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Quality Risk Management. 20 th March 2009 - SAPRAA. Helena van Schalkwyk Quality Assurance Manager Boehringer Ingelheim, South Africa. Agenda. Risk Management - The Essentials Background of QRM Structured Risk Management Process: ICH Q9 - PowerPoint PPT Presentation
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QRM - SAPRAA 20 March 2009 PTSDr. R. Beerbohm
ABCD
Quality Risk Management20th March 2009 - SAPRAAHelena van SchalkwykQuality Assurance ManagerBoehringer Ingelheim, South Africa
QRM - SAPRAA 20 March 2009 2
Agenda
Risk Management - The Essentials
Background of QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 3
Agenda
Risk Management - The Essentials
Background of QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 4
Risk Management – The Essentials
• Keep Risk Management SIMPLE - Beware of the following pitfalls ……
Recruiting “Risk Management Experts” Writing a 30 page “Risk Management
Policy/SOP”” Seeing Risk Management as something NEW The appointment of Risk Management
CONSULTANTS
QRM - SAPRAA 20 March 2009 5
Risk Management – The Essentials (cont)
• We are already managing risks ……Because we live in a world full of risks!“Zero Risk” does not exist anywhere!
• Risk Management involves: Identifying risks (what can go wrong/ what are the hazards) Analysing risks (estimate risks associated with identified hazards) Evaluating risks (are these risk really that bad?) Controlling and reducing these risks
(mitigate severity, reduce probability of harm, increase likelihood of detection)
Accepting residual risk (accept level of risk)
QRM - SAPRAA 20 March 2009 6
Risk Management – The Essentials (cont)
• ICH Q9 Definitions “Harm” – damage to health, including the
damage that can occur from loss of product, quality or availability
“Hazard” – potential source of harm
“ Risk” – combination of probability of occurrence of harm and severity of harm
QRM - SAPRAA 20 March 2009 7
Risk Management – The Essentials (cont)
• What is risk?
You only have risk where a hazard exists Risk is the combination of probability of harm
and severity of that harm Some risks we can’t do anything about Other risks can be managed DRIVING to work is a risky business
QRM - SAPRAA 20 March 2009 8
Risk Management – The Essentials (cont)
• What is your perception of risk?
High, medium or low based on Probability of occurrence Severity of potential harm
Will you be satisfied with this level
of risk or not?
QRM - SAPRAA 20 March 2009 9
Risk Management – The Essentials (cont)
QRM - SAPRAA 20 March 2009 10
Risk Management – The Essentials (cont)
QRM - SAPRAA 20 March 2009 11
Risk Management – The Essentials (cont)
Are you prepared to take your chances and accept the risk?
or
Accept that the risk is unacceptable and in need of management and control?
QRM - SAPRAA 20 March 2009 12
Risk Management – The Essentials (cont)• Acceptable risk?
Your answer will depend on your
Attitude to risk
Your objective and subjective
assessment of information available to you
QRM - SAPRAA 20 March 2009 13
Risk Management – The Essentials (cont)
• The risks associated with DRIVING in South Africa:
Approximately 14,627 people are killed each year on South African roads
(Road Traffic Management Corporation - Road Traffic Report - March 2008 dated 17 April 2008)
That’s 40 people every day Roads will become even more congested Cars are becoming both faster and safer
Is the risk acceptable to you or not?
QRM - SAPRAA 20 March 2009 14
Risk Management – The Essentials (cont)
• Risk IDENTIFICATION What can go wrong?
You may be involved in a fatal road accident – (killing yourself or someone else)
You may be seriously injured and unable to work for a period of time
You may be sent to prison if found guilty of dangerous driving
Incur costs for repairs to damaged vehicles and the inconvenience factor
You driver’s license may be suspended due to (multiple) speeding offences
QRM - SAPRAA 20 March 2009 15
Risk Management – The Essentials (cont)
• Risk IDENTIFICATION (cont) What can go wrong?
The inconvenience of relying on public transport (currently very limited availability in SA!)
You may lose your job if you have lost your driver’s license
Social hardships as a result of no income Higher insurance premiums after the accident
claim High fuel costs resulting from uneconomical
driving style
QRM - SAPRAA 20 March 2009 16
Risk Management – The Essentials (cont)
• DRIVING: Risk ANALYSIS
What is the probability of occurrence?
What are the potential consequences (severity)?
Is this level of risk acceptable … or not?
How can I control (manage) the risks?
QRM - SAPRAA 20 March 2009 17
Risk Management – The Essentials (cont)• DRIVING: Risk ANALYSIS (cont)
Potential Risks Severity Probability (of
occurrence)
You may be involved in a fatal road accident – (killing yourself or someone else)
High ?
You may be seriously injured and unable to work for a period of time
High ?
You may be sent to prison if found guilty of dangerous driving
High ?
QRM - SAPRAA 20 March 2009 18
Risk Management – The Essentials (cont)• DRIVING: Risk ANALYSIS (cont)
Potential Risks Severity Probability (of
occurrence)
Costs for repairs to damaged vehicles and the inconvenience factor
Low ?
You driver’s license may be suspended due to (multiple) speeding offences
High to Medium
?
The inconvenience of relying on public transport (currently very limited availability in SA!)
Medium ?
QRM - SAPRAA 20 March 2009 19
Risk Management – The Essentials (cont)• DRIVING: Risk ANALYSIS (cont) Potential Risks Severity Probability
(of occurrence)
You may lose your job if you have lost your driver’s license
High ?
Social hardships as a result of no income
High to Medium
?
Higher insurance premiums after the accident claim
Medium ?
High fuel costs resulting from uneconomical driving style
Low ?
QRM - SAPRAA 20 March 2009 20
Risk Management – The Essentials (cont)• DRIVING: Risk CONTROL What actions can you take to
Reduce severity? Reduce probability of occurrence? Increase ability to detection?
You could Drive slower Increase following distance between you and the car in
front of you Buy a car with better safety specifications Sell your high performance car for a slower/more
economical one Drive at a safer and slower speed Leave earlier to reach your destination in time
QRM - SAPRAA 20 March 2009 21
Risk Management – The Essentials (cont)
• DRIVING: Risk CONTROL (cont) You could
Purchase a “Radar Detector” Please Note: Do NOT use RM to justify what you know is inherently
wrong! (Like purchasing a “Radar Detector” system!) Attend an advanced driving skills course Talk to those who have witnessed accidents close
by Travel at alternative times (non-peak hours) of
the day Ensure that your car is always in a roadworthy
condition
QRM - SAPRAA 20 March 2009 22
Risk Management – The Essentials (cont)
• DRIVING: Risk REVIEW Circumstances or situations could change which may then influence your original decision
You may be able to afford a safer car You may decide to move to a job closer to home that
would result in less stressful and dangerous travel You may witness a serious accident that would influence
your driving behaviour/style New laws may be implemented to lower maximum speed
limits, and much tougher enforcement of the traffic laws You may have children which will motivate you to drive
more careful
QRM - SAPRAA 20 March 2009 23
Risk Management – The Essentials (cont)
• FINALLY….. remember the following:
Never use Risk Management to justify what you know is INHERENTLY wrong
Invest in an advance driving skills course
instead of purchasing a “Radar Detector”
QRM - SAPRAA 20 March 2009 24
Agenda
Risk Management – The Essentials
Background of QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 25
Background of QRM
• FDA’s CONCERNS – 2001:Pharmaceutical Manufacturing
Innovation/continuous improvement difficult due to delays in approval at HA’s
Many product formulations and processes derived empirically
Too little knowledge on mechanisms impacting product quality
Very low efficiency and high cost – the opposite of what is necessary in a competitive global market
Industry hesitant/afraid to use new technologies
QRM - SAPRAA 20 March 2009 26
Background of QRM (cont)
• FDA’s CONCERNS – 2001 (cont):FDA unable to deliver on their statutory inspection obligations (low budget and high demand)• FDA’s CONCLUSION:
Current approach likely to be inadequate to meet future needs
Need to place emphasis on science and risk-based approaches
• FDA’s INITIATIVES since 2002: Process Analytical Technology (PAT)
– not just testing, but a philosophy of Process Understanding
Control in-process rather than end-product testing
Minimises risks of poor quality
QRM - SAPRAA 20 March 2009 27
Background of QRM (cont)
• FDA’s INITIATIVES since 2002 (cont): Quality by Design (QbD) approach – which parameters
are critical to product quality? Statistically designed experiments ICH Q8
QRM - SAPRAA 20 March 2009 28
Background of QRM (cont)
• FDA’s INITIATIVES since 2002 (cont):
• PARADIGM SHIFT: Traditional Paradigm
Starting Materials
Variable
Processing Parameters
Fixed
Product
Variable
QRM - SAPRAA 20 March 2009 29
Background of QRM (cont)
• PARADIGM SHIFT (cont): QbD paradigm:
Starting Materials
Variable
Processing Parameters
Variable
Product
Fixed
QRM - SAPRAA 20 March 2009 30
Background of QRM (cont)
• ICH
EU and Japan joined USA to define a new paradigm at an ICH workshop in Brussels in July 2003
This workshop agreed a 5 year vision: Create a single, harmonised global
quality standard and interpretation based on good science and risk management principles
QRM - SAPRAA 20 March 2009 31
Background of QRM (cont)
• ICH (cont)
Achieve 5 year vision by incremental stepsPharmaceutical Development (Q8)
Old: Data transfer / variable outputNew: Knowledge transfer / consistent output
Quality Risk Management (Q9)Old: Unstructured approachNew: Structured process
Quality Systems (Q10)Old: Large variability on Q-systemsNew: Consistency on Q-systems
QRM - SAPRAA 20 March 2009 32
Background of QRM (cont)
• ICH (cont)Flexible Regulatory Approach
Regulators evaluate risk, based on: Product and Process Design (Q8) Measures to evaluate and manage risks (Q9) Q-system implementation (Q10)
Regulators determine risk and modify level of oversight accordingly for: Submissions Post-approval review GMP Inspections
Result Removal of barriers to continuous improvement Efficient use of resources by industry and regulator
QRM - SAPRAA 20 March 2009 33
Background of QRM (cont)
• Design Space
Design space is the multi-dimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality
Knowledge Space
Design SpaceBatch process/control
parameters
The batch process/control parameters are NOT registered and, hence, moving them within the Design Space is NOT a change
QRM - SAPRAA 20 March 2009 34
Background of QRM (cont)
• ICH Q10 – Pharmaceutical
Quality System Objective of Q10 - to
establish a new guideline describing model for an effective QMS for the Pharmaceutical Industry, referred to as the Pharmaceutical QMS
QRM - SAPRAA 20 March 2009 35
Background of QRM (cont)
• Q10 and Management Responsibility
Management commitment, management review and communication are important
Senior Management Establish a PQS appropriate for the organisation and
compliant with regulations Ensure that PQS responsibilities and authorities are defined
and communicated Has ultimate responsibility to foster a company-wide
commitment to quality and for the successful functioning of the PQS
QRM - SAPRAA 20 March 2009 36
Background of QRM (cont)
• ICH Q11 – API Development Q11 will aim to define the development process for API’s
similar to those contained in Q8 for medicinal products (Detail for the 3.2.S.2 Section of the CTD)
•The New Regulatory Paradigm – Conclusion It makes sense FDA is driving it forward If we can make it to work, it will benefit
patients, industry and regulators We should focus on what adds value for patients
QRM - SAPRAA 20 March 2009 37
Background of QRM (cont)
• QRM – Summary
Realise that current situation is not sustainable By Industry By Regulators current situation is not in the best interest for
patientsQRM is a win: win: win situation for: Industry Regulators and Patients
QRM - SAPRAA 20 March 2009 38
Agenda
Risk Management – The Essentials
Background of QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 39
Structured Risk Management Process: ICH Q9
• Q9 – Table of Contents1. Introduction2. Scope3. Principles of QRM4. General QRM Process5. RM Methodology6. Integration of QRM process into industry and
regulatory operations7. Glossary8. ReferencesAnnex I – RM Methods and ToolsAnnex II – Potential Appliances of QRM
QRM - SAPRAA 20 March 2009 40
Structured Risk Management Process: ICH Q9 (cont)
• Q9 – Principles of QRM Two primary principles:
1. The evaluation of the quality risk should be based on scientific knowledge and always links back to the protection of the patient.
2. The level of effort, formality and documentation of the QRM process should be corresponding with the level of risk.
QRM - SAPRAA 20 March 2009 41
Structured Risk Management Process: ICH Q9 (cont)
• QRM is:A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
• QRM Process: Consists of three stages:
Risk Assessment Risk Control Risk Review
QRM - SAPRAA 20 March 2009 42
Structured Risk Management Process: ICH Q9 (cont)
QRM - SAPRAA 20 March 2009 43
Structured Risk Management Process: ICH Q9 (cont)
• When a “situation/deviation” occurs Appoint a “situation/deviation” owner and start to
investigate Seniority dependent on initial severity assessment
Decide what approach to Risk Assessment is applicable
Use a multi-disciplinary team approach People with the right knowledge and experience for the
situation/deviation Team Leader At least one person who understands Risk Management tools/methods FACILITATOR
Determine deadline for completion
QRM - SAPRAA 20 March 2009 44
Example of process mapping ABCD
QRM - SAPRAA 20 March 2009 45
Structured Risk Management Process: ICH Q9 (cont)
Deciding on the Risk Management Approach:
QRM - SAPRAA 20 March 2009 46
Structured Risk Management Process: ICH Q9 (cont)
QRM - SAPRAA 20 March 2009 47
Structured Risk Management Process: ICH Q9 (cont)
QRM - SAPRAA 20 March 2009 48
Structured Risk Management Process: ICH Q9 (cont)
Formal tools of Risk Assessment according to ICH Q9, Annex I:
QRM - SAPRAA 20 March 2009 49
Structured Risk Management Process: ICH Q9 (cont)
• Conclusion:
Using a structured, systematic process for QRM adds value in more complex
situations ICH Q9 provides a good framework for this
structured approach Your company should develop its own
implementation approach Focus to be pro-active
QRM - SAPRAA 20 March 2009 50
Agenda
Risk Management – The Essentials
Background to QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 51
Practical Implementation of QRM in your company
• Implementation – Making it happen in your company “If you want to make enemies, try and change something” - Woodrow Wilson To effectively plan the process to move to a more effective
way of using QRM you have to look at the following:Context
OrganisationCulture
QRM
QRM - SAPRAA 20 March 2009 52
Practical Implementation of QRM in your company (cont)
• Planning for SUCCESSFUL Implementation Involve people early on in the process See the change from the perspective of others Create dissatisfaction with the current situation
(status quo) “ let them know there must be a better way of
doing things”• Your company MUST
Accept an open “risk aware” culture Acknowledge that ZERO RISK doesn’t exist Accept that you have “been doing” RM from day
one RM must be kept SIMPLE
QRM - SAPRAA 20 March 2009 53
Practical Implementation of QRM in your company (cont)
• Planning for SUCCESSFUL Implementation (cont)
There must be a clear objective – give DIRECTION Start small and go for early wins Communicate extensively Publicise your successes and give credit to people Make sure that your company
Is aware of ICH Q9 and the business benefits Is aware that your competitors are already using RM as
well Does not re-invent the wheel … learn from others (HSE,
etc)
QRM - SAPRAA 20 March 2009 54
Practical Implementation of QRM in your company (cont)
• Planning for SUCCESSFUL Implementation (cont) Important Rules to remember:
RULE 1Ensure that you have expert knowledge of your PRODUCTS, PROCESSES, PROCEDURES at operational level, on each site and in each department RULE 2Ensure your organisation is aware of ICH Q9 and the opportunity
it affordsProvide education and training and start with SENIOR
MANAGEMENT
QRM - SAPRAA 20 March 2009 55
Practical Implementation of QRM in your company (cont)
• Important Rules (cont): RULE 3Encourage an open, risk awareness culture Understand that risks always exist Understand current QRM approach Take ICH Q9 into account during your QRM
process Identify opportunities for improvement
Where will a more structured approach add value?
Complex issues, recurring deviations
QRM - SAPRAA 20 March 2009 56
Practical Implementation of QRM in your company (cont)
• Important Rules (cont): RULE 4 Keep RM SIMPLE
Focus on the outcome, not the tools Learn from others (HSE, Medical Devices, Food Industry, etc.)
RULE 5 Integrate QRM with existing QMS
Remember ICH Q8, 9 and 10 work together Q9 needs to be applied across the whole product lifecycle Do NOT set up separate risk departments Coordinate implementation and allocate resources Prioritise projects
QRM - SAPRAA 20 March 2009 57
Practical Implementation of QRM in your company (cont)
RULE 6Be open to new ways of thinkingExpect resistance – this is normal. Work with resistance, NOT
against it Remember that you can’t force anyone to do anything …
unless they really want to Proper PLANNING = successful IMPLEMENTATION
QRM is a better way of doing what you are already doing
WHEN it is necessary. – Peter Gough, DBA
QRM - SAPRAA 20 March 2009 58
Agenda
Risk Management – The Essentials
Background of QRM
Structured Risk Management Process: ICH Q9
Practical Implementation of QRM in your company
Summary and conclusions
QRM - SAPRAA 20 March 2009 59
Summary and conclusions
We must do RM properly Poor RM will not impress the regulators The regulators will think we do not know
what’s really important If we don’t know what’s insignificant,
how can we know what’s important?
If EVERYTHING is critical, NOTHING is critical
Ultimately, it is all about CREDIBILITY!*****************************************************
******
QRM - SAPRAA 20 March 2009 60
Acknowledgements and References• Contents of QRM Presentation prepared for the SAPRAA Meeting
of 20 March 2009 based on contents of presentation slides and notes from “Practical Application of QRM” course presented by David Begg & Associates and with the permission of David Begg & Associates to use material from DBA in this presentation.
Please visit: www.david-begg-associates.com for more information
about the company and services offered.
• ICH Q8, 9 and 10
• Annex 20 to the updated proposed South African GMP Guide (4.01 SA Guide to GMP Sept08 v3.doc)