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Project Plan <br />Revision 6 <br />1/8/1988 <br />Page 20 of 37 <br />labelling and preparation dates. Reagents are not to be used after the <br />date at which their stability may become suspect. Standard solutions are <br />to be freshly prepared according to lab instructions. Findings are to be <br />discussed at monthly safety meeting. <br />6.5 Chain of Custody Checks <br />At the end of each month the chain of custody file for that month is <br />to be checked for proper usage. <br />6.6 Corrective Action Procedure <br />Should any of the above checks indicate improper adherence to quality <br />assurance guidelines or procedures the matter is to be brought to the <br />attention of the laboratory director. The director in tum will review the <br />matter and take corrective action. <br />When a method is found to be out of control, the GA Officer proposes a <br />course of corrective action, to be entered on ELI form QA -01 corrective <br />action request form, entry is also made in ELI QA -02 master log. The <br />laboratory director must approve the plan indicating steps taken to improve <br />the method. The Analysis Coordinator ensures the implementation of the <br />improvements, working closely with the Group Managers. Before the method <br />may be used again for reportable data, it must be demonstrated that the <br />method is back in control. To demonstrate this, the failed test must be <br />repeated successfully. In addition, there should be another kind of <br />verification, such as replication, check sample or control, depending on <br />the nature of the original failed test. <br />The status of the Quality Assurance program is to be reported bi- <br />monthly in a form of topical report. The Quality Control Officer, with <br />� <br />26 <br />