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Problem Management Scenario # 2
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  1. Problem Management Scenario # 2 September 17,2005

  2. Scenario # 2 • Weekly EM (static readings, at rest) in one of the facility’s BSCs is outside the acceptable range. • What do you do?

  3. General Investigational Approach • Determine the severity of the excursion. • Evaluate recent trending data. • Initiate investigation: limited or full • Identify products processed in BSC. • Review sterility results for affected products. • Based on investigation results, evaluate potential impact on products, patients & operations.

  4. What should be done if… • Alert level is exceeded for either the particle counts or the viable air sample.

  5. Alert Level Exceeded: Investigation • Limited investigation to include: • Inspect cleanliness of BSC and adjacent areas • Review BSC equipment log (maintenance & cleaning records, calibration date) • Review EM trending data for the BSC • Review sampling device PM & calibration • Identification of organism (if viable air sample in question)

  6. Alert Level Exceeded: Follow-Up • Document the investigation and any corrective/preventative actions. • If problems identified, possible actions include: • BSC Service to verify proper operation – remove from service if fails • Revision of BSC cleaning procedure • Increased monitoring frequency and sites • Staff retraining

  7. Alert Level Exceeded: Follow-Up • Ensure product document includes a cross-reference of the investigation document. • Affected Products: Investigation should determine if stored products are suitable for use. • Product recall unlikely unless BSC malfunction identified.

  8. What should be done if… • Action level is exceeded for either the particle counts or the viable air sample.

  9. Action Level Exceeded: Investigation • Limited or full investigation depending on product, processing, trending data, size of excursion • Same as for Alert Level Investigation • Possible additional actions include: • Verify proper operation of BSC, sampling device • Remove hood from service if excursion serious or BSC fails verification • Thoroughly clean & sanitize BSC • Increase monitoring frequency and sites • Evaluate EM trending for adjacent areas

  10. Action Level Exceeded: Follow-Up • Same as for the Alert Limit Scenario. • Follow Deviation Reporting SOP to notify appropriate medical/ reporting groups • May consider product ‘recall’ based on conclusions of investigation (e.g. organisms identified, nature of BSC malfunction). • Immediately notify FDA district office if recall intended.