q51-75 Flashcards
Define the controlled cycle in quality management systems
PLAN - EXECUTE - RECORD - IMPROVE.
Why are confidentiality agreements important to companies?
legal tools that protect products, patents, trademarks, and secret information from being leaked to competitors or the public. They also safeguard citizens by preventing health service providers from disclosing information.
What professional development opportunities might an employee be reasonably expected to engage with? List five.
Conventions (Annual; National / International)
Conferences (e.g., National / International Research)
Workshops (e.g., Methods / Instruments)
Seminars and Trade Shows
Forums (e.g., For discussion; problem-solving, etc.)
Give two examples of reflective learning
Questions after an incident in the laboratory, Questions after a period of training
What THREE attributes differentiate the amateur and the professional?
How they look as they need to look presentable with a suit tie, etc
How they talk (pronounce their words correctly and use appropriate vocabulary)
How they write.
What is the basic unwritten expectation of personal professionalism?
To exhibit the highest level of professionalism at all times, both within and outside of work, and to always respect and represent the best interests of your employer and end users
What is the importance of Quality management systems (QMS)
way of working that ensures that separate procedures within an organization combine into an overall system to provide a consistent quality of goods or services.
The key purpose of the QMS is to keep everything transparent and traceable, linking all the resources going INTO an operation (i.e., people, training, purchases, etc.) with all aspects of the product coming OUT.
Give a definition of “Ethics”
Ethics is defined in the reference text as a system of moral principles or standards governing conduct
List three desirable and three non desirable behaviours in the ethics of professionalism
Desirable behaviours:
Altruism
Accountability
Excellence
Undesirable behaviours:
Abuse of power
Bias
Harassment
What do you understand by the term “Fabrication”? Give THREE examples
Fabrication in a scientific context is generally taken to be the deliberate and intentional act of falsifying research results
Outright synthesis of experimental data reporting experiments never conducted (so-called “dry-labbing”).
or outright manufacture of experimental data.
Statistically invalid, “culling” of experimental data, such as the intentional exclusion of experimental runs which contradict the hypothesis the scientist is trying to demonstrate.
What are the FOUR key aspects of personal development planning?
Education & Training
Reflection
Personal Development Planning (PDP)
Retraining
Generic and pioneer product
PP - Drug developed by s pharmaceutical industry after extensive work
GP - Biological copy of the drug after its patent expires
Quality control and quality insurance
QC - Focuses on identifying and correcting defects in the products
QA - Preventing defects by improving systems
How long is ISO9000 accreditation valid
3y, requires annual surveillance audits to maintain compliance
SOP
Step-by-step instructions to ensure tasks are completed consistently and safely across an organisation
4 egs of professional development opps
Convention
Conference
Workshops
Seminars
4 responsibilities of a quality manager
Ensuring compliance and safety
Managing lab ops
Ensuring quality control
Personnel training
Define QA with 2 elements
Activities associated with ensuring measurements are made properly and reported
SOP
Sample tracking
GCP GLP
Good clinical practice
Good laboratory practice
What should be obtained before a clinical trial
Free consent
Example of an offence under the tissue act
Trafficking human tissue for transplantation
egs of biohazard
Biohazards - Human tissue and blood
Chemicals - Acids and alkaline
What is the purpose of local rules at a specialist facility
Protocols to ensure safety, compliance, and efficiency within that environment
List 4 safety solutions for a bio hazard at a lab
Cleanliness
Protection
Storage of chemicals
Disposal of biohazards
