The Quality Management Groups Operations

The QMG's operations include, but are not limited to, the following:

  • The TDL & TDL Genetics Quality Management Group (QMG) meet on a regular basis, at the appropriate site, to review all quality matters pertaining to the various constituent laboratories of TDL, and TDL Genetics.

The meetings are normally held between the senior members of the QMG and the Laboratory Quality Co-ordinators and/or Quality representatives and can also include senior TDL & TDL Genetics group management and consultants. Frequent meetings between the senior members of the QMG are also held.

Quality matters reviewed include External Quality Assessment (EQA) returns and associated analytical problems, quality standards and training, internal quality assurance audits and their responses and overall quality system management and documentation.

External Quality Assessment (EQA) reviews are a key function of the QMG meetings. The purpose is to review and assess the performance of all EQA by reviewing the returns. Any performance that is considered to be outside the limits set by the EQA scheme organisers is quickly tackled and subsequently monitored.

The laboratories receive and initially review EQA returns after which they are discussed at the QMG meeting. The department's consultant also reviews the returns. Results from the return are summarised within a quarterly report for the TDL, TDL Genetics & WSL board of directors.

Out of limits EQA data is reported immediately to the senior members of the QMG who monitor remedial action and report promptly to the TDL, TDL Genetics & WSL senior management if necessary.

  • Provision of regular audits and inspections of the laboratory functions and all areas of the Quality Systems to assure the quality of the data generated and to ensure compliance to the required standards (e.g. CPA and GCP).

The procedures use audit schedules to ensure all required areas and facilities are inspected on a regular basis and inspection findings are followed up after a suitable time period. They provide a mechanism whereby audit findings can be quickly reported to senior management.

The areas inspected within the laboratories include, but are not limited to, personnel, facilities, equipment, reagents, standard operating procedures (SOPs), raw data, archives and results. Procedures also exist to inspect and monitor general compliance of the various accreditations and regulations the Organisation subscribes to.

  • The preparation and maintenance of quality manuals for all sites and quality management documentation (QMG SOPs etc.) for all areas within the organisation.

Most quality accreditation bodies require the production and maintenance of a quality manual. A quality manual describes the quality management system of a laboratory and includes the quality policy arrangements for its implementation. Quality manuals for all sites should be available to all personnel within the laboratories and be reviewed regularly, updated as required and changes communicated to all personnel concerned.

  • The provision of expert advice and interpretation on Quality matters and relevant standards to all areas within the organisation.
  • The provision, where necessary, of appropriate Quality training to all members of the QMG and staff at all sites within the organisation.

 

Quality Management Group Activities

 

QMG Activities