A7 - good scientific and clinical practice Flashcards
what objectives must we achieve?
consistency
predictability
reproducibility
reliability
how must we achieve the 4 objectives?
using SOP
effectively managing calibration and maintenance of equipment
effectively managing stock
appropriately storing products, materials and equipment
what is a SOP?
standard operating procedure
a set of steps or instructions in a sequence that are designed to standardise the approach to a process or action, so that everyone learns to do it the same way.
what are 4 things SOP can be used for?
receiving goods, booking them into stock and informing the accounts department that the invoice can be paid.
cleaning a room in a healthcare facility or a microbiology lab.
producing a batch of a pharmaceutical ingredient.
analysing that batch to make sure it meets standards of purity, activity and safety.
why is it important for everyone to follow SOP?
maintaining health and safety
enabling consistency approach
meeting any legal or organisational requirements
upholding professional standards
demonstrating compliance for audit purposes
how do you access SOP’s for a given activity?
carrying out detailed index searches
completing staff induction and ongoing training
ensuring the SOP is the up to date version
ensuring all relevant documentation has been signed and completed
where should SOP’s stored?
hard copy or electronic format and be readily available for use
what are the potential impacts of not regularly cleaning and preparing surfaces for use?
risk to health and safety (spread of infections, production of toxic products)
invalid results
inefficient working practices
damage to equipment
what are the potential impacts of not maintaining, cleaning and servicing equipment?
reduced function of equipment
why is it important to calibrate and test equipment to make sure its fit for use?
ensuring accuracy of measurements
prolonging life of equipment
meeting legal requirements
how to escalate concerns if equipment is not correctly calibrated/unable for use?
taking the equipment out of action
labelling the equipment as out of use
reporting concerns to relevant person inline with polices and procedures
recording concerns according to organisational procedures
why is it important to order and manage stock?
ensuring sufficient supply of required consumables and materials
ensuring materials are used before their expiry date
reducing the cost of excess stock
improving efficiency and productivity
ensure safety of stock
what are the potential consequences of incorrectly storing products, materials or equipment?
cross - contamination
products exceeding expiry date
breakdown of limited stability products
loss of samples or degradation of regents stored at incorrect temperatures
risk to health and safety
stock is difficult to locate
financial loss
