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IMPROVEMENT ACTION REPORT

COMMERCIAL IN CONFIDENCE
Please return evidence to AFB_CMMCustomerService@ukas.com quoting your UKAS Ref.No. in the subject field.

Name of Organisation International Potato Center (CIP) BE ID(s) & type(s) 89837 (Surveillance)

Rosario Falcon
Av La Molina 1895 Organisation Janny van Beem
La Molina Giovanna Muller
Assessment Location representative(s)
Lima Segundo Fuentes
Peru Reinhard Simon

UKAS Assessor:

Recommended

Required (Y/N)
Finding No.

Mandatory or
Ben Courtney and IAR Ref No: BC/SW Date of issue: 16/9/2010 UKAS Ref No(s): 4229

Evidence
Stuart Wale

Description of Finding Agreed Improvement Action


(Including reference to Accreditation Criteria & Principal Clause(s)) (agreed between UKAS and Customer)

1 Clause: 5.5.2 Source an organisation providing traceable measurement


Temperature measuring equipment seen in the Serology laboratory for the thermocouples or acquire new, calibrated
does not have a programme of calibration. The temperature temperature measuring devices.
measuring devices are used to monitor the ongoing performance of
fridges containing reagents critical for the accredited testing Devise an appropriate maintenance plan for all equipment
(antibodies). critical for the accredited testing. M Y
A maintenance plan for the plate reader in Serology is also
required. Any future applications (e.g. PCR) will require a similar
plan of maintenance. It may be beneficial to formalise an
agreement with the maintenance department to ensure continued
support for all equipment.

F212 Issue: 7 Page 1 of 3


UKAS Assessor:

Recommended

Required (Y/N)
Finding No.

Mandatory or
Ben Courtney and IAR Ref No: BC/SW Date of issue: 16/9/2010 UKAS Ref No(s): 4229

Evidence
Stuart Wale

Description of Finding Agreed Improvement Action


(Including reference to Accreditation Criteria & Principal Clause(s)) (agreed between UKAS and Customer)

2 Clause: 4.9.1 Provide evidence of awareness training for technical staff in


The nonconforming work procedure is not being consistently the nonconforming work procedure.
implemented. Fridges and freezers in the Serology laboratory were
M Y
demonstrated to be consistently out of tolerance. No action has
been documented.

3 Clause: 4.1.2/LAB 1 Declare accreditation status of testing on phytosanitary


The laboratory performs tests outside of the scope of accreditation statement – additional declaration. Provide an example as
M Y
and there is currently no mechanism in place to make clients aware evidence.
as to which testing is accredited and which is not.
4 Clause: 4.5.2 As improvement action in BC-3
There is no evidence that the customer is advised of the M N
arrangement to subcontract work where required.
5 Clause: 4.3.2.3 Incorporate unique identification into all documents. Submit
Some documents for use within the laboratory are not uniquely serology fridge maintenance sheet as an example.
identified. SOPs produced do not indicate page numbering or a
M Y
mark to signify the end of the document. Maintenance sheet
templates contain no unique identification and need incorporating
into the management system.
6 Clause: 4.13.2.3 Put a plan together to ensure an audit trail can be
Current database system precludes audit trails. Changes in established in future and that records cannot be deleted.
M Y
records cannot be tracked and the facility exists to completely
delete a record.
7 Clause: 5.4.7.2b) Write an Operating Procedure and submit as evidence.
There is no formal procedure in place to verify continued integrity of M Y
data entry, storage, transmission or processing.
8 Clause: 5.2.1 Incorporating into the test witness audit plan and document
There are no records of ongoing competence of staff. By the nature in training records.
of work in the greenhouse (visual identification of disease), this is
less significant as an experienced member of staff regularly works M Y
together with technicians. However, in ELISA, this needs more
formal documentation in training records. (Competency could be
verified by internal audit test witnessing).
F212 Issue: 7 Page 2 of 3
UKAS Assessor:

Recommended

Required (Y/N)
Finding No.

Mandatory or
Ben Courtney and IAR Ref No: BC/SW Date of issue: 16/9/2010 UKAS Ref No(s): 4229

Evidence
Stuart Wale

Description of Finding Agreed Improvement Action


(Including reference to Accreditation Criteria & Principal Clause(s)) (agreed between UKAS and Customer)

9 Recommendation:
It is recommended that staff members countersign training records R N/A
to confirm that they feel competent to perform tasks.
10 Recommendation:
Training records will benefit from referencing specific procedures R N/A
rather than a generic title.
11 Clause: 5.9.1 Put together a plan documenting how test assurance will be
Current quality control checks are limited. No proficiency testing addressed. Submit the plan as evidence.
scheme is available for the testing but alternative methods of
independent confirmation of test assurance are required. The M Y
laboratory need to consider inter laboratory comparisons and more
challenging IQC in addition to the standard negative and positive
controls currently in place.
12 Recommendation:
It is strongly recommended that the laboratory analyse succession
management for the areas of testing. Individuals within areas have
extensive knowledge in the specific testing area and there is a high
R N/A
risk that this would be lost if and when the staff member leaves the
organisation. Consideration should be given to shadow training, a
collection of training material and more formal interlaboratory
communication to support this.
13 Recommendation:
There may be reduction in contamination risk if the laminar flow R N/A
cabinets for quarantine are moved to a separate area.
14 Recommendation:
For sweet potato, it would benefit the laboratory to investigate
further mechanisms to detect a wider range of viruses. For R N/A
instance, an increase in the types of indicator plants or other
methods.
END OF REPORT

F212 Issue: 7 Page 3 of 3

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