1. “Whatever is worth doing at all, is worth doing well” -Philip Dormer Stanhope

2. Total Quality Management Quality Risk Management
Sreenath RN
Deputy General Manager- R&D
Karnataka Antibiotics and Pharmaceuticals Limited, Bengaluru

3. SIPOC- Overall Process
Suppliers
Inputs
Process
Output
Requirements
Customers
Manufacturers
Vendors
Service Providers
Equipment
Utilities
Skilled / Trained Manpower
Drug Product
Patients
Hospitals
Quality
Safety
Efficacious
Affordable
On-Time Availability
Dispensing
Granulation
Drying
Blending
Tableting
Coating
Packing

4. Total Quality Management

5. Total Quality Management [TQM]
…means “doing the right thing right the first time”
must be considered at planning as well as during activities of operations
directed at improving existing processes
focuses on achieving customer satisfaction
A means of defining and updating organization's expectations and translating these into internal goals and objectives
Identifying and effecting continual improvement in all areas

6. Total Quality Management
Appropriate quantitative measurement techniques, including analysis of both positive and negative trends
Performance-based assessment of ongoing activities with feedback to planning and other management functions
Positive fault correction, including effective corrective and preventive actions well as proper adaptive actions

7. If TQM program were totally effective, some of the elements which focus on problems are not necessary However…

8. ..if “doing the right thing right the first time” represents the ideal situation, then ‘doing the right thing right the second time” seems the next best performance

9. Root cause analysis can help identify the more obvious and needed improvements to current operations, since It focuses on present obstacles --Therefore, root cause analysis techniques can be used to identify these likely opportunities for improvement, as well as provide the road map for their attainment

10. TQM efforts when used in a,
reactive mode, it can prevent problems from recurring
proactive mode, it can examine current operations and help to identify areas and activities to be improved

11. Enhanced product and process understanding
RFT- How?
By obtaining increased process and product understanding in
order to identify and appropriately manage critical sources of
variability and hence achieve “right first time” performance
Need for a shift in paradigm:
From compliance
Enhanced product and process understanding

12. Quality Risk Management

13. Quality Risk Management [QRM] –ICH Q9
…a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle

14. Initiating Quality Risk Management process
..should include systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk
Possible steps used to initiate and plan a quality risk management process might include the following:
Define the problem and/or risk question, including pertinent assumptions
identifying the potential for risk
Assemble background information and/ or data on the potential hazard,
harm or human health impact relevant to the risk assessment
Specify a timeline, deliverables and appropriate level of decision making
for the risk management process

15. Risk Assessment
Risk assessment consists of the identification of hazards and the analysis
and evaluation of risks associated with exposure to those hazards
Risk identification
.. is a systematic use of information to identify hazards
referring to the risk question or problem description
Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders
Risk identification addresses the “What might go wrong?” question, including identifying the possible consequences

16. Risk Assessment Risk analysis
.. is the estimation of the risk associated with the identified hazards
It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harm

17. Risk Assessment Risk evaluation
..compares the identified and analysed risk against given risk criteria
Risk evaluations consider the strength of evidence for all three of the fundamental questions

18. Risk Control
Risk control includes decision making to reduce and/or accept risks
The purpose of risk control is to reduce the risk to an acceptable level
The amount of effort used for risk control should be proportional to the significance of the risk

19. Risk Control Risk reduction
..focuses on processes for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level
Processes that improve the detectability of hazards and quality risks might also be used as part of a risk control strategy

20. Risk Control Risk acceptance .. is a decision to accept risk
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

21. Process Scale-up & Tech Transfer
Risk Management
Product Development
Process Development
Process Scale-up & Tech Transfer
Manufacturing
Implementation
Excipient & drug substance
design space
Product/prior Knowledge
Risk Assessment
Risk Assessment
Process design space
Process Understanding
Product quality
control strategy
Risk Control
Continual
improvement
Process History
Risk Review
Risk Management

22. Risk Management Methodology
Quality risk management supports a scientific and practical approach to decision-making
It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the Probability(P), Severity(S) and sometimes Detectability (D) of the risk
Risk Priority Number (RPN) – SxP (or) SxPxD
Arranged in descending order with a cut-off for investigation and corrective action

23. Risk Management Methodology
Traditionally, risk to quality were assessed using empirical procedures, such as observations and trends
Additionally, risk management tools are also being used, such as,
Basic risk management facilitation methods (flowcharts, check sheets
etc.)
Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects and Criticality Analysis (FMECA)
5 Why’s
Define, Measure, Analyze, Improve and Control (DMAIC)
Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP)
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk ranking and filtering
Supporting statistical tools

24. Failure Mode Effects Analysis (FMEA)
The 8 M’s in Manufacturing: (Toyota-Model)
Machine (technology)
Method (process)
Material (Includes Raw Material, Consumables and Information)
Man Power /Mind Power
Measurement (Inspection)
Milieu/Mother Nature (Environment)
Management/Money Power
Maintenance

25. Failure Mode Effects Analysis (FMEA)

26. 5 Why’s The Problem Product is getting delivered late to the customer
Too many orders backlogged in the system
Couldn’t ship particular orders for almost 3 weeks
Out of a specific piece of equipment on the orders
Material shortage on a component
Only one single source for the component and the supplier could not deliver the component (the root cause)

27. Finally... Procedures & Quality Systems
Say What You Do Do What You Say!
Check What is Done!
Systems Manual,
SOPs, WIs, Records
Internal
Practices

28. Thank you!