Why have Stralfors (SIS) completed a PS9000 and ISO15378 certification process for all sites?

PS9000:2011 Launch

London 2011-09-14

Arne Hoffmann Christiansen

Post Norden Group

Stralfors2011-09-01:Eson Pac and Strålfors have agreed on a sale of Strålfors Identification Solutions (SIS) toEson Pac.

ESON PAC Group

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• 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.

ESON PAC Group

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• 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.

Stralfors has 2 divisions

• Division Area Information Logistics– communication from one to many –

• Division Area Identification Solutions (SIS)

–With 2 Business units:

• Industrial

• Healthcare

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Stralfors

ESON PAC Group

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

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Carton

Gothenburg

Tåstrup

Aesch

Multi labelLabelBooklet Leaflet Wallet

Healthcare products per Site

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

Benefits of dual certification to PS 9000 and ISO 15378• We chose dual certification to PS 9000 and ISO 15378 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

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

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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

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We used this clause in the standard• Segregation controls (7.5.1.1 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.

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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

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Customer agree and accepted our setup

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

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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

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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

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GAP Analysis tool • A sheet for each chapter (Clause 4 - 8)

• 4 functions are the built-in

1. Easy way of finding demand of: Documented procedure and records

2. ISO 15378 and PS 9000 Correlation – input from the training team

3. PS 9000:2001 and PS 9000:2011 Correlation - input from the training team

4. Client's analysis and verification – control of the process to close the GAP

• Lets see: GAP analysis PS9000-2011-Draft-05

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