1. PS9000:2011 Launch London 2011-09-14 Arne Hoffmann Christiansen
Why have Stralfors (SIS) completed a PS9000 and ISO15378 certification process for all sites?
PS9000:2011 Launch
London
Arne Hoffmann Christiansen

2. Post Norden Group :
Eson Pac and Strålfors have agreed on a sale of Strålfors Identification Solutions (SIS) to
Eson Pac.
Stralfors

3. ESON PAC Group
The sale incorporates the SIS units in Sweden, Switzerland and Denmark which produces cartons, labels, leaflets and booklets together with the sales offices in England, Germany, France and Norway.
The new company, Eson Pac Group AB, will have a turnover exceeding 1 billion SEK and employ 550 persons in six countries.
Eson Pac Group will have head office in Veddige, Sweden and existing owners will have majority ownership. Strålfors will for a period of time remain joint owners in the new company Eson Pac Group.

4. ESON PAC Group
With these conditions the right platform is created for a future strong development of the business towards being one of the leading companies on the European packaging market.
Our core product portfolio is being extended and with other products from well selected partners we strengthen our offer within the complete packaging solution.
Customer areas will be as today; pharma, healthcare, food and industrial.
This presentation was made before the sales of SIS and therefore you will see Stralfors in the rest of my presentation

5. Stralfors has 2 divisions
Division Area Information Logistics – communication from one to many –
Division Area Identification Solutions (SIS)
With 2 Business units:
Industrial
Healthcare
Stralfors
ESON PAC Group

6. Division Area Identification Solutions (SIS)
Business unit Industrial
Develops and produces market information carriers for marking and identification
Specialist for automotive industries
Focus on Multi-Labels
Development within digital printing techniques and RF-applications
Business unit Healthcare
Focus on Pharmaceutical and Healthcare
Labels and Multi-Labels
Information leaflets and booklets
Cartons

7. Healthcare products per Site
Booklet
Leaflet
Wallet
Carton
Label
Multi label
Tåstrup
Gothenburg
Aesch

8. Benefits of dual certification to PS 9000 and ISO 15378
Status start at 2010:
One site had ISO9000 and PS9000 certification
Another had ISO9000 and ISO15378 certification
The third had ISO9000 was waiting for either an ISO15xxx for secondary products or an update of ISO15378
The fourth had ISO9000 certification - Industrial
The PS9000 was not known by all our customers
The ISO15378 was not detailed enough for secondary products
We wanted to implement common processes on all 4 sites, Industrial and Healthcare

9. Benefits of dual certification to PS 9000 and ISO 15378
We chose dual certification to PS 9000 and ISO for the 3 healthcare sites
International known and recognized
Detailed for secondary products
We could use it to work with common processes on all 4 sites
The certification process for all 3 healthcare sites was completed end 2010
Our customers recognize our certification in connection with the audits and status meetings, some are even a bit impressed

10. Benefits to suppliers and the Pharmaceutical Industry
With the dual certification, we have defined what GMP means for our production
And in this way, we are stronger in relation to customer requirements, ex. at audits when the customer transfers GMP for Pharmaceutical production to our production of secondary packaging material
Hygiene rules, Line Clearance, Validation, Physical separation between the batch in intermediate storage
We will do a lot to fulfill customer requirements – but we won’t do overkill
Or if the customer want more, then it costs extra

11. Example of different point of view
A customer had a finding at an audit
The pallets from different batch in intermediate storage has to be physical segregated
It is a general GMP role
We used the standard text to say
We don’t agree
A physical segregation will not give us a more secure process
We don’t have the space to do the segregation
It will take us extra time to do it
We have done a risk assessment and implemented additional precautions in our SOP for the next process

12. We used this clause in the standard
Segregation controls ( Cleanliness of product and contamination controls)
Materials and products that cannot be segregated by physical barriers shall be protected by other means (e.g. taped top sheet, stretch/shrink wraps, covers, nets or enclosed cages) to avoid risk of cross-contamination.
The processing of products with similar appearance (e.g. design, shape, colour) in close proximity to each other shall be avoided to reduce the risk of cross-contamination.
If this cannot be avoided, additional precautions based on the evaluation of risk shall be taken to protect the product from cross-contamination.

13. Customer agree and accepted our setup
Each pallet is marked and protected on top
ID control of each pallet into next process
Next process (gluing) has a 100% barcode reading with a bounce system
Customer agree and accepted our setup

14. Benefits to suppliers and the Pharmaceutical Industry
In a few cases, we use the standards as the argument, when customers want us to do something that involving risk of error.
Ex: There is an error in the approved artwork file we have received from the customer
We stop the process in Prepress and contact the customer
Due to time pressure, the Customer wants us to correct the error and continue the production without any approval from them
We say no – It is better to be an idiot day 1, than day 10 with a 1 million cartons with an error

15. Benefits to suppliers and the Pharmaceutical Industry
We experience very different conception of GMP in the various departments of our customers
Development – just do it now
Artwork – be my friend and correct my errors
Procurement – we need the material now
Goods in and warehouse – it has to be easy for us
Quality control – it has to be correct
With the dual certification – it is easier to say yes or no at the right time – with benefits for us and our customers
No new versions on new files, drawings
There benefits – if they need to send the file with the error to another supplier – there are no security that the error is detected
Split an order into 2 for fast delivery – without new order documents for us and our batch documentation
This order shall be delivered on 2 trucks – because it is to large for us – but it is one batch
The updated artwork or drawing is not in there system an then they reject

16. Planned - next step for the 3 “SIS” sites
On the planned follow-up audits, in the autumn of 2011, to convert to PS 9000:2011
We have done some preparation and developed a GAP Analysis tool in cooperation with Tony Harper and PQG
The GAP Analysis tool will be ready and shared later this autumn

17. GAP Analysis tool A sheet for each chapter (Clause 4 - 8)
4 functions are the built-in
Easy way of finding demand of: Documented procedure and records
ISO and PS 9000 Correlation – input from the training team
PS 9000:2001 and PS 9000:2011 Correlation - input from the training team
Client's analysis and verification – control of the process to close the GAP
Lets see: GAP analysis PS Draft-05