Pre requisites for QRM Ensure procedure in place based on ICHQ9 guideline
Prerequisites
›› Including a standard site scoring criteria and ensure that the definitions are appropriately customised to the item under study
Meet a typical QRA team
Risk Question / Scope
›› Develop QRM document management structure (Templates, repository, list of documents, approval process, tool selection criteria)
2
QRA Trigger Impact: reactive in nature, identified through
Team Formation
Scope
risk tool s, Informal or Forma l? Timeline
Retrospective: to gain additional process understanding, to establish a baseline.
Pre-work
Outcome: QRA Strategy is agreed
Procedure Trends
Select Methodologies
y Strateg
Risk Identification
s
Proces Map
of Sources y t in uncerta
›› Training on QRM approach and methodologies
›› Spend time reviewing the risk ranking criteria and action levels to add specific layering to increase objectivity when scoring.
›› Ground rules and behaviours ›› Awareness training on the types of bias and human heuristics
›› Draft risk question and risk ranking criteria.
Risk Acceptance
›› Provide training using examples to ensure a consistent approach.
›› Draft potential failure modes and current controls
Advanced
Examples of BIAS to watch out for ›› 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
Human Heuristics ›› 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
Medium: The risk associated with the Failure Mode may be acceptable provided Flowcharts Memo additional measures are taken (e.g. risk control/mitigation measures, validation, etc.) Comprehensive or appropriate justification is documented.
Severity HACCP
Fishbone
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.
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.
Minor
Likely
Filtering
LEVEL OF RISK ASSESSMENT FORMALITY
Moderate Critical
Medium
High
High
Unknown
Level of Risk Understanding
Low
Low
Basic
Medium
Low
High
Hazop
Medium
Checksheets
FME(C)A
of a hazard.
Flowcharts Technical Memo
Risk Evaluation
Unknown LEVEL OF RISK UNDERSTANDING
Unacceptable
FMEA / FMECA
FTA
HACCP
HAZOP
PHA
RR&F
Is risk ranking desired?
Is demonstration of the effectiveness of risk controls required?
Note:
Is risk indenitification a challenge, do hidden risks need to be revealed or is structured brainstorming desired?
/
For informal RA, don't forget to document it.
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?
A combination of basic and advanced tools is also an option.
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.
Count
The systematic use of information to identify potential sources of harm (hazards)
Risk Analysis
HACCP Risk Ranking & Filtering
Comprehensive
Risk Identification:
Risk Identification
Cause & Effect
Fishbone
Tool Selection Criteria Considerations
Risk Assessment
PHA
Process Mapping
A 9 box grid may be useful to calculate high, medium and low risks
Severity: A measure of the possible consequences
Bespoke Risk Assessment
Brainstorming
Risk: The combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).
Initiate QRM Process
Advanced
Risk Communication
Knowledge management
Risk review: Impacts from deviations, Capa's & change control
PHA
Average
Risk communication
Assessment Mapping
Remote
Link to validation studies
FME(C)A
HAZOP
Liklihood of Occurrence
›› Lack of awareness of inappropriate behaviours and impacts of bias
Mode is acceptable. No mitigation is required prior to implementation. Non Critical Impact
›› Inadequate training on QRM purpose, process and roles & responsibilities
Conduct risk assesment
Risk Evaluation
Critical Impact
QRM Acceptance Criteria: Checksheets Low: The risk associated with the Failure Brainstorming Testing your risk mitigation controls
Useful Definitions
Level of Risk Assessment Formality Basic
›› Over reliance on detection controls for risk mitigation
QRA In Progress
Any good risk assessment must always have the two key principles of scientific understanding and patient safety at their core.
Pitfalls to Avoid ›› Inappropriate Team Selection: Team should not all be from one department
Identify assumptions
Key principles of QRM
Next Steps
QRM Pitfalls
›› Ensure the risk question is specific and detailed to assure the risk assessment is exploring the problem or issue fully.
Residual Risk
Critical Impact
Preparation for quality risk assessment
3
›› Facilitator training program
Data
tor facilita r manage er n w o s Proces E SM Quality
Risk strategy:
selection
Process owner meets Manager & agrees support team
o go Good t
Risk Mitigation
Risk Ranking
Non Critical Impact
A Practical Approach
Quality
RISK EVALUATION
Training
Process owner
Process owner meets the SME to discuss
Team
ol Risk To ation confirm
Risk Analysis / Assessment
Trained facilitator
Roles & Expec tations
Goals
equipment, system, process, product, technology
Detailed Scope / Complexity
SME
process owner meets facilitator in advance
event or issue.
Proactive: identified through intelligence, new
›› Review process for following up on actions plans / CAPAs / and risk mitigation controls
manager
QRA Trigger occurs, Process Owner alerts team
Risk Assessment can be initiated in a number of ways:
›› Outline a risk communication process
Patient
QRA Trigger
Risk Control Risk Reduction Risk Acceptance
Risk Management Tools
1
Patient Focused Quality Risk Assessment
Preparation for Risk Assessment
Steps for Success
Output of QRM Process
Risk Review
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 identification 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)
Review Events PHARMA CHEMICAL IRELAND
Adapted from ICH Q9 QRM Diagram
PRST Produced by the Pharmaceutical Regulatory Science Team @ DIT for Pharmachemical Ireland. For reprints contact P CI on info@ibec.ie