Quality Risk Management Tool Selection
When to Select FMEA: QRM Tool Selection Matrix
Quality Risk
Management Tools
The ICH Q9 guideline, Quality Risk Management, provides a list of
methods widely used in the industry for risk management:
No. Risk Management Method
Basic risk management facilitation methods (flowcharts, check sheets, cause and effect diagram etc.) Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects, & Criticality Analysis (FMECA)
Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP) 1.
2.
3.
4.
5.
Potential Areas of Use(s)
Organize data and facilitate decision making in the areas of failure investigations and root cause analysis
Prioritize risks
Monitor the effectiveness of risk control activities Equipment and facilities
Analyse a manufacturing process to identify high-risk steps or critical parameters
Utilized on failures and risks associated with manufacturing processes
Establish the pathway to the root cause of the failure Investigate complaints or deviations to fully
understand their root cause
Ensure that intended improvements will fully resolve the issue and not lead to other issues
Evaluate how multiple factors affect a given issue Identify and manage risks associated with physical, chemical and biological hazards
Useful when process understanding is sufficiently comprehensive to support identification of critical control points (critical parameters / variables)
No. Risk Management Method
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk ranking and filtering
Supporting statistical tools 6.
7.
8.
9.
Potential Areas of Use(s)
Useful in analysing existing systems or prioritizing hazards
Evaluate the types of hazards for the general product type, then the product class and finally the specific product
Most commonly used early in the development of a project when there is little information on design details or operating procedures; thus, it will often be a precursor to further studies
Manufacturing processes Equipment and facilities
Evaluating process safety hazards Primarily as starter of a HACCP Operator error (“use error”)
Used to prioritize manufacturing sites for inspection/audit by regulators or industry
Particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool
Evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework
Monitors critical parameters
Provides information to determine Process capability, Variability and Control
Some charts are dealing with warning limits or trend analysis
Note: No single tool or method is appropriate for all cases.
Ref: ICH Q9 Annex 1
Quality Risk Management
Tool Selection
Risk assessment can be done by using any of the tools mentioned
above. It is a challenging exercise for Risk Management teams to select a
perfect risk management tool.
An efficient QRM requires flexibility in the selection of risk assessment
tools.
The level of effort or the tools should be used based on the level of risk
potential and knowledge about the product and the process. It is
important to set the standards before selecting and commencing with the
risk assessment tool.
The most widely used Risk Assessment tool in Pharmaceutical Industry
is
When to Select FMEA:
QRM Tool Selection Matrix
Considerations FMEA Suitability
If process design /product / system knowledge is limited (early lifecycle phases)
If process design /product /system knowledge is advanced (later lifecycle phases)
If process design /product / system failures are easy to identify
If process design /product / system failures consequences are well known If a detailed risk assessment is requiredIf a quantitative risk ranking is desired If demonstration of the effectiveness of risk controls measures is required If demonstration of the implementation stages (e.g. DQ, IQ, OQ, PQ) of risk controls measures is required
What is FMEA?
How did FMEAs Start?
Application of FMEA in Pharmaceutical Industry
What can FMEA do for you?
When to Conduct FMEA?
What is FMEA?
FMEA is an acronym for Failure Mode and Effect Analysis.
It is an ongoing quality improvement process for identifying potential
design and process failures and what their effect would be – before any error
actually happens. FMEA is a proactive inductive reasoning process used to
look carefully and systematically at vulnerable areas or processes. So,
basically it is an approach of thinking what could go wrong ahead of time and
averting that from happening. The overall process is illustrated in the
following diagram
Failure
Mode
Effect
Analyse
What could go wrong with a product or process? And how a product or process might fail?
Find the possible causes of failures and the likelihood
of failures being detected before
occurrence. What are the
consequences of that failure?
