Quality and safety assurance
All laboratories should have practices and procedures in place which safeguard the health and safety of laboratory staff and technicians and the quality of experiments, research and results.
A fundamental part of quality and safety assurance in the laboratory is documentation of organisational processes and training that should cover many aspects of the laboratory including the laboratory environment, quality control procedures, communication, record-keeping, staff competence and training, procurement of good quality reagents and equipment and equipment function and maintenance.
In particular, the writing and use of standard operating procedures (SOPs) and risk assessments is essential for quality and safety assurance. All staff should be aware of and follow relevant SOPs and risk assessments. Risk assessments will determine the safety measures required to perform a procedure with the minimum risk which is reasonably practicable. It is essential that personal protective equipment (PPE) which is recommended in the risk assessment is available to staff and that its use is enforced.
Quality management systems exist to provide a framework to guide requirements to ensure quality within the laboratory. Such systems may be assessed and monitored internally or, in full or part, be externally audited e.g. performance of specific assays may be monitored using external quality assurance (EQA) schemes.
Good Laboratory Practice (GLP) can be followed as an assurance of quality (see the WHO Good Laboratory Practice Handbook). When GLP procedures are in place the laboratory can apply to be audited by the relevant authority; for example, in the UK this is the UK Good Laboratory Practice Monitoring Authority (UK GLPMA), to gain an official statement of GLP compliance. Other country-based or international quality management system guidelines also exist, such as from The Clinical & Laboratory Standards Institute (CLSI). International accreditation is provided by the International Organisation for Standardization (ISO 15189 for medical laboratories).
More information on quality management systems can be found within the WHO Laboratory Quality Management System traing tool kit (link) and web pages of the Clinical and Laboratory Standards Institute, the World Health Organisation (WHO) Handbook of Good Laboratory Practice, or the OECD or EMA pages on Good Laboratory Practice. Discuss with your laboratory manager what applies to you, your country and your work.
The aim of OpeN-Global is to support the objective, detailed, accurate and high-quality assessment of nutritional biomarkers used in Global Health population surveys and research. We do this through the provision of comprehensive fact-sheets on assessment of nutritional biomarkers.
We offer (i) fully referenced general information; (ii) links to laboratory methods in either open-source Standard Operating Procedures (SOPs) format, links to published manuscripts describing the method in question, or SOPs provided directly by institutions from the OpeN-Global partner network; (iii) information and advice on quality control including details on where laboratories can seek method accreditation; (iv) availability of an expert partner network to answer technical queries that arise; and (v) a non-exhaustive list of relative useful links and signposting.
All information provided on this website is, to the best of our knowledge, accurate and up to date, and we readily accept suggestions for improvement.
Whilst we make every effort to find and include examples of laboratory methods and evidence-based recommendations where appropriate and possible, our list is non-exhaustive. Further, the information is provided herein as a service to the OpeN-Global community, and is not meant as an endorsement of any particular method or procedure.
For any labs choosing to use the resources given on this website, particularly the methods and SOPs, we emphasise the importance of adapting these to suit local requirements.
Neither OpeN-Global, nor its partners, are responsible for the conduct of any research conducted using, or the results obtained from, the content of OpeN-Global. Further, neither OpeN-Global, nor its partners, hold any liability for the application or negligence thereof, of Good Laboratory Practice or other appropriate quality and safety procedures.