Checklist for Site Sop Required Elements

SMILE

Johns Hopkins University

Baltimore, MD USA

CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:

General Equipment

Author:
Erin Gover / Document Number / Pro71-07
Effective Date: / 12 August 2008
Review History: / Date of last review / 20 May 2010
Reviewed by: / Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
Element
Present / CONTENT-SPECIFIC REQUIRED ELEMENTS
GENERAL REQUIREMENTS FOR LABORATORY EQUIPMENT
Appropriate Personal Protection Equipment must be used whenever service or maintenance is performed on equipment or instruments that are considered contaminated with biohazard or chemical substances.
Equipment and instruments must be inventoried and uniquely identified. This documentation should at least include: manufacturer, model, serial number, date placed in service, location and current service contact, if any.
Equipment and instruments must have written records of service and maintenance for the life of the instrument.
Documentation of equipment and instruments should be kept at least two years after the end of its service life or as otherwise specified by study requirements.
Procedures and records must be kept to establish that daily or periodic maintenance was performed. This documentation must at least include: the instrument, type of maintenance, the date and the initials of the person who completed the service and lab director or designee review.
Equipment and instruments must undergo a validation process and written documentation of the results of the validation must be maintained for the life of the instrument or as otherwise specified by study requirements.
Calibration and verification of equipment and instruments must be preformed and documented at periodic intervals. Intervals determined by manufacture’s recommendations or good clinical laboratory practice (GCLP).
When applicable, linearity and calibration of instrumentation must be verified every six months.
A step-by-step procedure of instrument operation must be available to the operator of the instrument. This should at least include: start-up, running controls, normal operation, troubleshooting and shutdown. Appropriate sections of an operator’s manual may be referenced.
Comments:
TEMPERATURE MONITORING & THERMOMETER VALIDATION
SOPs detailing monitoring of temperature sensitive equipment must be maintained. The SOP should be connected with a daily monitoring chart that contains the equipment name, unique ID, criteria of acceptable ranges, date, temperature and initials of person responsible.
Examples of temperature sensitive equipment include: freezers (all types and temperatures), refrigerators, incubators (Dry, Water, or Air), laboratory room temperature, ovens, heating blocks, water baths, etc.
SOPs must detail temperature monitoring after hours, during weekends and holidays of any equipment in continuous use.
Acceptable ranges or criteria must be defined, with documentation of action taken in response to out of range temperatures.
On individual temperature sensitive equipment SOPs maintenance should be documented and performed per manufacturer’s specifications or more frequently if deemed good laboratory practice. Should be documented on logs that are reviewed by periodically.
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k.) / Describe procedure to verify thermometer calibration. The procedure should include:
a.)  Frequency (at least yearly).
b.)  Validated against NIST certified device.
c.)  Information on where NIST device will be obtained or recertified.
d.)  List of equipment that needs to be validated.
e.)  NIST thermometer is place under the same conditions as the device being verified.
f.)  Record both NIST and test thermometer readings.
g.)  Calculate the difference in the readings.
h.)  Determine acceptability validation criteria for different instruments.
i.)  Acceptable devices are labeled with the date, tech initials and any difference noted.
j.)  Unacceptable devices are removed from service.
k.)  All documentation is dated and signed by lab director and kept for life of equipment or as otherwise specified by study requirements.
Comments:
CENTRIFUGES
SOPs detailing use, maintenance, and calibration of centrifuges must be maintained. Documentation of these activities should contain the equipment name, unique ID, criteria of acceptable calibration ranges, date, and initials of person responsible.
Maintenance should be performed per manufacturer’s specifications or more frequently if deemed good laboratory practice.
Centrifuges shall be calibrated or calibration verified initially and then each twelve months or after major service. This shall include: timer, rotation speed and refrigeration if applicable.
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j.) / Describe procedure to verify centrifuge calibration. The procedure should include:
a.)  Frequency (at least yearly) or after service.
b.)  Step-by-step instructions on use of tachometer to measure rotational rate.
c.)  If applicable, step-by-step instructions on verification of refrigeration temperature with NIST thermometer.
d.)  Step-by-step instruction on verification of centrifuge timer against a NIST stopwatch.
e.)  Determine acceptability validation criteria for rotational rate, temperature, and timer of the centrifuge.
f.)  Record all readings from centrifuge and validation equipment.
g.)  Calculate the difference in the readings.
h.)  Acceptable devices are labeled with the date, tech initials and any differences noted.
i.)  Unacceptable devices are removed from service.
j.)  All documentation is dated and signed by lab director and kept for life of equipment or as otherwise specified by study requirements.
Comments:
TIMERS
SOPs detailing calibration of timers must be maintained. Documentation of these activities should contain the equipment name, unique ID, criteria of acceptable calibration ranges, date, and initials of person responsible.
Timers shall be calibration verified initially and then each twelve months.
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h.) / Describe procedure to verify timer calibration. The procedure should include:
a.)  Frequency (at least yearly).
b.)  Step-by-step instructions on use of NIST stopwatch to determine timer accuracy.
c.)  Determine acceptability validation criteria for timer accuracy.
d.)  Record readings.
e.)  Calculate the difference in the readings.
f.)  Acceptable devices are labeled with the date, tech initials and any differences noted.
g.)  Unacceptable devices are removed from service.
h.)  All documentation is dated and signed by lab director and kept for life of equipment or as otherwise specified by study requirements.
Comments:
PIPETTES
SOPs detailing use, maintenance, and calibration of pipettes must be maintained. Documentation of these activities should contain the equipment name, unique ID, pipette volume(s), criteria of acceptable calibration ranges, date, and initials of person responsible.
Maintenance should be performed per manufacturer’s specifications or more frequently if deemed good laboratory practice.
Pipettes shall be calibrated or calibration verified initially and then, at a minimum, every six months or after major service.
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f.) / Describe procedure to verify pipette calibration. The procedure should include:
a.)  Frequency (every 6 months).
b.)  Step-by-step instructions on method used to measure pipette accuracy. (If the service is contracted out, include the name of the local vender.) See below for procedure details.
c.)  Determine acceptability validation criteria based on pipette manufacture recommendations.
d.)  Acceptable devices are labeled with the date and tech initials.
e.)  Unacceptable devices are removed from service.
f.)  All documentation is dated and signed by lab director and kept for life of equipment or as otherwise specified by study requirements.
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i.) / Step-by-step procedure should include:
a.)  Recording ambient room temperature.
b.)  Use water brought to room temperature.
c.)  Use calibrated balance.
d.)  Tare weight of weigh boat and pipette tip.
e.)  Weigh room temperature water with tip for a given pipette and record.
f.)  Repeat 10-20 times, recording all values.
g.)  Provide calculations for accuracy and precisions (including %CV).
h.)  Calculate accuracy and precisions.
i.)  For adjustable pipettes, repeat above steps for several representative volumes.
Comments:
BALANCE
SOPs detailing use, maintenance and calibration of balances must be maintained. Documentation of these activities should contain the equipment name, unique ID, criteria of acceptable calibration ranges, date, and initials of person responsible.
Maintenance should be performed per manufacturer’s specifications or more frequently if deemed good laboratory practice.
Balances shall be calibration verified initially and then each twelve months.
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i.) / Describe procedure for use, maintenance, and verify balance calibration. The procedure should include:
a.)  Frequency (at least yearly).
b.)  Step-by-step instructions on normal use of balance.
c.)  Step-by-step instructions on daily, monthly, internal, and yearly maintenance.
d.)  Determine acceptability validation criteria for balance accuracy.
e.)  Record readings.
f.)  Calculate the accuracy of the readings.
g.)  Acceptable devices are labeled with the date, tech initials and any differences noted.
h.)  Unacceptable devices are removed from service.
i.)  All documentation is dated and signed by lab director and kept for life of equipment.
Comments:
MISCELLANEOUS: Rotators, Plate readers & Washers, Autoclaves, Laminar Flow Hoods, Microscopes, Generators or Battery Power Backups and etc.
All items used in the laboratory should be uniquely identified and maintained per manufacturer’s instructions, so that results produced in connection with their use are of verifiable quality.
Appropriate acceptability criteria for continued use should be determined and documented. Any equipment determined as unacceptable is removed from service.
Appropriate documentation shall be maintained on these items to insure traceable quality.
Comments:
References:
·  OSHA 29 CFR Part 1910.1200: Hazard Communication
·  OSHA 29 CFR Part 1910.1450: Hazardous Chemicals in Laboratories
·  OSHA 29 CFR Part 1910.1030: Bloodborne Pathogens Standard
·  OSHA “Needlestick Safety and Prevention Act”
·  Federal Register, Department of Transportation, 49 CFR Parts 171, 172, 173, 177, and 178: Hazardous Materials: Revision to Standards for Infectious Substances: Final Rule
·  39 CFR Part 111: Hazardous Materials: Proposed Domestic Mail Manual Revisions for Division 6.2 Infectious Substances and Other Related Changes
·  Clinical Laboratory Improvement Amendment (CLIA) Self-Assessment Questionnaire
·  College of American Pathologists (CAP), Laboratory General Checklist for Laboratory Accreditation Program
·  ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)
·  21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies (GLP)
·  42 CFR Part 493: Laboratory Requirements

SMILE Document Page 1 of 5 SOP Checklist – Equipment/Instruments