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processes [2025/09/19 04:26] – adminprocesses [2025/09/19 12:23] (current) – [Amendment Log] admin
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 =====Process for Selection, Procurement, Installation, Acceptance testing, Handling, Transport, Storage, Use, Maintenance and Decommissioning of Equipment=====  =====Process for Selection, Procurement, Installation, Acceptance testing, Handling, Transport, Storage, Use, Maintenance and Decommissioning of Equipment===== 
 ^Name^Unique ID^Edition^Date of Edition^ ^Name^Unique ID^Edition^Date of Edition^
-|Process for Selection, Procurement, Installation, Acceptance testing, Handling, Transport, Storage, Use, Maintenance and Decommissioning of Equipment |LSSTH/B/Central/DP/6.4.1/5| 1 | 01-03-2023|   +|Process for Selection, Procurement, Installation, Acceptance testing, Handling, Transport, Storage, Use, Maintenance and Decommissioning of Equipment |LSSTH/B/Central/DP/6.4.1/20| 1 | 01-03-2023|   
    
 ^Preparing authority^Approving authority^Review period^Review Date^ ^Preparing authority^Approving authority^Review period^Review Date^
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 **Procedure for Selection & Procurement of Equipment:** **Procedure for Selection & Procurement of Equipment:**
-Selection & Procurements will be done within limits of Government of Gujarat rules and regulations. + 
-Required Equipment can be purchased through Parent institutes that are Sir T Hospital, Bhavnagar and Government Medical College Bhavnagar. +  * Selection & Procurements will be done within limits of Government of Gujarat rules and regulations. 
-If any equipment is to be purchased, prepare its specifications, send demand & specifications to the Dean(Procurement from Medical College) or Medical Superintendent(Procurement from Sir T Hospital). +  * Required Equipment can be purchased through Parent institutes that are Sir T Hospital, Bhavnagar and Government Medical College Bhavnagar. 
-Communicate the requirement with specification to the parent institute. +  * If any equipment is to be purchased, prepare its specifications, send demand & specifications to the Dean(Procurement from Medical College) or Medical Superintendent(Procurement from Sir T Hospital). 
-The parent institute can purchase it by plotting a tender.  +  * Communicate the requirement with specification to the parent institute. 
-Select and approve suppliers based on the laboratory's requirements & Specifications. This process is called Technical Scrutiny. +  * The parent institute can purchase it by plotting a tender.  
-Send the list of selected and approved suppliers of equipment at the office of the parent institute. +  * Select and approve suppliers based on the laboratory's requirements & Specifications. This process is called Technical Scrutiny. 
-Ask the parent institute to procure the equipment from the finalized supplier. +  * Send the list of selected and approved suppliers of equipment at the office of the parent institute. 
-Procedure for Installation & Acceptance testing +  * Ask the parent institute to procure the equipment from the finalized supplier. 
-When the equipment arrives in the laboratory verify that equipment specifications and other conditions required from suppliers are acceptable. + 
-If above conditions are not met,return the equipment to the supplier as per rules and regulations. +**Procedure for Installation & Acceptance testing** 
-If above conditions are met, enter equipment details into the equipment stock register & give indent of received equipment to the central store department. + 
-After Installation of equipment Installation qualifications, Performance qualifications & Operational qualifications should be checked by using traceable reference material. +  * When the equipment arrives in the laboratory verify that equipment specifications and other conditions required from suppliers are acceptable. 
-Run quality control materials, to find whether the performance of equipment is appropriate to the need or not.+  * If above conditions are not met,return the equipment to the supplier as per rules and regulations. 
 +  * If above conditions are met, enter equipment details into the equipment stock register & give indent of received equipment to the central store department. 
 +  * After Installation of equipment Installation qualifications, Performance qualifications & Operational qualifications should be checked by using traceable reference material. 
 +  * Run quality control materials, to find whether the performance of equipment is appropriate to the need or not.
  
 **Acceptability Criteria:** **Acceptability Criteria:**
-Validation of Equipment will be done as per applied specifications & Verification data will be checked and recorded+  * Validation of Equipment will be done as per applied specifications & Verification data will be checked and recorded.
  
 **Procedure for Handling, Transport, Storage:** **Procedure for Handling, Transport, Storage:**
-as per manufacturer's instructions +  * as per manufacturer's instructions 
-Procedure for use and maintenance + 
-Arrange for training of all personnel who are likely to use it for examination of patient samples. +**Procedure for use and maintenance:** 
-Store manufacturers instructions in electronic format and communicate with users, so that they are available to everybody whenever required. + 
-Prepare instructions for use of equipment and required standard operative procedure and communicate with users and store preferably in the google drive & dokuwiki documentation system of the laboratory. +  * Arrange for training of all personnel who are likely to use it for examination of patient samples. 
-Perform preventive maintenance as per manufacturer’s instructions. +  * Store manufacturers instructions in electronic format and communicate with users, so that they are available to everybody whenever required. 
-Whenever equipment is found to be defective mark it 'Not working' till it is appropriately repaired. +  * Prepare instructions for use of equipment and required standard operative procedure and communicate with users and store preferably in the google drive & dokuwiki documentation system of the laboratory. 
-If any breakdown occurs in any equipment, it will be corrected either by lab person or company person and will be recorded in the NC record. +  * Perform preventive maintenance as per manufacturer’s instructions. 
-Write Non-Conformities Scenario, root cause, immediate action, corrective action & risk management in this register. +  * Whenever equipment is found to be defective mark it 'Not working' till it is appropriately repaired. 
-Periodically Review NC records to find out common causes and possible corrective actions can be taken to decrease breakdown and malfunctions. +  * If any breakdown occurs in any equipment, it will be corrected either by lab person or company person and will be recorded in the NC record. 
-Once repaired, Calibrate, if required, and use it for performing examinations for which it is required, using quality control materials, to find whether the performance of equipment is appropriate to the need or not. +  * Write Non-Conformities Scenario, root cause, immediate action, corrective action & risk management in this register. 
-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. +  * Periodically Review NC records to find out common causes and possible corrective actions can be taken to decrease breakdown and malfunctions. 
-Preventive maintenance will be performed as per manufacturer's instructions.  +  * Once repaired, Calibrate, if required, and use it for performing examinations for which it is required, using quality control materials, to find whether the performance of equipment is appropriate to the need or not. 
 +  * 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. 
 +  * Preventive maintenance will be performed as per manufacturer's instructions.  
  
 **Procedure for disposal:** **Procedure for disposal:**