AQP Training presentation definitions...

AQP data

1. Alpla Qualification Process AQP Training V13 Corporate Quality Assurance

2. AQP is a mandatory special validation procedure valid for all molds in ALPLA. Standardized acceptance process at mold hand over being sure that the mold is working properly Statistical evidence that production within specification is possible fulfilling internal and external requirements Statistical evidence that production process is stable reduce waste and prevent complaints This will increase process stability and customer satisfaction AQP What is AQP and its benefits

3. It is an ALPLA Standard! AQP Who needs to perform AQPs It is a team task ! ( TC ) Plant Management Resources, Has lead in verification phase Quality Assurance Measure samples and analyse data Production Setup process and perform sampling Project/ Packaging Management Organize, finalize report, communicate to plant and customer Has lead in Qualification phase

4. AQP is the Operational Qualification of a mould validation . AQP AQP is part of the development process C2 Installation qualification Operational qualification Performance qualification Process control in the plants

5. There are two types defined for different purposes to save time and resources: AQP Types of AQP Standard AQP AQP light The AQP is used to qualify molds and processes (initial validation) with the: main material and main master batch for 3-5 critical characteristics AQP light is a short version of the standard AQP. Goal : does the mold work also with other materials ? It is used for: new or multiple master batch formulations new resin or backup resins light weighting initiatives mold relocation mold families/copy molds

6. The general process works as the following : AQP Steps of an AQP Trials and Debugging run to find optimized process Thermal balance of machine First testing of products in lab  Installation qualification Sampling according special sampling plans Measuring and reporting  Operational qualification Handover to plant verification phase Process monitoring over a specified time  Performance qualification Review Project closing

7. Commissioning run (C-Run) Qualification run (Q-Run) Determines cavity equivalence Are all the cavities the same? Determines short term process capability Does the process change in a 4 – 8 hours run? Q-Run and C-Run are sampled simultaneously during a 4-8 hours run, according to specified sampling plans (technology, mold size) AQP Sampling Plans: 2 combined runs

8. Q-Run and C-Run are sampled simultaneously (4-8 hours run), according to specified sampling plans (technology, mold size) AQP Sampling Plans for EBM and SBM 1 2 3 4 5 6 7 8 9 … 23 24 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Cav Samples C-Run Q-Run 4 - 8 hours S1-S3 1st hour C-run data 3 shots within 1 st hr Q-run data Three more shots in cavity Order and min. 30 pcs. Sampling plan automatically provides the subgroup size of each pull.

9. AQP Sampling Plans for IMcaps 1 2 3 4 5 6 7 8 9 … 23 24 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Cav Samples C-Run Q-Run 4 - 8 hours S1-S5 1st hour C-run data 5 shots within 1 st hr Q-run data Min. 30 pcs. and min. 3 shots Q-Run and C-Run are sampled simultaneously (4-8 hours run), according to specified sampling plans (technology, mold size)

10. Q-Run and C-Run are sampled simultaneously (4-8 hours run), according to specified sampling plans (technology, mold size) AQP Sampling Plans for IMpre 1 2 3 4 5 6 7 8 9 … 23 24 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Cav Samples C-Run Q-Run 4 - 8 hours S1-S2 1st hour C-run data 2 shots within 1 st hr Q-run data Cav. ≤32 pull in order min. 30 pcs. and min. 2 shots Cav. >32 pull random min. 90 pcs. in SG of 5

11. Q-Run and C-Run are sampled simultaneously (1 hour run), according to specified sampling plans (technology, mold size) The following assumptions need to be fulfilled to perform AQP light: mold has been qualified historical data available no metal changes to the mold have been done AQP Sampling Plans for AQP light 1 2 3 4 5 6 7 8 9 … 23 24 x x x x x x x x x x x x Cav Samples C-Run 60 minutes run time S1 C-run data 1 full shot Q-run data 30 pcs. pulled randomly Full shot (C-Run) 6x 5 pcs. pulled randomly = 30pcs

12. AQP Performing AQP Prepare sampling plan (Template in Insight) Schedule qualification Inform involved people (Operators, Planning, Mngt . Etc.) Prepare palettes and boxes Organize storage area Waterproof pens, adhesive tape and bags (caps) Box labels according sampling plan All equipment is functional and in thermal balance (min. 20min), process is stable and all characteristics perform in process window: test one shot in the lab (Fresh start). If the shot is ok, start AQP sampling. If not, adjust process. Machine keeps running during measurements! Fresh samples need to wait 15 minutes before measuring! No adjustments during C- and Q-Run Document every process change and interruption Pull samples according sampling plan Store them immediately in prepared boxes Analyze data according to analyzing guideline and generate the graphics and the report on the following pages, by using After approval , the long-term evaluation begins ( verification ): under ongoing production conditions Included in process control should include at least 1 color change (if applicable) and one mold change-over minimum 20 days of production to maximum 3 months or maximum 20 lots

13. IM-Caps SBM and EBM IM-Pre Xbar/R Chart Cav. to Cav. S1 – 5 Shows if cavity equivalence Xbar/R Chart Shot to Shot SG1 – SGx Info about process changes Process capability SG1 – SGx Info about process stability Xbar/R Chart Cav. to Cav. S1 – 3 Shows if cavity equivalence Xbar/R Chart Shot to Shot SG1 – SGx Info about process changes Process capability SG1 – SGx Information about process stability Xbar/R Chart Cav. to Cav. S1 – 2 Shows if cavity equivalence Xbar/R Chart Shot to Shot SG1 – SGx Info about process changes Process capability SG1 – SGx Information about process AQP Analysing the data with 1 2 3 4 5 6 7 8 9 … 23 24 1 2 3 4 5 6 7 8 9 … 23 24 1 2 3 4 5 6 7 8 9 … 23 24

14. AQP light AQP data is not linked to AQP light data. If AQP light fails measures need to be defined and initiated! Prepare sample plan, print out and document sample times. I/MR Chart S1 Shows if cavity equivalence USE SPC RULES FOR INDIVIDUALS Xbar/R Chart SG1-SG6 Information about process changes USE HALF TOLERANCE METHOD Process capability SG1 – SG6 Check cpk values Information about process stability AQP Analysing the data with 1 2 3 4 5 6 7 8 9 … 23 24 60min run time

15. AQP Report The final AQP report with the approval , provided by the packaging manager contains: Basic project information Approval of qualification (yes or no) Material data including batch or additives Details about the choice of the critical characteristics Reason of interruptions during Qualification Run Change of master batch, change of shifts, … Data analysis and attachments Provide comments for unexpected observations Cavity to cavity analysis Shot to shot analysis Process capability analysis