Quality Risk Management

Quality Risk Management


1.800.782.0580 | www.busintellsol.com | info@busintellsol.com

Process consisting of well-defined steps which, when
taken in sequence, support better Decision Making by
contributing to a greater insight into risks and their
impacts.
It includes elements such as risk identification,
assessment, mitigation, elimination and
communication.

Risk= probability and severity


What is the problem being solved
• Product may not be available to patients, when needed
• May increase the potential for the release of unacceptable product to the
market
• New product introductions to the marketplace may be delayed
• Delays may occur during implementation of changes and improvements to
processes
• Safe and effective drugs may be discarded or recalled from the market
• Manufacturers may be reluctant to implement new technologies or
continuous improvements to the products or processes
• Scarce resources may not be optimally allocated
• Lack of appropriate data to evaluate risk most effectively


Benefits
– Enhanced patient confidence in decision making on
pharmaceutical quality

– Promotes more effective use of regulatory agency and industry
resources

– Establishes a systematic, well-informed and thorough method of
decision making which leads to greater transparency and
predictability

– Increased knowledge of exposure to risk

– Fosters quality by design, continuous improvement and new
technology introduction, which generally leads to enhanced
product quality

Process
1. Initiate Process
2. Assess
3. Control
4. Communicate
5. Review


Guiding principles
• The evaluation of the risk should ultimately link back to
the potential risk to the patient.
• The extent of the risk management process should be
commensurate with the level of risk associated with the
decision.
• A more robust data set will lead to lower uncertainty.
• It is essential to have a clear delineation of the risk
question.
• Risk management should be an iterative process.
• People who apply risk management should have the
appropriate training, skills and experience.
• The risk management process should be appropriately
documented and verifiable.


Guide to initiating risk management
• Defining specifically the risk management problem or question,
including the assumptions leading to the question.
• Assembling background information and data on the hazard, harm
or human health impact relevant to the assessment.
• Defining how the assessment information and conclusions will be
used by the decision makers.
• Identifying the necessary resources, members of the team who have
the appropriate expertise, with the leader clearly identified.
• Asking the right risk assessment question(s)
• Stating clearly the assumptions in the risk assessment
• Assessing the quality and sufficiency of relevant data
• Specifying a timeline and deliverables for the risk assessment

Risk Assessment
– What can go wrong?

– What is the likelihood (probability) it would go
wrong?

– What are the consequences?
• Risk analysis is a systematic use of information to identify specific
sources of harm (hazards) and to estimate the risk.

• Risk evaluation compares the estimated risk against given risk
criteria using a quantitative or qualitative scale to determine the
significance of the risk.


Risk Control
Risk control describes the actions of implementing risk management decisions.

– What can be done to mitigate and reduce risks?
– What options for controlling risks are available?
– What are the impacts of current risk management decisions on
future options for risk management?

• Risk mitigation focuses on a reduction of severity of harm.
• Risk reduction focuses on the reduction of probabilities of occurrence of harm and
detection of harm.
• Risk acceptance is a decision to accept risk, i.e., no additional risk control activities are
necessary at that time.


Risk communication

• Risk communication is the exchange or sharing of
information about risk and risk management between
the decision maker and other stakeholders. The
information can relate to the existence, nature, form,
probability, severity, acceptability, treatment,
detectability or other aspects of risks to quality.
• The communication among stakeholders concerning
quality risk management decisions can be made through
existing channels.


Risk monitoring and review

• All risk management processes are
dynamic/iterative.

• Quality risk management when applied should
benefit from new knowledge with each decision
cycle and used to enhance future decisions
allowing for continuous improvement.


Initiate
Process flow
Risk Management Process

Risk Assessment

Risk Analysis
Risk Management tools & statistic toolbar

Risk Evaluation
(Resources, Interfaces & Line functions)

Risk Control
Risk Mitigation
(incl. elimination and avoidance)
[Severity]

Risk Reduction
[Probability]

Risk Acceptance

Risk Communication

Output / Results of the Review
Risk Management Process (e.g. Inspections/Audits, Complaints)

No additional risk

Risk management Tools
1. Process mapping
2. Preliminary Hazard Analysis (PHA)
3. Hazard Analysis of Critical Control Points (HACCP)
4. Hazard Operability Analysis (HAZOP
5. Fault tree analysis (FTA)
6. Failure Mode Effects Analysis (FMEA)
7. Failure Mode, Effects and Criticality Analysis (FMECA)
8. Risk Ranking and Filtering
9. Informal Risk Management
10. Taguchi, variation risk management method


Supporting Statistical Tools

• Design of experiments (DOE)
• Process Capability Analysis
• Control charts:
1. acceptance control charts
2. Shewhart control charts
3. Accumulative sum charts


Integration of Quality Risk Management into Operations

1. Development (e.g. Specification Setting, Test Method Selection
and process development).
2. Regulatory scrutiny during pre and post approval.
3. As a component of Quality systems ( e.g. Auditing,
Deviations/Discrepancies, Complaints & Recall Management,
Change management)
4. Facility systems management ( e.g. Design, Hygiene,
Qualification, environmental control, Preventative maintenance
and Computerized systems)
5. Materials Management (e.g. Supply chain, Assessment and
evaluation of suppliers and contract manufacturers, procurement
and release of material)

Integration of Quality Risk Management into
Operations (Continued)

6. Production (e.g. PAT, Validation, in-process sampling, testing,
reporting and trending)

7. Laboratory controls (e.g. validation, testing, methods
development, stability).

8. Packaging and labeling (e.g. Selection of container closure system
and label controls).

9. Regulatory Authority Activities


Definitions
• Decision Maker - process owner of risk management process
• Dynamic / Iterative Process - TBD
• Harm – Damage to health, including the damage that can occur from loss of product efficacy, safety, quality or
availability
• Hazard - the source of harm. Can be a chemical, biological or physical substance, or an event that can cause harm.
• Product Lifecycle – All phases in the life of a product covering both the inherent characteristics of the product and how
these may change over time. The lifecycle is from the initial development through pre- and post-approval until the
product’s discontinuation and includes the associated regulatory processes.
• Quality – Degree to which a set of inherent characteristics of a product, system or process fulfills requirements
• Quality System – A formalized system that documents the structure, responsibilities and procedures required to achieve
effective quality management.
• Requirements – Needs or expectations that are stated, generally implied or obligatory by the patients or their surrogates
(e.g. health care professionals, regulators and legislators)
• Risk – Combination of the probability of occurrence of harm and the severity of that harm (from ISO/IEC Guide 51)
• Risk Management – Process consisting of well-defined steps which, when taken in sequence, support better Decision
Making by contributing to a greater insight into risks and their impacts.
It includes elements such as risk identification, assessment, mitigation, elimination and communication.
• Severity – Measure of possible consequence of a potential source of harm
• Stakeholder - Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a
risk. The decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are
the patient, healthcare professional, authority, regulator, industry, business, customer.

Business Intelligence Solutions | 1.800.728.0580 | www.busintellsol.com


Quality Risk Management

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