Minsk Site Quarterly Review

Q3 2021 Results
Date: XX.10.2021

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 Last Qtr Review Takeaways
- What are the drivers of the overheads increase? / Slide 4
- 2021 full volume impact and recovery plan.
- Ostomy data collection (Javier Cueli can be asked for assistance).
- How packaging issues can be addressed?
- How do you address open CAPAs? / Quality
- Vos Logistics – escalation process should be shown. Who is working on it?
Start escalation process in case of poor performance / Logistics
- Training Plan breakdown should be added / HR
- Voice of the Customer / Quality Week / exposure to doctors and nurses should
be considered / HR
- Employees’ grades should be added / HR
- Quality, Logistics split by people should be provided to Constantinos separately /
HR
- Evaluate possibility to expand the usage of local Steriliser / Logistics
- What is the proportion of PVC and ABS usage? PP and PVC instead of ABS and
SAN should be considered.
- OEE target should be set as 85% / Production
- Our plan regarding the increased number of Technicians / Technical Department

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 Overall Summary by Plant
Accomplishments Challenges
• Growth of COVID-19 positive cases;
• Q@S, HandyVac data collection process established; • The Hazard Observation Ratio did not meet the targets;
• ISO 45001:2018 pre-assessment BSI audit; • Validated saving from CI projects is less than expected due to volume dropdown
• Annual idea generation workshops are completed. Prioritization and ideas estimation process
and complexity of implementation;
are completed, list of potential future projects defined. Annualized estimated saving USD200k; • Struggling with RCA and SWI tools usage;
• BO level in target - 32k$ at week 40, inventory is in target as well; • 1 truck with Unometers blocked at external warehouse at NL after customs
• No more trucks are in sterilization queue, sterilization backlog due to capacity shortage
inspection at Poland boarder;
eliminated; • Medplast HD sterilization cycle for LD products – JHT passed, functional testing
• DS Smith A/S saving project: new price list from September agreed;
failed;
• MDR project for class I Non-sterile products was partly completed, 18 out of 22 SKUs were • 4 sterilization cycles (128 pall) were blocked under NCs for sterilization process
implemented fully;
at Steris Venlo;
• Sales price 2021 adjustment; • No responses from Steris for SCARs.
• Electronic Engineer hired;
• Green belt project “Decreasing scrap rate in routine production for Unometer bags ref.
925532.3SFG” has been completed.

Current Qtr 90 Day Plan – Key Deliverables

• Focus Factory concept;
• Start of sterilization 3 SKUs of Passive drains at Medplast, equal to current RU SKU;
• Adoption of Low Density to High Density cycle for Medplast;
• WAVE initiative#20406 Robots for transporting of molding components. URS development ongoing
soon.

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QUALITY

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Accomplishments Challenges
• Stop-ship for film with delamination issue is completed. 5 internal audits •21 Planned deviations are initiated;
were conducted in Q2;
•CAPA 1468642 for Careline;
• Requalification Master Plan for sterilization at Medplast approved;
• 1 Green Belt project is successfully completed; •Fins on the UnoMeter lid due to the defect of mold;
• QaS New Data collection forms are implemented for HandyVac, move to •Failed new method of gluing (UM products);
Level3; •SFG with not established expiry date are stored at the warehouse;
• QaS QCP developed.
•SCAR handling process with Steris-Venlo;
•Supplier Audit Scheduled for 2021;
•Control of handling of damaged goods at Steris-Venlo;
•QаS Manufacturing Workstream for OP-Flex Handles/Sets is in progress.

Current Quarter 90 Day Plan – Key Deliverable

• MDR project;
• Best In Class projects;
• 2 Green Belt projects;
• Start HC and FC cycles at Medplast in frame of CCR-DMR-00283;
• EO testing in frame of sterilization requalification at Medplast;
• Synchronization of Level 1, 2 and 3 for QaS project;
• Keep metrics for NC/CAPA process within the established limits;
• MA plan implementation.

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 Compliance
Q1 Q2 Q3
Metric Average Average Average JUL AUG SEP Goal
CAPA aging (Implementation phase)
No No No No No No 0 – major;
NC Per External Audit data* data* data* data* data* data* ≤2 minor
450
420
365 365 365 365 365 365 365 365 365 365 365 365 CAPA Effectiveness 100% 100% 100% 100% N/A** 100% ≥90%
320
Closed by due date with no
Days open

263 100% 100% 100% 100% N/A** 100% ≥75%

216 extension
181 204
147 154 162 155 Closed by due date with no
119 more than 1 extension 100% 100% 100% 100% N/A** 100% ≥85%
CAPA Aging Total -average 340 334 363 335 366 387 365
OCT- NOV- DEC- Jan- Feb- Mar- Apr- May- Jun- Jul-2021 Aug- Sep- (Days)
2020 2020 2020 2021 2021 2021 2021 2021 2021 2021 2021
CAPA records open longer than
12 months 46% 45% 38% 30% 40% 43% 10%

Average days CAPA open Target

*no external audits have been conducted **no CAPAs have been closed

CAPA Aging (Effectiveness check phase)

CAPAs open longer than 1 year (actual for the 1st of October 2021)
713 722 PR ID Short Description
642
682 1230949 Defective Filterflow found by Acoma (Effectiveness check)
612 1293438
581 Hard to clamp tube in HandyVac (in progress)
551
1338549 Software validation (Effectiveness check)
Days open

483 504
478 476
444
Actions Taken/ Planned (actual for the 1st of October 2021)
CAPAs open: 7
CAPAs in Effectiveness check phase: 3
Closed CAPAs (Q2) : 8
New CAPAs (Q2) : 1
OCT- NOV- DEC- Jan- Feb- Mar- Apr- May- Jun- Jul-2021 Aug- Sep-
2020 2020 2020 2021 2021 2021 2021 2021 2021 2021 2021 CAPAs > 1year older: 3
CAPAs pending Action/EC plan: 0

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 Post Market
  August, September, Q3 YTD
45.00

July, 2021 40.00

CPM, 2021

2021 2021 (01-Oct-2021) CPM, 2020

Limit (13,65) 2021

35.00
Limit (15,17) 2020

Total Complaints, pcs 13 19 12 168

30.00

25.00 23.65
CPM 23,65 15,63 6,06 10,79
20.00
17.13
PPM 23,65 15,63 15,16 27,82*
14.16
15.63
15.00
*YTD value in ppm is significantly bigger than cpm value due to a single complaint for 200 pcs of 12.09
10.00 9.83 8.46
Cathy product received in Jan-2021
5.28 6.06
5.00

Top 5 complaints last 12 month 0.00

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Blue part of bag outlet valve is de-

tached/leakage (UM SP)
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Actions Taken/ Planned for most critical issues:
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Leakage between chamber and bag
(UM SP)  Blue part of bag outlet valve is detached/leakage (UnoMeter Safeti Plus) – this
47
14 issue relates to free-flow taps, produced by Slovakia plant. CAPA was initiated by
Double lumen tube detached from Slovakia plant.
the chamber (UM SP)  Double lumen tube detached from the chamber of UnoMeter Safeti Plus – the
investigation revealed the likely causes of the issue and Correction were initiated.
Leakage of bag BY (UM SP)
29  Handy Vac does not hold vacuum - the investigation revealed the likely causes
HandyVac does not hold vacuum of the issue was initiated. CAPA was opened to implement new DEHT material for
HandyVac tubes.
 Leakage between chamber and bag of UnoMeter Safeti Plus - the investigation
revealed the likely causes of the issue and CAPA were initiated.

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 Process Control
NC by category in Q3 TOP 4 of NC in Q3 2021
Packaging Transportation Supplier quality of RM Sterilization
81
17

14
NC, pcs

7
6
5 5 5
14 4 4
9 3 3
1
Product / Process Material Other
Jul-2021 Aug-2021 Sep-2021

TOP defects Q3 2021

Q1- Q2- Q3- Jul- Aug- Sep- Poor quality of printing on individual package
Metric
2021 2021 2021 2021 2021 2021 Poor quality of sealing line of individual package
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# Non-Conformances (NCRs) Open 86 132 104 20 35 49 foreign particles in individual package
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# Non-Conformances (NCRs) Closed 123 115 113 45 39 35 Damaged shippers

3 3 3
Stop-ship:
1. Event TW# 1433510 – Film with delamination (Closed) 2 2 2

1 1

Jul-21 Aug-21 Sep-21

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 Supplier Control
  Jan, 2021 Feb, 2021 Mar, 2021 Apr, 2021 May, 2021 Jun, 2021 Jul, 2021 Aug, 2021 Sep, 2021
Opened 6 11 9 6 14 8 3 13 16
Closed 6 1 4 7 0 0 11 0 8
SCAR Overdue
83% 43% 67% 100% 93% 100% 67% 69% N/A
(15 days)
SCAR Overdue
83% 14% 56% 67% 79% N/A 33% 69% N/A
(30 days)*
SCAR Overdue 17% 14% 56% 50% 79% N/A 0 N/A N/A
(45 days)*
Audits 0 0 0 0 0 0 0 0 0

*Overdue: According to WI-0499 - Supplier has to send a response for SCAR within the 30-day requirement, an additional 15 days may be extended
to supplier. Top 5 External Suppliers' issues
4%
Top supplier QA issues
Top 5 External Suppliers'
9% issues
35
31
30 10%

25 23

20 13%
64%
15
11
10 Steris-Venlo
Vos Logistics
5 4
DS SMITH PACKAGING DENMARK A/S
0 MODEL OBALY A.S. OPAVA
Sterilization issues Damages of goods during boxes with manufacturing defects Alert risk level for the results of
transportation/ handling Supplier Monitoring NORDIC TRANSPORT GROUP EAST A/S
9
Number of SCARs

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MANUFACTURING

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Accomplishments Challenges
• Production plan Q3 2021 positive result; • Niko-Fix new printer project implementation delay;
• 100% capacity utilization in October-November 2021, • New gluing method for UM Safeti SFG, trial failed;
24/7 working schedule; • UM bags production (A004), UM cord welding (UW04) -
• Total Safety Leadership roll-out in production; material efficiency negative impact.
• OHI plan implementation,
new motivation standard for production employees;
• Q@S program support, HandyVac product data collection
  finalized;
• Molding area layout optimization;
• AOP 2022 completion;
• Annual idea generation session;
• Mid-Year-review.

Current Qtr 90 Day Plan – Key Deliverables

• TSL training deployment;
• KOM upgrade;
• CI Maturity Assessment;
• UM Safeti line balancing project implementation;
• SWI development;
• Process engineer replacement;
• GB projects implementation support;
• Daily monitoring of COVID-19 situation at production.

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 Overall Equipment Effectiveness (OEE)
OEE (%, vs. target)
100.0%

95.0%

89.3%
90.0% 88.9% 88.0% 88.3%
87.3% 87.7% 87.8%
86.5% 87.0%

85.0%
Greater quantity and production time for
machines with an average OEE<80%:
80.0%
packaging & semi automated assembling
machines
75.0%
Jan 2021 Feb 2021 Mar 2021 Apr 2021 May 2021 Jun 2021 Jul 2021 Aug 2021 Sep 2021 Oct 2021 Nov 2021 Dec 2021

Overall Equipment Effectiveness, % Series2

What was done:
• Update OEE analysis method to the SKU level
• Change the source of OEE calculation data: cycle times from KOM system to ideal cycle times from machine cards for every SKU
• Extend quantity of machines to analyze
• Semi automated data entry process: performance data from KOM
Next steps:
• Fully automate the data entry process: transfer availability data from KOM
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OEE – Molding, Packaging, Extrusion

Adding more packaging

machines to the analyze.
summer Machines average OEE≈76%.
shutdown

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OEE – Ostomy, Bags, AS777

GB projects and tech

updates

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