Research SOP: Quality Manual: Section 5.7 What is Sampling and How the testing laboratories Handling of test and calibration items?

5.7 Sampling

5.7.1 The PTL has a sampling plan and procedure (PTL/QSP/18) for sampling. This procedure includes the selection, sampling plan, withdrawal, and preparation of a sample to yield the required information. The sampling plan and procedure are available at the location where sampling is undertaken. Sampling plans are based on statistical methods.

5.7.2 Where the customer requires deviations, additions, or exclusions from the documented sampling procedure, these are recorded in detail with the appropriate sampling data and are included in all documents containing test results, and are communicated to the appropriate personnel.

5.7.3 The PTL has a procedure (PTL/QSP/18) for recording relevant data and operations relating to sampling that forms part of the testing that is undertaken. These records include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant), and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

Records

The records of sampling are maintained in the procedure (PTL/QSP/18).

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5.8 Handling of test and calibration items

Policy

The PTL is handling test items to protect the integrity of test.

5.8.1 The PTL has procedure (PTL/QSP/19) for the transportation, receipt, handling, protection, storage, retention and/or disposal of test items, including all provisions necessary to protect the integrity of the test item, and to protect the interests of the laboratory and the customer.

5.8.2 The PTL laboratory has a system for identifying test items. The identification is retained throughout the life of the item in the laboratory. The system is designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents.

5.8.3 Upon receipt of the test item, abnormalities or departures from normal or specified conditions, as described in the test method, are recorded.

When there is doubt as to the suitability of an item for test or when an item does not confirm to the description provided or the test required is not specified in sufficient detail, the laboratory consult the customer for further instructions before proceeding and record the discussion.

5.8.4 The laboratory has procedures (PTL/QSP/19) and appropriate facilities for avoiding deterioration, loss or damage to the test item during storage, handling and preparation. Handling instructions provided with the item shall be followed.

When items have to be stored under specified environmental conditions, these conditions are maintained, monitored and recorded. Where a test item or a portion of an item is to be held secure, the laboratory has arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.

Records

Record of handling of test items are maintained, for each item following information is recorded:

a) Laboratory Identification no.

b) Name of the customer

c) Date of receipt

d) Sample description

e) Condition of receipt

f) Date of test/measurement completed

g) Sample disposal date

h) Identity of assigned analyst

Retention time of test records is min. two year. For internal audit and MRM records is min. three years.

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