Quality Risk Management Quiz

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Questions and Answers

Which team is typically responsible for quality risk management activities?

Quality unit (correct)

Legal

Production operations

Sales and marketing

What is the primary goal of quality risk management (QRM)?

To eliminate all risks in production

To improve science-based decision making regarding risk (correct)

To enhance the speed of production

To focus solely on compliance with regulations

What is a Critical Material Attribute (CMA)?

A property of input material that affects output quality (correct)

A risk management process step

A process characteristic that must be controlled

An evaluation of human health impacts

Which of the following is NOT a step in initiating a quality risk management process?

Formulate a marketing strategy Signup and view all the answers

What is the purpose of risk assessment in the context of critical quality parameters (CPPs)?

To identify and rank potential CPPs Signup and view all the answers

Which of the following best describes a Critical Process Parameter (CPP)?

A variable that impacts a Critical Quality Attribute (CQA) Signup and view all the answers

Which of the following best describes the relationship between CPPs and CQAs in quality risk management?

CPPs can affect CQAs, necessitating risk analysis to assess their impact. Signup and view all the answers

What kind of methods can be used for risk analysis in quality by design (QbD) approaches?

A combination of simplistic methods like fishbone diagrams and detailed assessments like FMEA Signup and view all the answers

Which area is essential for forming interdisciplinary teams in quality risk management?

Experts from various relevant fields including engineering and clinical Signup and view all the answers

What is an essential component of background information needed for risk assessment?

Potential hazard and human health impact data Signup and view all the answers

What criteria are used to classify risks during the risk ranking process?

High, medium, and low based on their potential impact Signup and view all the answers

Which of the following statements regarding critical material attributes is accurate?

CMAs must remain within limits to ensure output quality Signup and view all the answers

What aspect must be monitored and controlled to ensure the critical quality attributes (CQAs) remain unchanged?

The design space specifications and limits Signup and view all the answers

What is the primary goal of Failure Modes Effects Analysis (FMEA)?

To identify and eliminate potential failures Signup and view all the answers

Which step is NOT part of the FMEA process?

Conducting market analysis Signup and view all the answers

How is the Risk Priority Number (RPN) calculated in FMEA?

RPN = Occurrence (O) x Detection (D) x Severity (S) Signup and view all the answers

Which aspect does the severity ranking NOT typically encompass?

Impact on employee morale Signup and view all the answers

In the context of FMEA, what does a high Risk Priority Number indicate?

Significant risk that requires immediate action Signup and view all the answers

Which tool can be used to identify risks in the FMEA process?

Fishbone Diagram Signup and view all the answers

What is the primary purpose of HACCP?

To systematically assure product quality and safety Signup and view all the answers

How many steps are there in the HACCP process?

7 Signup and view all the answers

What should be done after implementing corrective actions based on FMEA?

Revisit the FMEA to assess effectiveness Signup and view all the answers

Which of the following statements about FMEA's multidisciplinary team is correct?

Diverse expertise is beneficial for evaluating processes. Signup and view all the answers

What does FMEA evaluate?

Potential failure modes and their impact Signup and view all the answers

Which step in HACCP involves establishing critical limits?

Step 3 Signup and view all the answers

What is one benefit of conducting a hazard analysis in the HACCP process?

It helps to identify preventive measures for risks. Signup and view all the answers

What can the output of a HACCP analysis facilitate?

Monitoring of critical control points Signup and view all the answers

What is a key characteristic of FMEA?

It breaks down complex processes into manageable steps. Signup and view all the answers

Which of these is NOT a step in the HACCP process?

Establish a system for financial audits Signup and view all the answers

What is the primary focus of the risk management process in pharmaceuticals?

Protecting the quality of the drug and the patient Signup and view all the answers

Which of the following is NOT a principle of quality risk management according to ICH Q9?

Documentation should be elaborate regardless of risk level Signup and view all the answers

In the context of risk management, what does the acronym FMEA stand for?

Failure Mode and Effects Analysis Signup and view all the answers

What is the definition of risk as outlined in the course content?

The combination of probability and severity of occurrence of harm Signup and view all the answers

Who among the following is NOT considered a stakeholder in pharmaceuticals?

Retail customers Signup and view all the answers

Which of the following best describes risk management in pharmaceuticals?

A systematic process involving assessment and review of risks Signup and view all the answers

What aspect of the risk management process is crucial for diverse stakeholders?

Understanding different perceptions of risk Signup and view all the answers

How should the level of effort and documentation in quality risk management relate to the level of risk?

They should be proportional to the level of risk Signup and view all the answers

What should be continuously reviewed in the quality risk management process?

The output/results of risk management processes Signup and view all the answers

Which of the following is NOT considered a basic risk analysis tool?

Six Sigma methodologies Signup and view all the answers

What does Fault Tree Analysis (FTA) primarily evaluate?

System or sub-system failures Signup and view all the answers

In the context of risk management, what is a major goal of using Cause and Effect Diagrams?

To visualize causal relationships Signup and view all the answers

What is one expected outcome of effective risk assessment tools during quality management?

To enhance decision-making processes Signup and view all the answers

What type of events should continuously inform the quality risk management decisions?

Both planned and unplanned events Signup and view all the answers

Which logical operators are utilized in Fault Tree Analysis to describe fault modes?

AND and OR Signup and view all the answers

What does HACCP stand for in risk management?

Hazard Analysis and Critical Control Points Signup and view all the answers

What is the primary goal of implementing a review mechanism in the quality risk management process?

To ensure continuous improvement based on new insights Signup and view all the answers

Which tool is most effective for investigating complaints or deviations in a process?

Fault Tree Analysis Signup and view all the answers

What does the term 'continuous improvement' imply in the quality risk management context?

Adjusting risk management practices based on ongoing feedback Signup and view all the answers

Which tool helps in structuring risk management while organizing data?

Fishbone diagrams Signup and view all the answers

What does risk ranking and filtering, like Pareto analysis, assist with in risk management?

Identifying and prioritizing risks Signup and view all the answers

What aspect of risk management does effective documentation primarily affect?

Improvement of communication and traceability Signup and view all the answers

Study Notes

Regulatory Science: Risk Management Tools and Techniques

Regulatory Science is a discipline focused on the risk management tools and techniques used in the pharmaceutical industry.
The presentation uses ICH Guidelines Q9 for Quality Risk Management; it details the principles and applications for different aspects of pharmaceutical quality.
Includes considerations for development, manufacturing, distribution, and inspection and submission/review processes of drugs, including those from biotechnology.
Importance is placed on scientific knowledge and linking the risk evaluation to patient protection.
The document emphasizes the need for the level of effort in the quality risk management process to be commensurate with the degree of risk.

What is Risk?

Risk is the combination of the probability of harm and the severity of that harm. (ISO/IEC Guide 51)
A hazard is something with the potential to harm someone.
Risk is the likelihood that a hazard will cause harm.

Stakeholders

Achieving a shared understanding of risk management among diverse stakeholders is challenging, as each stakeholder may have unique perceptions of potential harms, their likelihood, and severity.
Key stakeholders in the pharmaceutical industry include medical practitioners, government, industry professionals, and patients.
Patient protection, by managing the risk of quality, is a primary concern.

Who is Responsible for Risk Management?

Interdisciplinary teams are tasked with carrying out quality risk management activities, although this isn't always the case.
Teams should include experts from various relevant areas, such as quality units, business development, engineering, regulatory affairs, production operations, sales and marketing, legal, statistics, and clinical experts.
Individuals knowledgeable of the quality risk management process are also essential.

Systematic Approach to Risk Management

Quality risk management (QRM) is designed for coordinating, facilitating, and improving science-based decision-making regarding risks.
Steps in the process are defining the risk problem, gathering background data/information, identifying resources, assigning a timeframe for the process, and determining the decision-making level.

Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs)

Critical Material Attributes (CMAs) are physical, chemical, biological, or microbiological properties of input materials; these properties must be within specified parameters in order to ensure quality output.
Critical Process Parameters (CPPs) are process parameters whose variability impacts Critical Quality Attributes (CQAs). To ensure quality, they are monitored and controlled.

Risk Analysis

Risk analysis relates CPPS and CMAs to CQAs based on experience and scientific understanding.
The risk evaluation of quality should reflect scientific knowledge linking to the protection of the patient.
Risk analysis involves evaluating the impact of attributes on CQAs by assessing the likelihood of effect.
The process should have a level of effort proportionate to the risk level.
Different levels of detail exist in risk analysis (e.g. simplified traffic light approach vs. detailed FMEA).

Identifying CQAs

Critical Quality Attributes (CQAs) are characteristics that directly impact the safety and effectiveness of pharmaceutical products (e.g. Safety, Efficacy, Identity, Potency, Purity, and Other properties relevant to the specific product).
QTPP (Quality Target Product Profile) is reviewed for possible CQAs
Identifying CQAs are needed across the development/manufacturing process

Risk Analysis - Ranking

Risk ranking involves categorizing risks as High, Medium, or Low.
Risk analysis should focus on the most critical factors to reduce cost and time by prioritizing high-risk factors.

How is a Quality Attribute Deemed Critical?

A quality attribute is deemed critical when it impacts safety, efficacy and product quality.
A change in criticality happens only with a change in severity.

When is a Quality Attribute a CQA?

A quality attribute is a CQA when it affects the patient. This involves issues like incorrect dosage, harmful by-products, or damaged product.

Risk Control

The goal of risk control is to reduce risk to an acceptable level.
The amount of effort should correspond to the significance of the risk (high/medium/low) to be managed and controlled.
Acceptable risk may be dependent on other variables.

Risk Reduction/Risk Acceptance

Risk reduction involves mitigating risk.
Sometimes a decision to accept risk is necessary in cases where the best practices to control the risk might not fully eliminate the risk, or the impact of the risk is low.
Risk control needs to be documented and assessed

Risk Communication

Risk communication involves sharing risk and risk-management information among stakeholders.
The results of the quality risk management process need to be communicated and documented accurately.
Communication should happen at each step of quality risk management.

Review Risk Management

Risk management review is a continuing, ongoing factor of the quality management process.
Review is necessary to monitor and evaluate events to determine root cause for corrective action.
Reviews should be structured to handle and learn from both planned and unplanned events, and used to identify additional risks that may arise as a result of controlling a risk factor.

Basic Risk Analysis Tools

FMEA (Failure Mode and Effect Analysis),
Flowcharts,
Check Sheets,
Process Mapping,
Cause-and-effect Diagrams,
Fishbone Diagrams.
Pareto charts,
Statistical Tools (e.g., to organize data)

Fault Tree Analysis (FTA)

FTA is a system to identify causal factors and pathways of failure by producing a visual representation.
It uses logical operators like AND or OR in different levels and combinations
Can aid the identification of the root cause of a failure
Can help to understand how multiple factors affect a problem

Hazard Analysis and Critical Control Points (HACCP)

HACCP is a proactive and preventive tool that helps with product quality assurance and safety.
Consists of seven key steps including a hazard analysis and identification of preventive steps for each step of a process, identifying critical control points, establishing critical limits, monitoring control points, and establishing corrective actions when control points are not within specification.
Useful for managing risks associated with physical, chemical, and biological hazards.

Failure Modes and Effects Analysis (FMEA):

FMEA is a thorough failure identification procedure, used to prevent possible failures.
It includes steps in identifying all possible process failures, the consequences of each failure, and methods of preventing these failures from occurring once identified.
This method requires a multidisciplinary team.

FMEA Steps

Outline all process steps
Identify potential failures for each step
Specify the potential outcomes of each failure
Evaluate the likelihood and severity of issues using a Risk Priority Number (RPN) calculation, to prioritize issues and direct corrective actions
The results can be analyzed by Pareto method.
Implement corrective actions
Revisit the FMEA after implementing corrective actions.

FMEA Case Study

The presentation includes a case study examining the use of FMEA in the pharmaceutical industry. The case study uses an example of blending, granulation, milling, lubricant blending, sieving, and tabletting in the creation of a pharmaceutical tablet.

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Description

Test your knowledge on quality risk management activities and concepts in the pharmaceutical industry. This quiz covers essential topics such as Critical Material Attributes, Critical Process Parameters, and the role of interdisciplinary teams in QRM. Enhance your understanding of risk assessment and management in quality assurance processes.