Planning for Safety 5 Key Considerations for an Effective Recall

R. Sabbagh

4/22/2016

Planning for Safety

Introduction

Neglecting risks considered unlikely may cost a regulatory agency more than they bargained for. When

implementing a new state commerce program, resources are often consumed to capacity and proper

allocation is of primary concern. During this time, consideration as to product recall effectiveness will

often be relegated to the backseat as it becomes overshadowed by more pressing matters. Such an

approach however, exposes the program to what can be devastating risks.

Product recalls happen. They are unavoidable. What is important is the agency’s preparedness and

execution of a recall. An effective product recall demonstrates the agency’s ability to protect public safety.

It points to the agency’s leadership in safety as well as to its understanding of stakeholders’ needs. Too

often does one find instances of both public and private sector organizations that were not adequately

prepared for such an event. In those instances, in addition to the

potential tragic loss of human life, the organization often suffered

irrecoverable harm to its reputation and consumer confidence.

Lack of preparation for a recall is often due to an ROI assessment in

light of an event considered highly unlikely. The likelihood of a recall

should not be underestimated, however. By mid-April, the USDA and

FDA have already reported over 156 product recalls for 2016 alone.

Based on information published by the FDA, pharmaceutical recalls

have skyrocketed in recent years (see Figure 1), suggesting it is more important than ever to be adequately

prepared.i Fortunately, methodologies and tools exist to ensure that your agency is properly equipped

for a successful recall. The following pages present five key considerations for a safe and effective recall.

Figure 1. FDA Drug Recalls by Date

An effective product recall makes a

governing agency credible. It

demonstrates the agency’s

leadership in safety as well as to its

understanding of stakeholders’

needs.

Planning for Safety

Five Key Considerations for an Effective Recall

Segregation

Segregation refers to the ability to identify a specific lot of product as separate from others manufactured

within the same production cycle.

In September of 2007, E. coli was discovered in beef products manufactured by Topps Meat Company. It

was promptly discovered by the USDA that the company had not employed adequate manufacturing

process controls. The company lacked the ability to identify specifically which lots had been affected,

leading it to have to recall nearly 22 million pounds of product as opposed to their initial recall of 300

thousand. The company was not able to overcome the economic

impact of a recall of that magnitude and permanently shut its

doors shortly thereafter.ii

Segregation amongst production lots would have saved Topps. It

is the key to being able to identify specific lots that may have

emerged from a process or event. Without segregation, the

agency will not be able to properly mitigate costs involved in a

mass recall.

In order to avoid this pitfall, the agency must ensure that the process controls are such that when a lot of

product is divided in to sub-lots (for manufacturing or distribution purposes) one must be able to identify

and locate each sub-lot independently. When segregation is available, the governing agency has the

flexibility to limit or expand the scope of the recall as necessary and avoid prohibitive costs to the agency

and industry stakeholders.

A potential difficulty with segregation is the need to label lots with some form of a unique identifier that

represents their segregation from other similar lots (i.e. a different serial number for each lot).

Figure 2. Segregation

Segregation amongst production

lots… is the key to being able to

identify specific lots that may have

emerged from a process or event.

Planning for Safety

Tracking

Tracking refers to the ability to track each unit from its source to its final destination.

If the recall system in place relies on accurate and complete tracking data, then the agency is able to track

the path of a product’s life cycle from end-to-end. This is of utmost importance in industries where the

final product may have gone through multiple stages of processing. The implementation of a proper

tracking system enables the agency to identify consumer products resulting from a particular step within

the manufacturing process.

Specific to an agricultural industry, tracking is vital to tracing the product’s life cycle from seed to sale. If

the agency leverages a robust tracking system, then the user is equipped with the knowledge as to which

manufacturing process a harvested batch of product has gone through, which retail outlets have received

the final consumer-ready products, and even to which

particular consumer a product was sold. The different

lifecycle stages which should be considered for tracking in a

highly regulated agricultural industry such as medical

cannabis can be seen in Figure 3.

A potential difficulty with tracking is the level of experience

and coordination needed to implement an effective

tracking system for products with unique tracking

challenges.

The implementation of a proper

tracking system will provide the

agency with the ability to perform

an effective recall on consumer end

products should a defect be

identified at any stage of the

production cycle.

Figure 3. Seed to Sale Tracking

Planning for Safety

Control

Control refers to the ability to properly execute the recall process as it relates to protocol and outcome.

It is important to account for the actual methodology that the agency will use to execute a recall. Ideally,

the agency should have the ability to systematically control the fate of the recalled product as much as

possible. Where this level of control is not available, the regulatory agency is limited to notifying affected

parties and placing the onus on businesses to cooperate.

Whenever possible process controls should be implemented which allow the regulatory agency to control

how the product is to be handled once recalled. An example of such a control would be to systematically

“freeze” all specified product barcodes from being sold through the business’ point-of-sale (POS) system.

A potential difficulty with control is ensuring that the agency is equipped with controls matched to the

regulatory policies in place.

Automation

Automation refers to the ability to execute subsequent and consecutive steps without manual input.

With public safety in mind, it is important to ensure that no lot of

product slips through the cracks due to human error. Automation

is key to ensuring thoroughness with the least amount of time lost

throughout a very time sensitive process. Without automation,

the likelihood of a safe and effective recall diminishes, allowing

more room for error.

In order to avoid this pitfall, the agency must ensure that process

controls are such that when a recall is initiated, subsequent steps should be automated at every possible

stage. It is not likely that the entire recall in all of its steps will be eligible for automation. But, by

automating whenever possible, the agency is provided with assurance as to the effectiveness of steps

such as tracking inventory lots, notifying businesses, and setting identified inventory into “quarantine”

status wherever available.

A potential difficulty with automation is the fact that once a plan is set in motion it will be difficult to stop

subsequent steps from occurring.

Automation is key to ensuring

thoroughness with the least amount

of time lost throughout a very time

sensitive process.

Planning for Safety

Communication

Communication refers to the ability to notify stakeholders with timely and accurate information.

In October of 2014, the NHSTA suffered a public relations nightmare due to its handling of an airbag recall.

In the midst of a whirlwind of developing information and ongoing investigation, it was difficult for NHSTA

to keep motorists informed with accurate and up to date information. The NHSTA’s major fault was the

lack of proper communication. Today the

recall is best remembered for NHTSA’s

failure to provide motorists adequate detail,

except for an advisory to check the NHTSA

site, which was non-functional for days

following said advisory.iii

The expected window for communication

turnaround times has continuously

diminished over time. The trend for rapid

response extends to the expected

turnaround time for recall completion as

well. Time to completion for Class 1 FDA

recalls dropped from an average of 600 days

to 15 days between 2009 and 2012 alone.iv This trend has become much more of a norm than the

exception. Proper communication is vital to ensuring a quick and safe execution.

Effective recall communication should occur in mass where possible and focus on the following:

- What do businesses and consumers need to know to stay safe?

- What should businesses and consumers do with any faulty product they currently possess?

- What should businesses and consumers expect as a timeline to resolution?

A potential difficulty with communication is the ability to contact all businesses and consumers and

confirm that the message has been received and is being acted upon (if a central database is not available).

Figure 4. Number of Completed Class 1 FDA Recalls and Time to Termination

Planning for Safety

Executing a Safe and Effective Recall

Waiting until a recall strikes to think about your recall strategy is similar to waiting until a fire has ignited

to put a proper fire suppressant system in place. By being mindful of the five key considerations, you are

much more likely to execute a safe and effective recall, complete with sprinklers and fire extinguishers.

By segregating product lots, you will be able to keep the scope limited to only those lots affected. Tracking

products throughout their entire lifecycle provides you with the ability to draw linear correlations

between segregated lots and find all derivatives of the recalled product lot.

Perhaps you’ve found that a batch of intermediate material

used in the creation of final products has tested positive for

residual solvents. This batch of material may have been used

to create multiple lots of the same final product. When the

residual solvent was found, it came to light that one of the lots

used a different process which contaminated that one line of

product moving forward. By pairing segregation with tracking,

one is able to separate this specific lot and track it through the

product lifecycle to any sub-lots and/or derivatives

subsequently created all the way through to which particular

registered consumers (if applicable) purchased the product. With this you will be able to execute a recall

on that specific batch of product instead of the needing to recall the entire production line.

If a central database is available, as it is in some agricultural and pharmaceutical industries, then controls

can be used once the affected lots have been identified. Depending on the how robust the database is,

the agency can flag the identified product barcodes or and have them systematically frozen or

quarantined from being sold from a POS system. If there is no central database available, the same can

be accomplished by having policies in place ahead of time.

Once the recalled product has been segregated and tracked, it is imperative to notify all affected

stakeholders in an effective manner in regards to recall expectations. This step can be automated and

remain effective, as long as the message communicated is substantive. By automating any steps possible

the agency is able to provide a streamlined rollout.

Every industry/market will have its own unique variables to consider when executing a recall, but by being

mindful of the five key considerations your agency will be laying the foundation for a safe and effective

recall process

By pairing segregation with tracking,

one is able to separate this specific lot

and track it through to any sub-lots

and/or derivatives made all the way

through to which particular registered

consumers (if applicable) purchased

the product.

Planning for Safety

About BioTrackTHC

BioTrackTHC (www.biotrackthc.com) specializes in seed to sale tracking and business intelligence

software for the cannabis industry. The company provides inventory and sales management solutions

through a single platform while giving complete real time visibility to state regulatory agencies via the

BioTrackTHC State Traceability System. The BioTrackTHC B2B model links growers, processors and retail

dispensaries together to ensure that the entire supply chain is monitored from seed-to-sale.

i 2016 Recalls, Market Withdrawals & Safety Alerts. (n.d.). Retrieved April 21, 2016, from http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2016/default.htm?Page=1 FSIS. (n.d.). Retrieved April 21, 2016, from http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/current-recalls-and-alerts ii Belson, Ken; Fahim, Kareem (October 6, 2007). "After Extensive Beef Recall, Topps Goes Out of Business". The New York Times. Retrieved 2007-10-06. NJBIZ article "Potentially Deadly Threat Led To Recall - Topps Meat must re-evaluate sanitation and process controls" published September 8, 2007 Associated Press article "USDA Defends 18-Day Wait on Beef Recall" by HOPE YEN and JEFFREY GOLD published October 5, 2007 Archived October 8, 2007, at the Wayback Machine. iii "NHTSA's Botched Airbag Recall Leaves Car Owners in Dark." Automotive News. Web. 22 Apr. 2016. http://www.autonews.com/article/20141023/RETAIL05/141029897/nhtsas-botched-airbag-recall-leaves-car-owners-in-dark “‘Slow to act’ GM rankled NHTSA, email shows.” Automotive News. Web 22 Apr. 2016 http://www.autonews.com/article/20140419/OEM11/304219956/slow-to-act-gm-rankled-nhtsa-e-mail-shows "Takata’s Airbag Recall a Result of Converging Forces". New York Times. May 20, 2015. ... exploding airbags that have been linked to nine deaths and more than 130 injuries iv Medical Device Recall Report FY2003 to FY2012. (n.d.). Retrieved April 22, 2016, from http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm388442.pdf