key principles of qrm useful
Post on 11-Dec-2021
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Definitions:
Informal Tools: e.g: brain storming or risk ranking can also be applied across the RA spectrum, but will typically be used for better understood/ lower complexity situations/ risk questions.
Formal tools: e.g: FMEA, HACCP can be used throughout the spectrum of RA - simple to complex - formal tools can be adapted to suit the situation they are being applied to - for example a formal tool can be applied in a light manner to a relatively simple/well understood situation.
Note: A combination of basic and advanced tools is also an option.
For informal RA, don't forget to document it.
How to structure Formal Risk Assessment:Standardise your templates to include date, team members, the risk question, quality unit approval.
Potential headings:
✓ Critical Parameter ✓ Failure Mode, ✓ Likelihood x Severity ✓ Overall Risk score/rank.
front
Adapted from ICH Q9 QRM Diagram
FME(C)A
Risk
Eva
luat
ion
Level of Risk Understanding
Comprehensive Unknown
Non
Crit
ical
Im
pact
Criti
cal
Impa
ct
Level of Risk Assessment Formality
Basic Advanced
Memo
PHA
HACCP
HAZOP
Fishbone
Brainstorming
Mapping
Assessment
Filtering
Checksheets
Flowcharts
LEVEL OF RISK ASSESSMENT FORMALITY
Basic Advanced
Comprehensive Unknown
LEVEL OF RISK UNDERSTANDING
RISK
EVA
LUAT
ION
Criti
cal I
mpa
ctNo
n Cr
itica
l Im
pact
Checksheets
Brainstorming
Process Mapping
Fishbone
Technical Memo
Bespoke RiskAssessment
Cause & Effect
Risk Ranking& Filtering
FME(C)AHazop
Flowcharts
PHA
HACCP
Tool Selection Criteria
ConsiderationsFMEA / FMECA
FTA HACCP HAZOP PHA RR&F
Is risk ranking desired?
Is demonstration of the effectiveness of risk controls required?
Is risk indenitifi cation a challenge, do hidden risks need to be revealed or is structured brainstorming desired?
/
Is risk detection capability within the process in question?
/ / /
Is process / product / system knowledge limited?
Is process / product system knowledge advanced?
Is the problem statement simple or is an elegant assessment appropriate?
Is the problem statement complex or is a detailed assessment required?
Is risk data more qualitative in nature?
Is risk data more quantative in nature?
Count
Initiate QRM Process
Risk Assessment
Risk Identification
Risk Analysis
Risk Evaluation
Risk Control
Risk Reduction
Risk Acceptance
Output of QRM Process
Risk Review
Review Events
Risk
Com
mun
icat
ion
Risk
Man
agem
ent T
ools
Unacceptable
Patient Focused Quality Risk Assessment
Key principles of QRM
A Practical ApproachPreparation for
quality risk assessment
Back
Risk: The combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).
Severity: A measure of the possible consequences of a hazard.
Risk Identification: The systematic use of information to identify potential sources of harm (hazards)
Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identifi cation of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
Risk Control: Actions implementing risk management decisions (ISO Guide 73)
Risk Communication: The sharing of information about risk and risk management between the decision maker and other stakeholders.
Risk Management & Uncertainty: A core principle underpinning effective Risk Management is the principle that Risk Management explicitly addresses uncertainty i.e., that it explicitly takes account of uncertainty, the nature of that uncertainty, and how it can be addressed (ISO 31000:2009(E)
Useful Definitions
Testing your risk mitigation controls
Risk communication
Link to validation studies
Conduct risk assesment
Risk review: Impacts from deviations, Capa's & change controlKnowledge
management
SEVERITY
LIKL
IHOO
D OF
OCC
URRE
NCE Minor
Medium
Low
Low
Like
lyAv
erag
eRe
mot
e
Moderate
High
Medium
Low
Critical
High
High
Medium
Any good risk assessment must always have the two key principles of scientifi c understanding and patient safety at their core. Next Steps
QRM Acceptance Criteria:
Low: The risk associated with the Failure Mode is acceptable. No mitigation is required prior to implementation.
Medium: The risk associated with the Failure Mode may be acceptable provided additional measures are taken (e.g. risk control/mitigation measures, validation, etc.) or appropriate justifi cation is documented.
High: The risk associated with the Failure Mode is not acceptable. Additional risk control measures or additional data are required to reduce risk to within an acceptable level.
A 9 box grid may be useful to calculate high, medium and low risks
Produced by the Pharmaceutical Regulatory Science Team @DIT for Pharmachemical Ireland.
For reprints contact P CI on info@ibec.ie
PRST
Prerequisites QRA Trigger
Risk Question / Scope Team Formation
Detailed Scope / Complexity
Pre-work
Select Methodologies
Risk Identification
Risk Analysis / Assessment
Risk Ranking
Residual Risk
RiskAcceptance
Risk Mitigation
Goals
Timeline
Roles & Expectations
Teamrisk tools,Informal or Formal?
QRA Trigger occurs, Process Owner alerts team
process owner meets facilitator in advance
Process owner meets Manager & agrees
support team
Process owner meets the SME
to discussProcess
Map
Good to go
facilitator
manager
Process owner
SMEQuality
Identify assumptions
Sources of
uncertainty
Risk Tool
confirmation
Trends
Procedure
Data
Scope
selection
QRA In Progress
Pre requisites for QRM
Trainedfacilitator
Patient
manager SME
Process owner Quality
QRM Pitfalls
QRA TriggerRisk Assessment can be initiated in a number of ways:
Impact: reactive in nature, identified through event or issue.
Proactive: identified through intelligence, new equipment, system, process, product, technology
Retrospective: to gain additional process understanding, to establish a baseline.
Preparation for Risk AssessmentSteps for Success
Outcome: QRA Strategy is agreed
Strategy
Risk strategy: › Ensure the risk question is specific and detailed to assure the risk assessment is exploring the problem or issue fully.
› Spend time reviewing the risk ranking criteria and action levels to add specific layering to increase objectivity when scoring.
› Draft risk question and risk ranking criteria.
› Draft potential failure modes and current controls
Ensure procedure in place based on ICHQ9 guideline
› Including a standard site scoring criteria and ensure that the definitions are appropriately customised to the item under study
› Outline a risk communication process
› Develop QRM document management structure (Templates, repository, list of documents, approval process, tool selection criteria)
› Review process for following up on actions plans / CAPAs / and risk mitigation controls
Training
› Facilitator training program
› Training on QRM approach and methodologies
› Ground rules and behaviours
› Awareness training on the types of bias and human heuristics
› Provide training using examples to ensure a consistent approach.
Meet a typical QRA team
1
2
3
Pitfalls to Avoid
› Influence of the first item we hear
› Preference to keep things ‘mostly’ the same
› Known option can be preferred to unknown option
› More immediate benefits can add weight to preferences
› Recent memories of events, perhaps emotionally charged ones can influence our bias
› Heuristics are cognitive behaviours which are based on our experiences & memories.
› Heuristics can result in bias, which means we don't approach a situation with an 'open mind'
› They come into play when we make judgments in the presence of uncertainty
› Heuristics are a source of significant bias and errors in judgment
› Awareness of the potential adverse influences of human heuristics on the outcomes of QRM exercises is key to designing and implementing your QRM tools successfully
› Inappropriate Team Selection: Team should not all be from one department
› Over reliance on detection controls for risk mitigation
› Inadequate training on QRM purpose, process and roles & responsibilities
› Lack of awareness of inappropriate behaviours and impacts of bias
Examples of BIAS to watch out for
Human Heuristics
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