Download MHRA INspection Review for East of England RTC

Summary of Recent MHRA Inspections in
the East of England – Common Themes
East of England RTC
Lisa
Haythornthwaite
NSC TADG Chair
February 2013
Recent MHRA Inspections in the East of England
Overview
 4 Hospitals were all inspected in
October/November 2012
 Three out of the four hospitals had the same
inspector Stephen Grayson. The other was
inspected by Richard Funnell.
 None of the hospitals inspected received a critical
non-conformance but 3 out of the 4 received one
major each.
Recent MHRA Inspections in the East of England
Key Findings for 1 Hospital
 Major – Deviations. This was separated into four subsections, all
linked to chronic staff shortages by the inspector.
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Delay in recording/no timescales
Delay in closing (clinical source of delay)
Inconsistent quality of RCA
Inappropriate classification of some deviations
 Other
 No formal capacity plan
 Internal recalls well hidden!
 Analyser solutions topped up
 Validation failures noted but sign off not explained (rr/capacity)
 Comments
 LIMS upgrade for manual entry of blood group – Action plan in place
 Central database being set up for C & A competencies
Inspector was willing to change date of inspection
Recent MHRA Inspections in the East of England
Key Findings for 2 Hospital
 Major – Traceability
 Failed to meet statutory requirement of 100%
 Other
 QMS – Deviations (early assessment/insufficient detail/RCA), recall, change
control, documentation (deletions/doc control)
 No Trust staff blood collection competencies
 Management of computerised systems – no formal merging process, lack of
senior control, back-up location, reinstall, periodic requalification, no SLA
 Laboratory activities – Equipment (centrifuges), reagents, QC, result editing,
issuing components (line clearance)
 Mapping of temperature controlled storage devices – No protocol/acceptance
criteria, routine monitoring probe not referenced, maximum thermocouple
error not specified/end determination of unit status
 Comments
 Site to provide traceability data on a quarterly basis
 Site to provide a PAS merging procedure of inspector to review
Recent MHRA Inspections in the East of England
Key Findings for 3 Hospital
 Major – Traceability
 Failed to meet statutory requirement of 100%
 Other
 QMS – Deviations (early assessment/insufficient detail/RCA), recalls,
change control, OOH competency – No QMS content
 Merging (no training records, unmerging, no senior review), database
management, IT SLA provision
 Laboratory activities – premises (lab/cold room), sample labelling, sample
bar coding, reagent storage, temperature monitoring (hourly intervals),
equipment (centrifuges), QC failure, temperature mapping (no
protocol/acceptance criteria/conclusions)
 Comments
 Significant recent document review & audit activity
 Site to provide quarterly traceability data indefinitely
Recent MHRA Inspections in the East of England
Key Findings for 4 Hospital
 Major – None
 Other
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Premises
Completeness of QMS (change control review)
GMP/Documentation (deletions)
Collection of blood (via laboratory)
Inspector was unwilling to change date of inspection even though
Transfusion Manager was off sick
Recent MHRA Inspections in the East of England
Inspector One – SG - Common Findings
 QMS - change control review post go live, documentation
 Deviation – early assessment, formal RCA, insufficient
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detail, recall
Traceability – need >99%
QC - Failures
Centrifuges – procedures/settings
Merging (lack of senior control, training, procedure)
IT - SLA’s, disaster recovery, back-ups
Temperature mapping – No protocol and no final
conclusion
Pre-transfusion testing
Recent MHRA Inspections in the East of England
Inspector Two - RF
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QMS
Deviations (timely & consistent reporting)
Validation (analysers!!)
Pre-transfusion testing, particularly electronic
issue, automation and manual edit
 IT
 Traceability
 Training and competency assessment (Trust/Lab)
 Temperature mapping & monitoring
Recent MHRA Inspections in the East of England
Conclusions
 Inspector styles observed
 Generic GMP themes
 Expect recent MHRA guidance/hot topics
 Find out why you are being inspected
 End inspection report ‘almost’ in standards format
– useful
 Consider external contractor to map temperature
controlled storages devices
 Higher standards achieved