QP 000 002
Mini-vertical audit
MINI-VERTICAL AUDIT
Edition No.
Edition No. 1.0
Replaces:
Operative Date:
2/12/2016
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.
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Document available from: D:\106729579.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 000 002
Mini-vertical audit
MINI-VERTICAL AUDIT
A. OVERVIEW
This document provides a brief overview on how to carry out a mini-vertical audit and assumes
that a full vertical audit has been carried out in the last 3 months – please consult the laboratory
quality manager before proceeding.
B. WHAT YOU WILL NEED
1.
2.
3.
4.
Mini-vertical audit checklist form (QF 000 001)
Auditors (2 minimum)
Mini-vertical audit SOP (QP 000 002)
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 mini-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.
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.
b.
DNA sample(s) - check sample is present, filed correctly etc.
c.
Worksheet(s) – check present and filed correctly.
d.
Report(s) – check present and filed correctly
e.
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.
4. Record findings on mini-vertical audit form (QF 000 001)
5. Note any partial or non-compliances on form (QF 000 004)
6. Sign form and return to Lab Quality Manager.
Document available from: D:\106729579.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)