Title Page

  • Site conducted

  • Prepared by

  • Conducted on

Machine Cycle & Product Checks

  • 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 Recipe

  • Fill Time / Injection

  • Cool Time

  • Cycle Time

  • Does the Physical Product match the ISF?

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

  • Take a picture of the ISF

  • Explain the why is the machine Down?

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

  • What mold will be put in?

CM 2 Machine

  • Machine Status

  • Machine Recipe

  • Fill Time / Injection

  • Cool Time

  • Cycle Time

  • Does the Physical Product match the ISF?

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

EN3 Machine

  • Machine Status

  • 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)

  • 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)

  • 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

  • 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.

  • 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?

  • Take a Picture of the Labeling

  • Explain the issue and take a picture of the defects

  • 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)

  • Frijel Water Temp
  • Weight (lbs) Top

  • Weight (lbs) Bottom

  • Length

  • Width

  • Does the Physical Product match the ISF?

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

KM4 Machine

  • Machine Status

  • 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)

  • 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)

  • 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

  • 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.

  • 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?

  • Take a Picture of the Labeling

  • Explain the issue and take a picture of the defects

  • 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)

  • Frijel Water Temp
  • Weight (lbs) Top

  • Weight (lbs) Bottom

  • Length

  • Width

  • Does the Physical Product match the ISF?

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

HU5 Machine

  • Machine Status

  • Machine Recipe

  • Fill Time / Injection

  • Cool Time

  • Cycle Time

  • Does the Physical Product match the ISF?

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

EN6 Machine

  • Machine Status

  • Machine Recipe

  • Fill Time / Injection

  • Cool Time

  • Cycle Time

  • Does the Physical Product match the ISF?

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

KM7 Machine

  • Machine Status

  • 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)

  • 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)

  • 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

  • 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.

  • 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?

  • Take a Picture of the Labeling

  • Explain the issue and take a picture of the defects

  • 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)

  • 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)

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

KM8 Machine

  • Machine Status

  • 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)

  • 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)

  • 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

  • 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.

  • 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?

  • Take a Picture of the Labeling

  • Explain the issue and take a picture of the defects

  • 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)

  • 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)

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

  • Take a picture of the current ISF on the machine

  • Explain the why is the machine Down?

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

  • What mold will be put in?

Material Verification

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

CM1 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

CM2 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

EN3 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

KM4 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

HU5 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

EN6 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

KM7 Materials

  • Machine Status

  • Virgin Material

  • Color Blender Percentage %

  • Regrind 1

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

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

  • Regrind 2

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

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

KM8 Materials

  • Machine Status

  • Virgin Material

  • A-Barrel Color Blender Percentage %

  • B-Barrel Color Blender Percentage %

  • Regrind 1 - A Barrel

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2 - A Barrel

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 1 - B Barrel

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

  • Regrind 2 - B Barrel

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

  • Blender Compartment

  • Material Line

  • Vessel

  • Regrind Percentage %

Color Information

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

CM1 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

CM2 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

EN3 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

KM4 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

HU5 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

EN6 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

KM7 Color Information

  • Machine Status

  • 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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

KM8 Color Information

  • Machine Status

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).

  • or Enter Data Manually

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

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

  • Explain it doesn't match?

KM8 - B Barrel (Core) Color Information

  • Are we running the Skin color into the core?

  • Color (JDE#)

  • Color Box Percentage %

  • Color Formulation#

  • Color Lot#

  • Enter Core Color Percentage

Completed

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

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