Issuu on Google+

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


Pharma A0 Poster