S TANDARD O PERATING P ROCEDURE
(Name of the Blood Centre)
Number SP 031 Version 1
Effective Date
Pages 4
Author
Authorised by
Review Period 1 Year LOCATION
No. of Copies
Approved by
Date
SUBJECT Equipment Manitenance DISTRIBUTION - Quality Assurance Manager - Master File
Quality Assurance Laboratory FUNCTION Preventive Maintenance contracts and schedules
1. SCOPE & APPLICATION
This procedure applies to all the instruments and equipments used within the blood centre.
2. RESPONSIBILITY
It is the responsibility of the supervisor of each laboratory to:
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Where relevant, prepare specifications and validation reports for new and modified equipment. Write an individual SOP for all equipment which defines all the maintenance requirements (eg. Routine, Preventative, Calibration etc.) regardless of whether carried out by an external agent. The requirements may be defined in the service contract referenced in the SOP. Prepare the maintenance schedules for all equipment items. The schedule is to include: o o o o Preventive. Routine. Extra maintenance. Cleaning and sanitation.
3. REFERENCES
1. Technical Manual of American Association of Blood Banks 13 Edition, 1999, Page 5. 2. Quality Manual, International Federation of Red Cross and Red Crescent
th
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Societies, 1998, Pages 23-24. 3. The Gazette of India extra ordinary notification G.S.R. 245 (E) dated 5 th April 1999, new Delhi, Part II Sec. 3 (i), Page 40.
4. PROCEDURES
4.1 Maintenance overview: 4.1.1 4.1.2 Identify each item of equipment in the unit that requires maintenance. Ensure all items have an Asset Number. Include clear outline of the relevant procedures, routine maintenance and preventive maintenance and cleaning of equipment. Write operator instructions for each item of equipment. Also include those responsible and names of service personnel. Maintain a documented log of servicing for all items. Identify the relevant procedures for equipment maintenance determine the frequency of calibration and cleaning procedures clearly identifying the times eg., daily, monthly etc. Prepare a complete equipment and instrumentation list consisting of the following headings: Equipment name / description. Asset Number. Serial Number. Model Number. Operation: o Operating Range.
4.1.3
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Calibration: o o o Frequency. Referenced documents. Performed by
Performance Check: o o Frequency. Referenced documents.
Preventive maintenance: o o o Frequency. Referenced documents. Performed by.
Routine maintenance: o o Frequency Referenced documents.
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Cleaning: o o Frequency. Referenced documents.
4.1.4
Maintain a list of all equipment and instruments used in all sections / departments in the QC lab to ensure all equipment within the department are documented.
4.2
Maintenance Schedules:
Draw up suitable schedules by maintenance type and frequency or by equipment type. Define forward dates for the completion of maintenance and record the date of actual performance in the schedule. 4.3 Service contracts: 4.3.1 4.3.2 4.3.3 Contracts need to be in place for all equipment items maintained by an external agent. Each service contract shall define exactly what is carried out / the frequency and by whom it is completed. At the completion of the service, a maintenance report is to be supplied, signed by the contractor and the officer in charge. The report shall detail the work carried out by the contractor.
4.4
Repair & breakdown: 4.4.1 Operating instructions for each item of equipment shall identify the steps required to be taken in the event of a fault or breakdown, and shall identify who is responsible for organising service or replacement. A log book of errors and corrective actions is to be maintained for all equipment items. In the event of equipment breakdown, it is essential that it be clearly labelled and identified as being OUT OF SERVICE.
4.4.2
4.5
Maintenance overdue:
The Quality Control Laboratory shall determine the suitability for ongoing use of any equipment that has passed it due date for routine maintenance (where this routine maintenance does not involve calibration). The laboratory must document their reasons for continuing to use an item of equipment that is overdue for maintenance. Where appropriate this should include explanation (and supportive evidence where available) that product quality has not been compromised by this delay in maintenance. Where possible, documentary evidence from the manufacturer supporting this decision should be provided. Steps should be taken at the next instance of routine maintenance to evaluate whether any discernible damage has been caused to the equipment by the delay in maintenance.
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5. DOCUMENTATION ! ! ! !
Maintain individual files of service reports of all equipments. Enter the details of all routine as well as trouble-shooting service calls by the manufacturer's engineer in the equipment maintenance register. Maintain a file of all manufacturer's instructions and where required display them close to the equipment. Record the name, address and telephone number of the service engineer to be contacted in case of need.
6. END OF DOCUMENT
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