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Nonconformance
Problems of various types and degrees of complexity are inherent in any analytical process. The entire Shealy organization strives to minimize occurrences and the potential severity of problems within our control, especially those that pose a threat to the generation of quality data. Any measure of QC that fails to rate within established limits and any anomalies that arise during an analysis are considered a nonconformance event. In cases where a nonconformance event occurs, the problem and the solution are fully documented.

Any employee discovering a nonconformance event completes a nonconformance memo (NCM) to document the nonconformance. The appropriate technical directors and QAO review the memo, evaluate data, determine corrective actions, and direct implementation of corrective procedures. As it is impossible to address all data evaluation circumstances, Shealy's directing principle is to use established policies and procedures, along with scientific evidence and good judgment, to make sound data evaluations.
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