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Suguna Management System       Ver 1.0 / SOP / FQL / P1 - 02  Page  1 of 6























           2. Lab Equipments Maintenance &

               Handling Procedure



                                                                malfunctions immediately to the responsible person for
           EQUIPMENTS MAINTENANCE AND SERVICE
                                                                the instrument and clearly indicate that it is "OUT OF
           The procedures to determine, maintain, and monitor   ORDER" when a malfunction occurs. When available,
           instrument performance are an integral part of a quality
                                                                service  contracts  which  include  semi-annual/annual
           control  program  as  they  promote  a  high  degree  of   maintenance of certain pieces of equipment should be
           confidence  in  analytical  results.  Each  procedure  is   obtained.
           described  in  the  respective  equipment  SOP.  All
           essential  testing  equipment  has  its  own  SOP  and   Calibration:  The  validity  of  the  analytical  results
           maintenance  records  that  document  operation,     produced is strongly related to the performance level of
           calibration and routine maintenance.                 the  instrumentation  used  for  analysis.  It  is  therefore
                                                                essential that for each instrument and each method,
           Maintenance:  Complete  and  accurate  installation
                                                                proper calibration procedures be established and that
           instructions,  operating  manuals,  parts  manuals,   calibration results be recorded and used as a basis for
           service manuals and written guarantees or contracts   continuous  assessment  of  the  instrument
           are  kept  with  each  instrument  to  assure  proper   performance. The method calibration requirements are
           functioning.  The  implementation  of  a  preventive   included as part of the method. Equipment/instrument
           maintenance  program  which  includes  the  testing  of   calibration and traceability to national standards should
           equipment against specifications and procedures for
                                                                be documented. Certified weights and thermometers
           frequent  calibration,  checking  and  cleaning,  is   are  available  and  should  be  used  and  the
           essential.  The  performance  of  instruments  and   documentation maintained in the laboratory.
           equipment is evaluated on a regular basis to ensure
           that the equipment or instrument continues to function   Inventory:  A  permanent  inventory  record  of  all
           properly and has the appropriate historical records to   equipment is kept by the Laboratory in charge. This
           properly audit and to evaluate. Routine maintenance   record includes the equipment's name, model number,
           tasks such as cleaning, adjusting, replacing of parts or   serial  number,  manufacturer,  date  of  acquisition,
           lubricating are performed on each instrument by the   original  cost  and  present  location  and  any  unique
           responsible officer according to instructions provided   identifier assigned locally.
           in  the  operating  manual  of  the  instrument  or  as
                                                                Parts and Supplies: The analyst must maintain a list of
           identified by past experience. All maintenance tasks
           and repairs performed by the analyst or the service   spare parts kept that are critical to keep the instrument
           representative are recorded on the current instrument   operating and must review this list at least annually. This
           log sheet for each instrument. Analysts must report all   list is to be kept in the Instrument Log Book.




          Prepared by :                                                             Approved by :
                                                             11                                    Director - Technical
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