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![Quality Risk Management - Process
Item/
Function/
Step
Event (Potential
Failure Mode)
Effect
(Severity)
Severity (S)
[1<2<3<4<5]
Potential Cause
of Failure
Probability (P)
[1<2<3<4<5]
Existing Controls
(Current Controls)
Detectability (D)
[1>2>3>4>5]
(RPN =
S*P*D)
Risk %
(R % = RPNX100/
125)
Preparation of
blank and
STD test
solution
• Wrong weight.
• Wrong Dilution.
un-correct
results
5 • Un-calibrated
balance.
• Analyst fault.
2 Calibration balance
check as per SOP.
Attach the weight with
worksheet and sign of
analyst.
1 10 8
Risk Identification
Describe as a manner in which the
process fails to meet specified conditions.
Potential failure modes are listed
assuming that they could “occur” and not
necessary “occur”.
Use official technical term/ Guidelines
language.
Risk Analysis
Failure effect is what will be
experienced or perceive once failure
occurs. E.g. product degradation,
contamination etc
Potential cause of failure shall be
described beyond/ depth to root
cause thoroughly.
Risk Evaluation
Risk Priority Number
Risk Ranking
1. less than or equal to 5 % is considered as Low –
Acceptable.
2. Above 5 % and less than or equal to 19 % are
considered as Medium (not acceptable).
3. Above 20 % are considered as High (Intolerable).
Fouad Serag El. Dein, MSc](https://image.slidesharecdn.com/qrm-ichq9iso31000-230716181535-a857e7ba/85/QRM-ICH-Q9-ISO-31000-pdf-25-320.jpg)
![Quality Risk Management - Process
Recommended Actions
(Risk Reduction Strategy)
After Implementation
Comments
Severity
(S)
[1<2<3<4<5]
Probability
(P)
[1<2<3<4<5]
Detectability
(D)
[1>2>3>4>5]
Risk
Priority
Number
(RPN
=
S*P*D)
Risk
%
(R
%
=
RPNX100
/
125)
• Proposed action/ study based on accurate
and scientific decision and so on.
5 1 1 5 4 Accepted
Risk Reduction Risk Review Risk Acceptance
Fouad Serag El. Dein, MSc](https://image.slidesharecdn.com/qrm-ichq9iso31000-230716181535-a857e7ba/85/QRM-ICH-Q9-ISO-31000-pdf-32-320.jpg)
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- 2. Risk in General BusinessOrganization Structure Business Risk Assessment Objectives Quality Risk Management o Scope, o General Quality Risk Management Process, o Applicability & Evaluation Tools, o Case Study. Contents Fouad Serag El. Dein, MSc
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- 7. Business Organization Structure-PharmaceuticalIndustry Operation Quality Quality Assurance Quality Control Research & Developmen t Production Warehouse Supply Chain Engineering/ Maintenance Distribution Quality Safety Efficacy Main Objective Fouad Serag El. Dein, MSc
- 8. Business Risk AssessmentObjectives 1. Studying new investment and ROI. 2. Expand Business to new area as per market segmentation. Fouad Serag El. Dein, MSc
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- 10. Quality Risk Management “Qualityby Design-paradigm” ICH Q8-9-10 Fouad Serag El. Dein, MSc Quality by Design ICH Q8 Pharmaceuti cal Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceuti cal Quality System
- 11. Quality Risk Management- Scope • Principles and examples of tools for quality risk management can be applied to different aspects of pharmaceutical quality. • These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products. Fouad Serag El. Dein, MSc
- 12. Quality Risk Management 1.Scope, 2. General Quality Risk Management Process, 3. Applicability & Evaluation Tools Fouad Serag El. Dein, MSc
- 13. Quality Risk Management- Process Definitions – Harm: Damage to health; the damage that can occur from loss of product quality. – Hazard: The potential source of harm. – Severity: A measure of the possible consequence of a hazard. Fouad Serag El. Dein, MSc
- 14. Quality Risk Management- Process Definitions – Risk: Combination of the probability of occurrence of harm and the severity of that harm. Risk = Probability * Severity. – Quality Risk Management: Systematic process for the assessment, control, communication and review of risks to the quality of the drug substance/ and drug (medicinal) product across the product lifecycle. Fouad Serag El. Dein, MSc
- 15. Quality Risk Management- Process Definitions (ISO Perspective) – Risk: Effect of uncertainty on objectives. An effect is a deviation from the expected. – Two types: Positive Risk Negative Risk Create Opportunities Create threats +ve Impact and outcome -ve Impact on the project Manage to complete a project under budget Delay happened during project delivery/ RM delivery lead time Fouad Serag El. Dein, MSc
- 16. Quality Risk Management- Process Principles • QRM is based on the following two primary principles: – Evaluation of risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. – Level of effort and documentation of the quality risk management process should be commensurate/ appropriate with the level of risk Fouad Serag El. Dein, MSc
- 17. Quality Risk Management- Process ICH Q9 links back to Patient Safety Design Facilities Materials Process Manufacturing Distribution Patient Opportunities to impact risk using quality risk management Fouad Serag El. Dein, MSc
- 18. Risk Management Process •ICH Q9 Quality Risk Management document can be broadly divided into – Main Body gives a broad idea about the “What ?”. – Annexure – 1 gives a broad idea about the “How ?” Titled: “Annex I: Risk Management Methods and Tools” – Annexure – 2 gives a broad idea about the “Where ?” Titled: “Annex II: Potential Applications for Quality Risk Management” Quality Risk Management - Process Fouad Serag El. Dein, MSc
- 19. Risk Management Lifecycle QualityRisk Management - Process Risk Review Ri s k C ommun ic at i on Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 20. Quality Risk Management- Process • Initiation of Risk Management Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 21. Quality Risk Management- Process Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools • Risk Assessment (Risk Assessment tells us whether a risk is acceptable or not) – Risk Identification (What might go wrong ?) • A systematic use of information to identify hazards/ or Failure Modes referring to the risk question or problem – Through historical data – Theoretical analysis – Information / opinions of end users / team members – Concerns of stake holders Fouad Serag El. Dein, MSc
- 22. Quality Risk Management- Process Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools • Risk Assessment – Risk Analysis (What is the likelihood (probability) it will go wrong ?) (What are the consequences (severity) if it go wrong ?) • The estimation/ calculation of the risk-including: 1. Risk Likelihood (Probability) & (Severity). 2. A qualitative or quantitative process of linking the likelihood of occurrence (Probability) and (Severity) of harm. 3. How to detect the Harm (Detectability). Fouad Serag El. Dein, MSc
- 23. Quality Risk Management- Process Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools • Risk Assessment – Risk Analysis – Examples of qualitative severity levels: – Examples of qualitative probability levels: Common Terms Possible Description Significant Death or loss of function or structure Moderate Reversible or minor injury Negligible Will not cause injury or will injure slightly Common Terms Possible Description High Likely to happen, often, frequent Medium Can happen, but not frequently Low Unlikely to happen, rare, remote Fouad Serag El. Dein, MSc
- 24. Quality Risk Management- Process Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools • Risk Assessment – Risk Evaluation • Comparison of identified and analyzed risk against given/pre-defined risk criteria • Derivation of Risk Priority Number (RPN) Quantitative Method Fouad Serag El. Dein, MSc
- 25. Quality Risk Management- Process Item/ Function/ Step Event (Potential Failure Mode) Effect (Severity) Severity (S) [1<2<3<4<5] Potential Cause of Failure Probability (P) [1<2<3<4<5] Existing Controls (Current Controls) Detectability (D) [1>2>3>4>5] (RPN = S*P*D) Risk % (R % = RPNX100/ 125) Preparation of blank and STD test solution • Wrong weight. • Wrong Dilution. un-correct results 5 • Un-calibrated balance. • Analyst fault. 2 Calibration balance check as per SOP. Attach the weight with worksheet and sign of analyst. 1 10 8 Risk Identification Describe as a manner in which the process fails to meet specified conditions. Potential failure modes are listed assuming that they could “occur” and not necessary “occur”. Use official technical term/ Guidelines language. Risk Analysis Failure effect is what will be experienced or perceive once failure occurs. E.g. product degradation, contamination etc Potential cause of failure shall be described beyond/ depth to root cause thoroughly. Risk Evaluation Risk Priority Number Risk Ranking 1. less than or equal to 5 % is considered as Low – Acceptable. 2. Above 5 % and less than or equal to 19 % are considered as Medium (not acceptable). 3. Above 20 % are considered as High (Intolerable). Fouad Serag El. Dein, MSc
- 26. Quality Risk Management- Process • Risk Control Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Control Is the risk above an acceptable level? What can be done to reduce (to an acceptable level) / eliminate a risk? Is the risk within the acceptable level? Accept the risk Fouad Serag El. Dein, MSc
- 27. Quality Risk Management- Process • Risk Control – Risk Reduction – Mitigation or Avoidance of Quality Risk when it exceeds the acceptable level: • Action taken to mitigate the severity & probability. • Improve or introduce a new control strategy (detectability). Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 28. Quality Risk Management- Process • Risk Control – Risk Acceptance – Risk Acceptance (the decision making activity) • The risk will be accepted if it is reduced to an acceptable level. • Made on case by case basis: For some types of harms, even the best quality risk management practices might not entirely eliminate risk. In these circumstances, it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level. Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 29. Quality Risk Management- Process • Risk Control / Risk Acceptance • Risk Acceptance (Who has to accept ?) – Person(s) with the competence and authority to make appropriate and timely quality risk management decisions – Decision makers / Stake holders • Any individual, group or organization (Multi-disciplinary team) Def. (Stakeholder): Person or organization that can affect, be affected by, or perceive themselves to be affected by decision or activity. NB: The term “interested party” can be used as an alternative to “stakeholder”. ISO 31000:2018 Fouad Serag El. Dein, MSc
- 30. Quality Risk Management- Process • Risk Communication – Communication of information about risk and risk management between the decision makers and others. – Parties can communicate at any stage of the RA process. – Communication to be carried out for each and every risk acceptance. – Communicate and document the output/result of the QRM process. Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 31. Quality Risk Management- Process • Risk Review – Ongoing part of the quality management process. – Review the output / results of the QRM process. – The frequency of any review should be based upon the level of risk. e.g. STD case may be daily, in case of stability may be 3 or 6 months. – Implement a mechanism for revision and monitoring. Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Risk Review Risk Communication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Management tools Fouad Serag El. Dein, MSc
- 32. Quality Risk Management- Process Recommended Actions (Risk Reduction Strategy) After Implementation Comments Severity (S) [1<2<3<4<5] Probability (P) [1<2<3<4<5] Detectability (D) [1>2>3>4>5] Risk Priority Number (RPN = S*P*D) Risk % (R % = RPNX100 / 125) • Proposed action/ study based on accurate and scientific decision and so on. 5 1 1 5 4 Accepted Risk Reduction Risk Review Risk Acceptance Fouad Serag El. Dein, MSc
- 33. Quality Risk Management 1.Scope, 2. General Quality Risk Management Process, 3. Applicability & Evaluation Tools Fouad Serag El. Dein, MSc
- 34. Quality Risk Management-Applicability & Evaluation Tools • Application ❑ Integrated Quality Management e.g. Documentation, Change control / management system, Audit and compliance, training…… ❑ Industrial Operations e.g. Material management, product development, facilities, equipment and utilities, production, packing and labeling, laboratory controls, stability management…… ❑ Regulatory Operations (by regulatory bodies) e.g. Inspections, Assessment activities…… Fouad Serag El. Dein, MSc
- 35. Quality Risk Management-Applicability & Evaluation Tools • Evaluation Tools ❑ Failure Mode Effects Analysis (FMEA) ❑ Failure Mode, Effects and Criticality Analysis (FMECA) ❑ Fault Tree Analysis (FTA) ❑ Hazard Analysis and Critical Control Points (HACCP) ❑ Hazard Operability Analysis (HAZOP) ❑ Preliminary Hazard Analysis (PHA) ❑ Other supporting statistical tools No one tool or set of tools is applicable to every situation in which a QRM procedure is used Fouad Serag El. Dein, MSc
- 36. Case Study Fouad SeragEl. Dein, MSc
- 37. Case Study- Scope 1.Evaluation of potential failure modes for Rapid Mixer Granulator and their likely effect on product quality. Fouad Serag El. Dein, MSc
- 38. Case Study- Wetgranulation process flow chart Fouad Serag El. Dein, MSc
- 39. Case Study –Risk Assessment Procedure (Severity Rating) Effect Severity of effect Rating Very high Very high severity ranking when a potential failure mode effects safe operation or involves non- compliance with regulations without warning. Equipment/production stopped, with loss of function 5 High Equipment/production continuing with reduced output 4 Moderate Equipment/process in operating conditions but may cause damage to equipment or repair 3 Low Process or equipment may cause slight inconvenience to operations 2 Very low Very minimum or un noticeable effects None Process/equipment under normal conditions except few non noticeable effects 1 Fouad Serag El. Dein, MSc
- 40. Case Study –Risk Assessment Procedure (Occuring Rate) Probability of occurrence Criteria for rating of Occurrence Occurance Very high Failure is almost inevitable 5 High Repeated Failures 4 Moderate Occasional Failures 3 Low Relatively few Failures 2 None Failure is unlikely 1 Fouad Serag El. Dein, MSc
- 41. Case Study –Risk Assessment Procedure (Detection Rate) Detection Criteria for ranking Detection Ranking None There are no detection controls existing or cannot detect any failure occurring 5 Low Low chance of failure to be detected before occurring 4 Moderate Moderate chance that a failure would be detected 3 High High chance that a failure would be detected 2 Very High Very high chance of detection capabilities of failures 1 Fouad Serag El. Dein, MSc
- 42. Case Study –Risk Assessment Procedure (Risk Percentage Scale) Risk Percentage Classification Risk percent below 5% Acceptable Risk percent obtained falls between 5% and 19% Un-acceptable Risk percent above 20% Intolerable Fouad Serag El. Dein, MSc
- 43. Case Study –Risk Assessment Procedure (Risk Percentage Scale) Item Function Potential Failure mode Failure mode effects SEV Potential failure causes O Current Controls DET RPN % RPN Risk % Scale Chopper assembly Chopper drive. Motor. • Granules are not uniform. • Variation in speed of mixing. 5 Any electrical / circuit/ mechanical problem 2 PLC. HMI display. 1 10 8 Un acceptable Impeller assembly Impeller drive. Motor. • Inadequate granulation. • Inadequate process performance. 3 Shaft problem. Motor failure. 2 PLC. HMI display. 2 12 9.6 Un acceptable Calculation of % RPN %RPN= Obtained RPN for failure/ Maximum obtainable RPN for failure * 100 Fouad Serag El. Dein, MSc
- 44. Case Study –Risk Assessment Procedure (Implementation of actions) Item Function % RPN Risk % Scale Actions Chopper assembly 8 Un acceptable SOP. Verification during qualification PMP. Impeller assembly 9.6 Acceptable SOP. PMP. After Implementation SEV O DET RPN 1 1 1 0.8 1 1 1 0.8 Fouad Serag El. Dein, MSc
- 45. Thank you Fouad SeragEl. Dein, MSc