Focus Surgical Instruments - Medical Tools and Equipment
Friday, 27 April 2012
Manufacturing Process and Quality control
Manufacturing Process and Quality control
Posted on April 25, 2012
Our Surgical Instruments Manufacturing Process and Quality control
SURGICAL/DENTAL INSTRUMENTS MANUFACTURING STEPS
1. Steel
The quality of steel is very important in the production of quality instruments. The best you select the best you produce. In order to ensure the finest of quality steel, we have imported or best quality local steel as required by valued customers.
2. Forging
Forging is a process of cutting shaped raw instruments with the help of dyes and hammers. Here, the skilled hands give life to the metal and give it the rudimentary shape that will go through series of complicated processes.
3. Forging Inspection
At this stage, forged tools are checked to ensure no piece contains any cracks or is reshaped beyond acceptable limits. Checking the quality of raw instruments for: -
a. Shape fault
b. Broken
4. Machining
In this process forging is cut or shaped by machines i.e. cutting sharp edges and raw material in the shape. Here instruments are given their shape through grinding and hammers. For this purpose, extremely skilled labor is required and this process is carried out by instrument specialists only.
5. Milling
Drilling of holes in the instruments where required for screws. Different kids of screwing machines are used and instruments are made pairs here. Instruments with even the slightest difference in whole positions will suffer otherwise.
6. Inspection
At this stage, all the instruments are inspected not only for machining and milling, but for every process they’ve been through. It’s the stage where only best instruments are selected and instruments with tiny holes and manufacturing faults are again sorted out.
7. Filling
At this stage the steel is not too hard so filling is used to shape the instruments in the exact shape they are required to be. The workers match the shape exactly with the samples provided at this stage. So the instruments get most of their shapes at this stage.
8. Filling Inspection
After filling the inspection is made and measurements and shapes are checked according to samples.
9. Binding and Temper
At this step the instruments are bound in groups of 12 pieces. Then they put them in temper machine, which is filled with a particular material. Here instruments are tempered and its ensured that every instrument get equal heat and treatment so a consistent quality would achieve.
10. Snaffing Fitting
For scissors and forceps they are in two pieces so they are joined in this process with screw. Forceps (Tweezers) are joined before and their joint is leveled with a machine by burning the raw material on the joint. At the same stage, instruments are filled to eliminate welding suspensions.
11. Plant or Heat Treatment
In this process the instruments are dipped in a material by hanging for five minutes to harden the material.
12. Polishing
Instruments are polished at this stage. Till this point at manufacturing stage, all the necessary shaping is done. Polishing makes every millimeter of instrument clear and any instrument with hidden defects are revealed could be sorted out.
13. Q. A Inspection 2%
2% of each lot of instruments is checked by executives and then go the further processing. In inspection they see each and every part and defective parts are marked with red marker and if rejected send to polishing again.
14. Ultrasonic Cleaning
In this process the instruments are dipped in two materials for cleaning the polish raw thing on it. 1 min. for first material and then for half min. for other material. Ultrasonic cleaning cleans any polishing material stuck and leaves the instrument crystal clear.
15. Lubrication
All the instruments involving screws are lubricated at this step. Lubricating the instruments moveable portions facilitates the instrument movement.
16. Tuck checking
In this process workers check the cuts and all other things just by viewing the instruments individually.
17. Etching
Putting each instrument on stamp pad and burning process to put stamp on each instrument. This stamping procedure is done through electronic etching machines that make the stamp reliable and even sustainable under high boiling temperatures when instruments are sterilized.
18. Cleaning and Checking
Instruments are cleaned and checked again one by one. Again it’s the checking for operation, measurements, polish and usability.
19. Q. A Inspection 4 %
4% of the instruments are inspection by Q. A. Directors. Samples for inspection are taken randomly and are observed to every bit of detail. Even the slightest difference from acceptable standards could result in rejection of whole lot.
20. Packing
Packing in boxes each contains 100 pieces. 10 Boxes in a Carton. Here instruments are packed with respect to sizes and types. Instruments boxes are properly labeled and stored in proper storing environment.
21. Labeling
Labels are put in this process.
22. Storage
Storage by lot and order number
23. Delivery
These processes are also included as required.
* Passivation
* Boil Test
* Gold plating in different manner.
* Copper Sulphate test.
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