Mondelez International, Inc. · NASDAQ:MDLZ
Mondelez International — Technical Presentation (2023)
30 slides from Mondelez International's technical presentation, 2023
Slide 1: Validation of Devices
VALIDATION OF DEVICES Dave Lillie – Global Food Safety/Supplier Mondelēz Global Supplier Quality and Food Safety Training Fall 2023
Slide 2: About Today's Session
ABOUT TODAY’S SESSION This webinar is being recorded Send any questions you have throughout today’s session using the Q&A panel Questions will be addressed near the middle and at the end of the webinar If your questions are not answered, please contact us through email Please be sure to complete the
Slide 3: Today's Exercises
Go to www.menti.com and use the code TODAY’S or use the link in the Q&A panel EXERCISES or scan the QR code below Please keep the Mentimeter window open
Slide 4: Moderators and Presenter
Moderators For Today’s Training ChriS D’ANCONA Craig Sember Supplier Quality Manager Quality Program Leader Mondelēz Global Supplier Quality Mondelēz Global Food Safety East Hanover, NJ, United States Bournville, United Kingdom Today’s Presenter DAVE LILLIE Associate Principal, Supplier Food Safety
Slide 5: Introduction, Extraneous Matter Control Devices, Validation
Introduction Extraneous Wrap-up and Matter Control Q&A Devices Validation Mondelēz SQE Protocol and Requirements Examples
Slide 6: Key Takeaways for a Successful Validation
KEY TAKEAWAYS FOR TODAY! FOR A SUCCESSFUL VALIDATION 1. Design of the Validation 2. Establish right sensitivity (minimum test piece size capable of detection) 3. Determine POD and FRR (with standard product flow)
Slide 7: Extraneous Matter Control Plan
EXTRANEOUS MATTER CONTROL PLAN IS AN OVERVIEW OF ALL YOUR CONTROLS Prerequisite Programs GMP’s Preventive Maintenance EXTRANEOUS • Control of Wooden Pallets Program MATTER CONTROL • Control of Glass and Plastics • Gasket Controls • Maintenance activity line PLAN • Hair coverings… • Uniforms clearanc
Slide 8: Extraneous Matter Control Devices
Reminder- all devices have limitations. EXTRANEOUS MATTER CONTROL DEVICES Metal Detectors Or X-Rays CRITICAL! . All lines must have an End of Line Metal Detector or X Ray You must have the right type of device for the hazard Metal Detector X Ray Can detect Metal Can detect Stones Can detect Glass Ca
Slide 9: Time for an Exercise!
Go to www.menti.com and use the code TIME FOR AN or use the link in the Q&A panel EXERCISE! or scan the QR code below Please keep the Mentimeter window open
Slide 10: Validation – Calibration – Verification – Monitoring
VALIDATION – CALIBRATION - VERIFICATION – MONITORING Operational functionality Conducted ideally before first production, if any FRR issues, VALIDATION Can it consistently detect and reject and/or after maintenance POD adjustments Technical functionality CALIBRATION Air pressure, Electrical integr
Slide 11: Pause for Questions
PAUSE FOR QUESTIONS
Slide 12: Introduction, Extraneous Matter Control Devices, Validation
Introduction Extraneous Wrap-up and Matter Control Q&A Devices Validation Mondelēz SQE Protocol and Requirements Examples
Slide 13: MD and X ray Validation
MD and X ray Validation A validation is required for all metal detectors or X-ray devices. Lets go through it Can be used for single pack, bulk products, throat or gravity fall Metal Detectors and X-Ray Frequency : • Prior to first production/ commercialization, ideally during installation • Post ma
Slide 14: Mondelēz SQE Audit Nonconformities for Metal Detector Validations
MONDELĒZ SQE AUDIT NONCONFOrMITIES FOr METAL DETECTOr VALIDATIONS Most frequent Key Driver Needs Improvement and Needs Refinement findings • Validation does not include POD/FRR • Test pieces standards used for validation are larger than Mdlz required 1.5mm Fe, 2.0 N-Fe & 2.5 SS • Validation does not
Slide 15: Introduction, Extraneous Matter Control Devices, Validation
Introduction Extraneous Wrap-up and Matter Control Q&A Devices Validation Mondelēz SQE Protocol and Requirements Examples
Slide 16: Validation Protocol Part A: Establishing the Right Sensitivity
VALIDATION PROTOCOL PART A : ESTABLISHING THE RIGHT SENSITIVITY ENSURE STEP 2 •10 passes are successful •If “No" is recorded when (= Yes), pass smaller test • Start with target pieces •Pass 10 times each test passing largest pieces, piece 10 times & evaluate Optimal settings for on which the device
Slide 17: Filling the Format
FILLING THE FORMAT Test piece type Ferrous Test piece type Non Ferrous| Test piece type: $s Comments, if any a5mm_ [1.2mm [1.00mm [2.0mm [1.8mm _ [1.6mm 25mm [2.0mm [1.8mm First part of Validation protocol Second part of Validation protocol 30 Yes = Detected& Rejected INo= Detected & Not Rejected or
Slide 18: Filling the Format
FILLING THE FORMAT No. of Test piece type Ferrous Test piece type _NonFerrous| _Test piece type: ss__ |Comments, if any 1.5mm [12mm |1.00mm_ |2.0mm_|1.8mm_|1.6mm_ |2.5mm_|2.0mm_|1.8mm g 1 Yes oom Yes fves_ (ives ives _—i[ves g 2 Yes Yes Yes Yes Yes Yes Ives = 3 Yes Yes Yes Yes Yes Yes Yes s 4 Yes Ye
Slide 19: Determining FRR & POD
Determining FRR & POD Add a further 20 pieces from the smallest test contaminant, evenly distributed in X quantity of foreign body free product - Use standard line speed and product flow Determination of X : For bulk : Identify the finished product weight (gms or kg) in each SKU. Multiply FP product
Slide 20: POD & FRR Calculations
POD & FRR CALCULATIONS The POD limit is defined by the smallest dimension achieving a POD of 30/30 (detected & rejected) POD Calculation:- POD = 100 × Correctly Rejected Test Samples Total Test Samples w/ contaminants Inspected Measured during production by adding/ not adding known amount of contami
Slide 21: Worst Case Scenarios Considerations for MD
Worst Case scenarios considerations for MD 1. While doing the validation test piece need to be kept as close as possible to the center of aperture. 2. Back to back contaminants. 3. Emergency Stop / Power Failure :- Such situations should be simulated to know the reaction of the detection & rejection
Slide 22: Worst Case Scenarios Considerations for X-Ray
WORST CASE SCENARIOS CONSIDERATIONS FOR X-RAY 1. Depth of product on the conveyor. 2. Conveyor speed.
Slide 23: Worst Case Scenarios Considerations for X Ray
WORST CASE SCENARIOS CONSIDERATIONS FOR X RAY For Product Packed in Jars/Glass For Product packed in Pouches containers : Top of jar ( in the neck area ) Horizontal Seal Top : Lay over the product : Top corner Side Edges : Body At the Vertical Seal : Bottom top Horizontal Seal Bottom : Bottom - come
Slide 24: Worst Case Scenarios Considerations for X Ray Contd.
ORST CASE SCENARIOS CONSIDERATIONS FOR X RAY....CONTD. Jar Inspections (Packaging variations) Blind Spot Formation 22 | TPE Acceptable } Notacceptable “in specification” {| “outof specification” Notto be rejected Can be rejected eMondeléz, International ‘SNACKING MADE RIGHT
Slide 25: POD & FRR Calculation Examples
POD & FRR CALCULATION EXAMPLES The POD limit is defined by the smallest dimension achieving a POD of 30/30 (detected & rejected) POD Calculation:- POD = 100 × Correctly Rejected Test Samples Total Test Samples w/ contaminants Inspected # of rejected products 30 # of rejected products 20 # of correct
Slide 26: POD & FRR Calculation Examples
POD & FRR CALCULATION EXAMPLES Measured during production by adding/ not adding known amount of FRR contaminants with product amount equivalent to (200 – 2000 SKU). Evaluate each rejected product and classify it as a False Reject or not Recommended target: not more than 0.1% Calculation:- FRR= 100 ×
Slide 27: Time for an Exercise!
Go to www.menti.com and use the code TIME FOR AN or use the link in the Q&A panel EXERCISE! or scan the QR code below Please keep the Mentimeter window open
Slide 28: Introduction, Extraneous Matter Control Devices, Validation
Introduction Extraneous Wrap-up and Matter Control Q&A Devices Validation Mondelēz SQE Protocol and Requirements Examples
Slide 29: Key Takeaways for a Successful Validation
KEY TAKEAWAYS FOR TODAY! FOR A SUCCESSFUL VALIDATION 1. Design of the Validation 2. Establish right sensitivity (minimum test piece size capable of detection) 3. Determine POD and FRR (with standard product flow) Purpose of this event: To assure all of us provide the safest product to our consumers
Slide 30: Thank You! Q&A
THANK YOU! Q&A Please complete the quiz and survey for today’s training by scanning the QR code or using the link provided. We value your feedback! https://forms.office.com/r/KuT0TY0xcC
Mondelēz International — Technical Presentation (2023) on 6ix