In the modern day, a company's competitive advantage in most industries will be determined by maximizing its relationships and the diligent management of its forward and backwards facing supply chains.
The ability to effectively manage risks in a supply chain is an absolute must in the skill set of any current supply chain professional. This course will equip and develop procurement and supply chain professionals to be able to operate diligently and effectively with their supply base, mitigating any risks and maximizing all opportunities to gain competitive advantage in their market place.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Complaints in Quality Management SystemMayuriMore15
Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.
Definition
Regulatory Bodies that oversee Pharmaceutical Waste Management
Type of Waste
Methods of product disposal
Waste product Disposal Procedure
Scales of product disposal
Pharmaceutical Waste Management Guidelines
Records
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Ind...Stuart Silverman
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – India Segment
SPECIAL FOCUS - The environment as a risk to the supply chain.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Complaints in Quality Management SystemMayuriMore15
Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.
Definition
Regulatory Bodies that oversee Pharmaceutical Waste Management
Type of Waste
Methods of product disposal
Waste product Disposal Procedure
Scales of product disposal
Pharmaceutical Waste Management Guidelines
Records
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Ind...Stuart Silverman
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – India Segment
SPECIAL FOCUS - The environment as a risk to the supply chain.
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
The operation of Supply Chain of Management (SCM) is predominantly perceived from commercial facet of a
business. Pharmaceutical products affect the health of the user hence it is obligatory to produce and deliver the
products of predetermined quality standards. This can only be achieved by designing quality centric procedures
and pursue them at each stage during distribution process. Quality is considered as the most sensitive aspect of
pharmaceutical business during manufacturing as well as distribution. Quality of medicinal products is
concurrent to its objective of curing the patients. Many drug regulatory agencies have issued guidance ‘Good
distribution practices (GDP)’for pharmaceutical manufactures. The Good Distribution Practices (GDP) is
considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products.
Due to lack of proper understanding and commitment, product quality issues are noticed by manufacturer’s
quality assurance department. Since most of the quality aspects of pharmaceutical products are not known to
the common patients, the survey to characterise them with help of quality professionals has been found useful.
This research study finds that there is an enhanced need of control over the supply chain management
operations to align its procedure and practices with quality objectives of pharmaceutical ‘Good Manufacturing
Practices (GMP)’
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
Supply chain issues in Pharma industryJaimeen Rana
Supply Chain Management in pharmaceutical industry plays a very critical part as availability of the product at right time has to be ensured for unpredictable demand patterns. Issues being faced in this industry and solutions for those problems are mentioned in the presentation.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Presentation: Pharmacovigilance requirements inspected and example findingsTGA Australia
Presentations given at the TGA information sessions cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
2. Course Objectives
• Know the characteristics of pharmaceutical supply chain
• Know the challenges facing the pharmaceutical supply chain
• Mapping your supply chain
• Define risks associated with your supply chain
• Know the risk mitigation strategies
3. Importance of the supply chain
• “Companies don’t Compete, supply chains compete”
Quote by CIO of Nortel
• Organizations nowadays competes through their supply chains
not their products.
• Valsartan Problem (2018)
4. Importance of the supply chain
Valsartan Problem:
-FDA ordered for the recall of all products containing
Valsartan from a Chinese supplier due to contamination
with a impurities (N-Nitro Sodium Ethyl Amine)
-NOVARTIS Egypt beats the competition through a
declaration in the newspaper that availability of their
Valsartan-containing products wasn't affected by these
decisions as the mentioned supplier is not a registered
supplier for NOVARTIS and the Supply of their Valsartan is
from their own manufacturing facilities so they assure its
safety & efficacy
-Key messages in the declaration
•Availability
•Supply
•Safety & Efficacy
5. What is a Supply Chain?
A supply chain consists of the flow of products and services from:
– Raw materials manufacturers
– Component and intermediate manufacturers
– Final product manufacturers
– Wholesalers and distributors and
– Retailers
– Consumers (End users)
Connected by transportation and storage activities, and
Integrated through information, planning, and integration
activities
Many large firms are moving away from in-house Vertically
Integrated structures to Supply Chain Management
8. What is a Supply Chain?
• SC is a network of partners.
• Each partner in the chain is responsible directly for a process or
activity that adds value to the product.
• Those networks of partners, processes & activities should be
managed effectively & efficiently.
9. Supply Chain Management
• “The planning and management of all activities involved in
sourcing and procurement, conversion and all logistics
management activities. Importantly, it also includes
coordination and collaboration with channel partners, which
can be suppliers, intermediaries, third-party service providers
and customers.” The Council of Supply Chain Management Professionals (CSCMP)
definition
10. Supply Chain Management
• Supply chain management involves two main functions:
1- Planning: “Making a plan on how much of each product should
be bought, made, distributed, sold and when”
2- Controlling: Keeping to plan – in spite of the many problems
that may get in the way
11. • Chopra & Meindl defines five areas to be the performance
drivers for any supply chain
- Production
- Inventory
- Location
- Transportation
- Information
Supply chain Performance Drivers
11
13. • Why does the pharmaceutical or generally healthcare supply
chain need specific attention?
• Simply because of the End User
Specific Nature of Pharmaceutical Supply Chain
13
14. • Dissatisfied customer means
- Untreated patient (Drug shortage or lack of therapeutic effect, leading to prolonged
illness)
- Hospitalization (in case of severe ADR or Contaminated products)
- Death (in case of life saving medications)
• So all parties of the supply chain need to ensure that their
activities both support the health & well being of the patient
and maintain business continuity.
Specific Nature of Pharmaceutical Supply Chain
15. • All these parties could be the focal firm in the supply chain of
pharmaceutical products
- Pharmaceutical manufacturers
- Pharmaceutical distributors
- Contract manufacturing organizations (CROs)
- Pharmacies & Hospitals
- Non Governmental organizations (WHO, Doctors without borders..)
• Each one of these entities may face its own challenges within
its supply chain, although they share most of challenges
The focal organization in pharmaceutical supply chain
15
16. Pharmaceutical supply chain challenges:
• Lack of coordination
• Outsourcing (Regulatory & quality compliance)
• Inventory management
• Absent demand information
• Storage Conditions & Temperature control
• Counterfeit Medications
• Uncertainty
17. Pharmaceutical supply chain challenges:
• Lack of coordination
- There are often so many links in the chain that the most resilient, adaptable
and successful supply chains must be well coordinated.
- is not always an easy task.
18. • Outsourcing (Regulatory & quality compliance)
- Increased sourcing & outsourcing of manufacturing to low cost
countries
* Stretched the supply chains
* Increasing chances of disruption
* Making tight Control More Challenging
- Quality agreements (define detailed responsibilities)
- The accountable organization has all the responsibility against the
regulatory authorities
- Short & simple supply chains are preferred for better control
Pharmaceutical supply chain challenges:
19. • Inventory management
Pharmaceutical companies tends to follow JIC strategy instead of JIT.
JIT strategy have high risks of delayed delivery specially in case of life saving
drugs.
JIC strategy leads to holding excess inventory which freeze the working
capital and hence the organization capabilities.
Time of holding inventory is very critical in case of biologics and even more
in case of radioactive drugs which may need only few days to decay causes
huge losses.
So the challenge is How to Balance
Pharmaceutical supply chain challenges:
20. • Absent demand information
- Pharmaceutical companies need greater customer insight and
planning for assessing (What, when & How much of supply) to
avoid
* Shortage of supply
* Excess inventory (in case of perishable or radioactive drugs may cause
potential huge losses if they go to waste)
Pharmaceutical supply chain challenges:
21. • Storage conditions & Temperature control
- Developing countries
- Very big countries with wide range of temperature distribution
(India)
- The patient****
Pharmaceutical supply chain challenges:
22. • Storage conditions & Temperature control (Cont’d)
- Survey Done by Pharmaceutical & Packaging News in 2015 found
that of temperature sensitive products:
- 51% were ambient
- 31% were refrigerated
- 17% were frozen
- 32% shouldn’t be allowed to freeze
- Many pharmaceuticals also, react to humidity & light
- So all these factors should be consistent through the whole supply
process of the drug (Storage, Manufacturing, Transportation,
Warehousing, on the shelf an also at the patient side)
Pharmaceutical supply chain challenges:
23. • Counterfeit Drugs
In 2017, the WHO estimated 1 in 10 medical products
circulating in low- and middle-income countries is either
substandard or falsified, according to new research from WHO.
- Consequences
Untreated patients may lead to death
Losing of brand image
Hinders the flow of the product supply by feedback mechanism
Pharmaceutical supply chain challenges:
25. • Uncertainty
With complexity comes uncertainty
It comes from missing information “many unanswered question
marks”
25
Pharmaceutical supply chain challenges:
26. • Uncertainty (Cont’d)
Uncertainty leads to high risk profile to the whole supply chain
Supply risks
Operations risks
Delivery risks
26
Pharmaceutical supply chain challenges:
28. • Due to all these challenges, the supply chain is always running
under risk. So it is essential to go through
28
29. • “What is our plan for when things go wrong?”
• Reacts to uncertainty
• Appropriate when managers lack sufficient control over
operational affecting factors.
Risk Management
29
30. Supply Chain Risk Management
• Definition of risk
- Effect of uncertainty on objective (Risk Management guidelines ISO
31000:2018)
- The combination of occurrence of harm and the severity of that
harm (ICH Q9 guidelines)
31. • Definition of risk
- Business wise: it is the probability for loss to the focal
organization
- Regulatory wise: it is the probability for health damage
Pharmaceutical supply chain challenges:
32. • Characteristics of the risk
- Uncertainty: May or may not happen (no 0% risk or 100% risk)
- Future consequences results in loss
Pharmaceutical supply chain challenges:
33. • Potential risks may come from:
- Natural disasters (Earthquakes, Tsunami,…)
- Political instability (middle east region)
- Outsourcing activities
- breaching regulatory requirements
- Loose regulatory control over the whole supply chain (developing
countries)
- Non accurate demand forecasting
- Inefficient operations management
- Inefficient sourcing activities
- Uncontrolled storage conditions through the whole distribution
channels (Warehouse, transportation, distributors, pharmacies &
clinics and the end user)
Pharmaceutical supply chain challenges:
34. • Importance of applying risk management
- Supporting business continuity and secure products supply.
- Reduce costs.
- Minimize costs of non-conformance.
- Improve business efficiency.
- Increase confidence of customers & regulators.
- Reduce liability.
- Avoid waste & scrap.
Pharmaceutical supply chain challenges:
35. • Principles of risk management
- Open communication
- Shared vision
- Team work
- Integration
- Future consideration
- Continuous process
Pharmaceutical supply chain challenges:
36. • Risk Management
“Coordinated activities to direct and control organization with regard to risk”
36
Pharmaceutical supply chain challenges:
38. • Risk management process
Identify the risks
Evaluate & prioritize the risks
Develop a strategy for each risk
Pharmaceutical supply chain challenges:
39. Risk Management Process
1- Establish the risk context & Criteria
1.1. Establish the Context
• The strategic & organizational context in which the risk management will
take place.
• For Example
- Strategic priorities of the organization
- Type of the business
- Geographic areas where your business runs
- Top selling products
40. 1.2. Define the risk criteria
- How consequences & likelihood will be defined & measured.
- How the level of risk will be determined
- Scoring technique that will be used
- Tools that will be used
Risk Management Process
1- Establish the risk context & Criteria
41. Risk Management Process
2- Risk assessment
2.1. Identify the risk
- A systematic use of information to identify hazard referring to the risk
question or problem description (ICH Q9)
- Main objective of this stage is to determine “what might go wrong”
- Brainstorming, process mapping, Cause & effect diagram “Fish bone
diagram” are useful tools for this stage.
42. Risk Management Process
2- Risk assessment
2.1. Identify the risk
- At this stage you have to map your supply chain from different perspective
(process flow, geographical flow)
• Essential step for effective risk management
• Creates visibility
• Shows hotspots & areas of potential risks
• Show areas of impact
43. Risk Management Process
2- Risk assessment
2.1. Identify the risk (Cont’d)
- At this stage collect information as much as you can.
- There are two types of information/data
Sources of Data/Information used in risk identification
Hard DataSoft Data
- Facts
- Measurements
-Analytical result
-Trends
-Attributes
-Observations
-Experience
-Assumptions
44. 2.2. Analyze the risk
- At this step, we attempt to estimate the level of risk in terms of
A- Severity of harm
B- likelihood of occurrence
C- delectability
- It provides qualitative or quantitative estimate for each risk.
Risk Management Process
2- Risk assessment
45. 2.2. Analyze the risk
- How to analyze the risk
- Choose the suitable analysis tool
in the early beginning, you can
start with simple tools and as
experience grows, you can transit
to the more complex tools
- Assign a rank or a score for each
identified risk
Risk Management Process
2- Risk assessment
46. 2.3. Evaluate the risk
- The purpose: Comparing the
results of the risk analysis with
the established risk criteria
Risk Management Process
2- Risk assessment
48. 1- Avoidance Strategy:
• the organization choose to avoid the activities that lead to that
risk
• used when the risk is above the limit of tolerance
• (Example: Avoidance of making direct investment in struggle
regions like Syria or Yemen)
Risk Management Process
3- Risk treatment
49. 2- Reduction Strategy:
• the organization take the necessary mitigation actions and
controls to lessens the effect of the risk
• Reduce either the probability or the severity or both
• The main objective is to drive the risk below the level of
tolerance
Risk Management Process
3- Risk treatment
50. 3- Transfer Strategy:
• the organization transfers all or part of the risk to a third party
• The main forms of this strategies are insurance & outsourcing
Risk Management Process
3- Risk treatment
51. 4- Acceptance Strategy:
• the organization sees the opportunities within the risk
• The main forms of this strategies are insurance & outsourcing
Risk Management Process
3- Risk treatment
52. After taking the necessary actions for treating the risks, don’t
overlook:
• The Residual risks: Risks remaining after making the necessary control
measures
• The Secondary risks: Control measures taken results in risks at their own
Risk Management Process
3- Risk treatment
53. Risk Management Process
4- Risk Communication
• It is the umbrella that should cover all risk management
process.
• The internal & external communication is critical for the success
of any risk management plan.
54. Risk Management Process
5- Monitor & Review
• In identifying, analyzing and treating the risks, the organizations
make assumptions an decisions based on situations that are
subjected to change
• Risk review is required to ensure that the outputs of the Risk
Management process are:
• Revisited at defined intervals
• Actively evaluated in response to current events or new
information
55. Risk Management Process
Summary of the Risk Management Process
1) Define the context your business you need to manage its associated risks
and criteria that will be used
2) Map you supply chain
3) Identify the risk events related to your supply chain.
4) Analyze the potential risk events regarding probability & severity.
5) Rank & prioritize the risks
6) Determine the treatment strategy for each risk
7) Communicate your risk management plan
8) Implement the determined risk controls.
9) Monitor and review and repeat the process
56. In this activity, every participant will choose a product from his
organization and implement the risk management process for
this product.
Steps:
Develop the context & criteria for determining the risks
Map the supply chain for this product (try to get to the deepest tiers as you can.
Assign the hotspots and areas under risk
Analyze these risks
Rank the risks & prioritize tem
Choose the treatment strategy for each risk
Assign the appropriate control
Activity
56
57. • You can share your activity outputs with me for
further discussion on
Email: m_elnadi@reyadapro.com
WhatsApp: +201091081800
57
Activity