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Sunday, August 15, 2010

UIA PARA LA PRESENCIA DE ANALISIS EN LABORATORIOS DE TERCERA PARTES

TEST OBSERVATION AT THIRD PARTY LABORATORIES
(Previously “Witnessing of Analysis”)
IFIA Guidelines recommend that Member Companies carry out testing in their own laboratories. An IFIA member company that draws samples and conducts its own laboratory analysis can be certain of the provenance of the samples tested and can vouch for the analysis results. When engaged only to do Test Observation, however, an inspection company:
• Cannot guarantee the origin of samples they did not participate in drawing,
• Cannot guarantee that when samples are split to allow multiple tests to be conducted on sub-samples at different testing stations, such samples are tested without alteration,
• Cannot observe multiple tests being conducted at multiple test stations at the same time,
• Cannot vouch for the accuracy, calibration and maintenance of testing equipment that it does not own and operate, and
• May not, at every location, ordinarily engage an observer with qualifications sufficient to judge whether the laboratory techniques employed for specific tests are appropriate and properly executed.
Where Members are contracted to observe tests carried out by designated third party laboratories this is on the basis that the Member bears no responsibility for the accuracy of the results but simply that a suitable representative (an inspector or laboratory technician) will attend during the testing and ascertain by observation that in his/her opinion the tests were carried out on the correct sample.
Recent discussions have been held with client organisations in order to reinforce the above position, particularly with regard to responsibility. The position has not changed but the following outline scope of work has been suggested to form the basis of a service that will provide some additional value for the client while at the same time avoiding unreasonable responsibilities for the Member.
Check the test slate. •



Enquire whether the designated laboratory can perform the required tests. If not, advise the client, possibly suggesting that some tests are performed at the Member’s laboratory.
Prepare a Check List for the agreed test slate.
This should be a simple sheet listing the tests to be carried out with results to be noted for each test.
If agreed, draw samples, deliver to the laboratory and observe compositing.
Where samples are from an auto-sampler available performance data should be noted in accordance with normal procedures. Where samples are ‘supplied’ this should be clearly noted.
Confirm that the correct sample is used for each test.
Alternatively state that this cannot be confirmed, eg not present, missing seal, etc.
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Obtain copies of result print outs where available. •



Report/record whether results are within or outside the agreed specification, if available.
Countersign the Test Report issued by the designated laboratory adding a suitable disclaimer, eg ‘Observed Only and without Responsibility for Results’. A similar disclaimer should be included on the Check List.
Attach the Observation Report and completed Check List to the designated laboratory’s Test Report. Results are to be issued only on the designated laboratory paperwork and NOT transcribed on to Member Company letterhead. The Member Company should never represent as its own, results from tests conducted by others or tests carried out on samples of unknown or uncertain provenance.
This bulletin is for information and guidance and addresses the limitations upon the process of Test Observation and the risks inherent in relying upon it. IFIA strongly recommends that attention is given to comments regarding responsibility for analyses and disclaimers and, particularly recommends that third party results, whether observed or not, should be reported only on the document prepared by the designated laboratory and must NOT be transcribed.
Parties to Letter of Credit transactions where an independent Certificate of Analysis is required ordinarily should not expect to receive such a certificate based solely upon Test Observation. Attention is drawn to the IFIA Technical Bulletin relating to Letters of Credit, TB 06-02.
If an IFIA Member is contracted to observe testing in a third-party (e.g. terminal) laboratory, which is operated by that same IFIA Member, the IFIA Member Company will advise the Principal immediately of the situation.
Note: 'Test Report' in this bulletin refers to any document issued by a third party laboratory containing test results. Such documents may also be referred to as Laboratory Reports, Certificates of Quality, Certificates of Analysis etc., depending on the location.