B-603

Insight Throat Metal Detector

Section B — Manufacturing Revision 0 3 pages

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the setup, operation, cleaning, and
 
 calibration of the Insight Throat Metal Detectors 
 
 Scope 
 
 This procedure applies to the Insight Throat Metal Detectors in operation at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all personnel operating the Insight Throat metal detectors to
 follow this procedure. 
 
 3.2 It is the responsibility of Production management to implement this procedure and to
 ensure that the procedure is being followed. 
 
 4.0 Definitions 
 
 4.1 QC- Quality Control 
 
 5.0 References 
 
 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 6.0 Procedure 
 
 6.1 Setup, Operation, and Calibration Verification 
 
 6.1.1 Calibration verification will be performed before each use using a calibration
 sample kit. Annual calibration will be performed with a QC- Controlled
 Calibration sample kit. The sample kit will consist of the following test pieces:
 
 6.1.1.1 2.00mm Ferrous 
 
 6.1.1.2 3.00mm Ferrous 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Insight Throat Metal Detector B-603 0 Page 2 of 3 
 
 6.1.1.3 2.00mm Aluminum 
 
 6.1.1.4 3.00mm Aluminum 
 
 6.1.1.5 2.00mm SS316 (Stainless steel) 
 
 6.1.1.6 3.00mm $8316 (Stainless steel) 
 
 Note: Refer to the machine manual for setup and operation instructions.
 
 6.1.2 Plug in metal detector. 
 
 6.1.3 Ensure there is a metal-free zone around the aperture to prevent any false
 triggering. 
 
 6.1.4 The machine test set up setting is set up at the factory to detect the standard test
 sample provided with the metal detector. 
 
 After turning on the metal detector, on the bottom of the detector’s display, a
 
 line of rectangles is displayed. If the rectangles are solid, it indicates that metal
 has been found. 
 
 6.1.6 Pass the test samples through the center aperture of the detector. The line of
 rectangles should be solid indicating metal was found. The detector should also
 sound off. If this does not occur, contact the department supervisor and refer to
 
 troubleshooting in the detector’s manual. 
 
 6.1.7 Calibration sample results will be recorded in the batch record at start up, and
 metal detector checks will occur by QC and production every 1 hour during
 production run. 
 
 6.1.8 During the production run, if metal is detected, the detector will sound. Pass the
 
 product through the metal detector again, and if metal is still detected, re-pass
 product through in smaller increments until the metal has been found, and
 discard any metal/affected product. 
 
 6.1.9 Annual external metal detector validation is performed by Loma Systems, Inc.
 
 6.2 Cleaning 
 
 6.2.1 Remove all materials/paperwork from the previous batch. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Insight Throat Metal Detector B-603 Page 3 of 3 
 
 6.2.2 Refer to SOP B-111 Cleaning of Manufacturing/Production areas and
 Equipment to follow the cleaning procedure that is applicable to the equipment
 type. 
 
 6.2.3 Document cleaning in the cleaning log book. 
 
 6.2.4 Contact a QC inspector to inspect and verify equipment cleanliness and sign off
 cleaning in the log book. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/03/21 | New procedure. N/A K. Blozousky | - | - |