I want the gemba walk section in proper way. The g...

Below is a ready-to-paste replacement for Section 5.0 – Gemba Walk. It separates actual observations from the preliminary technical understanding and further investigation. The details are based on the uploaded investigation report. (Draft Investigation Report. - Copy.docx)

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5.0 GEMBA WALK (GO AND SEE)

A cross-functional investigation team was formed with members from Production, Engineering, and Quality Assurance. The team visited the Secondary Packing Hall, Blister Packing Line-4, Large Scale Area, to see the actual condition of the line and understand how the event occurred.

Mr. Birma Gurjar, the line operator, and Mr. Lokesh Jadhav, the Packing Officer, who were present when the event occurred, accompanied the investigation team during the Gemba walk.

The team walked through the complete packing line, starting from the blister packing machine and ending at the shipper packing and weighing area. The team spoke with the operator and Packing Officer, inspected the conveyors, checked the checkweigher HMI, observed the positions of the sensors and rejection mechanism, and physically examined the cartons kept in the rejection bin.

At the time of the Gemba walk, the line was handling the following product:

• Product: Lonart 20/120 AQCOAT Tablets
• Batch No.: 0360093A
• Packing configuration: Three blisters and one leaflet in each carton
• Blister configuration: 3 × 8 tablets

The following observations were made during the Gemba walk.

5.1 Packing Line Arrangement and Product Flow

The Secondary Packing Line-4 was found to be an integrated packing line. The equipment was installed in the following sequence:

Blister Packing Machine → Auto-Cartonator → Checkweigher → Track and Trace Machine → Automatic Sticker Labelling Machine → Top Scanner → Shipper Packing and Weighing

The team followed the movement of the product through each stage of the line.

5.1.1 Blister Packing Machine

The blister packing activity starts at the Blister Packing Machine, Equipment ID 100336.

The machine forms blister cavities, fills the tablets, and seals the blisters. Each blister contains tablets in a 3 × 8 configuration. The sealed blisters are discharged from the machine and transferred towards the Auto-Cartonator through a conveyor.

The team visually checked the blister discharge and transfer arrangement. No visible obstruction was seen at the blister transfer point.

5.1.2 Auto-Cartonator

The blisters enter the Auto-Cartonator, Equipment ID 100338.

The Auto-Cartonator is configured to place the following components into each carton:

• Three blisters
• One leaflet

The team checked the blister infeed, leaflet feeding area, carton magazine, carton opening area, and carton discharge area.

The cartonator infeed arrangement was found properly positioned, and no visible blockage was seen at the time of inspection.

The Auto-Cartonator has a rejection collection point for blisters, leaflets, or cartons rejected by its detection system. The team checked the rejection collection point and the surrounding area.

After three blisters and one leaflet are placed inside the carton, the carton is closed and discharged from the Auto-Cartonator.

The challenge tests for missing blister, missing leaflet, and pharmacode detection had been performed before the batch operation. As these tests were performed before the event, their records and results were assigned for a separate detailed review.

5.2 Conveyor Arrangement

The team observed three main conveyor sections between the Auto-Cartonator discharge and the Track and Trace Machine:

1. Auto-Cartonator exit conveyor:
   This conveyor receives the closed cartons discharged from the Auto-Cartonator and transfers them towards the Checkweigher.

2. Checkweigher conveyor:
   This conveyor carries each carton through the checkweigher. The load cell is installed below the weighing section of this conveyor.

3. Track and Trace infeed conveyor:
   This conveyor receives cartons from the Checkweigher and carries them towards the infeed star-wheel of the Track and Trace Machine.

The team observed that the Checkweigher exit and the Track and Trace infeed were installed very close to each other. There was no separate buffer conveyor or sufficient free space between these two machines.

5.3 Checkweigher Arrangement and Working

The closed cartons coming from the Auto-Cartonator enter the Online Checkweigher, Equipment ID 100423.

The checkweigher was set for the following weight limits:

• Target weight: 18.81 g
• Lower limit: 17.53 g
• Upper limit: 20.09 g

The team observed the following main parts of the checkweigher:

S1 Sensor

The S1 sensor is installed at the entry side of the Checkweigher. It detects the arrival of a carton and sends a carton-presence signal to the machine control system.

S2 Sensor

The S2 sensor tracks the position of the carton as it moves towards and through the weighing section.

Load Cell

The load cell is installed below the weighing conveyor. It measures the weight of each carton while the carton is moving.

Programmable Logic Controller

The Programmable Logic Controller compares the measured carton weight with the approved lower and upper weight limits.

A carton within the approved limits is treated as an acceptable carton. A carton below or above the approved limits is identified for rejection.

Pneumatic Rejector

The pneumatic rejector is installed after the weighing section. When the Checkweigher identifies an underweight or overweight carton, the rejector pushes that carton from the main conveyor into the Checkweigher rejection bin.

Rejection Confirmation Sensor

The rejection confirmation sensor is installed immediately after the rejector.

Its purpose is to confirm that the rejected carton has moved out of the main product flow and entered the rejection bin within the set time.

If the sensor does not confirm the removal of the rejected carton, the Checkweigher generates a rejection confirmation alarm and stops the line.

5.4 Condition of the Line at the Time of Inspection

The packing line was found in a stopped condition.

The Checkweigher HMI was displaying the following active alarm:

“ERROR-17 – REJECTION CONFIRMATION FAILED”

The last carton weight displayed on the Checkweigher HMI was 18.70 g.

Refer to Photograph 1.0: Checkweigher HMI displaying ERROR-17.

Filled cartons were found accumulated at the exit side of the Checkweigher and at the infeed side of the Track and Trace Machine.

Some accumulated cartons had entered the area near the Checkweigher rejection confirmation sensor.

5.5 Tilted Cartons at the Auto-Cartonator Exit

The team observed that some cartons coming from the Auto-Cartonator were not travelling in a straight and square position. Some cartons were slightly tilted on the conveyor.

Refer to Photograph 1.1: Tilted carton at the Auto-Cartonator exit.

The tilted cartons travelled through the Checkweigher, and the load cell was able to measure their weight. However, when a tilted carton reached the Track and Trace infeed star-wheel, it did not enter the star-wheel correctly.

The tilted carton became stuck at the Track and Trace infeed.

Refer to Photograph 1.2: Tilted carton stuck at the Track and Trace infeed star-wheel.

5.6 Insufficient Space Between the Checkweigher and Track and Trace Machine

The team physically inspected the space between the Checkweigher exit and the Track and Trace infeed conveyor.

The available space was very short. No buffer conveyor or carton-holding space was provided between the two machines.

Because of the short distance, a carton stopping at the Track and Trace infeed immediately affected the movement of cartons coming from the Checkweigher.

Refer to Photograph 1.3: Short distance between the Checkweigher exit and the Track and Trace infeed.

5.7 Carton Accumulation

When a tilted carton became stuck at the Track and Trace infeed star-wheel, the cartons travelling behind it could not move forward.

The following cartons then started forming a queue:

1. Cartons stopped at the Track and Trace infeed.
2. Following cartons accumulated on the Track and Trace infeed conveyor.
3. The accumulation moved backwards towards the Checkweigher.
4. Cartons entered and remained in the rejection confirmation sensor area.

The cartons were seen close to one another, without enough space between them.

Refer to Photograph 1.4: Carton accumulation extending towards the Checkweigher rejection confirmation area.

5.8 Rejection Bin Observation

A rejection bin was provided at the Checkweigher to collect cartons rejected by the pneumatic rejection mechanism.

The team checked the cartons available in the rejection bin. Acceptable-looking cartons and actual rejected cartons were found together in the bin.

The operator explained that the cartons rejected by the machine and the cartons manually removed during the line stoppage had been collected in the same rejection bin.

The team opened the collected cartons and physically checked their contents. Some cartons contained all the required components:

• Three blisters
• One leaflet

These complete cartons were passed again through the Checkweigher. During rechecking, the cartons passed through the Checkweigher and were accepted by the machine.

This showed that some physically complete and acceptable-weight cartons had entered the rejection collection during the event.

5.9 Observation of the Rejection Confirmation Area

The rejection confirmation sensor was located close to the Track and Trace infeed conveyor.

When cartons accumulated in this area, the sensor remained covered by a carton.

The sensor could detect the presence of a carton, but it could not identify whether the carton was:

• A rejected carton that had failed to leave the main conveyor, or
• An acceptable carton that had moved backwards into the sensor area because of downstream accumulation.

The HMI alarm “ERROR-17 – REJECTION CONFIRMATION FAILED” was consistent with the physical condition seen in this area.

This was treated as an important observation for further technical investigation. A final conclusion was not made only on the basis of the Gemba walk.

5.10 Downstream Equipment

After passing through the Checkweigher, acceptable cartons normally move to the following equipment:

1. Track and Trace Machine, Equipment ID 100358
2. Automatic Sticker Labelling Machine with Conveyor Belt, Equipment ID 100297
3. Top Scanner, Equipment ID 100384
4. Outer carton and shipper packing area
5. Shipper weighing station

The team visually inspected these equipment and the surrounding area.

No visible damage was observed on the Track and Trace Machine, Automatic Sticker Labelling Machine, or Top Scanner during the Gemba walk.

The main physical abnormality observed was at the Track and Trace infeed, where tilted cartons could become stuck and cause carton accumulation.

5.11 Packed Shippers and Material Status

At the time the discrepancy was noticed, 36 shippers had already been packed.

The packed shippers were kept under control for further assessment.

The cartons collected during the event were also kept separately for physical verification, component checking, and weight re-verification.

5.12 Discussion with Operating Personnel

The investigation team spoke with the line operator and Packing Officer who were present during the event.

They informed the team that:

• The line was running during routine secondary packing.
• Acceptable cartons were seen moving towards the Checkweigher rejection side.
• The “Rejection Confirmation Failed” alarm appeared on the Checkweigher HMI.
• Cartons were accumulating near the Checkweigher exit and Track and Trace infeed.
• The line was stopped immediately after the abnormal rejection was noticed.
• Production, Engineering, and Quality Assurance were informed.
• B1 Notification No. 1000187 was raised for Engineering inspection and rectification.

The statements provided by the operating personnel were consistent with the physical conditions observed during the Gemba walk.

5.13 Key Gemba Walk Observations

The following important conditions were directly observed:

1. The packing line was stopped.
2. The Checkweigher HMI displayed “ERROR-17 – REJECTION CONFIRMATION FAILED.”
3. The last displayed carton weight was 18.70 g.
4. Some cartons coming from the Auto-Cartonator were slightly tilted.
5. A tilted carton could become stuck at the Track and Trace infeed star-wheel.
6. There was very little space between the Checkweigher exit and the Track and Trace infeed.
7. No buffer conveyor was installed between the two machines.
8. Cartons accumulated backwards from the Track and Trace infeed towards the Checkweigher.
9. Accumulated cartons occupied the Checkweigher rejection confirmation sensor area.
10. Acceptable-looking cartons and rejected cartons were found together in the rejection bin.
11. Some cartons from the rejection bin contained all three blisters and one leaflet.
12. Complete cartons passed when they were rechecked through the Checkweigher.
13. Thirty-six shippers had already been packed when the event was noticed.
14. No visible abnormality was noted at the Automatic Sticker Labelling Machine or Top Scanner.

5.14 Further Investigation to Be Carried Out

Based on the Gemba walk, the following activities were identified for detailed investigation:

1. Review the Batch Packing Record, line-clearance records, and in-process check records.
2. Review the Auto-Cartonator challenge tests for missing blister, missing leaflet, and pharmacode detection.
3. Review the Checkweigher weight calculation, target weight, upper limit, and lower limit.
4. Review the Checkweigher challenge-test results for good, underweight, and overweight cartons.
5. Check the position and working of the S1 sensor, S2 sensor, load cell, pneumatic rejector, and rejection confirmation sensor.
6. Review the reject delay, reject timing, hold delay, and rejection confirmation timing settings.
7. Check the Checkweigher alarm history and available audit-trail records.
8. Recreate the condition by passing tilted cartons through the line under controlled conditions.
9. Check whether a tilted carton can repeatedly become stuck at the Track and Trace infeed star-wheel.
10. Measure the actual distance between the rejection confirmation sensor and the Track and Trace infeed.
11. Evaluate the need for a buffer conveyor between the Checkweigher and Track and Trace Machine.
12. Review the qualification, preventive maintenance, calibration, and equipment history records.
13. Review previous B1 notifications related to the rejection confirmation sensor.
14. Interview the concerned operator, Packing Officer, and Engineering personnel.
15. Physically verify all cartons collected during the event for the presence of three blisters and one leaflet.
16. Re-pass the verified cartons through the Checkweigher as per the approved procedure.
17. Assess the impact on packed shippers, in-process material, product quality, and batch disposition. :::

The root-cause conclusion should remain outside the Gemba Walk section. The Gemba section should record only what the team saw, checked, heard from the concerned personnel, and identified for further investigation.