Webcast Wrap Up: Establishing a State of Readiness: Mass Serialization as a Business Strategy

In October, Joseph Ringwood, COO, Systech International, joined PMP News Editor Daphne Allen to discuss the global serialization landscape in a live Webcast. Earlier this year, Allen interviewed Ringwood along with Systech’s customers to prepare the white paper, “Establishing a State of Readiness: Mass Serialization as a Business Strategy.” Systech International has more than 150 lines serialized and is involved in 90% of all serialization deployments.

Together the whitepaper and Webcast sought to provide pharmaceutical manufacturers a strategic view of what manufacturers should consider when selecting a serialization approach.

Figure 1. During PMP News’s Webcast, “Establishing a State of Readiness: Mass Serialization as a Business Strategy,” attendees were asked whether they had a formal serialization strategy. Poll results are above, based on the responses of 45 attendees who answered this question (out of a total of 103 live event attendees).

During the Web event, attendees were asked to answer the following poll questions: Do you have a formal serialization strategy? What is your timeline for item serialization? And, Do you plan to use pilot programs? The results are shown in Figures 1–3.

Ringwood answered several attendee questions during the Web event. We have summarized and excerpted several of those questions below.

Q: How long does it take to spec out and implement a serialization platform?

Ringwood: We recommend that companies start with an assessment of global serialization requirements and then develop specifications that meet a company’s high-level needs for the operation. That is a relatively short engagement. As companies start to role out, they should then look at individual lines and append that master document to accommodate the uniqueness of any lines. For one of the major companies we worked with, once we standardized what we were doing, we did a five-line plant in four days. That was after developing a standardized approach for the plant. It can happen very quickly but will depend upon the strategy of the manufacturer.

Q: Do you think there is any reason to serialize down to the dose level?

Ringwood: This will be an individual decision. Everything we are seeing today defines the item as the smallest unit of sale.

Q: In terms of using preserialized labels, is there really no impact to a packaging line?

Ringwood: Yes and no. One of the goals of serialization is that you do not want to impact throughput on the packaging line because of interactions with IT. From our perspective, using preprinted labels is no different from numbering items online. All the process functions are the same, but instead of telling a printer to print a number, read it, verify it, and commission it, you are reading a pre-encoded label and determining whether that number is in an acceptable number range—commissioning numbers as you go. Process wise, it makes no difference to us.
 

Figure 2. During PMP News’s Webcast, “Establishing a State of Readiness: Mass Serialization as a Business Strategy,” attendees were asked about their timelines for item serialization. Poll results released during the Webcast initially indicated that 33% are currently serializing items for market, 33% are serializing items in pilots, and 33% are planning to serialize more than 2 years from the date of the Webcast. Final poll results are above, based on the responses of 43 attendees who answered this question (out of a total of 103 live event attendees).

Q: Does serialization fall into any one department? Or, if it is a group effort, how do you get departments to work together that never really did before?

Ringwood: In my opinion, it absolutely is a cross-functional decision. It involves packaging, IT, supply chain, brand protection, and other professionals. Serialization creates new paradigms and requires that everyone comes to the understanding that multiple departments are dependent upon one another to create a solution.

Q: Should companies hold an internal pilot first?

Ringwood: That is a good approach. We had one customer build a fully functional production system in a nonproduction environment to develop best practices. But honestly, depending upon the regional mandates, if companies were going to take the pilot approach, they probably should have started years ago.

Q: What are the penalties for not complying with serialization
mandates?

Ringwood: Companies will have to look at individual mandates to see what the penalties are for noncompliance. California will start with fines and fees for manufacturers that do not comply, so companies that do not comply will need to evaluate whether the added costs are worth doing business in California.

Q: What about data carriers? Should we use 2-D Data Matrix or RFID?

Ringwood: Early on, we saw a lot of people using RFID, and there were a number of reasons for doing so in terms of supply-chain advantages. As serialization progressed, we saw manufacturers turn to 2-D Data Matrix. I think this may have had to do with cost drivers. Some companies have made a commitment to RFID, but also work with 2-D Data Matrix, as well. So at this point we see almost 100% adoption of 2-D Data Matrix.

Q: Are you getting involved with medical device packaging lines, too? They are awaiting Unique Device Identification standards, perhaps even mandates, but not serialization mandates.

Ringwood: Some of the early movers implementing serialization were medical device companies. They were not driven by mandates, but by other business drivers, like antidiversion programs.

Q: Does the industry need mandates to move forward with serialization, or is a business strategy enough of a driver to begin?

Ringwood: There are absolute business drivers that justify serialization for ROI from a manufacturer’s perspective. But what I am hearing from manufacturers is that they need regulations to drive implementation throughout the supply chain because much of those ROI benefits depend upon wide-scale implementation.
 

Figure 3. During PMP News’s Webcast, “Establishing a State of Readiness: Mass Serialization as a Business Strategy,” attendees were asked whether they plan to use a pilot program. Poll results released during the Webcast initially indicated that 73.6% are planning to use a pilot program. Final poll results are above, based on the responses of 39 attendees who answered this question (out of a total of 103 live event attendees).

Q: How can companies get started today if they are grappling with tight or reduced capital budgets?

Ringwood: Companies should look at scalable solutions that can be built upon and scale as they go forward to maximize their initial investments. They should also begin studying their requirements now to determine what they will need and how to standardize their processes so they are prepared for when they finally have the budget to move forward.

Q: Do companies need entirely new equipment or lines to handle serialization?

Ringwood: No, serialization will not require complete line rebuilding. Many of the lines we have serialized have been retrofits. Depending on the line and what they are doing, there might be a specific machine on the line that needs upgrading, but we find that most lines do not require mass upgrades.

To view the archived Webcast, register here. The event will be archived until October 2011.