Blister Pack line validation Report

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Blister Pack line validation Report – ALU/PVC

 

  1. Objective:

      To validate the packing process of __________________________________

  1. No. ________________________ Batch size _________________ & pack size _________________________________ on the Blister Pack line.

 

  1. Scope:

Applicable to Blister Packing of tablets.

 

  1. Justification:

___________________________________________________________

 

  1. Site of study:

Packaging Department I

  1. Responsibility:

Production              : ___________

Quality Assurance  : ___________

Engineering            : ___________

(Individuals to be named )

 

  1. Description of equipment to be used:

      BLISTER PACK MACHINE

Code No. : ______________

Equipment Qualification done on: _______________

 

CARTONATOR

Code No. : ______________

Equipment Qualification done on: _______________

 

INKJET PRINTER / CONDOT PRINTER

 

Code No. : ______________

Equipment Qualification done on: _________________

 

 

Reviewed by sign and Date : _______________

 

CHECK WEIGHER

Code No. : ______________

Equipment Qualification done on:  _________________

 

SHRINK WRAPPING MACHINE (if applicable)

Code No. : ______________

Equipment Qualification done on:   _________________

 

SHIPPER WEIGHING BALANCE

Code No. : ______________

Equipment Qualification done on:   _________________

 

 

  1. Standard Operating Procedure (SOP) to be followed :

Packing of the product done as per SOP No. :

  1. Standard Operating Procedures (SOP) for operating Operation of the Blister pack machine.

SOP No. : __________

 

  1. Standard Operating Procedures (SOP) for operating Cartonator :

SOP No. : __________

 

  • Standard Operating Procedures (SOP) for operating Inkjet / Condot Printer.

SOP No. : __________

 

  1. Standard Operating Procedures (SOP) for Check Weigher :

SOP No. : __________

 

  1. Standard Operating Procedures (SOP) for Shrink Wrapping Machine (if applicable):

SOP No. : __________

 

  1. Standard Operating Procedures (SOP) for Shipper Weighing balance:

SOP No. : __________

 

 

Reviewed by sign and Date : _______________

 

  1. Batch packing record (BPR) to be followed:
  2. Record pack code as per BPR

Pack code : ______________

 

  1. Controls: Requirements :
    1. Blister Pack Machine:
  2. Blister Pack machine speed.

Machine speed : _______________      Limit : _______________

 

  1. Temperature Range of Film Heater : ___________ to ___________ and Blister Sealing roller : __________ to __________

 

  1. Ambient temperature under which packing operation of the product under study is carried out should 220C ± 30C

Ambient Temperature : ________________

 

  1. Calibration :

Calibrated Vacuum Pressure gauge. Code No. _______________

Calibration of Vacuum pressure gauge done on : ______________

Calibration of Vacuum pressure gauge due on : _______________

 

  1. Cartonator :
  2. Working of Carton Level Detector, Enclosure Detector and Product Sensor.
  3. Vacuum pressure should be NLT 50 Psi,
  4. Functioning of Pharma code reader.

 

  • Ink Jet Printer / Condot Printer:
  1. The printer must be adapted to production line.
  2. The printer must be initialized.
  3. Access Code.
  4. Sensor for sensing the carton should be kept “ON”.

 

 

 

Reviewed by sign and Date : ____________

 

  1. Check Weigher System :
    1. Sufficient compressed air pressure should be kept at carton blow station. (NLT4 bar).

 

  1. Conveyor speed.
  2. During validation ensure that pack with improper content should be rejected and same should be ensured.

 

  1. Optical Sensor to Detect the product.
  2. Pressure switches to ensure that Machine does not Operate in case of low pneumatic pressure.

 

  1. Shrink Wrapping Machine:

During validation it is ensure that wrapping of shrink must be done properly.

 

  1. Shipper Weighing Balance :

During validation ensure that shipper with improper count should be rejected and same should be ensured.

 

  1. Calibrations:
Equipment Code No. Calibration done Calibration due
       
       
       
       
       
       
       
       
       
       

 

 

Reviewed by sign and Date : ____________

 

 

 

  1. Training:

Training details of personnel involved in validation.

Name Training status Training report availability Checked by
       
       
       
       

 

  1. Precautions:

Safety aspects while operation of equipments and process must be ensured.

 

 

  1. Validation Procedures:

 

                                             Packing Process Flow Diagram :

Blister packing

 

 

 

 

Cartonator

Cartons                                   Cartonating

 

 

 

Ink Jet Printer / Condot printer

 

Carton Overprinting

[

 

 

 

 

Check Weigher

Weighing of Carton

 

 

 

 

Shrink Wrapping Machine

Shrink Wrapping (if Applicable)

 

 

 

Outer     carton

 

 

 

 

Shipper Packing

 

Reviewed by sign and Date : ____________

 

 

Department :  
Product :  
Batch No :  
Date of Validation :  

 

 

Equipment : Blister Pack machine
Code No:  
Make :.  

 

 

Equipment : Cartonator
Code No:  
Make :.  

 

 

Equipment : Ink Jet / Condot Printer
Code No:  
Make :.  

 

 

Equipment : Check Weigher System
Code No:  
Make :.  

 

 

Equipment : Shrink Wrapping Machine (As applicable)
Code No:  
Make :.  

 

 

Equipment : Shrink Wrapping Balance
Code No:  
Make :.  

 

 

Reviewed by sign and Date : ____________

  1.  Acceptance criteria:
    1. Blister Pack Machine:
    2. Leak test observed should be NIL.
    3. Temperature of film Heater.

For EPI 2500:

  1. Temperature of film heater for PVC film should be between 140 – 1700
  2. Temperature of film heater for PVC /PVDC or PVC / PE / PVDC should be between 150 – 1600
  3. Temperature of Sealing Roller 170 – 2100C

 

  1. Cartonator :
  1. Only set size Blister should be released in the Blister cell.
  2. Carton and leaflet should not be released by the respective sensors.
  3. No Blister :
    1. Carton sensor should not release the carton.
      1. No Carton :
      2. Pusher should not come out.
        1. Removal of carton after closing of flap Cartons flap (front and rear) should get closed properly.
        2. Ensure that Inter Locks are available for Emergency off, Guards open, Hand wheel, Loading safety, Motor overload, No carton, No Product, No leaflet & Low air pressure pusher overload.
        3. Quality of carton should comply as per product specification after closing of flap for Embossing, Printing, Insertion of Leaflet (if any).
        4. System Should not Accept Incorrect Password.
        5. Leaflet and Carton should Recognized as “ERROR” and machine must stop.

 

  • Ink Jet Printer / Condot Printer :
  1. System should not accept incorrect password.
  2. The overprinted details on carton should match with that of BPR entries.

 

 

 

 

 

 

Reviewed by sign and Date : ____________

 

  1. Check Weigher System :

Carton with target should pass through the Check Weigher System and under and over weight cartons should be rejected along with the LED indicator by the Check Weigher System.

 

  1. Shrink Wrapping Machine : (if applicable)

During validation it is observed that wrapping of shrink must be done properly.

 

  1. Shipper Weighing Balance :

The alarm should be actuated whenever count is less or more than the standard fill value of the shipper.

 

  1. Non Compliance:

 

  1. Details of Deviations :
Deviation Report dated Checked by
   
   

 

  1. Details of OOS Results :
OOS Report dated Checked by
   
   

 

Reviewers Comments / Remarks

 

  1. Type of Validation :

Concurrent Validation:

  1.  Frequency :
    1. Concurrent Validation: Three successful validation exercises.
    2. Re-validation (After major change.)

 

 

Reviewed by sign and Date : _______________

 

 

  1. Results:
  2. Blister Pack machine :

 

Date/ Time Temperature of film Heater/platen heater  Range:

___ to ___

 Temperature of Sealing Roller Leak Test NIL Checked by
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         

 

Reviewed by sign and Date : _______________

 

                         II.

Date/ Time Pin Holes Knurling Uniformity Wrinkles Break Test (for  Combipack / Scoring) Embossing / Overprinting Checked by
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             

 

Reviewed by sign and Date : _______________

 

 

  • Camera Challenge:
    1. Remove One Tablet
Date Time Audio alarm for sensing missing tablets

Yes/No

 Non filled pack Rejected / Passed Filled pack Rejected / Passed Checked by
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           

 

 

 

 

Reviewed by sign and Date : _______________

 

 

  1. Insert Half Tablet
Date Time Audio alarm for sensing missing tablets

Yes/No

 Non filled pack Rejected / Passed Filled pack Rejected / Passed Checked by
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           
           

 

 

 

Reviewed by sign and Date : _______________

 

  1. Empty blister

 

Date/ Time Audio alarm for sensing missing tablets

Yes/No

 Non filled pack Rejected / Passed Filled pack Rejected / Passed Checked by
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         

 

 

 

Reviewed by sign and Date : _______________

 

  1. Observation at lower speed: ____________
Condition Date Time Temperature of film  heater

______ to _______

 Temperature of Sealing roller

_____ to_____

 Knurling Uniformity

 

 Checked by
Lower Temp.            
Higher Temp.            

 

 

Condition Date Time Leak Test Wrinkles Pin Holes Break Test (for combipacks) Perforation (if applicable) Checked by
Lower Temp.                
Higher Temp.                

 

  1. Observation at Higher speed: ____________
Condition Date Time Temperature of film  heater

______ to _______

 Temperature of Sealing roller

_____ to_____

 Knurling Uniformity

 

 Checked by
Lower Temp.            
Higher Temp.            

 

 

Condition Date Time Leak Test Wrinkles Pin Holes Break Test (for combipacks) Perforation (if applicable) Checked by
Lower Temp.                
Higher Temp.                

 

 

Reviewed by sign  and Date : _______________

 

  1. Observation at Optimum speed: ____________
Condition Date Time Temperature of film  heater

______ to _______

 Temperature of Sealing roller

_____ to_____

 Knurling Uniformity

 

 Checked by
Lower Temp.            
Higher Temp.            

 

 

Condition Date Time Leak Test Wrinkles Pin Holes Break Test (for combipacks) Perforation (if applicable) Checked by
Lower Temp.                
Higher Temp.                

 

 

 

  1. Cartonator:

 

Date Time Tests Acceptance Criteria Observation
    Set size of blister to be released from the blister cell. Only Set size of blister should be released in the blister cell.  
    No blister in the blister cell Cartons and leaflet should not be released.  
    Leaflet below sensor level in the leaflet magazine box. Machine should stop with proper justification on monitor.  
    Carton below sensor level on the packing line. Machine should stop with proper justification on monitor.  

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

Date/ Time Tests Acceptance Criteria Observation
— — — 1 2 3 4 5
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          

 

Reviewed by sign  and Date : _______________

Date/ Time Tests Acceptance Criteria Observation
— — — 1 2 3 4 5
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          

 

Reviewed by sign  and Date : _______________

 

Date/ Time Tests Acceptance Criteria Observation
— — — 1 2 3 4 5
  Remove the carton after closing of flap,

Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.

 i. Cartons flap (front and rear) should get closed properly.          
ii. Cartons flap should get properly embossed or printed. (if applicable)          
iii. filled blister and enclosure should be present in the carton printing should done properly.          

 

Check the interlocking of following:

 

Tests Acceptance Criteria Observation
Emergency off Interlock should be available for these.  
Guards open Interlock should be available for these.  
Hand wheel Interlock should be available for these.  
Pusher Overload Interlock should be available for these.  
Motor overload Interlock should be available for these.  
No carton Interlock should be available for these.  
No leaflet Interlock should be available for these.  
Quantity of carton after closing flap for proper closing. Embossing / printing, number of blisters, insertion of leaflet Pack should comply with the standard pack specification Initial End
   

 

 

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

 

 

Pharmacode system :

 

Date / Time Checks Acceptance Criteria Observation
  Password verification for editing product:

Enter incorrect password for editing the set product parameters.

 System should not accept the incorrect password.  
  Access code verification for Adjustment Menu:

Enter incorrect access code to enter into adjustment menu.

 System should not accept the incorrect password  
  Access code verification to advanced configuration option:

Enter incorrect access code to enter into configuration option.

 System should not accept the incorrect password  
  Password verification for editing product:

Enter incorrect password for editing the set product parameters.

 System should not accept the incorrect password.  
  Access code verification for Adjustment Menu:

Enter incorrect access code to enter into adjustment menu.

 System should not accept the incorrect password  
  Access code verification to advanced configuration option:

Enter incorrect access code to enter into configuration option.

 System should not accept the incorrect password  
  Password verification for editing product:

Enter incorrect password for editing the set product parameters.

 System should not accept the incorrect password.  
  Access code verification for Adjustment Menu:

Enter incorrect access code to enter into adjustment menu.

 System should not accept the incorrect password  
  Access code verification to advanced configuration option:

Enter incorrect access code to enter into configuration option.

 System should not accept the incorrect password  

 

Reviewed by sign  and Date : _______________

 

 

Date / Time Checks Acceptance Criteria Observation
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  
  Prepare a leaflet by adding a bar code to the code on the front side. Cartonator must stop.  

 

 

 

Reviewed by sign  and Date : _______________

 

 

  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  
  Add an additional bar code to the code on the carton flap. Cartonator must stop.  

 

 

 

Reviewed by sign  and Date : _______________

 

 

  1. Ink Jet Printer:

 

  1. Enter Incorrect password for printer

Observation :

_________________________________________________________

 

 

  1. Enter correct password for printer

Observation :

__________________________________________________________

 

 

III. Product details fed in the Ink Jet Printer /condot Printer/stereo printing.

 

Carton _________________________________

_________________________________

_________________________________

_________________________________

 

 

Date / Time Overprinting Details Observation
   
   
   
   

 

 

 

Reviewed by sign  and Date : _______________

 

Date / Time Overprinting Details Observation
   
   
   
   
   
   
   
   
   
   
   

 

 

 

Reviewed by sign  and Date : _______________

 

 

  1. Check Weigher System:

 

 

Date / Time Count shown LED indicator Observations Checked by
1 2 3 4 5
  Carton with one more enclosure Y            
Carton without enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton without Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton without enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton without Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton without enclosure. R            
Carton with standard fill value (as per specification) G            

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

Reviewed by sign  and Date : _______________

 

Date / Time Count shown LED indicator Observations Checked by
1 2 3 4 5
  Carton with one more Blister. Y            
Carton without Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton with out enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton with out Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton with out enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton with out Blister. R            
Carton with standard fill value (as per specification) G            

 

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

Reviewed by sign  and Date : _______________

 

 

Date / Time Count shown LED indicator Observations Checked by
1 2 3 4 5
  Carton with one more enclosure Y            
Carton with out enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton with out Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton with out enclosure. R            
Carton with standard fill value (as per specification) G            
  Carton with one more Blister. Y            
Carton with out Blister. R            
Carton with standard fill value (as per specification) G            
  Carton with one more enclosure Y            
Carton with out enclosure. R            
Carton with standard fill value (as per specification) G            

 

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

 

Reviewed by sign  and Date : _______________

 

  1. Shrink Wrap Machine: (if applicable)

 

Date / Time Test Observation Checked by
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        

 

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

 

Date / Time Test Observation Checked by
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        
  Sealing        
Wrapping        
Shrinking        

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

 

  1. Set the temperature – Lower temperature ___________ 0

 

Date / Time Test Observation Checked by
  Sealing        
Wrapping        
Shrinking        

 

  1. Set the temperature – Higher temperature __________ 0

 

Date / Time Test Observation Checked by
  Sealing        
Wrapping        
Shrinking        

 

  1. Set the temperature – at optimum temperature ___________ 0

 

Date / Time Test Observation Checked by
  Sealing        
Wrapping        
Shrinking        

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

  1. Shipper Weighing balance:

 

Date / Time Count shown Observation Alarm Checked by
Actuated Not Actuated  
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      

 

 

 

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

 

 

Date / Time Count shown Observation Alarm Checked by
Actuated Not Actuated  
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
  Shipper with one carton less.      
  Shipper with standard fill value (as per specification)      

 

 

 

 

 

Reviewed by sign  and Date : _______________

 

Date / Time Count shown Observation Alarm Checked by
Actuated Not Actuated  
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
Shipper with one carton less.      
Shipper with standard fill value (as per specification)      
  Shipper with one carton more.      
  Shipper with one carton less.      
  Shipper with standard fill value (as per specification)      

 

 

 

 

Reviewed by sign  and Date : _______________

 

 

17.Summary of finding of validation (inference):

 

 

 

 

 

 

 

 

 

 

 

 

 

18.Recommendation:

 

 

 

 

 

 

 

 

 

 

 

 

19.Team Approval:

 

 

_____________          _______________            _____________

Production                 Quality Assurance               Engineering

 

Date:

 

 

 

Reviewed by sign  and Date : _______________

 

  1. Review: (Inclusive of follow up action, if any):

 

 

 

 

 

 

  1. Approved by:

 

_______________                             ___________

Quality Assurance                                Plant Head

 

Date:

 

 

  1. Annexures :

 

 

  1. Abbreviations:

 

NFD          : Non Filled Detection

PVC          : Polyvinyl Chloride

PVDC       : Polyvinyl  Dichloride

PE            : Polyethylene

0C            : Degree Celsius

SOP         : Standard Operating Procedure

QA            : Quality Assurance

No.            : Number

NLT           : Not Less Than

PSI            : Per Square Inch

LED           : Light Emitting Device

Mins.          : Minutes

Kg./Sq.cm  : Kilogram per Square Centimeter

 

 

 

 

Reviewed by sign and Date : _____________

 

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