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LABORATORY AUDIT CHECKLIST
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Jan 2
|
Dear SIR ,
BE PREPARED FOR QMS AUDIT BY ASKING SELF THESE QUESTION .
LABORATORY AUDIT CHECKLIST
1. Safety Equipment
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Working
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Accessible
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Last checked
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a. fume hoods
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_________________
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_________________
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_________________
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b. biological hoods
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_________________
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_________________
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_________________
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c. eye washes
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_________________
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_________________
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_________________
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d. showers
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_________________
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_________________
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_________________
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e. fire extinguisher(s)
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A B C D
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_________________
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_________________
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2. House-keeping
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Y
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N
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a. food, beverages and appliances
absent from the laboratory?
|
_____
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_____
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b. food absent from chemical
refrigerators and vice versa?
|
_____
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_____
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c. bench tops clean and
unobstructed?
|
_____
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_____
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d. emergency numbers posted by
telephone?
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_____
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_____
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e. laboratory doors closed?
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_____
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_____
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f. floors, aisles and exits
unobstructed?
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_____
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_____
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g outside hallways uncluttered?
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_____
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_____
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3. Chemical Storage
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Y
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N
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a. all containers appropriately
labeled?
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_____
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_____
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b. no flammables in unapproved
refrigerators?
|
_____
|
_____
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c. liquid chemicals equipped with
secondary containment?
|
_____
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_____
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d. flammable liquids within
allowable quantities?
|
_____
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_____
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e. chemicals stored appropriately
(incompatibles separated)?
|
_____
|
_____
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f. gas cylinders secured and
stored appropriately?
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_____
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_____
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g. empty and full cylinders
separated?
|
_____
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_____
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4. Waste Management
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Y
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N
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a. chemical wastes tightly capped?
|
_____
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_____
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b. incompatible chemicals
separated?
|
_____
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_____
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c. liquid chemicals equipped with
secondary containment?
|
_____
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_____
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d. chemical wastes labeled
appropriately?
|
_____
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_____
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e. weekly chemical waste
inspections documented (where required)?
|
_____
|
_____
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f. sharps disposed in proper
containers?
|
_____
|
_____
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4. Waste Management (cont.)
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Y
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N
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i. broken glass disposed in
labeled container?
|
_____
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_____
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j. radioactive materials disposed
in approved containers?
|
_____
|
_____
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5. Mechanical Equipment
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Y
|
N
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a. guards in place (fans,
centrifuges, drive belts)?
|
_____
|
_____
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b. belts/pulleys in good
condition?
|
_____
|
_____
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6. Electrical Equipment
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Y
|
N
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a. grounded?
|
_____
|
_____
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b. fitted with overload protection
device?
|
_____
|
_____
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c. outlets located outside of
hoods?
|
_____
|
_____
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d. motors intrinsically safe
(where appropriate)?
|
_____
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_____
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e. cords in good condition?
|
_____
|
_____
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f. current carrying parts not
exposed?
|
_____
|
_____
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g. GFIs on outlets within 6 feet
of a sink?
|
_____
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_____
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7. Paper Work
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Y
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N
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a. training records available?
|
_____
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_____
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b. training records current?
|
_____
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_____
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c. training records complete (for
all employees)?
|
_____
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_____
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d. Incident Report forms available
(for work-related illnesses and injuries)?
|
_____
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_____
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e. MSDSs accessible?
|
_____
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_____
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f. Chemical Hygiene Plan
accessible?
|
_____
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_____
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g. written laboratory-specific
SOPs available?
|
_____
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_____
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h. staff knows the laboratory
safety officer?
|
_____
|
_____
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i. Hazardous Chemical Waste
Management Guidebook accessible?
|
_____
|
_____
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j. Radiation Protection Manual
accessible?
|
_____
|
_____
|
Is the Laboratory operating under a
documented Quality Assurance Program?
• Is
the list of all test equipment maintained with serial numbers, and calibration
due dates?
• Is
the independent calibration of equipment traceable to nationally recognized
standards when appropriate
• Is
the lab only performing tests that are covered in the scope of accreditation?
• Is
the Laboratory operating under a documented Safety Control Program?
• Are
records of relevant training, skills, and experience of the technical
personnel being maintained?
• Are
records of tests performed being kept for the minimum 10 years as
required?
Microbiology Laboratory
Audit Check List- Facilities Yes
|
No
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SOP /Document No.
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Remarks
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Is there an adequate space for all
the activities performed in the laboratory?
|
|||
Is there an orderly placement of
equipment, Instruments, and materials to prevent mix-up and cross
contamination?
|
|||
Are there dedicated areas for the following?
• supplies receipt, and storage? • sample receipt, storage and testing • media preparation, and storage • microbial purity testing • sterility testing • handling and identification of microorganisms • personnel offices • break room • biohazard material |
|||
Are the work
surfaces, walls, and floors smooth, free of cracks and easy to clean?
|
|||
Is the laboratory furniture made
of non-porous materials that are easily cleaned?
|
|||
Is there a formal
cleaning program in place that includes cleaning and disinfection of overhead
ducts, pipes, light fixtures, sinks, cabinets, bench tops, furniture, walls,
floors, ceiling, workbenches and trash cans?
|
|||
Are the disinfectants used in the
laboratory qualified and the expiration dates for the prepared solution validated?
|
|||
Is there a formal program in place
to assess the air quality and surfaces in the general laboratory area?
|
|||
Are alert and action levels
established for air quality and surfaces?
|
|||
Is the frequency of environmental
monitoring based an initial facility
|
|||
qualification data?
|
|||
Are environmental monitoring data
generated routinely reviewed, trended, and checked for excursions?
|
|||
Is there a requirement to perform
investigation of out of trend (OOT) or out of alert/action (OOA)
environmental monitoring data?
|
|||
Is there a requirement for
characterization of microbial isolates from the general laboratory
environment to establish a valid database , and to demonstrate effectiveness
of the cleaning and disinfection procedures
|
|||
Is there a system in place to
control traffic in the laboratory?
|
|||
Is the temperature in the general
laboratory area controlled and monitored?
|
|||
Is the temperature and humidity in
the media storage area controlled and monitored?
|
|||
Is there a dress code for
laboratory personnel as well as visitors?
|
|||
Are activities appropriately
segregated to prevent mix-ups and cross-contamination?
|
|||
Are biohazard waste and
contaminated glassware segregated in an area that is clearly labeled as
containing biohazard materials?
|
|||
Is there a validated
decontamination process for biohazard material prior to disposal or cleaning?
|
|||
Are clean glassware segregated in
an area clearly labeled as such?
|
|||
Is there a requirement not to
store cardboard boxes in the laboratory?
|
|||
Is there a requirement for
containment, i.e., to close all cabinet doors, and doors leading to the general
laboratory area, and the sterility suite?
|
|||
Are trash cans emptied on a daily basis?
|
|||
Is the daily cleaning and
disinfection activities recorded, and reviewed for accuracy and completeness?
|
|||
Are safety signs posted in the
laboratory?
|
|||
Are there procedures in place to address the following?
• cleaning and house-keeping practices for the general laboratory area • handling of biohazard waste and materials • dress code for the laboratory |
|||
• handling of chemicals and
biological spills
• cleaning of glassware
• monitoring of temperature,
humidity and air and surface quality
• control of traffic
|
With best regards,
(2015)
Dr. AMAR NATH GIRI(2015)
M.Sc. -Environmental Science,Ph.D -Environmental Science law & DIPLOMA AS - P.G.D.E.P.L,CES, DCA,
EX IIM LUCKNOW FELLOW, EX RESEARCH SCIENTIST
IGIDR-MUMBAI
9912511918
amarnathgiri@nagarjunagroup.
http://www.nagarjunagroup.com
http://www.
http://dramarnathgiri.
http://dramarnathgiri.
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6:59 AM (3 minutes ago)
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