1-2 introduction to quality risk management (qrm)

8/11/2019 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 Contents1 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


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1 Quality Risk Management (QRM)

1.1 Introd uct io n 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?


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Remember, whatever solutions we put in place there will always be residual

risk. There is rarely a perfect solution. Ac ceptance 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


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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.


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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 alwa ys 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-managementin 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


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1.2 Success ful ly Managing RiskRisk 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/intendedpurpose 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

R i s k a s s e s s m e n

t

R i s k m a n a e m

e n

t

Schematic representation of the risk management process (adapted from ISO 14971 Application of Risk Management to Medical Devices)


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1.3 Risk Ass essment 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

InitiateQuality Risk Management Process

Risk Identification

Risk Analysis

Risk Evaluation

Risk Assessment

Risk Reduction

Risk Acce tance

Risk Control

Output / Result of theQuality Risk Management Process

Risk Events

Risk Review

RiskManagement Tools

R i s k C o m m u n

i c a t i o

n m

ICH-Q9 Overview of a typical risk management process


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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


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1.4 Oppo rtuni ty for Imp rovem entIn general, the risk management process can be applied to any problem /opportunity for improvement, as follows:

unacceptable

Problem statement: identification ofopportunities for improvement

Use and/or adapt risk assessment tool(s) toindividually scrutinise and analyse eachreason/cause that lead to the problem

Evaluate and prioritise reasons/causes todetermine extent of mitigation required basedon risk to product quality, and currentresource loadings

Risk Assessment

Based on the mitigation strategies to beused, develop a project plan and a scheduleof activities for completion. Accept andimplement the plan.

Risk Control

Quality improvements: superior systemperformance, enhanced and betterunderstanding of the process, improvedcapability to react to system upsets, andincreased opportunity for continuous

improvements.

Periodic reapplication of (adapted) riskassessment tool(s) to problem statementfollowing implementation of risk controlstrategies. Confirm actual improvements toquality. Determine if there is additional roomfor further improvements.

Risk Review

RiskManagem

ent Tools

R i s k C o m m u n

i c a

t i o n

Typical site application of risk management process toidentification of opportunities for improvement

Use and/or adapt risk assessment tool(s) toidentify reasons/causes for current poorperformance

Set up a dedicated project team. Take aproblem-solving approach and decide onoptimum mitigation strategies.


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The following is the hypothetical application of the risk management processto 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 suitableformulation for a new drug substance.

Use and/or adapt risk assessment tool(s) torobustly scrutinise and analyse eachidentified formulation risk(s) that could leadto the patient harm.

Evaluate and prioritise formulation risk(s) todecide on a suitable manufacturing conceptbased on risk to patient health, and businessrequirements. Choose the formulation andidentify the critical process parameters.

Risk Assessment

Determine the product release concept forthe chosen formulation.

Risk Control

The output is robust pharmaceuticaldevelopment study that demonstrates to theregulatory authorities an advancedunderstanding of the process, an opportunityfor continuous improvements, and a firmbasis for process validation studies.

Periodic reapplication of (adapted) riskassessment tool(s) to problem statementfollowing formulation choice. As the processdesign evolves determine if there isadditional room for further improvements tothe chosen formulation approach.

Risk Review

RiskManagement Tools

R i s k C

o m m u n

i c a

t i o n m

Use and/or adapt risk assessment tool(s) toidentify risks to patient health based on arange of proposed formulations.

With the critical process parametersidentified, determine the process controlconcept for the chosen formulation.


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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 GusGrissom

.. 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 andtraining exercise on 27 January

1967 killing all three Apollo 1 crew.

Eugene Francis "Gene" Kranz athis console in the MissionOperations Control Room, MissionControl Center, Houston


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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 orprecedent 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 difficultbusiness 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.


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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 crewand mission control.


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3rd: Run failure simulations

IBM 7090 computer

Through simulation techniques in the

early 1960s, NASA's Saturn moon

flight rocket was "flown" thousands oftimes within the IBM 7090 computer

before real flight. The fully

transistorized 7090 could perform

229,000 calculations a second.


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4th: Monitor reactions

Monitor reaction of crew and mission control to upset conditions. If observedreactions 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


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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!

1-2 introduction to quality risk management (qrm)

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