Eighth Edition - R.3 - Human Fertilisation & Embryology Authority
Eighth Edition - R.3 - Human Fertilisation & Embryology Authority
Eighth Edition - R.3 - Human Fertilisation & Embryology Authority
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Index<br />
identification of processes needed 23.2a<br />
documentation T33(23), 23.5<br />
contents T33(23), 23.5<br />
inspection by HFEA 23.5<br />
internal audit of procedures 23.20<br />
effectiveness, improvements 23.26d<br />
in quality policy 23.7c<br />
establishing/maintaining 23.3–23.4<br />
centre management role/tasks 23.3<br />
internal audit 23.19c<br />
processes, included in quality manual 23.11e<br />
quality manager’s responsibilities 23.4<br />
resources for 23.3d<br />
inter-laboratory comparisons<br />
see inter-centre/inter-laboratory comparisons<br />
internal audits 23.19–23.22<br />
criteria for assessing 23.19<br />
documented procedure 23.20<br />
focus on quality indicators 23.22<br />
frequency<br />
T36(23)<br />
personnel undertaking T36(23), 23.20c, 23.21<br />
quality manager’s role 23.21<br />
records of 23.20f<br />
responsibilities, scope and actions 23.20a, 23.20b,<br />
23.20d, 23.20e<br />
witnessing protocols 18.29<br />
monitoring/evaluation/improvement 23B, 23.26–23.28<br />
corrective action for nonconformities 23.27<br />
criteria for 23.26<br />
in management review 23.14<br />
personnel awareness of importance of 23.3e<br />
planning/operation of processes, documentation 23.5c<br />
quality and safety standards to be established T35(23)<br />
records 23.5d<br />
requirement to implement<br />
T32(23)<br />
reviews of see quality management review<br />
staff suggestions 23.12e, 23.18<br />
third party procedures integrated 23.3h, 24.3<br />
in review of quality management system 23.12e<br />
user satisfaction assessment see users<br />
quality manager 23.3a<br />
planning of audit programme 23.21<br />
responsibilities 23.4<br />
quality manual 23.11<br />
contents 23.11<br />
documentation 23.5b<br />
quality objectives 23.3c, 23.9–23.10<br />
coverage and review of 23.9, 23.10<br />
documentation 23.5a<br />
establishment/maintained by centre management 23.10<br />
plans to establish/maintain 23.3c, 23.5a, 23.10<br />
quality policy 23.3b, 23.6–23.8<br />
commitments in, centre management’s role 23.7<br />
communicating about 23.8b<br />
definition 23.6<br />
documentation 23.5a<br />
inclusion in quality manual 23.11b<br />
reviewing 23.8c<br />
signing and issuing 23.8a<br />
quarantine<br />
donated gametes/eggs T53c(11), 11.16<br />
traceability of all material 19.1b<br />
R<br />
radio frequency identification (RFID)<br />
effect on gametes/embryos 18.45<br />
manual labelling with 18.37<br />
radio wave frequency 18.44<br />
risk assessment 18.44–18.45<br />
tags for storage containers 18.31e, 18.38<br />
witnessing using 18.3<br />
see also witnessing, electronic systems<br />
recall of gametes/embryos 15C, 15.15d<br />
recall of products, after serious adverse<br />
event/reaction, procedure<br />
T122(27)<br />
receipt of gametes, requirements 15.9, 15.10–15.12<br />
records 31.1–31.9<br />
access to<br />
confidentiality 30.1<br />
control of T44(30), 31.7<br />
restrictions on<br />
T45(30)<br />
standard operating procedures for<br />
T44(30)<br />
age of donors 11.5<br />
amendment by hand 31.5<br />
archived, off-site storage 30.5f, 30.6, 31.2, 31.9<br />
to be provided for <strong>Authority</strong><br />
T41(31)<br />
centre staff 2.2<br />
communication difficulties, in giving consent 29.16<br />
complaints register 28.7<br />
conscientious objection by staff 29.15<br />
consent 5C, 5.14–5.15<br />
see also under consent<br />
contents for each patient/donor<br />
T46(31)<br />
control procedures for 31.4b<br />
copies/extracts for <strong>Authority</strong><br />
T41(31)<br />
corrective action, inter-laboratory comparisons 23.25<br />
counselling 3.12<br />
definition 30.4, 31.2<br />
donors, unsuitability 11.18<br />
embryo use for research/training 22.3<br />
equipment and materials, for traceability 19.1c<br />
format 30.4, 31.2<br />
gamete supply to other centres 19.4<br />
hand written and transfer to computers/microfilm T38(31)<br />
information recorded as specified in Directions T39(31)<br />
information removal not allowed<br />
before expiry of period<br />
T40(31)<br />
of internal audit on quality management system 23.20f<br />
keeping for 30 years<br />
T48(31)<br />
legible and indelible<br />
T38(31)<br />
<strong>Human</strong> <strong>Fertilisation</strong> and <strong>Embryology</strong> <strong>Authority</strong><br />
Index<br />
Version 3.0
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