Case Study – Product Serialization and Coding

Designing and implementing capabilities to meet emerging legislative requirements for the application of machine readable coding and serialisation of products.

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France Coding Project
Top 5 Global Pharma business.
 
Situation
The company needed to ensure that they would be able to respond in a timely and cost effective manner to the product coding requirements recently issued by French legislators. Furthermore, they wanted to ensure that any solutions would provide a foundation for anticipated European serialisation requirements. The timetable for the legislation posed a significant risk to the supply of product to France given the significant number of manufacturing lines that the company used to pack French market product.
 
How We Helped
As the global lead for the newly formed serialisation organisation in the company, one of our team members lead the team to develop:

•   A series of standard solutions to apply and verify coding on French secondary packaging.

•   New quality procedures and equipment to ensure compliance with the requirements.

•   Favourable supply agreements for the large numbers of new coding machines required.

•   A small central team to manage the procurement and supply of the new machines and coordinate the program of local installation and commissioning projects.

 
The Results
A number of machines have been installed and tested. The program continues and is on track to enable the company to meet the legislative requirements. The project won an award for excellence.

 

California Serialisation Pilot
Top 5 Global Pharma business.
 
Situation
The company needed to ensure that they would be able to respond in a timely and cost effective manner to the emerging California product serialization requirements. The initial timetable for the legislation, whilst looking unrealistic, posed a significant risk to the supply of product to the vital US market.
 
How We Helped
As the global lead for the newly formed serialisation organisation in the company, one of our team members worked with many departments to develop: •   The ability to understand and, where appropriate, contribute to the emerging legislation. •   A pilot project to serialise some products and issue electronic pedigrees to downstream supply chain partners. •   A supporting scalable local and enterprise level IT capability to support serialisation. •   A small organisation to run the pilot once implemented. •   An ongoing collaboration with downstream supply chain partners to understand how to operate and improve capabilities to meet the emerging legislation.
 
The Results
The company has an ongoing capability to understand the emerging legislation, contribute to it and other standards body related activity. The pilot project was implemented. Serialised product and electronic pedigrees were delivered to downstream supply chain partners until late 2009. A great deal was learned from this experience in this very complex area.

 

Serialization Strategy Development
Top 5 Global Pharma Company.
 
Situation
This global company recognised that there were a number of pieces of legislation beginning to emerge which required individual packs to be uniquely identified and tracked in different ways. Up until this point, a number of individual, uncoordinated initiatives had been initiated to deal with individual pieces of legislation. The company did not have a clear understanding of what serialisation was. Nor did it have an understanding of how to manage the implementation of these requirements. What it did suspect was that it was at risk of non-compliance if it did not get to grips with this emerging area. It also recognised that the costs of not reacting in a coordinated way could be huge.
 
How We Helped
Members of our team ran a strategy development project which delivered the following:

•   An understanding of the disparate activities that had been going on in the company.

•   Future state operating model, including regulatory tracking, standards development involvement, project and programme initiation and execution capability.

•   IT architecture to support the new operations.

•   New serialization management organisation design.

•   New serialization governance model.

•   Pilot projects.

•   Plan to implement the above.

•   Buy in from more than 100 stakeholders to the recommendations.

 
The Results
The strategy was implemented in it’s entirety. One of our team members went on to run the new serialization organisation for two years.