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nchsls:c:pathology:document:20

Procedure for management of equipments

NameUnique ID Edition/Date of Edition
Procedure for management of equipmentsnchsls:c:Pathology:document:20 03-01-2015
Preparing authorityApproving authorityReview period
All teaching staff of Pathology DepartmentHOD Pathology1 year
Controlled copy of this document exist in electronic form at IP address 12.207.3.240 of LAN at NCH, Surat
Printed copy of this document with signature of authorised person is to be considered controlled.

Processes requiring this procedure

Material resource management process

Subprocesses for equipment management process
Procurement
Use and maintenance
Disposal

Procedure

Procedure for procurement

  1. Perform following procedure within limits of Government of Gujarat rules and regulation
  2. Parent institute is both New Civil Hospital Surat and Government Medical College Surat.
  3. If completing an examination procedure require an equipment prepare its specifications and other conditions required from suppliers, in consultation with the parent institute.
  4. Communicate the requirement with specification to the parent institute.
  5. The parent institute selects a list of suppliers from which the department can choose one or more supplier
    • select and approve suppliers based on their ability to supply external services, equipment, reagents and consumable supplies in accordance with the laboratory’s requirements. This process is called Technical Scrutiny
    • The list of selected and approved suppliers of equipment is maintained at office of the parent institute.
  6. Ask parent institute to procure the equipment from finalized supplier(s).
  7. Communicate the laboratory management regarding adequacy of supply and maintenance by the supplier from time to time, e.g when inadequacy is found or during MRM.

When the equipment arrives in the laboratory

  • verify that equipment specifications and other conditions required from suppliers are acceptable.
  • Use it for performing examinations for wich it is required, using quality control materials, to find weather the performance of equipment is appropriate to the need or not.
  • In the event above conditions are not met, do not use equipment for examinations of patient samples. Follow rules and regulations of the parent institute to return equipment to the supplier.
  • If above conditions are met, enter its details in to equipment registers, as per rules and regulations of parent institute.

Procedure for use and maintenance

  1. Arrange for training of all personnel who are likely to use it for examination of patient samples and appoint specific personnel as authorized person.
  2. Store manufacturer’s instructions in electronic format as far as possible, so that they are available to everybody in need.
  3. For laboratory instructions for use of equipment, develop laboratory specific instructions for use of equipment, where required, and store preferably in file for records of SOP/WDI.
  4. wherever required, calibrate equipment
    1. as per manufacturer's instructions.
    2. With meteorologic traceable reference material
  5. Perform preventive maintenance as per manufacturer’s instructions.

  6. Whenever equipment is found to be defective
    1. mark it 'Not working' till it is appropriately repaired.
    2. Repair it following manufacturer's instruction.
    3. Once repaired, Calibrate, if required, and use it for performing examinations for which it is required, using quality control materials, to find weather the performance of equipment is appropriate to the need or not.
    4. Follow Procedure for identification, control, correction and prevention of nonconformities and shown by verification to meet specified acceptance criteria.
  7. If any adverse incidents and accidents occur that can be attributed directly to specific equipment, follow Procedure for identification, control, correction and prevention of nonconformities and report to the manufacturer and appropriate authorities.
  8. If any breakdown occurs in any equipment, will be corrected either by internal person (lab person) or external person (company person) and will be recorded file HP:C:/ External maintenance record.Yearly reminder for reviewing of All NC's will be done before Internal Audit assesment.

Procedure for disposal When an equipment cannot be used for examination without compromising required quality or when it is not required or obsolete, dispose it as per rules and regulations of parent institute and manufacturer's instructions.

Required records

Equipment Documents and Records
Requirement Type and Location Help
a.identity of the equipment Document in c:/records/file/14/master record of equipments. Use Equipment Name and Hospital Register page Number to create ID.
b.manufacturer’s name, model and serial number or other unique identification Document in c:/records/file/14/master record of equipments. Unique ID of equipment in manufacturer's context
c.contact information for the supplier or the manufacturer Document in c:/records/file/14/master record of equipments. Address, company/local sale/engineer phone/email, number for automated complaint registration etc
d.date of receiving and date of entering into service Document in c:/records/file/14/master record of equipments. Same as in register
e.location Document in c:/records/file/14/master record of equipments. Lab section/room etc
f.condition when received (e.g. new, used or reconditioned) Document in c:/records/file/14/master record of equipments.
g.manufacturer’s instructions Document in c:/records/file/14/master record of equipments. User manual pdf
h.Procedural document for and records that confirmed the equipment’s initial acceptability for use when equipment is incorporated in the laboratory Document in c:/records/file/14/Installation reports with IQ,OQ,PQ. Document may be in user manual. In that case write chapter/page numbers for easy reference
i.Record of maintenance carried out and the Procedural(schedule) document for preventive maintenance
j.Procedural document and records that confirm the equipment’s ongoing acceptability for use;Such records include copies of reports/certificates of all calibrations and/or verificationsDocument in c:/records/file/14/Calibrations records with Raw data and traceability records
k.Documented Procedure for repair and Records of damage to, or malfunction, modification, or repair of the equipment Document in c:/records/file/14/Breakdown & repair records, Adverse incident records
nchsls/c/pathology/document/20.txt · Last modified: 2022/08/13 07:34 (external edit)