QP 000 003
Vertical audit
VERTICAL AUDIT
Edition No.
Edition No. 1.0
Replaces:
Operative Date:
2/15/2016
Review Date:
October 2004
Location:
NGRL, UKNEQAS Office, EMQN Office
Author:
Simon Patton
Signature:
Date:
October 2003
Updated by:
Signature:
Date:
Authorised by:
Rob Elles
Signature:
Date:
Copy No.
1
Document History
Edition No.
Date:
Comment:
1
2
3
4
5
Document available from: D:\533559920.doc
QUALITY PROCEDURE
Edition No. 1.0
CONTROLLED DOCUMENT - DO NOT PHOTOCOPY
Page 1 of 2
Central Manchester and Manchester Children’s University Hospitals NHS Trust – National Genetics Reference Laboratory (Manchester)
QP 000 003
Vertical audit
VERTICAL AUDIT
A. OVERVIEW
This document provides an overview on how to carry out a full vertical audit – please consult the
laboratory quality manager before proceeding.
B. WHAT YOU WILL NEED
1.
2.
3.
4.
Vertical audit form (QF 000 002)
Auditors (2 minimum)
Vertical audit SOP (QP 000 003)
You might also want to refer to the summary of the CPA accreditation standards (QP 000 005)
and as well as the full CPA standards (QP 000 004).
C. PROCEDURE
1. Select starting point for vertical audit. For example, if conducting a vertical audit on a disease
diagnosis, select at least 1 sample. The recommended approach is 1 sample for 3 different
disease diagnoses, or at least 3 samples for 1 disease diagnosis.
2. Choose sample booking in date appropriate to service profile. There is no hard and fast rule
however for a test with a quick turnaround time, such a FRAX, choose the 1st FRAX sample
from 3 months previously. Alternatively for a test with a long turnaround time, such as L1CAM,
choose the 1st sample from the same month but 1 year previously.
3. Use lab database to trace the sample(s) from reception to reporting. Pull off all information
relating to the sample including:
a.
Information for the users – check that the information for referrers is correct.
b.
Specimen transportation – check that there are SOPs relating to safe transportation of
samples.
c.
Sample card (s) and referral information. Check that referral information is
appropriate, card is correctly filled in, all associated paper work is filed and that
transcription of information on to lab database is correct.
d.
Sample collection – check that the sample arrived in the correct sample tubes.
e.
DNA sample(s) - check sample is present, filed correctly etc.
f.
Worksheet(s) – check present and filed correctly.
g.
Report(s) – check present and filed correctly
h.
SOP(s) – check present, up to date, information is relevant to service and that locations
on where to find information on samples, primers etc is correct.
i.
Validation – check for evidence of test procedure validation.
j.
Equipment – check that there is evidence that equipment used in testing has had routine
maintenance.
k.
EQA – check that there is evidence that there has been participation in EQA (if a scheme
exists for the selected disease diagnosis).
l.
Staff training – check for evidence that staff involved in the testing have appropriate
training, job description, contracts, appraisal, registration, annual leave and sickness
review, attendance at fire and health & safety training, attendance of staff meetings and
CPD.
4. Record findings on vertical audit form (QF 000 002)
5. Note any partial or non-compliances on form (QF 000 004)
6. Sign form and return to Laboratory Quality Manager.
Document available from: D:\533559920.doc
QUALITY PROCEDURE
Edition No. 1.0
CONTROLLED DOCUMENT - DO NOT PHOTOCOPY
Page 2 of 2
Central Manchester and Manchester Children’s University Hospitals NHS Trust – National Genetics Reference Laboratory (Manchester)