The Human Factor: How to Make The Weak Link Strong

Cool chain air shipping(CCAS) temperature sensitive pharmaceutical products (TSPP’s) has always been a challenge. No matter how sophisticated the means, the human factor is often the weakest link; awareness and problem ownership can help to make the weak link strong.

A quarter of a century ago the cool chain facilities were not as well developed as in these days. There were no carriers or forwarders having a structure in place, neither in philosophy nor in physical systems, to safeguard the quality of temperature sensitive pharmaceutical products during handling and transport. The only transport modalities supporting refrigerated or frozen transfer of products were road and sea freight.

For many products, especially in the pharmaceutical industry, the lead-times in those modalities were often too long, or the shipment volume was too small, as only full load services were offered.

In the course of time "co-makership" involving individual pharmaceutical companies and their transporters, has brought the first solutions. Also in airfreight; on simple, straight forward routes insulated cool packages were shipped with no constant level of success.

In the mid-nineties of the last century the first steps were taken in the execution of air-transport using active refrigerating. ULD’s with insulated walls, battery operated fans blowing cold air into the load compartment, where the temperature was monitored by a thermostat. The required temperature for the compartment could be set between -20°C and +20°C. When internal temperature rises cold air was provided by the fan blowing over carbon dioxide (dry ice). This really was an improvement, but the system had lots of malfunctions, mainly caused by human interference: staff simply not adhering to the manual. Too low internal temperatures could not be prevented as the system could only provide cold air. Result was lots of temperature excursions and lots of problems with health authorities because of that, leading to potential disruption in healthcare and commercial disasters.
[eventpdf]
Since that time CCAS has improved a lot due to improvements made to insulation, temperature monitoring and the introduction of new active systems which can cool and heat.

Main challenge, however, remains the human factor. Air-shipping, even on simple A to B routes where capacity nor frequency lacks, is still sometimes problematic. Uncontrolled handling often leads to exposure to extremes like sun, rain, wind, snow and ice. This human factor must be seen as the WEAK LINK in CCAS of temperature-sensitive pharmaceutical products (TSPP’s).

How to prevent the negative impact of this human factor, how to strengthen the weak link?.

The answer lies in creating awareness and problem ownership. All parties involved in CCAS must be aware of the threats and risks, all parties have to acknowledge that a good result in shipping will strengthen the ties between shipper and forwarder/carrier. How can such be achieved?

Below I describe the methodology I use, which has led to many successful airfreight shipping campaigns ever since I introduced it.

The company involved is a flu-vaccine producer with activities across the globe. The product output has a 2 campaign structure each year, a northern and southern hemisphere campaign. Each of them with a lot of different destinations and a high variety of shipment volume per destination. All shipments have to be shipped and stored at a temperature between + 2°C and +8°C. Shipment size vary from a single cool-box of approx. 6 kgs to 100 block pallets with total chargeable weight of 33.000 kgs.

The production is closely planned and the product is scheduled to arrive within given weeks determined by to the local vaccination-schemes. These schemes are set in close corporation with the local health authorities.

Because the quantities sold are known only eight to ten weeks before scheduled arrival, the race against time starts immediately after completion of the production planning.

First step is the determination of required packaging. The choice for a package method for a given destination is fully dependent of the following aspects:

1. What is the capacity of the aircraft used
2. Can temperature in cargo hold of aircraft be maintained at +5°C (only for eventual shipment without insulating protection)
3. Are direct flights available
4. If no, where is stop scheduled ( only one is allowed)
5. Are stops for re-fuel or for change of aircraft.
6. What is delivery deadline before departure
7. Is cool warehousing facility available and open for use at destination airport.

Answer to these aspects and the quantity to be shipped resulted in the determination of the outer packaging.

This could be:

1. active cooling on board of aircraft (not validated)
2. active cooling by ULD ( single and/or 4-pallet configuration)(not validated)
3. passive cooling by small cool-boxes, using cooled/frozen gel packs (max lead time 48 hrs, fully validated)
4. passive cooling by high volume cool pallets ( single and/or 2 block-pallet configuration (half PMC)), using cooled/frozen gel packs (max lead time 72 hrs, fully validated)
5. passive cooling by low volume cool pallets ( non-standard pallet), using cooled/frozen gel packs (max lead time 72 hrs, fully validated)

Based on the outcome of the above, a clear picture emerges on shipment sizes in volume and weight. Also the special conditions per destination become clear. With this outcome a "Request for Quotation"-document is build, outlining each destination for this campaign with all the shipment specifics. For the packaging only the fully validated systems have been used.

Second step is the determination of three airfreight forwarders, able to deal with the total campaign. A business plan for dealing with pharmaceuticals, including Quality certification ( ISO 9001/14001) is a requirement , as well as a global network, covered by ICT-structures that allowed track-trace ( ideally real-time). And last but not least they should have a clean and solid track-record, and should be well-known and well respected in the business . These three parties, were invited to participate in a shipment based LSP selection process. (LSP = Logistic Service Provider).

The RFQ- document is sent to the LSP’s, outlining the departure week, the shipment specifics and the destination. The LSP’s are asked to complete the document with data on shipment scheduling like collection date/hour, ETD and ETA-dates, the carrier , the suggested route, the price per kg, the pre-carriage costs, the handling costs etc.

A very important aspect is the departure planning. As the shipment should be pre-booked (capacity reservation) after final determination of the LSP, also a latest flight-cancellation moment (free of costs) has to be mentioned in the RFQ. Due to the fact that the products are not ready for shipment at time of quotation, lots of events could happen during the running production process. This could lead to postponement or change of the volume, or even cancellation of the shipment.

The LSP’s responses are used in eye to eye meetings with the LSP’s, where they can further clarify their offer and ask questions. After this round of consultation an internal evaluation is made resulting in the selection of one or sometimes two LSP’s for the upcoming campaign.

The weakest link.

Of utmost importance now is to build awareness in every person in the whole chain of activities to be performed during the shipment. In order to accomplish that, the LSP is invited to meetings bringing their operational personnel, front and back office staff, and land & airside responsible persons. Also the carriers involved, both sales and operations, should be part of these meetings.

In these meetings detailed information is exchanged on the threats and risks to the product and the processes after arrival of the product at destination. The 72 hours maximum lead time from collected to delivered is highlighted, special attention is made to indirect routes, because here are additional risks and threats. The carrier and the LSP are held responsible to pass on the obtained information to their local entities, especially on the handling at time of arrival, where exposure to extremes have to be avoided as much as possible. Confirmation of understanding the ins and outs of the shipment requirements are exchanged with the shipper. This all contributes to a high level of awareness and brings key-players in the process to a kind of ownership. The people involved are empowered to contribute to a successful process and so the weakest links is strengthened.

From the very start of the actual operation, an intense flow of communication is initiated by the shipper. Every step in the operation is monitored and all milestones are alerted and confirmed. This is of course of crucial importance; proactivity and timely exchange of information, adequate corrective action in case of the slightest disruption of the shipping process are key-elements for a successful operation. The LSP acts as CONTROL-TOWER, managing their local entities and their selected carriers.

Based on temperature-logging and the complete set of flight data, an assessment is made for every shipment. When necessary, this assessment is handed over to the health authorities and supported the timely release of the product strongly.

Apart from all efforts in pre working the process, the meetings and the discussions good result can only be achieved when parties involved share mutual trust and respect. Good spirit, harmony and a good sense of humour are of equal importance to build real teamwork, making the weakest links strong.