OOS调查表

OOS Documentation Form for OOS SOPThis investigation must be completed within twenty (20) business days of its inception or aDeviation Report must be filed for an extension.OOS #:Date:Product Name: Product Code #:Batch #: QC Control #: Test method:Specification: OOS Result:A) Initial Investigation – the original analyst will have a second analyst or chemist check all calculationsand notebook transcriptions for errors. This possible OOS occurrence must be reported to thesupervisor within one (1) business day.Yes – if the mistake was found, make the necessary corrections. This is not an OOS result buta QA Deviation Report must be completed and attached to this form. Was the error found? (Circle answer)No – proceed to step BAnalyst: Signature: Date: SecondAnalyst:Signature: Date: B) Second Investigation – did the apparent OOS result occur from a Conclusive Laboratory Error (incorrectdata resulting from instrument malfunction, failed system suitability, incorrect standards, expiredreagents, incorrect sample used, inadequate equipment cleaning, etc)?Yes – this data is saved but not reported, the instrument repaired, re-calibrated or the analyst re-trained. The analysis should be repeated on the original sample. This is not an OOS result but aQA Deviation Report must be completed and attached to this form. If the original sample is not available, a new sample is obtained and that procedure is documented. A ConclusiveLaboratory Error was found?(Circle answer)No – proceed to step C.Analyst: Signature: Date: SecondAnalyst:Signature: Date: C) OOS Investigation (part 1) – This is an OOS result and the directors of QA and Operations must benotified that a formal OOS Investigation has begun. The Heads of QC, QA and production or a processrelevant chemist will conduct the OOS Investigation; it should examine the following items, as aminimum.The Head of QC or designee must complete the following questionsWas the sampling procedure done properly? Yes No Was the original sample homogenesis? Yes No Was the analytical test method followed properly? Yes No Are all the calculations done properly? Were they re-checked? Yes No Was the instrument properly calibrated? Yes No Were there chromatographic problems, such as a) Normal/expected baseline (not noisy), b) Normal/expected peak resolution, c) Normal/expected integration reproducibility, d) Normal/expected reproducible and identified peaks, e) No evidence of contamination that could affected peak integration, f) Same injection volumes, g) Same temperatures, h) Same integration? Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No Was the relevant notebook data and entries reviewed and found to correct? Yes No Were the proper reagents, standards or other solutions used? a) Within expiry, b) Was the correct dilution used, c) No evidence of reagent contamination or degradation? Yes Yes Yes Yes No No No No Was the previous result from this instrument acceptable? Yes NoQuality Assurance must complete the following questionsWas the sampling procedure done properly? Yes No For Raw Materials: was the supplier’s CoA checked, was the material approved for use? Yes No Was the container inspected (it was not damaged, there was no indication of contamination)? Yes NoProduction or a process relevant chemist must complete the following questionsWere the production records checked for process deviations and none found? a) Was the proper production equipment used, b) Was this equipment cleaned and released prior to use by QA, c) Was the equipment properly calibrated, d) No evidence of equipment contamination, e) Were all process parameters within the specified ranges, f) No evidence of operator error (bumping during a distillation, spillage), g) No unusual observations noted during the batch, h) Were all process calculations verified, i) Were the correct raw materials used and lot numbers confirmed? Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No No NoAnother possibility - indicate Yes NoNo – this may be the assignable cause. If a QA or production error, complete a QA Deviation Report and attach a copy to this form. If a QC error, make the correction and repeat the analysis on the original sample. Re-sampling is permitted if the OOS result was caused by the sampling procedure itself or if the sample was shown to be unrepresentative. Complete a QA Deviation Report and attach a copy to this form.Were any of theanswers(Circle answer)Yes to all – the OOS is still undetermined, proceed to D. If the original sample is not available, anew sample is obtained and that procedure is documented.Analyst: Signature: Date: SecondAnalyst:Signature: Date: QA:Signature: Date: Production: Signature: Date:D) OOS Investigation (part 2) – A second analyst will test the original sample. If none is available, a new sample is obtained and that procedure is documented (re-sampling is not permitted unless the original is completelydepleted). Original value: 5th retest:1st retest: 6th retest: 2nd retest: 7th retest: 3rd retest Average of retests: Prepare seven (7) new test samples (solutions) to determine seven new reportable values (more samples may be tested at thediscretion of the Head of QC) to obtain a statistically significant result.4th retest: Standard Deviation (+/- 3%): Acceptable : all test results are within specifications, report these results and use to dispositionthe batch. Complete a QA Deviation Report and attach a copy to this form. The new, averaged valued is:(Circle answer) Unacceptable : if any single test result fails a specification, reject the batch, complete a QADeviation Report and attach a copy to this form.Analyst: Signature: Date: SecondAnalyst:Signature: Date: Director QA: Signature: Date: DirectorOperations: Signature: Date:。