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Week 2: Regulatory affairs and Ethics - Coggle Diagram

- - - - What is it?
        
        • Collection of technical documents
        • Description of device design, use
        • Risk Management
        • Testing and Clinical evaluation
        • Manufacturing
      - What is it for?
        
        • Evidence that the device complies with
        regulations
        • Safe and Efficacious
        • Performs as intended
        • Manufactured under appropriate controls
      - It starts with design process and DHF
        
        Risk Management
        Risk Analyses, Risk traceability matrices etc.
        
        Inputs
        Product Requirements Document(s)
        
        Outputs
        Product Specification (Drawings, BOM etc.)
        
        Verification Records
        Test Data and Certificates,
        Raw data (Lab Books)
        
        Validation Records
        Clinical Evaluation Reports and Records
        
        Project Management
        Plans, Meeting Records, Design Reviews and
        Approval records
      - And the End Result is
        the Technical File
        
        • Scope (Specific Device(s))
        • Admin Info
        • Declarations of Conformity and classification
        • Overview product description
        • Product documentation, labels, manuals • Product history
        • Risk analysis • Essential requirements check list
        • Specifications • Summary of Testing Reports / Certificates
        • Clinical evaluation • Overall manufacturing and inspection plan
      - Risk Based Assessment
        
        III and AIMD
        QA and Tech. File audit Design Dossier review
        
        IIb
        QA and Tech. File audit Design control required
        
        IIa
        QA and Tech. File audit
        No Design control
        
        I
        Self Assessment
        Notification to TGA
        
        IVD 4
        QA and Tech. File Audit
        Design Dossier review Reference Lab Type Test
        
        IVD 3
        QA and Tech. File audit
        Design Control Required
        
        IVD 2
        QA and Tech. File audit
        No Design control
        
        IVD 1
        Self Assessment
        Notification to TGA
  - - - DHF
        • Full description of the Design process including all key documents and project management records
      - DMR
        • Collection of documents specifying a device and the processes required for its manufacture
- - - - An engineer is expected to act on the basis of a well-informed conscience, be honest and trustworthy and respect the dignity of others.
        
        This means that members of the engineering profession will act impartially and without favour, even if this means some personal discomfort such as advising a manager that a certain proposed course of action is inadvisable due to engineering challenges that
        may not be possible to overcome.
    - - An engineer is to maintain their professional competence through ongoing personal development, mentoring and learning from their peers and leaders.
        
        They are also to practice only within their area of competence and not claim to hold skills beyond those they actually possess. This means that, from time to time, an engineer may need to decline some work if it is simply outside of their area of expertise.
    - - An engineer is expected to represent the profession in an honest and trustworthy way, responsible engage with the public, advocate and support ethical practices; promote the skills and development of all of their professional colleagues; honestly and effectively communicating on engineering services/costs/outcomes/risks.
    - - To perform their work in a way that recognises all of the stakeholders, including clients, suppliers and the broader community and, to perform their work with the needs and requirements of future generations in mind.
  - - - Codes of ethics are supported by different ethical theories
      - Different theories have their own focus
        
        – Duty Ethics
        
        – Rights Ethics
        
        – Utilitarianism
        
        – Virtue Ethics
        
        – Ethical Egoism
      - Different lenses to view a problem
    - - • Focus on self and own interests
      - • Intrinsically ethical if a person acts to protect or further their own interests
      - • Putting safety/health/happiness of the decision maker ahead of others’ safety/health/happiness
      - • Decisions rarely impact just one individual
      - • Compromises relationships with colleagues since the needs of the team/company are not taken into account when making decisions
    - - • Moral or immoral based on consequences
      - • Maximising human happiness (hedon), minimising human suffering (dolors):
        
        Happiness objective function = ∑ (hedons) - ∑ (dolors)
      - • Overall happiness of a community without accounting for its equal (unequal) distribution
      - • Often difficulty to accurately estimate and quantify happiness and suffering
    - - • Rightness or wrongness of an action is adjudicated according to a set of subjective rules
      - • Consequences are not considered (unlike utilitarian); greatest importance is on the quality, fairness and consistency of the decision process
      - Morally good acts should be distinct or detached from self-serving motives
    - - • Ethical decision is one that upholds the rights of all parties to the decision
      - • Consequences not considered, focus is on the process used for decision making
    - - • Ethical if motivated by the virtues of perseverance, courage, compassion and self regard
      - • Outcomes less important than the morality and character demonstrated by the decision maker
    - - • Complexity and diversity rather than ‘fuzziness’ and weakness
      - • Multiple theories may not necessarily mean different solutions
      - • Note their limitations and what each does not cover/address
      - • Use different angles, more perspectives
    - - Ethical Egoism
        
        • Not an issue, offer will enhance enjoyment of self, increase knowledge
        
        • Corporate image/colleagues/community are not considered
        
        • Take offer
      - Utilitarianism
        
        • Happiness objective function = ∑ (hedons) - ∑ (dolors)
        
        • ‘Happiness’:
        
        – Holiday (individual)
        
        – Increase knowledge (individual + corporate)
        
        – Establish good business relationship with vendor, potential benefits in the future (corporate)
        
        • ‘Suffering’:
        
        – Appears to be bribed (tarnish corporate/individual image)
        
        – Future decisions incorrectly influenced (community)
        
        – Appearance of bribery, creating anti-competitive environment for all other vendors (community)
      - • Duty Ethics
        
        – No impact on the current decision making process (recommendation prior to offer; same decision even if no offer - consistent)
        
        – Decision was made after proper testing and research (competently executed)
        
        – But could accepting the offer be driven by self-serving motives?
        
        – Backlash from bribery (seemingly) not considered
      - • Rights Ethics
        
        – Right to accept the offer upheld
        
        – Right of the company to benefit from gaining knowledge upheld
        
        – Rights of other vendors to a competitive environment might not be seen to be upheld if bribery is perceived to have taken place
      - • Virtue Ethics
        
        – Decision making was backed by testing and research (honesty) before the offer was made
        
        – Integrity of the decision maker could be challenged if perceived to be bribed
  - - - – Line drawing
      - – Flowcharting
    - - • Construct negative and positive paradigm cases (clear-cut extremes)
      - • Navigate between the continuum – where do we fit between the two extremes?
    - - Examples of a creative middle
        
        • Let someone else in the company, not connected to the decisionmaking, go on the trip
        
        • Look up company policy to find that employees are not to accept vendor rewards for buying vendor products
        
        • Make the conditions of the offer clear to everyone in the company, other vendors, the public
        
        • Suggest the company splits the bill with the vendor
    - - • Visually map the situation, decisions and consequences
      - • Helps emphasise different aspects of the same problem