Tuesday, 30 May 2017

BE PREPARED FOR QMS AUDIT BY ASKING SELF THESE QUESTION . LABORATORY AUDIT CHECKLIST



Dear SIR ,
BE PREPARED FOR  AUDIT BY ASKING SELF THESE QUESTION .
LABORATORY AUDIT CHECKLIST
1. Safety Equipment
Working
Accessible
Last checked
a. fume hoods
_________________
_________________
_________________
b. biological hoods
_________________
_________________
_________________
c. eye washes
_________________
_________________
_________________
d. showers
_________________
_________________
_________________
e. fire extinguisher(s)
A B C D
_________________
_________________
2. House-keeping
Y
N
a. food, beverages and appliances absent from the laboratory?
_____
_____
b. food absent from chemical refrigerators and vice versa?
_____
_____
c. bench tops clean and unobstructed?
_____
_____
d. emergency numbers posted by telephone?
_____
_____
e. laboratory doors closed?
_____
_____
f. floors, aisles and exits unobstructed?
_____
_____
g outside hallways uncluttered?
_____
_____
3. Chemical Storage
Y
N
a. all containers appropriately labeled?
_____
_____
b. no flammables in unapproved refrigerators?
_____
_____
c. liquid chemicals equipped with secondary containment?
_____
_____
d. flammable liquids within allowable quantities?
_____
_____
e. chemicals stored appropriately (incompatibles separated)?
_____
_____
f. gas cylinders secured and stored appropriately?
_____
_____
g. empty and full cylinders separated?
_____
_____
4. Waste Management
Y
N
a. chemical wastes tightly capped?
_____
_____
b. incompatible chemicals separated?
_____
_____
c. liquid chemicals equipped with secondary containment?
_____
_____
d. chemical wastes labeled appropriately?
_____
_____
e. weekly chemical waste inspections documented (where required)?
_____
_____
f. sharps disposed in proper containers?
_____
_____






4. Waste Management (cont.)
Y
N
i. broken glass disposed in labeled container?
_____
_____
j. radioactive materials disposed in approved containers?
_____
_____
5. Mechanical Equipment
Y
N
a. guards in place (fans, centrifuges, drive belts)?
_____
_____
b. belts/pulleys in good condition?
_____
_____
6. Electrical Equipment
Y
N
a. grounded?
_____
_____
b. fitted with overload protection device?
_____
_____
c. outlets located outside of hoods?
_____
_____
d. motors intrinsically safe (where appropriate)?
_____
_____
e. cords in good condition?
_____
_____
f. current carrying parts not exposed?
_____
_____
g. GFIs on outlets within 6 feet of a sink?
_____
_____
7. Paper Work
Y
N
a. training records available?
_____
_____
b. training records current?
_____
_____
c. training records complete (for all employees)?
_____
_____
d. Incident Report forms available (for work-related illnesses and injuries)?
_____
_____
e. MSDSs accessible?
_____
_____
f. Chemical Hygiene Plan accessible?
_____
_____
g. written laboratory-specific SOPs available?
_____
_____
h. staff knows the laboratory safety officer?
_____
_____
i. Hazardous Chemical Waste Management Guidebook accessible?
_____
_____
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
SOP /Document No.
Remarks
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
EHSQ , NFCL
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.com
http://www.nagarjunagroup.com
http://www.nagarjunafertilizers.com 
EHSQ BLOG : http://dramarnathgiri.blogspot.in/?view=magazine
http://dramarnathgiri.blogspot.in/2013/10/curriculum-vitae-of-dr-amar-nath-giri.html?q=BIO+DATA
http://dramarnathgiri.blogspot.in/2012/05/nagarjuna-management-services.html

Amar Giri <goswami248@gmail.com>

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