Validation of Control Measure Effectiveness of Standard

Stripping Pin in Die Cut Process

Date: September 28, 2023 Validation Control No.: APPI – VAL -005
Covered Area: Die Cut Process
Validated by: Monik T. Manuel
Equipment: NA

1.0 Pre Validation Tasks

1.1 Hazard (Identify hazards that are intended to be controlled):

1.1.1 Physical Hazards specially:

Die Cut trimmings

Parameter Limit
Choking Hazard 7mm or 0.3 inch

1.2 Food Safety Outcome & Objective required (Target; relevant to intended use; recognized international
standards; approved limits; effectiveness):

1.2.1 The objective of the study is to measure the overall effectiveness of standard stripping pin in die cut process
output thru Die Cut Appearance Inspection
1.2.2 Absence of die cut trimming of Die Cut Meal Box

1.3 Control Measure to be validated: Stripping pin

Die Cut Appearance Inspection for the control of Die Cut trimmings of laminated paper board
1. Die Cut output without stripping pin
2. Die Cut output with stripping pin

2.0 Materials

2.1 Die Cutted Meal Box

2.2 Die Cut Process Inspection Form APPI - QCD - F - 04

3.0 Parameters: Check applicable parameter

Time Water Activity Calibration

4.0 Decision Criteria
Temperature (Uncertainty, Variability,
pH & Performance of Control Measure)
Microbial Standard
Concentration Contact Time Spatial Configuration
4.1 Die Cut Appearance Inspection as a control measure will be considered validated if:
Humidity Pressure Viscosity
4.1.1 Fifteen (15) Samples of Die Cut output without stripping pin
Dwell time Equipment Settings Others: Additional component on Die cut
4.1.2 Fifteen (15) Samples of Die Cut output with stripping pin

5.0 Assemble relevant validation information/ Methodology: (Duration/ frequency of the validation; detailed
experimental trials, etc.)

5.1.The following preliminary steps are performed prior to the start of the validation study:
- Get one (1) sample per pallet of die cut sheet of with stripping pin and without stripping pin
- Visually inspect if the trimming is remove from the die cut sample.

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.
 Validation of Control Measure Effectiveness of Standard
Stripping Pin in Die Cut Process

Samples Sampling Size

Die cut output without stripping pin 15 sheets

Die cut output with stripping pin 15 sheets

6.0 Analysis and Results (Discussion on the results gathered; tables on gathered data; pictures, graph, statistical data
result, etc.)
6.1 The following data were obtained during the beginning of the validation study

With stripping Pin Without stripping Pin

Sample
Date Time Result Date Time Result
1 9:00 am Failed 10:00 am Passed

2 9:30 am Failed July 19, 203 10:30 am Passed

3 10:00 am Failed 11:00 am Passed

4 July 14, 2023 10:30 am Failed 11:00 pm Passed

5 11:00 am Failed July 20, 2023 11:30 pm Passed

6 11:30 am Failed 12:00 pm Passed

7 12:00 pm Failed 11:15 am Passed

8 8:45 am Failed July 26, 2023 11:45 am Passed

9 9:15 am Failed 12:15 pm Passed

10 9:45 am Failed 9:20 am Passed

July 27, 2023
11 10:15 am Failed 9:50 am Passed
July 17, 2023
12 10:45 am Failed 9:40 am Passed
Aug. 01, 2023
13 11:15 am Failed 10:10 am Passed

14 11:45 am Failed 9:35 am Passed

Aug. 02, 2023
15 12:15 am Failed 10:05 am Passed

Legend:
Passed - without trimmings
Failed - with trimmings

6.2 Analysis on absence of trimming on die cutted meal box

6.2.1 From die cut meal box sample without stripping output 100% failed out of 15 trials, with presence of
trimmings.
6.2.2 Reduction is significant in die cut process with stripping pin, absence of trimmings in die cut meal box
6.2.3 100% passed with stripping pin during die cut process

7.0 Document & References (Site references & attachments to this document)

7.1 Quality Control Procedure APPI - QCD - QP - 02

7.2 Die Cut Process Inspection Form APPI - QCD - F - 04

8.0 Conclusion Check the applicable box

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.
 Validation of Control Measure Effectiveness of Standard
Stripping Pin in Die Cut Process

Control measure 25 mm Standard Stripping Pin is capable of controlling the hazard to specified Food Safety
outcome and objectives if properly implemented
Is not capable of controlling the hazard; needs revalidation

Recommendation:
Standard Stripping Pin of 25 mm in Die Cut process is one of the best way to removed hazard such as
Paper trimmings thru the verification of die cut appearance inspection. Consistent observation of die cut appearance
compliance to the die cut process is required to sustain objectives.

Monik T. Manuel Lorna S. Duguran

Validated Reviewed

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.