Best Practices in Statistical Process Monitoring ... - IBC Life Sciences
Best Practices in Statistical Process Monitoring ... - IBC Life Sciences
Best Practices in Statistical Process Monitoring ... - IBC Life Sciences
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3. How to Manage OOT Response<br />
Survey comments<br />
● QC Lab<br />
– If no confirmed lab error, QC triggers deviation<br />
– If lab error, <strong>in</strong>itial result <strong>in</strong>validated after new result obta<strong>in</strong>ed<br />
– Lab error sometimes only detected <strong>in</strong> CI calculation (e.g. yield outliers)<br />
● <strong>Process</strong> Parameters & Consistency Indicators<br />
– Manufactur<strong>in</strong>g, technical, or (sometimes) validation responsibility<br />
– Immediately enter <strong>in</strong> quality system OR trigger discussion<br />
– OOT below a set “performance level” can be agreed as non-concern<br />
– If uncovered dur<strong>in</strong>g APR, <strong>in</strong>vestigation may be launched<br />
● Frequency of Data Review<br />
– Automate/alert after each discrete observation if possible<br />
– Cross-functional notification can facilitate resolution<br />
– Periodic data reviews for cont<strong>in</strong>uous data (e.g. run reviews)<br />
– Formal evaluation may not occur until APR
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