Problem Management Problem Management Scenario # 2Scenario # 2

September 17,2005September 17,2005

Scenario # 2Scenario # 2

Weekly EM (static readings, at Weekly EM (static readings, at rest) in one of the facility’s BSCs rest) in one of the facility’s BSCs is outside the acceptable range.is outside the acceptable range.

What do you do?What do you do?

General Investigational General Investigational ApproachApproach

Determine the severity of the Determine the severity of the excursion.excursion.

Evaluate recent trending data.Evaluate recent trending data. Initiate investigation: limited or fullInitiate investigation: limited or full Identify products processed in BSC. Identify products processed in BSC.

Review sterility results for affected Review sterility results for affected products. products.

Based on investigation results, Based on investigation results, evaluate potential impact on evaluate potential impact on products, patients & operations.products, patients & operations.

What should be done if…What should be done if…

Alert level is exceededAlert level is exceeded for for either the particle counts or the either the particle counts or the viable air sample.viable air sample.

Alert Level Exceeded: Alert Level Exceeded: InvestigationInvestigation

Limited investigation to include:Limited investigation to include: Inspect cleanliness of BSC and adjacent Inspect cleanliness of BSC and adjacent

areasareas Review BSC equipment log (maintenance Review BSC equipment log (maintenance

& cleaning records, calibration date)& cleaning records, calibration date) Review EM trending data for the BSC Review EM trending data for the BSC Review sampling device PM & calibrationReview sampling device PM & calibration Identification of organism (if viable air Identification of organism (if viable air

sample in question)sample in question)

Alert Level Exceeded:Alert Level Exceeded: Follow-Up Follow-Up

Document the investigation and any Document the investigation and any corrective/preventative actions. corrective/preventative actions.

If problems identifiedIf problems identified, possible , possible actions include:actions include: BSC Service to verify proper operation – BSC Service to verify proper operation –

remove from service if failsremove from service if fails Revision of BSC cleaning procedureRevision of BSC cleaning procedure Increased monitoring frequency and Increased monitoring frequency and

sitessites Staff retrainingStaff retraining

Alert Level Exceeded: Alert Level Exceeded: Follow-UpFollow-Up

Ensure product document Ensure product document includes a cross-reference of includes a cross-reference of the investigation document.the investigation document.

Affected Products: Investigation Affected Products: Investigation should determine if stored should determine if stored products are suitable for use.products are suitable for use. Product recall unlikely unless BSC Product recall unlikely unless BSC

malfunction identified.malfunction identified.

What should be done if…What should be done if…

Action level is exceededAction level is exceeded for for either the particle counts or the either the particle counts or the viable air sample.viable air sample.

Action Level Exceeded: Action Level Exceeded: InvestigationInvestigation

Limited or full investigation Limited or full investigation depending on product, processing, depending on product, processing, trending data, size of excursiontrending data, size of excursion

Same as for Alert Level InvestigationSame as for Alert Level Investigation Possible additional actions include:Possible additional actions include:

VerifyVerify proper operation of BSC, proper operation of BSC, sampling devicesampling device

Remove hood from service if excursion Remove hood from service if excursion serious or BSC fails verificationserious or BSC fails verification

Thoroughly clean & sanitize BSCThoroughly clean & sanitize BSC Increase monitoring frequency and sitesIncrease monitoring frequency and sites Evaluate EM trending for adjacent areasEvaluate EM trending for adjacent areas

Action Level Exceeded: Action Level Exceeded: Follow-UpFollow-Up

Same as for the Alert Limit Scenario. Same as for the Alert Limit Scenario. Follow Deviation Reporting SOP to Follow Deviation Reporting SOP to

notify appropriate medical/ reporting notify appropriate medical/ reporting groupsgroups

May consider product ‘recall’ based May consider product ‘recall’ based on conclusions of investigation (e.g. on conclusions of investigation (e.g. organisms identified, nature of BSC organisms identified, nature of BSC malfunction).malfunction). Immediately notify FDA district office if Immediately notify FDA district office if

recall intended. recall intended.