Quality - Blender Checks & Efficiency Data

• Site conducted

  Select

• Prepared by

  Select

• Conducted on

  Date

• Machine Cycle & Product Checks -
  Verify the following:
  * Process being used to manufacture parts (Machine Recipe, Fill Time, Cool Time, and Cycle Time)
  * Review the product being manufactured to ensure that it matches the ISF expectations
  * Review the material being used to ensure that it matches the expected plan

• Machine Recipe & Cycle Time Look Up - Instructions

CM1 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the ISF

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

CM 2 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

EN3 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Select the Mold Number Currently Running (by selecting the mold# it will prompt you to collect cell/machine/mold specific data)

  Select

• Part Weight

• Cart Serial Number

Frijel Water Temp

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Thickness Top

• Length Top

• Width Top

• Weight (lbs) Bottom

• Thickness Bottom

• Length Bottom

• Width Bottom

Floating Side Thermolator Temp Stationary Side Thermolator Temp

• WORK CELL FOOD SAFETY AUDIT<br>Is the KM4 operator's work cell clean and meets food-safe cleaning practices? <br> - Check the shift cleaning log and make sure the cleaning was documented.<br> - Ensure there is no product directly on the floor.a

  Yes

  No

• Ask Supervisor to perform the cell cleaning and ensure it gets documented

• Explain why the cleaning was not performed or documented.

• WORK CELL FOOD SAFETY AUDIT <br>Is everyone in the KM4 work cell meeting the GMPs and wearing the proper Food Safety PPE? <br>- No Jewelry or watches<br>- No food, drinks (only water in a closed clear container), or candy and gum. <br>- Hair-nets, Beard-nets, and gloves when handling the food-safe products.

  Yes

  No

• Explain the food safe concerns that were observed

Stationary Side Thermolator Temp Moving Side Thermolator Temp Chilled water Temperature
(This is the "Chilled Liquid Temperature" on the main tower system

• Are the parts being properly labeled per established standards?

  Yes

  No

• Take a Picture of the Labeling

  Yes

  No

• Explain the issue and take a picture of the defects

  Yes

  No
Frijel Water Temp

• Part Weight

• Width Top ID (center of cart)

• Cart Serial Number

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Weight (lbs) Bottom

• Length

• Width

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

KM4 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Select the Mold Number Currently Running (by selecting the mold# it will prompt you to collect cell/machine/mold specific data)

  Select

• Part Weight

• Cart Serial Number

Frijel Water Temp

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Thickness Top

• Length Top

• Width Top

• Weight (lbs) Bottom

• Thickness Bottom

• Length Bottom

• Width Bottom

Floating Side Thermolator Temp Stationary Side Thermolator Temp

• WORK CELL FOOD SAFETY AUDIT<br>Is the KM4 operator's work cell clean and meets food-safe cleaning practices? <br> - Check the shift cleaning log and make sure the cleaning was documented.<br> - Ensure there is no product directly on the floor.a

  Yes

  No

• Ask Supervisor to perform the cell cleaning and ensure it gets documented

• Explain why the cleaning was not performed or documented.

• WORK CELL FOOD SAFETY AUDIT <br>Is everyone in the KM4 work cell meeting the GMPs and wearing the proper Food Safety PPE? <br>- No Jewelry or watches<br>- No food, drinks (only water in a closed clear container), or candy and gum. <br>- Hair-nets, Beard-nets, and gloves when handling the food-safe products.

  Yes

  No

• Explain the food safe concerns that were observed

Stationary Side Thermolator Temp Moving Side Thermolator Temp Chilled water Temperature
(This is the "Chilled Liquid Temperature" on the main tower system

• Are the parts being properly labeled per established standards?

  Yes

  No

• Take a Picture of the Labeling

  Yes

  No

• Explain the issue and take a picture of the defects

  Yes

  No
Frijel Water Temp

• Part Weight

• Width Top ID (center of cart)

• Cart Serial Number

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Weight (lbs) Bottom

• Length

• Width

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

HU5 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

EN6 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Does the Physical Product match the ISF?

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

KM7 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Select the Mold Number Currently Running (by selecting the mold# it will prompt you to collect cell/machine/mold specific data)

  Select

• Part Weight

• Cart Serial Number

Frijel Water Temp

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Thickness Top

• Length Top

• Width Top

• Weight (lbs) Bottom

• Thickness Bottom

• Length Bottom

• Width Bottom

Floating Side Thermolator Temp Stationary Side Thermolator Temp

• WORK CELL FOOD SAFETY AUDIT<br>Is the KM4 operator's work cell clean and meets food-safe cleaning practices? <br> - Check the shift cleaning log and make sure the cleaning was documented.<br> - Ensure there is no product directly on the floor.a

  Yes

  No

• Ask Supervisor to perform the cell cleaning and ensure it gets documented

• Explain why the cleaning was not performed or documented.

• WORK CELL FOOD SAFETY AUDIT <br>Is everyone in the KM4 work cell meeting the GMPs and wearing the proper Food Safety PPE? <br>- No Jewelry or watches<br>- No food, drinks (only water in a closed clear container), or candy and gum. <br>- Hair-nets, Beard-nets, and gloves when handling the food-safe products.

  Yes

  No

• Explain the food safe concerns that were observed

Stationary Side Thermolator Temp Moving Side Thermolator Temp Chilled water Temperature
(This is the "Chilled Liquid Temperature" on the main tower system

• Are the parts being properly labeled per established standards?

  Yes

  No

• Take a Picture of the Labeling

  Yes

  No

• Explain the issue and take a picture of the defects

  Yes

  No
Frijel Water Temp

• Part Weight

• Width Top ID (center of cart)

• Cart Serial Number

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Weight (lbs) Bottom

• Length

• Width

• Does the Physical Product match the ISF? (If ROC verify that the Lids being used match the ISF)

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

KM8 Machine

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Machine Recipe

• Fill Time / Injection

• Cool Time

• Cycle Time

• Select the Mold Number Currently Running (by selecting the mold# it will prompt you to collect cell/machine/mold specific data)

  Select

• Part Weight

• Cart Serial Number

Frijel Water Temp

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Thickness Top

• Length Top

• Width Top

• Weight (lbs) Bottom

• Thickness Bottom

• Length Bottom

• Width Bottom

Floating Side Thermolator Temp Stationary Side Thermolator Temp

• WORK CELL FOOD SAFETY AUDIT<br>Is the KM4 operator's work cell clean and meets food-safe cleaning practices? <br> - Check the shift cleaning log and make sure the cleaning was documented.<br> - Ensure there is no product directly on the floor.a

  Yes

  No

• Ask Supervisor to perform the cell cleaning and ensure it gets documented

• Explain why the cleaning was not performed or documented.

• WORK CELL FOOD SAFETY AUDIT <br>Is everyone in the KM4 work cell meeting the GMPs and wearing the proper Food Safety PPE? <br>- No Jewelry or watches<br>- No food, drinks (only water in a closed clear container), or candy and gum. <br>- Hair-nets, Beard-nets, and gloves when handling the food-safe products.

  Yes

  No

• Explain the food safe concerns that were observed

Stationary Side Thermolator Temp Moving Side Thermolator Temp Chilled water Temperature
(This is the "Chilled Liquid Temperature" on the main tower system

• Are the parts being properly labeled per established standards?

  Yes

  No

• Take a Picture of the Labeling

  Yes

  No

• Explain the issue and take a picture of the defects

  Yes

  No
Frijel Water Temp

• Part Weight

• Width Top ID (center of cart)

• Cart Serial Number

• Take a picture of the lids being used on the cart bodies (Ensure the lids being used match the ISF requirements)

  Media
Frijel Water Temp

• Weight (lbs) Top

• Weight (lbs) Bottom

• Length

• Width

• Does the Physical Product match the ISF? (If ROC verify that the Lids being used match the ISF)

  Select Pass Fail N/A - Machine is Scheduled Down

  • Pass
  • Fail
  • N/A - Machine is Scheduled Down

• Take a picture of the physical part on all sides.

  Media

• Take a picture of the current ISF on the machine

  Media

• Explain the why is the machine Down?

• Take a picture of the FG Parts Physically in the Operator Cell

  Media

• What mold will be put in?

  Select

• Material Verifications -
  Verify the following:
  * Virgin and Alternative (Regrind) Material being used to manufacture the product

CM1 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

CM2 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

EN3 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

KM4 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

HU5 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

EN6 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

KM7 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• Color Blender Percentage %

• Regrind 1

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• LOT# (if running GMA sheets this is required)

• Regrind 2

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• LOT# (if running GMA sheets this is required)

KM8 Materials

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Virgin Material

  Select

• A-Barrel Color Blender Percentage %

• B-Barrel Color Blender Percentage %

• Regrind 1 - A Barrel

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2 - A Barrel

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 1 - B Barrel

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Regrind 2 - B Barrel

  Yes

  No

• Regrind Type (enter the type of regrind) if other write in the type of regrind in the notes section

  Select

• Blender Compartment

• Material Line

• Vessel

  Select

• Regrind Percentage %

• Material Verifications -
  Verify the following:
  * Color being used to manufacture the product and ensure it matches the Blender percentage

CM1 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

CM2 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

EN3 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

KM4 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

HU5 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

EN6 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

KM7 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

KM8 Color Information

• Machine Status

  Machine Running

  Mold Change

  Maintenance Downtime

  Schedule Down

KM8 - A Barrel (Skin) Color Information

• Take a Picture of the Color Box Label - to show the color being used to manufacture the parts (picture must show the color Name, JDE#, LDR%, Formulation and lot Number).

  Media

• or Enter Data Manually

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Does the Blender LDR% match the color Box LDR%?

  Yes

  No

• Explain it doesn't match?

KM8 - B Barrel (Core) Color Information

• Are we running the Skin color into the core?

  Yes

  No

• Color (JDE#)

• Color Box Percentage %

• Color Formulation#

• Color Lot#

• Enter Core Color Percentage

• I have completed my cycle checks, material verification and have confirmed that the product being produced matches the ISF expectations.

  Sign