Sunday, May 13, 2012

It's all about Setting Expectations

A lesson that stuck with me from my consulting days is the importance of setting expectations- never surprise a client with negative news.

So let me set expectations- Initially, your business process efficiencies will be impacted negatively by serialization.

Let's all understand that up front so that we can instead focus on the best ways to operate in a serialized world. Serialization changes the way you do business- period. It is almost ridiculous to assume that such a foundational change to manufacturing and distribution processes can be accomplished without taking some hits.

The issue in the industry, and the cause for the hyper-sensitivity, is that the focus is always, and only, on this negative. The loudest people in the room are often the packaging and distribution supervisors whose heads are on the line when throughput declines.

The unfortunate part is serialization its not being sold correctly to the business stakeholders.  I don't envy the folks in industry responsible for doing this and it's not entirely their fault.  For example we still don't have enough historical data from the industry to say "throughput is going to decline BUT here's exactly where, and how much, we'll make up in other areas."  This is changing though as companies are starting to require this level of analysis as part of their serialization initiatives.

Again my belief is the magnitude of change that serialization will bring must be made clear from Day 1.   The cost vs benefit question relative to process efficiency is a balancing act that should be documented as part of any enterprise serialization strategy.  The question at hand is:  How many events throughout the packaging and distribution processes should be captured?  The less events captured, the lower the impact to process efficiency however the more events captured, the greater process impact, but more ability to use data to facilitate process improvement.  The answer is neither extreme.

Some interesting ways how serialization data can be used (note these have nothing to do with regulations or product security) and can be used when 'selling' serialization.
  • Process Monitoring-  An example, serialization data can highlight why on Tuesday afternoons two of your distribution sites seem to have higher throughput than other days.   Serialization can provide that type of data
  • Supplier Contract Control-   Shhh.. don't let your CMOs and 3PLs know but essentially when asking them to capture serialization data for you you are really getting a detailed view into their operations.   How many items are damaged?  How long does it take to package a batch?  How often are orders re-worked?   All data that can be used going forward to enforce contract SLAs
  • Authentication-  The concept of authentication is starting to gain traction.  The rise of mobile technology allows for the tracking of product virtually anywhere.  Authentication is often associated to consumers, however, it should be thought of in terms of internal resources as well.   Authentication represents the best way to receive immediate value from serialization from the moment the first serialized item rolls off the line.  More on this in an upcoming post.

Friday, May 11, 2012

When is a Pilot not really a Pilot?

First a quick note- Congrats to EXLPharma for putting on a successful serialization and traceability conference in Philadelphia this week.   The existence of such focused workshops and conferences is yet another positive sign the industry is doing the necessary legwork to connect with industry peers and gather what's been learned to date.

The topic for this post came in part from this week's conference.   A very popular trend among pharma's taking on serialization is to run a 'pilot' to gain education and experience with how to operate in a serialized world.   I am all for the concept of pilots and agree they provide invaluable experience.   However I have a growing concern that these 'pilots' are too focused at the packing line level alone and not with core process integration.  As an analogy, my view is that serialization needs to be as core to a packaging/distribution processes as batch records and QA checks. 

Take this simple scenario:  How many pharma companies running pilots today would actually stop an order from shipping solely because a serialization related issue exists?    Or even go one step back:  How many companies would even know they have an issue with their serialization data prior to shipping product? 

In a still largely unregulated world- the reality is product supply, getting product out the door, will always trump serialization.   I completely understand this- in an unregulated environment- but highlights my concern that companies are not designing their serialization solutions to directly integrate with their core packaging and distribution processes. We all know it will have to be that way eventually- so why not at least plan for it from day 1?   

The interesting twist on this topic is that outside of pharma, high tech as a perfect example, the integration of serialization with core manufacturing and distribution processes is found in the earliest business requirement documents- and this in an industry that's not being told they have to do it.

The industry is already hyper-sensitive about process efficiency impacts due to serialization (which I'll expand on in an upcoming post) yet hasn't even reached the point in the maturation of serialization solutions where process impacts may be the greatest. 

My suggestion is to plan for a fully integrated serialization world, even if it means you dont stop shipments until required, by having the technical components to identify serialization issues and the SOPs to handle these exception scenarios.  This will help companies ensure that January 1st, 2015 (or whenever) is truly a non-event.

Thursday, May 10, 2012

Serialization in Life Sciences: How to go from Required to Desired.

You’ll likely find serialization ranked near the top of the ‘Most annoying/frustrating/irritating/just plain bad things to ask a Pharmaceutical Supply Chain executive’ list these days.  As is often true, being told you have to do something, rather than deciding to do it on your own, typically has negative connotations associated.  Not helping the cause are the occurrence of multiple delays to US state level regulations and an overall sense of confusion that still exists in the industry-  when will federal laws be defined, how do I meet the growing number of regulations around the world, who/what/when/where is needed to take on serialization at my company.
My goal with this blog is to provide some insights on how to envision the end state of serialization at your company, realizing it’s a journey, and most importantly what missteps should be avoided early in the process. 

While it’s unfortunate serialization has become a ‘dirty little word’ what’s more concerning are the initiatives that many companies have taken on to do ‘just what is needed’ to meet regulatory compliance- and not view serialization from a much broader perspective.  The narrow focus often means that process impacts are largely under-estimated and IT integration are siloed-  all topics of an upcoming blog entry.

But more impactful is the vicious cycle this creates between the industry and its serialization solution providers.   The minimalist approach of companies hasn’t pushed the majority of vendors to innovate.   As a consultant I’ve seen platforms that have gone largely unchanged in 4+ years- but in a sense can you blame the vendor?  Partially yes, but their customers were never driving them to expand and enhance their offerings.  The vicious cycle comes full circle then as pharma companies are stuck searching, confused as to where the mythical ROI, that everyone demands, will come from.

This trend (I say biasedly) is coming to an end as a crop of new vendors enter this space and push competition.  My hope is that companies expand their view of serialization, from the start, as not just bar coding unique identifiers on products to meet regulations, but as the enterprise wide, cross- discipline program it invariably becomes.

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