SHEL LAB IQ / OQ Services

Equipment qualification, in the context of quality management or validation, is an essential pre-requirement for a large number of companies in deciding on a specific supplier. In the past, end user companies have not always had sufficient information (especially in the form of engineering drawings and specifications) about the equipment they have purchased, to develop and put into place the quality of documentation that regulatory requirements demand. For correct and trouble free qualification, it is essential that the scope and quality of the proposed equipment documentation is specified at the equipment procurement stage. Sheldon Manufacturing, Inc. issues IQ/OQ certificates on request. To support the customers' own IQ/OQ certification, we also offer IQ/OQ documentation.

What is Installation Qualification?

The Installation Qualification verifies, through documented proof, that the equipment and all ancillary systems have been installed in accordance with relative drawings and/or specifications under the guidelines of the statutory safety regulations designated in the Design Qualification (DQ). These requirements must be satisfied before the IQ can be completed and the qualification process can proceed to the execution phase of Operational Qualification (OQ).

What documents are a part of the IQ?

The IQ contains 2 documents: The IQ Test Plan and the IQ report. The IQ test plan consists specific information on the appropriate tests to be done on the equipment as per the Installation Qualification. The IQ report is a detailed summary of results, along with analysis and evaluation of the IQ protocol. Any discrepancy in the report and subsequent adjustments are recorded. Once the discrepancies are rectified, they must be tested, documented, and evaluated again in a new IQ report.

When the IQ is accurately and successfully completed, the IQ is officially released by signatures within the report from all entities involved in the qualification process and countersigned by the user of the equipment, ultimately completing the IQ process and releasing the product to the OQ phase.

What is Operational Qualification?

The Operational Qualification establishes that all process equipment and sub-systems within are fully capable of operation within the limits and tolerances specified. The purpose of which is to demonstrate that newly acquired equipment functions as expected and does everything the user expects.

What documents are a part of the OQ?

The OQ also contains 2 verified documents: The OQ Test Plan and the OQ Report. The OQ Test Plan portrays all tests that are affiliated with the operation of relative equipment within the OQ. The OQ Report documents the results of OQ protocol and tests. Any discrepancy in the report and subsequent adjustments are recorded. Once the discrepancies are rectified, they must be tested, documented, and evaluated again in a new OQ report.

When the OQ is accurately and successfully completed, the OQ is officially released by signatures within the report from all entities involved in the qualification process and countersigned by the user for the equipment, ultimately completing the OQ process and releasing the product for use.