Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

XX. Title of Guidance Note
HFEA guidance (cont)
23.21 The quality manager should plan the audit programme. It must take into account the importance of the
processes and areas to be audited, and the results of previous audits. Auditors should not audit their own
areas of responsibility.
23.22 The audit should focus in particular on quality indicators established for systematically monitoring
and evaluating the centre’s assisted conception processes.
Participating in external reviews, and inter-centre and inter-laboratory comparisons
23.23 The centre should, where possible, participate in inter-centre comparisons and inter-laboratory
comparisons. The centre should evaluate the results of these comparisons and use relevant findings
to improve its service.
23.24 For inter-laboratory comparisons, the laboratory should establish documented procedures to define the
responsibilities and requirements for participation to ensure that:
(a)
a record of participation is maintained, to include reasons for failure to participate
(b) supervisory staff and staff doing the examinations evaluate the returned results against
agreed performance criteria, and, when nonconformities are identified, participate in
implementing and recording corrective action, and
(c)
the effectiveness of the corrective action is verified. When a formal inter-laboratory
comparison programme is not available, the laboratory should develop a way of determining
the acceptability of procedures not otherwise evaluated. Whenever possible, this should use
external materials, such as exchange of samples with other laboratories.
23.25 The centre should assess any external reviews indicating nonconformities or potential nonconformities and
take appropriate corrective or preventive action to ensure it continues to comply with the requirements and
expectations of this Code of Practice. The centre must keep a record of corrective and preventive action
it takes.
Monitoring, evaluation and improvement
Interpretation of mandatory requirements
The centre must plan and implement processes for monitoring, evaluation and improvement.
23B
23.26 The centre’s processes for monitoring, evaluation and improvement should:
(a) show that procedures and outcomes are satisfactory when judged against relevant
professional standards
(b)
(c)
(d)
show that the assisted conception processes are followed in a way that meets users’ needs
and requirements
ensure conformity of the quality management system, and
continually improve the effectiveness of the quality management system.
23.27 The centre should establish a documented procedure to take corrective action to eliminate the cause
of nonconformities. This should include:
(a)
reviewing nonconformities
(b)
(c)
(d)
(e)
(f)
determining the causes of nonconformities
evaluating the need for action to ensure nonconformities do not recur
promptly determining and implementing action needed
recording the results of corrective action taken, and
reviewing the corrective action taken.
Human Fertilisation and Embryology Authority
Guidance note Note |
23. The quality management system
Version 1.0 1.0