Facility Audit

• Audit Title

• Type of Audit:

• Audit Conducted On:

  Date

• Audit Performed By:

• Process Used:

FACILITY AUDIT CHECKLIST

A. Support Areas

• SOP Manual available. (Building 1 and 300 Hallways, GLP Modulars)
  MSDS present for chemical in area
  Emergency Contact List up-to-date
  Facility records complete and accurate (mark open/close of rooms, census, etc...)
  Carriers in good condition and animals can make normal postural adjustments
  Work area is clean, neat, well organized, stocked (sick animal forms and deficiency cards)
  Reagents/solutions properly labeled (opened, expiration date, name, conc., storage)
  No lights out
  Ventilation functioning properly, no blocked vents
  Filters changed monthly
  No chemicals next to food or enrichment toys
  Food elevated with tightly fitting lid, labeled per SOP
  Evidence of pest control (check logs)
  Eye wash stations checked weekly
  Biohazard materials stored/labeled/returned properly
  Food and drink only in designated areas
  Staff using proper PPE
  Biosecurity measures followed
  Procedures conducted as per SOP with proper asepcia
  Outdoor play areas shaded, enrichment supplies in good condition

B. Animal Housing Areas

• Door signs display study/animal information
  Treatment records up-to-date
  Water lines open
  Cage cards present w/ current study number
  Cages numbers, where appropriate
  No duct tape present
  No evidence of animal illness or injury (IDC, cherry eye, neurologic, discharge, lameness, etc...)
  No gaps in tenderfoot or any fencing interfaces
  No grooving to feeders/dividers (unsanitizable surfaces)
  No sharp edges or unraveled fencing
  Tenderfoot intact (no wearing to metal)
  All cage parts intact (bowl holders, tenderfoot stops)
  Slated floors completely covered
  Doors clipped, no rusted parts
  Waterlines clear (no mineral build-up)
  No excessive build-up of scale or rust on pens or flooring
  Ventilation working, no ammonia or other excessive odor
  Hooves/Nails trimmed, no unkempt animals
  Current and Monthly temperatures within Guide
  No lights out
  Evidence of environmental enrichment, appropriate for species
  No standing water or wet equipment
  No evidence of pests or vermin access points. Traps present and clean
  Space requirement met
  Feline resting boards in place, normal postural adjustment can be made underneath
  Bedding not over-saturated
  Animals have access to food and water as appropriate
  Animals uniquely identified
  If multiple studies are housed in the same room, adequate separation is maintained between studies
  Primates social housed by default
  Bite/scratch kits available and stocked
  Primate technicians adequetly trained
  

C. Mechanical Room

• Carcass fridge emptied and clean
  Alarm system functioning, no units out of range
  Compressed gas cylinders chained, tagged, and capped
  CO2 back-up full
  Units do not require defrosting, vents clear
  Room is free of clutter
  Emergency instructions posted and up-to-date
  Samples stored as per ultra-cold log

D. Pharmacy

• Controlled substances safe locked, no unattended substances
  Control substances logbooks accurate and legible
  Annual inventory completed
  Invoices match log, name, address, and DEA # present
  No expired drugs or biologicals present

E. Surgery

• CO2 and gas absorption changed per SOP
  Suites sanitized per SOP, Proper PPE in use
  EtO users trained
  Dedicated rodent surgical area
  Facility surgical/diabetic records filed in animal work files, records complete

F. Cage Wash

• Traffic flows dirty to clean
  Users safety trained
  Verification strips in use
  Logbook present, complete, and unit maintained per SOP
  Cages/racks tagged when clean

G. Feed Rooms

• Feed stored elevated, at least 6" from walls
  No evidence of pests/vermin
  Bags in good condition
  Accurate feed log corresponding to each pallet/food type
  Housekeeping adequate, no clutter
  COA on file for each lot of certified feed present, feed not released prior

H. Equipment

• Automatic, mechanical, or electronic equipment is properly calibrated/standardized
  Equipment calibration/standardization documented
  Equipment log books available and up-to-date
  SOPs available for each piece of equipment
  Computerized systems validated and secure (IQ/OQ/PQ, risk assessment, validation plan, SOP)

I. Specimens

• Specimens are labeled with: study number, matrix, date of collection, time-point (if applicable), and fixative (if applicable), storage.
  Specimens are maintained at the proper storage conditions

J. Recording and Access to Data

• Hand generated raw data are recorded: promptly, directly, legibly, in indelible ink, and on appropriate forms
  Entries are dated/initialed
  Corrections to data do not obscure original entry
  Corrections are justified/explained, dated/initialed
  If needed, raw data organized and easily accessible

FINDINGS

Finding

• Location

• Finding Classification (C - Critical, M - Major, Mi - Minor)

• Details

• Assigned To:

• Correction Deadline:

• Actual Correction Date: