1-2 Introduction To Quality Risk Management (QRM)

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1-2 Introduction to Quality Risk Management (QRM)

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Table of Contents
1 Quality Risk Management (QRM) ............................................................. 3
1.1 Introduction to Risk Management ...................................................... 3
1.2 Successfully Managing Risk .............................................................. 7
1.3 Risk Assessment Plan ....................................................................... 8
1.4 Opportunity for Improvement ........................................................... 10
1.5 Risk Management Case Study Example ......................................... 12


1 Quality Risk Management (QRM)
1.1 Introduction to Risk Management
Worst case scenarios
When designing any equipment system we need to consider an appropriate
response to any upset condition. Focus particularly on likely worst case
scenarios, with initially a high probability for failure.

Primary worst case scenarios are typically in the context of:
1. Product effectiveness and quality
2. Personnel safety both operator and customer.
At the outset we try to identify what could go wrong and what to expect in that
event.

Planning for worst case scenarios
Then we need to consider our reactions to these upset conditions. What are
we going to do, or what do we need to put in place, when these things do go
wrong?


Remember, whatever solutions we put in place there will always be residual
risk. There is rarely a perfect solution. Acceptance of residual risk will dictate
a go/no-go scenario with the product.

Causes of failures
Now we need to figure out what could trigger the fault with a view to
preventing it from occurring. Therefore, for each fault we try and identify
causes. We could also further describe specific deviations and/or effects
associated with each cause in the context of the overall fault.

Fault prioritization


Next, prioritize each cause and deviation/effect combination typically rating
against severity, and likelihood of occurrence (probability).

Control strategies
Based on priorities then choose which
faults over others we must endeavor
to control. The process predominately
culminates in a suitable control
strategy being decided upon and
implemented.

Remember there can be many solutions to choose from, but be sure they will
all cost money! If a solution is too expensive to implement it can render the
business initiative economically unviable, thus killing the project.

Risk communication

Communication to the
operator/customer is hugely
important particularly in the context
of managing the residual risk.
Residual risk is usually managed in
combination with procedures, as
opposed to being completely
designed out.


Risk review
Endeavour to track all post-
implementation and post-production
failures. Dont make the same
mistake twice!

Know what you dont know

Knowledge based on experience
is referred to as wisdom. But we
dont always have the benefit of
wisdom particularly when doing
something for the first time where
there is little or no precedence.

Plan to accumulate wisdom in advance of experience, using risk-management
in combination with well designed simulation and prototyping studies.
Find ways to unlock-wisdom not yet experienced.

Simulations
Gain experience with prototypes through well designed simulations and feed
back newly identified risks back into the evolving design


1.2 Successfully Managing Risk
Risk is an opportunity to incur a loss or an injury. To successfully manage risk
you must identify the processes, participants, and interactions between them.
Who is at risk of what? Who is liable for what? What is the potential for loss or
injury? What can be done to prevent or control those potential losses or
injuries?

Risk analysis
Intended use/intended
purpose identification
Hazard identification
Risk estimation
Risk evaluation
Risk acceptability decisions
Risk control
Option analysis
Implementation
Residual risk evaluation
Overall risk acceptance
Post-production information
Post-production experience
Review of risk
management experience
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Schematic representation of the risk management process
(adapted from ISO 14971 Application of Risk Management to Medical Devices)


1.3 Risk Assessment Plan
A risk assessment plan is an important design tool in the development of a
medicinal product. It is used to ensure that the products are designed safe
and effective. Unlike other processes however, the hazard evaluation is one
that never dies. In fact the risk plan should evolve especially as other risks are
identified such as when a problem occurs out in the field or when a
customer complaint is issued.
unacceptable
Initiate
Quality Risk Management Process
Risk Identification
Risk Analysis
Risk Evaluation
Risk Assessment
Risk Reduction
Risk Acceptance
Risk Control
Output / Result of the
Quality Risk Management Process
Risk Events
Risk Review
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ICH-Q9 Overview of a typical risk management process


The level of effort needed for actual management of risk, however, depends
on the product and its application. Risk management is, in reality, easier for
tongue depressors than it is for pacemakers.

Risk management requires clear executive policy, useful guidance, and
resource support in the form of human resources and training. You will need
effective assessment methodologies appropriate to the product or service,
and continual monitoring, assessment and improvement of the risk
management process. Risk management can be used to connect design
control, quality planning, process control, measurements control and core
problem solving processes. When this connection is made the interplay
between them becomes clear and potential problems can be prioritized and
addressed in the most effective way at the lowest possible cost.

Risk management process should to be used as part of a quality companys
management system and specify a procedure for the manufacturer of a
medicinal product to incorporate the following:
Identify hazards associated with the medicinal product device and its
accessories
Estimate and evaluate the risk associated with those hazards
Control those risks
Monitor the effectiveness of that control

To get started first determine what quality risk scenarios can occur, what is
the likelihood and the consequences given they occur. Second, estimate the
parameters used to determine the frequencies and probabilities of the various
events. The level of detail and quantification needed helps to determine the
tool to use:
Methodology: e.g. formal or informal risk management process
System risks: e.g. risk ranking and filtering, FMEA
Process risks: e.g. FMEA, HACCP, process mapping, flow charts
Product risks: e.g. flow charts, decision trees, tables, check sheets


1.4 Opportunity for Improvement
In general, the risk management process can be applied to any problem /
opportunity for improvement, as follows:
unacceptable
Problem statement: identification of
opportunities for improvement
Use and/or adapt risk assessment tool(s) to
individually scrutinise and analyse each
reason/cause that lead to the problem
Evaluate and prioritise reasons/causes to
determine extent of mitigation required based
on risk to product quality, and current
resource loadings
Risk Assessment
Based on the mitigation strategies to be
used, develop a project plan and a schedule
of activities for completion. Accept and
implement the plan.
Risk Control
Quality improvements: superior system
performance, enhanced and better
understanding of the process, improved
capability to react to system upsets, and
increased opportunity for continuous
improvements.
Periodic reapplication of (adapted) risk
assessment tool(s) to problem statement
following implementation of risk control
strategies. Confirm actual improvements to
quality. Determine if there is additional room
for further improvements.
Risk Review
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Typical site application of risk management process to
identification of opportunities for improvement

identify reasons/causes for current poor
performance
Set up a dedicated project team. Take a
problem-solving approach and decide on
optimum mitigation strategies.


The following is the hypothetical application of the risk management process
to identify a suitable formulation strategy for a new drug substance:

Hypothetical application of risk management process during
pharmaceutical development to identify a suitable formulation
unacceptable
Problem statement: identify suitable
formulation for a new drug substance.
robustly scrutinise and analyse each
identified formulation risk(s) that could lead
to the patient harm.
Evaluate and prioritise formulation risk(s) to
decide on a suitable manufacturing concept
based on risk to patient health, and business
requirements. Choose the formulation and
identify the critical process parameters.
Risk Assessment
Determine the product release concept for
the chosen formulation.
Risk Control
The output is robust pharmaceutical
development study that demonstrates to the
regulatory authorities an advanced
understanding of the process, an opportunity
for continuous improvements, and a firm
basis for process validation studies.
Periodic reapplication of (adapted) risk
assessment tool(s) to problem statement
following formulation choice. As the process
design evolves determine if there is
additional room for further improvements to
the chosen formulation approach.
Risk Review
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identify risks to patient health based on a
range of proposed formulations.
With the critical process parameters
identified, determine the process control
concept for the chosen formulation.


1.5 Risk Management Case Study Example
Know what you dont know
Knowledge based on experience is referred to as wisdom. But we dont
always have the benefit of wisdom particularly when doing something for the
first time where there is little or no precedence. Plan to accumulate wisdom in
advance of experience, using risk-management in combination with well
designed simulation and prototyping studies. Find ways to unlock-wisdom
not yet experienced. Gain experience with prototypes through well designed
simulations and feed back newly identified risks back into the evolving design

we should have caught it.

The Apollo 1 crew, from left to right,
Roger Chaffee, Ed White and Gus
Grissom
.. Somewhere, somehow, we
screwed up. It could have been in
design, build, or test. Whatever it
was, we should have caught it. We
were too gung ho about the
schedule and we locked out all of
the problems we saw each day in
our work. .
[Gene Kranz]

Command module (CM-012)
destroyed by fire during a test and
training exercise on 27 January
1967 killing all three Apollo 1 crew.

Eugene Francis "Gene" Kranz at
his console in the Mission
Operations Control Room, Mission
Control Center, Houston


How should we have caught it?
How can you predict problems?
Its got to be a bit like predicting the future
Nobody has ever done this before, so we have no benchmark or
precedent to compare against.
The only guarantee is that well never think of everything - never ever

How do you predict the future?
The consequences of our actions are
so complicated, so diverse, that
predicting the future is a very difficult
business indeed. [J. K. Rowling,
Harry Potter and the Prisoner of
Azkaban]

Uncertainty based on fear is the beginning of knowledge
It is the unknown we fear [J. K. Rowling, Harry Potter and the Half
Blood Prince]

We all fear the future to some extent. We learn from looking back, but we
achieve when we look forward. With risk management positively harness our
fear of the future by looking forward in apprehension when things wont go
correctly.

What to do when things go wrong
How do you plan to react when things do go wrong.
What could go wrong, where and when.
How do I find out what things could go wrong?

Nobody ever expects everything will go right all the time, especially the first
time; the big test is what will you do when things go wrong.


1st: Develop the concept

Describe desired processes and outcomes

2nd: Identify possible deviations
This is the trickiest part identify potential problems. A team of backroom
scientists and engineers, often with great amusement, would develop various
likely and unlikely scenarios. They would then feed a sequence of code into
the computer to simulate the problem, and monitor the reaction of the crew
and mission control.


3rd: Run failure simulations

IBM 7090 computer
Through simulation techniques in the
early 1960s, NASA's Saturn moon
flight rocket was "flown" thousands of
times within the IBM 7090 computer
before real flight. The fully
transistorized 7090 could perform
229,000 calculations a second.


4th: Monitor reactions
Monitor reaction of crew and mission control to upset conditions. If observed
reactions are undesirable, then proceed to mitigate and control. Either design-
out (preferable) or procedurilize-out (last resort) the problem. Remember,
there are many options available to mitigate and control faults.

5th: Communicate the action
Ensure only does that need to know
are updated with the communication.
Dont waste the time of those who
dont really need to know

Apollo Operations Handbook


6th: Review the action

Buzz Aldrin walks on the surface
of the Moon 20 July 1969

Apollo 11 astronauts in New
York

Mistakes will be made
Innovation and creativity are experimental processes where there are always
unknowns. Everything cannot be predicted where there is no precedent.
Mistakes are a necessary part of creative experimentation and will be made.

Dont make the same mistake twice!

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