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ACZ Laboratories, Inc. August 10, 2007 <br />Version 12 <br />Quality Assurance Plan <br />SOPAD018.08.07.12 Page 13 of 96 <br />Only QA/QC department personnel may open and close a major corrective action. When opened, the <br />corrective action will be assigned a unique tracking number (referred to as the CAR number) to ensure <br />that ACZ maintains a complete and accessible record of all Quality System deviations or failures, root <br />cause determinations and subsequent resolutions, and preventive actions. All associated documentation <br />must be retained for at least five (5) years as described in Section 10. <br />Other examples of circumstances requiring a major corrective action include, but are not limited to: <br />• Contamination trends as indicated by blanks routinely above acceptable levels <br />Spikes, surrogates and lab control samples continually outside acceptance limits <br />y, • Change to the MDL and/or PQL (RL) for a procedure <br />• Client inquiries about data anomalies <br />• "Not Acceptable" Proficiency Testing results <br />• Results of internal or external audits <br />1 • Discrepancies observed at any stage of data review or reporting <br />• Using expired receivables <br />• Hold times or deadlines routinely missed <br />• Evidence of insufficient or inadequate training <br />Following initiation, the procedure for a major corrective action proceeds to an investigation by the <br />assigned individual to determine the root cause of the problem and to identify possible resolutions to <br />rectify the problem. The action(s) most likely to eliminate the problem and prevent recurrence of the <br />problem must be selected, documented and implemented, and pertinent staff members must be trained, if <br />necessary. Changes resulting from the corrective action will be monitored, if necessary, to ensure the <br />resolution(s) are shown to be effective. A general outline of the procedure is as follows: <br />1) Initiation: Any employee may initiate a corrective action by notifying QA/QC. The department <br />manager should always be notified first of any problem and then inform QA/QC. If determined <br />to be necessary, QA/QC personnel will open a corrective action and assign a unique tracking <br />number. <br />2) Assignment: QA/QC assigns the corrective action to the person(s) responsible for performing <br />the "root cause" deterniination. <br />3) Investigation and Action: Must be completed within two (2) weeks from the date the corrective <br />action was initiated. The need for an extension must be communicated to the QA/QC department. <br />a. The assigned individual(s) perform a "root cause" determination to identify the suspected <br />cause(s) of the problem. <br />b. A resolution to correct the problem and prevent its reoccurrence must be determined, and the <br />estimated date by which the resolution will be completed and implemented must be indicated <br />' in the appropriate section of the form. Resolution may be done solely by the person(s) who <br />investigated the root cause or it may require input from one or more additional departments. <br />2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com <br />