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36C25818Q0268 Attachment 11 QASP - Janitorial.docx

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Text version

Task

Standard
Acceptable Quality Level
Surveillance

Method

All work is performed on a timely basis and recorded on appropriate checklists
All checklist fields will be completely and accurately filled in during appropriate timeframe
All checklists are kept current 95% of the time
Direct Obervation
All work in office space and warehouse storage areas is performed to an acceptable quality level
During bi-weekly facility walk-through inspections, work will be found to be completed thoroughly and performed to a meet a high standard of cleanliness
Work will be completely performed and will meet a high standard of cleanliness 95% of the time
Direct Observation
Personnel are available to respond to requests to complete clean-room and other cGMP-areas duties as described in Statement of Work
Personnel are available to respond to requests for these services during all hours of operation as described in Statement of Work
Personnel are available for these services 100% of the time
Direct Observation
Clean-room and cGMP-area duties are completely and thoroughly performed
Clean room duties are performed to meet clean room and cGMP specifications and all duties logged appropriately
Clean-room and cGMP duties meet specification standards and are logged 100% of the time
Direct Observation
Cardboard boxes are broken down and moved out of building daily to recycling area.
Cardboard boxes are broken down and removed daily to recycling area
Cardboard boxes broken down and removed daily 95% of the time
Direct Observation
Personnel available to perform duties and respond to cleaning requests in non-cGMP and non-clean-room areas
Personnel available during hours of operation as described in Statement of Work
Personnel available for non-cGMP and non-clean-room areas 95% of the time
Direct Observation

Semi-Annual

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