QUALITY ASSURANCE

JOB STARTER PACKAGE

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Welcome to the QA Job Starter Package!

Why to Enroll?

Enroll in our Quality Assurance Job Starter Package for comprehensive training in QA methodologies, tools, and best practices. Gain hands-on experience and boost your career prospects in the competitive job market. Let us guide you toward success in the dynamic field of quality assurance.

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This package is ideal for students and professionals seeking to enhance their skills and knowledge in quality assurance. Whether you’re new to the field or looking to advance your career, this package is tailored to meet your needs. If you’re aiming for success in QA roles across various industries, this is your pathway to proficiency and career growth.

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Pre-Assessment Quiz

You reached the maximum time limit for this mock test.

Quality Assurance Pre-Assessment Quiz

Time: 60 minutes

Questions: 55

The number of attempts remaining is 1

1 / 55

What is the role of Documentation Requirements in risk communication?

a) Thorough risk analysis

b) Update risk assessments

c) Record for regulatory compliance

d) Focus on periodic reviews

2 / 55

What is the first step in establishing a robust hazard analysis program?

a) Identify the specific areas and processes for assessment

b) Form a multidisciplinary team with expertise

c) Invest in regular training and education for the team

d) Conduct periodic reviews of the hazard analysis program

3 / 55

What stages of the product life cycle are mentioned as involving supply chain risks?

a) Early development

b) Post-marketing

c) Manufacturing

d) Both b and c

4 / 55

What are biological products derived from living organisms, often large and structurally intricate, and may include proteins, enzymes, vaccines, and monoclonal antibodies?

a) Traditional small-molecule drugs

b) Biosimilar products

c) Interchangeable biological products

d) Biological products

5 / 55

What methods can be employed in the Risk Analysis and Evaluation step?

a) Internal communication

b) Fault Tree Analysis (FTA)

c) Process improvements

d) Design changes

6 / 55

Why is timely communication with regulatory authorities important?

a) To avoid regulatory sanctions

b) To satisfy regulatory requirements

c) To minimize operational disruptions

d) To foster a culture of compliance

7 / 55

In the limitations of the Orange Book, what challenge may healthcare professionals face regarding therapeutic aspects of drug products?

a) Consulting additional sources for comprehensive understanding

b) Navigating the legal landscape

c) Limited international applicability

d) Real-time updates

8 / 55

What is a key principle of Six Sigma methodologies for identifying inefficiencies within processes?

a) Regular monitoring of key performance indicators (KPIs)

b) Emphasizing the elimination of non-value-added activities

c) Engaging employees in the improvement process

d) Conducting thorough root cause analyses

9 / 55

Why is communication emphasized in QRM?

a) Foster collaboration

b) Minimize communication

c) Increase complexity

d) Ignore risks

10 / 55

What aspect of employee involvement in Six Sigma encourages a collaborative environment for continuous improvement?

a) Employees work independently without management input

b) Employees provide no insights or ideas

c) Employees offer valuable insights and ideas

d) Employees resist any change in processes

11 / 55

What is the primary purpose of the Safety Measures section in an SOP?

a) To protect employees and the product

b) To designate individuals accountable for actions

c) To outline the importance of the procedure

d) To specify the types of records to be kept

12 / 55

How can the challenge of User Interpretation be effectively addressed during the implementation of the Orange Book?

a) Establishing robust data validation processes

b) Encouraging feedback from users

c) Developing user-friendly guides and educational materials

d) Collaborating with regulatory authorities

13 / 55

How many steps are involved in Hazard Analysis and Critical Control Points (HACCP)?

a) Five

b) Six

c) Eight

d) Seven

14 / 55

What is the significance of ongoing training programs?

a) Ensure regulatory compliance

b) Demonstrate commitment to continuous improvement

c) Verify facility readiness

d) Assess employee training

15 / 55

In the future, what may future trends of the Purple Book focus on to improve user accessibility?

a) Providing real-time updates and reducing data lag

b) Excluding biosimilars and interchangeable products from the database

c) Decreasing usability and accessibility

d) Including complex information without additional educational resources

16 / 55

Why is the establishment of Standard Operating Procedures (SOPs) important in documentation for pharmaceutical quality assurance?

a) To introduce variations in manufacturing

b) To reduce the likelihood of errors and promote reproducibility

c) To complicate processes and procedures

d) To discourage regulatory compliance

17 / 55

What does a collaborative approach in addressing audit findings involve?

a) Solo analysis by a single department

b) Ignoring diverse perspectives

c) Engaging relevant stakeholders across departments

d) Minimal analysis of the audit report

18 / 55

Why is the integration of EDMS with other quality management systems important?

a) To complicate overall efficiency

b) To ensure consistency and data accuracy across different processes

c) To hinder accessibility and collaboration

d) To discourage the use of electronic documents

19 / 55

What is a common violation associated with non-compliance in machine safety according to OSHA?

a) Failure to provide proper fall protection

b) Inadequate chemical labeling

c) Lack of emergency response protocols

d) Insufficient training on chemical hazards

20 / 55

What is the basis of Hazard Operability Analysis (HAZOP)?

a) Original design

b) Reactive events

c) Root cause analysis

d) Manufacturing processes

21 / 55

What is a potential future improvement of the Purple Book mentioned in the content?

a) Including less comprehensive information, such as product insights

b) Providing real-time updates, reducing data lag, and ensuring stakeholders have access to the most current information on licensed biological products

c) Excluding post-market surveillance data to maintain a narrow focus

d) Limiting user accessibility to enhance the exclusivity of information within the Purple Book

22 / 55

What is the purpose of the Revision section of an SOP?

a) To outline the roles and responsibilities of employees

b) To specify the types of records and documents that must be maintained

c) To define the boundaries of the procedure

d) To outline the process for revising the document, including who has the authority to make changes

23 / 55

What is the primary mission of OSHA?

a) Ensuring product quality

b) Preventing workplace injuries and fatalities

c) Regulating pharmaceutical prices

d) Enforcing tax compliance

24 / 55

What can compromise the quality of products in cleanrooms?

a) High humidity

b) Airborne particulate contamination

c) Low pressure

d) Microorganism enhancement

25 / 55

How do checklists facilitate regulatory compliance in the pharmaceutical industry?

a) Encourage Variations

b) Ignore Guidelines

c) Document Compliance

d) Increase Errors

26 / 55

Why is Consistency across documents considered crucial in Good Documentation Practices?

a) To increase the risk of errors

b) To complicate the documentation process

c) To discourage clarity and precision

d) To maintain a standardized approach

27 / 55

What kind of documentation is typically included in the accreditation process?

a) Employee vacation records

b) Proficiency testing participation records

c) Favorite laboratory equipment list

d) Daily weather reports

28 / 55

What is the first phase of the NABL accreditation process?

a) On-Site Assessment

b) Pre-Application Phase

c) Document Review

d) Accreditation Award

29 / 55

What distinguishes high-quality pharmaceutical manufacturers in terms of preventive actions?

a) Reactive approach

b) Proactive approach

c) Regulatory compliance only

d) Minimal risk assessment

30 / 55

What is the primary objective of implementing Clarity and Precision practices in writing an SOP?

a) To ensure clarity and avoid misinterpretation

b) To make it difficult for employees to understand

c) To use jargon and complex sentences

d) To include ambiguous phrases

31 / 55

How are decisions made in QRM according to the content?

a) Arbitrary factors

b) One-size-fits-all approach

c) Random selection

d) Grounded in data and analysis

32 / 55

How has GAMP evolved over time?

a) It has become obsolete

b) It has expanded to include non-pharmaceutical industries

c) It now includes fewer editions and guidance documents

d) It has adapted to technological advancements and regulatory changes

33 / 55

Which of the following is NOT a key principle of 21 CFR Part 11 compliance?

a) Validation of electronic systems

b) Access control

c) Audit trail functionality

d) Data encryption

34 / 55

What is a common principle emphasized by both ISO 9001 and ISO 14001?

a) Continuous improvement

b) Regulatory non-compliance

c) Resource wastage

d) Quality degradation

35 / 55

What is the purpose of stability testing in drug development?

a) To ensure the drug's quality, safety, and efficacy throughout its shelf life

b) To determine the drug's mechanism of action

c) To assess the drug's pharmacokinetics

d) To identify potential side effects of the drug

36 / 55

What is the primary mission of NABL?

a) To create confusion among laboratories

b) To promote unregulated laboratory practices

c) To discourage national and international trade

d) To establish and operate an accreditation system for testing and calibration laboratories in India

37 / 55

In calibration, what involves verifying and adjusting instruments to meet predefined accuracy standards?

a) Preparation

b) Comparison with a known standard

c) Making adjustments

d) Confirming meeting specified criteria

38 / 55

What do SOPs stand for in the pharmaceutical industry?

a) Standard Operating Procedures (SOPs)

b) Safety Oriented Protocols (SOPs)

c) Systematic Operational Plans (SOPs)

d) Structured Operational Processes

39 / 55

How does 21 CFR Part 11 impact the use of electronic signatures in the pharmaceutical industry?

a) It limits the types of documents that can be signed electronically

b) It prohibits the use of electronic signatures

c) It encourages the use of handwritten signatures

d) It establishes requirements for their use and acceptance

40 / 55

How are cleanrooms classified under I S O 14644-1?

a) Alphabetically

b) Numerically

c) Geographically

d) Based on particle counts

41 / 55

What component of the Purple Book provides information about the licensing status of each product, including the date of approval and any subsequent modifications?

a) Manufacturer Details

b) Product Categories

c) Approval Date

d) License Information

42 / 55

What is the primary benefit of Preliminary Hazard Analysis (PHA)?

a) Cost-effective risk management

b) Improved process safety

c) Early identification of potential risks

d) Regulatory compliance

43 / 55

Why is adherence to GAMP guidelines crucial in the pharmaceutical industry?

a) To maximize profits

b) To reduce manufacturing costs

c) To prevent data manipulation

d) To guarantee product quality, data integrity, and patient safety

44 / 55

What is an essential topic that should be covered in training programs to enhance competency in digital documentation?

a) Use of outdated technologies in document management systems

b) Incorporation of simulated exercises and real-world scenarios

c) Avoidance of discussions on functionalities of EDMS

d) Discouraging understanding of version control, electronic signatures, and access controls

45 / 55

Which step initiates the change control process?

a) Evaluation and Impact Assessment

b) Approval Process

c) Change Request Form submission

d) Documentation and Record-keeping

46 / 55

What is the purpose of Process Maps in the context of Six Sigma methodology?

a) To provide visual clarity for quick decision-making

b) To monitor and maintain process stability over time

c) To categorize potential root causes of a specific problem into branches

d) To illuminate complex organizational processes

47 / 55

In continuous improvement, what does a feedback mechanism aim to achieve?

a) Maintain status quo

b) Encourage team engagement

c) Ignore analysis methods

d) Identify areas for improvement

48 / 55

What is the role of OSHA in compliance assistance?

a) Developing workplace safety regulations

b) Providing educational resources and training

c) Conducting inspections for non-compliance

d) Enforcing penalties for violations

49 / 55

What is the optional feature that user registration could provide in accessing the Purple Book online?

a) Current information on database updates

b) Personalized searches or alerts for updates

c) Detailed information about selected products

d) Navigation tools for exploring related products or manufacturers

50 / 55

What is the purpose of New Employee Onboarding in relation to SOPs?

a) To discourage new employees from following SOPs

b) To confuse new employees with complex SOPs

c) To prevent new employees from accessing SOPs

d) To provide comprehensive training to new employees, including an introduction to relevant SOPs

51 / 55

What is the main focus of ISO 9001 in the pharmaceutical industry?

a) Reducing environmental impact

b) Reducing production costs

c) Enhancing customer satisfaction

d) Consistent product quality

52 / 55

What does ISO 14001 define for organizations implementing the standard?

a) Environmental policy

b) Objectives and targets

c) Environmental aspects

d) Legal and regulatory compliance

53 / 55

What is the primary goal of OSHA Hazard Communication Standard (HazCom)?

a) Ensure workplace cleanliness

b) Communicate information about the hazards of chemicals to employees

c) Enhance employee productivity

d) Improve workplace aesthetics

54 / 55

What is the purpose of Accessibility in SOP writing?

a) To make SOPs difficult to find

b) To limit access to relevant employees

c) To ensure that employees can quickly find and access SOPs

d) To restrict the usage of SOPs

55 / 55

What role does data integrity play in compliance with 21 CFR Part 11?

a) Implementing physical security measures

b) Ensuring electronic records are accurate, complete, and reliable

c) Conducting regular equipment calibration

d) Ensuring compliance with labeling requirements

Your score is

PRE-ASSESSMENT QUIZ

You reached the maximum time limit for this mock test.

Quality Assurance Pre-Assessment Quiz

Time: 60 minutes

Questions: 55

The number of attempts remaining is 1

1 / 55

Why is the Approval section of an SOP crucial?

a) It outlines the importance of the procedure

b) It provides a detailed breakdown of tasks

c) It ensures the procedure meets standards

d) It defines roles and responsibilities

2 / 55

What is the primary purpose of the FDA in inspections?

a) Ensure compliance with GMP

b) Verify documentation accuracy

c) Evaluate employee training

d) Assess facility readiness

3 / 55

What is the purpose of OSHA standards in the pharmaceutical industry?

a) Enhancing workplace aesthetics

b) Ensuring employee safety

c) Promoting product marketing

d) Minimizing administrative costs

4 / 55

What is the primary goal of integrating ISO 9001 and ISO 14001?

a) Compliance with pharmaceutical regulations

b) Enhance data security

c) Increase redundancy

d) Streamline management processes

5 / 55

What is crucial for effective hazard analysis collaboration?

a) Isolation of departments

b) Lack of communication channels

c) Cross-functional collaboration

d) Avoiding external stakeholders

6 / 55

Why is change control important for automated systems?

a) To maximize efficiency

b) To minimize documentation

c) To prevent negative impacts on product quality, safety, or data integrity

d) To encourage frequent changes

7 / 55

What is the primary purpose of aseptic areas?

a) To enhance workflow efficiency

b) To prevent contamination during sensitive processes

c) To reduce energy consumption

d) To minimize the use of sterile garments

8 / 55

What should a Version Control system for SOPs do?

a) Prevent any changes to SOPs

b) Track changes and updates, label documents with version numbers, revision dates, and authorship

c) Make SOPs lengthy and complex

d) Discourage employees from following SOPs

9 / 55

What do the Sortable Columns in the search results facilitate?

a) Alphabetical or numerical arrangement of results

b) Precise and targeted searches

c) Access to additional data on specific drug products

d) Exploration of the reference standards section

10 / 55

How does a QMS contribute to NABL accreditation?

a) It has no impact on accreditation.

b) It hinders the accreditation process.

c) It helps laboratories meet NABL standards and enhance their operations.

d) It discourages transparency and documentation.

11 / 55

What is the primary purpose of Standard Operating Procedures (SOPs) in pharmaceutical manufacturing and quality assurance?

a) To confuse employees

b) To avoid compliance with regulatory standards

c) To discourage repeatability and reliability

d) To provide step-by-step instructions for various processes

12 / 55

Which stability study design assesses the impact of short-term environmental variations on drug stability?

a) Stress testing

b) Intermediate stability

c) Long-term stability

d) Accelerated stability

13 / 55

What aspects of the pharmaceutical industry are covered by ICH Q9?

a) Only drug substances

b) Only drug products

c) Drug substances, drug products, biological and biotechnological products, and raw materials

d) Only raw materials

14 / 55

What is the core of the Purple Book that is organized systematically and includes information on biological products, license status, and relevant details?

a) Product Categories

b) License Information

c) Product Listings

d) Manufacturer Details

15 / 55

What role does the ALCOA Plus principle of “Authenticity” play in data integrity?

a) Ensuring data is genuine and attributable to its source

b) Verifying data accuracy and completeness

c) Documenting data creation and modification processes

d) Archiving data for long-term storage

16 / 55

What is a challenge during hazard analysis implementation for smaller organizations?

a) Lack of resources

b) Excessive expertise

c) Abundance of data

d) Sustaining continuous improvement

17 / 55

According to ICH Q9, what does the integration of principles focus on?

a) Fixed approach

b) Adaptability to the phase of the product life cycle

c) Random selection

d) One-time activity

18 / 55

Why are cleanrooms designed and maintained?

a) To create a specified level of cleanliness

b) To enhance temperature and pressure control

c) To minimize airborne particles

d) To promote microorganism growth control

19 / 55

Why is proper training essential for staff on checklist usage in pharmaceutical quality assurance?

a) Increase Complexity

b) Decrease Performance

c) Ensure Effectiveness

d) Avoid Encouraging Questions

20 / 55

What is one focus of ISO standards related to advanced manufacturing technologies?

a) Minimizing environmental footprint

b) Data integrity and cyber-physical security

c) Quality control of traditional processes

d) Regulatory compliance

21 / 55

What is a potential limitation of the Purple Book mentioned in the content?

a) Challenges in navigating and interpreting the information within the Purple Book

b) Ineffectiveness in ensuring real-time updates and providing a holistic view of post-market surveillance data and product insights

c) Limitations in coverage, potentially excluding certain categories of products or information

d) Delays in updating information due to regulatory approvals and product statuses being subject to change

22 / 55

What does the Therapeutic Equivalence evaluation Codes in the Orange Book indicate?

a) Dosage forms of generic drugs

b) Intellectual property landscape

c) Bioequivalence problems of generic drugs

d) Active ingredients of generic drugs

23 / 55

Which of the following is NOT an aspect of data integrity covered by ALCOA Plus principles?

a) Security

b) Accuracy

c) Completeness

d) Efficiency

24 / 55

What is a key element of the Verify phase in the D M A D V process?

a) Develop prototypes of proposed solutions

b) Collect data to evaluate the impact of implemented changes

c) Establish key metrics and identify critical-to-quality factors

d) Execute planned implementation of designed solutions

25 / 55

What is the role of documentation in QRM?

a) Record risk management process comprehensively

b) Create complexity

c) Avoid transparency

d) Ignore decision-making processes

26 / 55

What is a key distinction between biologicals and biosimilars in terms of the approval pathway and development process?

a) Biologicals undergo a regulatory pathway with comparative analytical studies and clinical trials

b) Biologicals are developed to be highly similar to an already approved first version biological product

c) Biosimilars follow a unique and often lengthy approval pathway, including extensive clinical trials

d) Biosimilars are often associated with higher costs due to research and development investment

27 / 55

What is the significance of the “audit trail” requirement in 21 CFR Part 11 compliance?

a) It provides a record of changes made to electronic records

b) It ensures data encryption for security purposes

c) It restricts access to authorized personnel

d) It verifies the accuracy of electronic signatures

28 / 55

When should risk assessments be updated in the Risk Review and Reporting process?

a) Never

b) Only during product development

c) When regulatory authorities request

d) Periodic reviews

29 / 55

In the case of inadequate hazard communication in a pharmaceutical setting, what is a likely consequence?

a) Enhanced employee understanding

b) Improved product quality

c) Misunderstandings and improper substance handling

d) Decreased OSHA inspections

30 / 55

What is the primary purpose of a risk-based approach in GAMP implementation?

a) Reduce cross-functional teams

b) Prioritize validation efforts based on risk assessments

c) Increase the paperwork burden

d) Minimize continuous training

31 / 55

How does the Purple Book categorize products to help users easily identify and differentiate between originator biologicals, biosimilars, and interchangeable biological products?

a) Product Categories

b) Manufacturer Details

c) Approval Date

d) Product Listings

32 / 55

What is one of the applications of the Purple Book mentioned in the content?

a) Assessing the competitive landscape and identifying opportunities for product development

b) Making clinical decisions by ensuring the most up-to-date information on licensed biological products

c) Supporting submissions and applications related to the approval and marketing of biological products

d) Leveraging the Purple Book for regulatory compliance and expedited FDA approval of biosimilar products

33 / 55

What does ILAC stand for, and why is it significant for NABL-accredited laboratories?

a) Indian Laboratory Accreditation Cooperation, it doesn't impact global recognition.

b) International Laboratory Accreditation Cooperation, it promotes international recognition of testing and calibration results.

c) Indian Laboratory Accreditation Corporation, it enhances credibility within Indi

d) International Laboratory Association for Calibration, it facilitates domestic trade.

34 / 55

What is a common challenge associated with the Complex Regulatory Landscape during the implementation of the Orange Book?

a) Difficulty in data accuracy

b) Navigating patent information and exclusivity details

c) Limited international applicability

d) User interpretation challenges

35 / 55

What is the main purpose of facility qualification?

a) To verify cleanliness levels

b) To assess temperature control

c) To evaluate HVAC system efficiency

d) To ensure compliance with regulatory standards

36 / 55

How does Change Control contribute to product safety and efficacy in the pharmaceutical industry?

a) Enhancing overall efficiency

b) Meeting regulatory requirements

c) Fostering a culture of continuous improvement

d) Preventing adverse effects on product quality

37 / 55

What materials are commonly used for cleanroom walls and ceilings?

a) Concrete and brick

b) Wood and plywood

c) Stainless steel or coated surfaces

d) Glass and mirrors

38 / 55

What is the Change Implementation Plan?

a) A random roadmap

b) A well-defined plan for execution

c) A plan for increasing risks

d) A plan for avoiding documentation

39 / 55

What is the Challenge of Resistance to Change during SOP implementation?

a) Employees readily accept new SOPs

b) Employees create their own SOPs

c) Employees actively encourage change in SOPs

d) Employees resist adopting new SOPs

40 / 55

What does international recognition of accreditation mean for laboratories?

a) It has no impact on laboratory operations.

b) It reduces the credibility of the laboratory.

c) It facilitates global trade and collaboration.

d) It results in increased isolation.

41 / 55

Why is effective change control crucial in the pharmaceutical industry?

a) To minimize risks

b) To avoid documentation

c) To increase risks

d) To ignore regulatory standards

42 / 55

What distinguishes inspections from audits?

a) Evaluate internal processes

b) Assess quality management system

c) Conducted by external entities

d) Focus on continuous improvement

43 / 55

Why is Traceability and Accountability considered a fundamental principle in Good Documentation Practices?

a) To avoid defining roles and responsibilities

b) To hinder accountability throughout the documentation process

c) To ensure every action and decision is traceable to an individual

d) To encourage vague language in documents

44 / 55

What is a key element of the Measure phase in the D M A I C methodology?

a) Identify and define key performance indicators

b) Develop prototypes of proposed solutions

c) Generate innovative ideas for improvement

d) Conduct pilot tests for proposed solutions

45 / 55

What is the primary purpose of checklists in meeting regulatory requirements in the pharmaceutical industry?

a) Increase Complexity

b) Document Compliance

c) Ignore Regulatory Guidelines

d) Avoid Validation Steps

46 / 55

What is the significance of Accountability in enforcing SOPs effectively?

a) To clearly define roles and responsibilities for enforcement

b) To set an example by not adhering to SOPs

c) To avoid designating responsibilities for enforcing SOPs

d) To exclude employees from monitoring compliance with SOPs

47 / 55

What role do Master Black Belts play in the Six Sigma hierarchy?

a) They serve as frontline leaders, driving and implementing strategic improvements

b) They act as entry-level participants contributing to improvement initiatives and bringing foundational knowledge

c) They are top experts, guiding Six Sigma projects and mentoring Black Belts

d) They are integral team members actively engaged in improving initiatives and balancing their regular job responsibilities

48 / 55

Which type of stability study assesses the stability of a drug product under recommended storage conditions?

a) Long-term stability

b) Accelerated stability

c) Forced degradation

d) Photostability

49 / 55

Why is the establishment of Standard Operating Procedures (SOPs) important in documentation for pharmaceutical quality assurance?

a) To introduce variations in manufacturing

b) To reduce the likelihood of errors and promote reproducibility

c) To complicate processes and procedures

d) To discourage regulatory compliance

50 / 55

When is Preliminary Hazard Analysis (PHA) most commonly used?

a) Late in the development process

b) Early in the development of a project

c) After manufacturing

d) After post-marketing activities

51 / 55

What is a common violation associated with non-compliance in machine safety according to OSHA?

a) Failure to provide proper fall protection

b) Inadequate chemical labeling

c) Lack of emergency response protocols

d) Insufficient training on chemical hazards

52 / 55

What is a cleanroom’s common goal?

a) To enhance pressure control

b) To prevent contamination

c) To promote microorganism growth control

d) To facilitate particle interference

53 / 55

Why are Standard Operating Procedures (SOPs) established through documentation?

a) To make things complicated

b) To discourage consistency in manufacturing processes

c) To increase the likelihood of errors

d) To define how tasks should be performed

54 / 55

What is the primary purpose of the risk-based approach in GAMP implementation?

a) To increase cross-functional teams

b) To minimize resources

c) To ensure comprehensive coverage and diverse perspectives

d) To prioritize validation efforts based on risk assessments

55 / 55

How does a pharmaceutical company benefit from a proactive approach through audits?

a) By preventing issues before they escalate

b) By verifying adherence to legal requirements

c) By conducting formalized reviews

d) By improving the effectiveness of the quality management system

Your score is

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