is an alternative method of PageRank computation which decomposes the input graph into a directed acyclic block-graph of strongly connected components, and processes them in topological order, one level at a time. This enables calculation for ranks in a distributed fashion without per-iteration communication, unlike the standard method where all vertices are processed in each iteration. It however comes with a precondition of the absence of dead ends in the input graph. Here, the native non-distributed performance of Levelwise PageRank was compared against Monolithic PageRank on a CPU as well as a GPU. To ensure a fair comparison, Monolithic PageRank was also performed on a graph where vertices were split by components. Results indicate that Levelwise PageRank is about as fast as Monolithic PageRank on the CPU, but quite a bit slower on the GPU. Slowdown on the GPU is likely caused by a large submission of small workloads, and expected to be non-issue when the computation is performed on massive graphs.
Explore our comprehensive data analysis project presentation on predicting product ad campaign performance. Learn how data-driven insights can optimize your marketing strategies and enhance campaign effectiveness. Perfect for professionals and students looking to understand the power of data analysis in advertising. for more details visit: https://bostoninstituteofanalytics.org/data-science-and-artificial-intelligence/
Techniques to optimize the pagerank algorithm usually fall in two categories. One is to try reducing the work per iteration, and the other is to try reducing the number of iterations. These goals are often at odds with one another. Skipping computation on vertices which have already converged has the potential to save iteration time. Skipping in-identical vertices, with the same in-links, helps reduce duplicate computations and thus could help reduce iteration time. Road networks often have chains which can be short-circuited before pagerank computation to improve performance. Final ranks of chain nodes can be easily calculated. This could reduce both the iteration time, and the number of iterations. If a graph has no dangling nodes, pagerank of each strongly connected component can be computed in topological order. This could help reduce the iteration time, no. of iterations, and also enable multi-iteration concurrency in pagerank computation. The combination of all of the above methods is the STICD algorithm. [sticd] For dynamic graphs, unchanged components whose ranks are unaffected can be skipped altogether.
2. Objectives of this Section
• Introduce the concept of risk assessment and
risk management and its role within UK
health and safety legislation.
• To define the principle components of risk
management.
• To outline advanced risk assessment
methodologies for use in QRA’s.
• To outline a practical risk assessment
process.
3. Principals of Risk Management
Risk management can be defined as:
The eradication or minimisation of the adverse
affects of risks to which an organisation is
exposed.
4. Stages in Risk Management
• Identifying the hazards.
• Evaluating the associated risks.
• Controlling the risks.
6. Regulation 3(1) of the ‘Management of Health
and Safety at Work Regulations 1992 states:-
• ‘Every Employer shall make a suitable and efficient
assessment of:-
a) The risks to the health and safety of his employees to
which they are exposed whilst they are at work.
b) The risks to the health and safety of persons not in his
employment arising out of or in connection with the conduct by
him or his undertaking;
• For the purpose of identifying the measures he needs
to take to comply with the requirements and
prohibitions imposed on him by or under the relevant
statutory provisions.’
7. Risk assessment can be a
‘very straightforward process based on
judgement requiring no specialist skills or
complicated techniques.’
This approach is commonly known as
qualitative or subjective risk assessment.
8. Major Hazards
• Major hazards associated with complex
chemical or nuclear plants, may ‘warrant the
need of such techniques as Quantitative Risk
Assessment’.
• In Quantitative Risk Assessment (QRA) a
numerical estimate is made of the probability
that a defined harm will result from the
occurrence of a particular event.
9. The Risk Management Process
Hazard Identification
Hazard :
The potential to cause harm. Harm including ill
health and injury, damage to property, plant,
products or the environment, production losses
or increased liabilities.
10. Hazard Identification
• Comparative Methods. e.g. checklists and
audits.
• Fundamental Methods: e.g. Deviation
Analysis, Hazard and Operability Studies,
Energy Analysis, Failure Modes & Effects
Analysis.
• Failure Logic: e.g. Fault Trees, Event Trees &
Cause- Consequence diagrams
11. Assessing the Risks
Risk:
The likelihood that a specified undesired
event will occur due to the realisation of a
hazard by, or during work activities or by
the products and services created by
work activities.
12. Assessing the Risks
Quantitative risk assessment
• Commonly used in the high technology
industries
• QRA tends to deal with the avoidance of
low probability events with serious
consequences to the plant and the
surrounding environment.
13. Assessing the Risks
Subjective risk assessment
• Qualitative risk assessment involves making a formal
judgement on the consequence and probability using:
Risk = Severity x Likelihood
14. Assessing the Risks
Example:
The likely effect of a hazard may for example be rated:
1. Major
Death or major injury or illness causing long term disability
2. Serious
Injuries or illness causing short-term disability
3. Slight
All other injuries or illnesses
15. Assessing the Risks
The likelihood of harm may be rated
1. High
Where it is certain that harm will occur
2. Medium
Where harm will often occur
3. Low
Where harm will seldom occur
16. Assessing the Risks
Risk
=
Severity of Harm
x
Likelihood of occurrence
• This simple computation gives a risk value of between 1 and 9
enabling a rough and ready comparison of risks.
• In this case the lower the number, the greater the risk, and so
prioritises the hazards so that control action can be targeted at
higher risks.
17. Controlling Risk
• Risk Avoidance – This strategy involves a
conscious decision on the part of the organisation to
avoid completely a particular risk by discontinuing the
operation producing the risk e.g. the replacing a
hazardous chemical by one with less or no risk
potential.
• Risk Retention – The risk is retained in the
organisation where any consequent loss is financed
by the company. There are two aspects to consider
here, risk retention with knowledge and risk retention
without knowledge.
18. Controlling Risk
• Risk Transfer – This refers to the legal
assignment of the costs of certain potential losses
from one party to another. The most common way is
by insurance.
• Risk Reduction – Here the risks are
systematically reduced through control measures,
according to the hierarchy of risk control described in
earlier sections.
19. ALARP
• Legislation requires employers to reduce
risks to a level that is as low as is reasonably
practicable (sometimes abbreviated as
ALARP).
• To carry out a duty so far as is reasonably
practicable means that the degree of risk in a
particular activity or environment can be
balanced against the time, trouble, cost and
physical difficulty of taking measures to avoid
the risk.
20. Types of Risk Assessment
Within Industry, three types of risk
assessment can be distinguished:
• Assessments of large scale complex hazard sites,
such as those found in the process and nuclear
industries. These require QRA’s
• General assessments of the complete range of
workplace risks – as required under the Management
of Health & Safety at Work Regulations, 1999.
• Risk Assessments required under specific legislation
– for example for hazardous substances (COSHH
Regulations, 1998), Manual Handling (Manual
Handling Operations Regulations, 1992).
21. Advanced Risk Assessment
Techniques
Quantitative Risk Assessment
• QRA is most commonly used in the process
industries to quantify the risks of ‘major hazards’.
• QRA used in the offshore oil and gas industries, the
transport of hazardous materials, the protection of the
environment, mass transportation (rail) and the
nuclear industry.
22. Quantitative Risk Assessment (1)
• Individual Risk is defined as ‘the frequency at
which an individual may be expected to sustain a
given level of harm from the realisation of specific
hazards’.
• Societal Risk
23. Usually expressed as risk contours:
CHLORINE
INSTALLATION
10-6
/year
risk contour
0.3*10-6
/year
risk contour
Site for
proposed
developmen
t
VILLAGE
10-5
/year
risk contour
1 km
24. Quantitative Risk Assessment:
Acceptance Criteria
• The HSE state that ‘broadly, a risk of death of 1 in
1000 (1x10 -3) per annum is about the most that is
ordinarily accepted under modern conditions for
workers in the UK and it seems to be the dividing line
between what is tolerable and what is intolerable’.
25. Failure Modes and Effect Analysis
The system is divided into sub systems that
can be handled effectively.
It involves:
• Identification of the component and parent system.
• Failure mode and cause of failure.
• Effect of the failure on the subsystem or system.
• Method of detection and diagnostic aids available.
26. Failure Modes and Effect Analysis
A typical format:
Component Function Failure
Mode
Failure
Rate
Failure
Effect
Criticality Detection
Method
Preventative
Measures
27. Failure Modes and Effect Analysis
• For each component’s functions, every conceivable
mode of failure is identified and recorded.
• It is also common to rate the failure rate for each
failure mode identified.
• The potential consequences for each failure must be
identified along with its effects on other equipment,
components within the rest of the system.
• It is then necessary to record preventative measures
that are in place or may be introduced to correct the
failure, reduce its failure rate or provide some
adequate form of detection.
28. Hazard & Operability Studies
• Hazard and Operability Studies
(HAZOP) have been used for many
years as a formal means for the review
of chemical process designs.
• A HAZOP study is a systematic search
for hazards which are defined as
deviations within these parameters
that may have dangerous
consequences.
• In the process industry, these
deviations concern process
parameters such as flow, temperature,
pressure etc.
29. Hazard & Operability Studies
• HAZOP is a team approach, involving a team of
people representing all different functions in a plant.
• They identify all the deviations by ‘brain-storming’ to a
set of guide words which are applied to all parts of
the system.
30. The process is as follows:
The system is divided into suitable parts or sub-systems,
which are then analysed one at a time.
For each sub-system each parameter (flow, temperature,
pressure, volume, viscosity etc.) that has an influence on it,
is noted.
Guidewords are applied to each parameter in each
subsystem. The intention is to prompt creative discussion of
deviations and possible consequences
For each significant deviation, possible causes are
identified.
Hazard & Operability Studies
31. Hazard & Operability Studies
NO or NOT No part of the design intent occurs, such as no flow in a
pipeline due to blockage.
MORE or LESS A quantitative increase or decrease of some parameter, such
as flow, temperature etc.
AS WELL AS All the design intentions are fulfilled and something happens
in addition
PART OF Only part of the design intention is fulfilled
REVERSE The logical opposite of the design intention occurs
Guideword Definitions
OTHER THAN Something completely different than attended occurs
32. Hazard & Operability Studies
Example
• Consider the simple process diagram below. It
represents a plant where substances A and B react
with each other to form a new substance C. If there is
more B than A there may be an explosion.
A
B
V1
V2
V3
V4
V5
A < B = Explosion C
Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
33. The HAZOP sheet for the section of the plant from A to C will be as
follows:
Guide Word Deviation Possible Causes Consequences Proposed
Measures
NO, NOT No A Tank containing A is empty.
V1 or V2 closed.
Pump does not work.
Pipe broken
Not enough A =
Explosion
Indicator for low
level.
Monitoring of flow
MORE Too much A Pump too high capacity
Opening of V1 or V2 is too
large.
C contaminated by
A. Tank overfilled.
Indicator for high
level.
Monitoring of flow
LESS Not enough
A
V1,V2 or pipe are partially
blocked. Pump gives low flow or
runs for too short a time.
Not enough A =
Explosion
See above
AS WELL AS Other
substance
V3 open – air sucked in Not enough A =
Explosion
Flow monitoring
based on weight
REVERSE Liquid
pumped
backwards
Wrong connector to motor Not enough A =
Explosion
A is contaminated
Flow monitoring
OTHER
THAN
A boils in
pump
Temperature too high Not enough A =
Explosion
Temperature (and
flow) monitoring.
Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
34. Fault Tree Analysis
• A fault tree is a diagram that displays the logical
interrelationship between the basic causes of the
hazard.
• Fault tree analysis can be simple or complex
depending on the system in question. Complex
analysis involves the use of Boolean algebra to
represent various failure states.
35. Fault Tree Analysis
• The first stage is to select the hazard or top event
that is to be analysed.
• The tree is structured so that the hazard appears at
the top. It is then necessary to work downwards,
firstly by identifying causes that directly contribute to
this hazard.
• When all the causes and sub-causes have been
identified, the next stage is to construct the fault tree.
36. Fault Tree Analysis
Symbol Designation Function
EVENT / CAUSE Causes or events that can be developed
further
BASIC
EVENT/CAUSE
Basic or Root Causes or events that cannot
be developed further
UNDEVELOPED
EVENT/CAUSE
Causes are not developed due to lack of
information or significance.
AND gate Output event occurs only if all input events
occur
OR gate Output event occurs if any one of the input
events occurs
37. Fault Tree Analysis
Example
• Consider the simple circuit diagram shown below:
+
-
LAMP
SWITCH
FUSE
BATTERY
POWER
UNIT
Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
38. Fault Tree Analysis
• The corresponding fault tree for the above circuit, with the top
event (or hazard) being the lamp not working is as follows:
Lamp does not
light
No current
through the lamp
No power supply
to the lamp
Broken circuit
No power feed
Faulty
Lamp
No Power
from battery
No Power
from unit
Broken
Circuit
Defective
switch
Defective
fuse
Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
39. Practical Risk Assessment
(from BS8800)
Classify work activities
Identify hazards
Determine risk
Decide if risk is tolerable
Prepare risk control action plan
(if necessary)
Review adequacy of action plan
40. Classify Work Activities
Possible ways of classifying work activities
include:
• Geographical areas within/outside the organisation's
premises.
• Stages in the production process, or in the provision
of a service.
• Planned and reactive work.
• Defined tasks (e.g. driving).
BS8800:1996
41. Identify Hazards
Broad categories of hazard
To help with the process of identifying
hazards it is useful to categorise hazards in
different ways, for example by topic, e.g.:
• Mechanical.
• Electrical.
• Radiation.
• Substances.
• Fire and explosion.
BS8800:1996
42. Hazards prompt-list
During work activities could the following
hazards exist?
• Slips/falls on the level.
• Falls of persons form heights.
• Falls of tools, materials, etc., from heights.
• Inadequate headroom.
• Hazards associated with manual lifting/handling of
tools, materials, etc..
• Hazards from plant and machinery associated with
assembly, commissioning, operation, maintenance,
modification, repair and dismantling.
BS8800:1996
43. Hazards prompt-list
• Vehicle hazards, covering both site transport, and
travel by road.
• Fire and explosion.
• Violence to staff.
• Substances that may be inhaled.
• Substances or agents that may damage the eye.
• Substances that may cause harm by coming into
contact with, or being absorbed through, the skin.
• Substances that may cause harm by being ingested
(i.e., entering the body via the mouth).
• Harmful energies (e.g., electricity, radiation, noise,
vibration).
BS8800:1996
44. Hazards prompt-list
• Work-related upper limb disorders resulting from
frequently repeated tasks.
• Inadequate thermal environment, e.g. too hot.
• Lighting levels.
• Slippery, uneven ground/surfaces.
• Inadequate guard rails or hand rails on stairs.
• Contractors' activities.
BS8800:1996
45. Determine risk
The risk from the hazard should be
determined by estimating the potential
severity of harm and the likelihood that harm
will occur.
46. Severity of harm
Information obtained about work activities is a
vital input to risk assessment. When seeking
to establish potential severity of harm, the
following should also be considered:
• Part(s) of the body likely to be affected;
• Nature of the harm, ranging from slightly to extremely
harmful:
– 1) Slightly harmful, e.g.:
• Superficial injuries; minor cuts and bruises; eye irritation
from dust.
• Nuisance and irritation (e.g. headaches); ill-health
leading to temporary discomfort.
BS8800:1996
47. Severity of harm
– 2) Harmful, e.g.
• Lacerations; burns; concussion; serious sprains; minor
fractures.
• Deafness; dermatitis; asthma; work related upper limb
disorders; ill-health leading to permanent minor disability.
– 3) Extremely harmful, e.g.
• Amputations; major fractures; poisonings; multiple
injuries; fatal injuries.
• Occupational cancer; other severely life shortening
diseases; acute fatal diseases.
BS8800:1996
48. Likelihood of harm
When seeking to establish likelihood of harm
the adequacy of control measures already
implemented and complied with needs to be
considered.
Issues considered:
•Number of personnel exposed.
•Frequency and duration of exposure to the hazard.
•Failure of services e.g. electricity and water.
•Failure of plant and machinery components and safety devices.
•Exposure to the elements.
BS8800:1996
49. Likelihood of harm
• Protection afforded by personal protective equipment
and usage rate of personal protective equipment;
• Unsafe acts (unintended errors or intentional
violations of procedures) by persons, for example,
who:
– 1) May not know what the hazards are.
– 2) May not have the knowledge, physical capacity, or skills to
do the work.
– 3) Underestimate risks to which they are exposed.
– 4) Underestimate the practicality and utility of safe working
methods.
BS8800:1996
50. Decide if risk is tolerable
One simple method for estimating risk levels and for
deciding whether risks are tolerable. Risks are
classified according to their estimated likelihood and
potential severity of harm.
Slightly harmful Harmful Extremely
harmful
Highly unlikely TRIVIAL RISK TOLERABLE
RISK
MODERATE
RISK
Unlikely TOLERABLE
RISK
MODERATE
RISK
SUBSTANTIAL
RISK
Likely MODERATE
RISK
SUBSTANTIAL
RISK
INTOLERABLE
RISK
BS8800:1996
51. Prepare risk control action plan
Risk categories shown form the basis for
deciding whether improved controls are
required and the timescale for action.
The outcome of a risk assessment should be
an inventory of actions, in priority order, to
devise, maintain or improve controls.
BS8800:1996
52. RISK LEVEL ACTION AND TIMESCALE
TRIVIAL No action is required and no documentary records need to be kept.
TOLERABLE No additional controls are required. Consideration may be given to a
more cost-effective solution or improvement that imposes no
additional cost burden. Monitoring is required to ensure that the
controls are maintained.
MODERATE Efforts should be made to reduce the risk, but the costs of prevention
should b e carefully measured and limited. Risk reduction measures
should be implemented within a defined time period.
Where the moderate risk is associated with extremely harmful
consequences, further assessment may be necessary to establish
more precisely the likelihood of harm as a basis for determining the
need for improved control measures.
SUBSTANTIAL Work should not be started until the risk has been reduced.
Considerable resources may have to be allocated to reduce the risk.
Where the risk involves work in progress, urgent action should be
taken.
INTOLERABLE Work should not be started or continued until the risk has been
reduced. If it is not possible to reduce risk even with unlimited
resources, work has to remain prohibited.
A simple risk-based control plan.
BS8800:1996
53. Prepare risk control action plan
The action plan should be reviewed before
implementation, typically by asking:
• Will the revised controls lead to tolerable risk levels?
• Are new hazards created?
• Has the most cost-effective solution been chosen?
• What do people affected think about the need for,
and practicality of, the revised preventive measures?
• Will the revised controls be used in practice, and not
ignored in the face of, for example, pressures to get
the job done?
BS8800:1996
54. Changing Conditions and Revising
Risk assessment should be seen as a
continuing process. Thus, the adequacy of
control measures should be subject to
continual review and revised if necessary.
BS8800:1996