August 26th, 2010

Greetings!

Welcome to Volume 6 of Cost-Effective Quality, ABC's newsletter for the food and drug industries regulated by FDA and the states.

Starting right now, you can look forward to: 

• cost-effective solutions to common industry issues
• clear explanations of regulatory requirements
• and exclusive opportunities not offered to others in the industry

Welcome, and I hope you find this edition of Cost-Effective Quality beneficial in your daily operations!

Unraveling the Regs

Compliance, Quality, and Operational Tips

Managing the Dreaded Recall



There are not too many words in the English language that cause consumers' heads to turn and industry insiders' skin to curl like the word, Recall. Recalls are situations that all companies in the food and drug regulated industries try their best to avoid, try their best to be prepared for, and think will never happen to them. However, it happened recently and in a big way with Wright County Egg!

What is a Recall



Simply put, a recall is a situation that is necessary when a product is found to be defective in some way where removing it from the marketplace is the only way to ensure consumer safety. In most situations, a company will discover through testing, either from their own routine testing program or as a result of a customer complaint, that a product lot does not meet one or more of the specifications that are established for that product. However, not all product failures that are discovered by a company lead to a recall.

Is It Really a Recall Situation

To determine whether a recall may be necessary the first step is to perform a risk assessment. By looking at the failure and what impact it has on the safety and efficacy of the product, conclusions can be drawn as to the chance a consumer or user can be harmed by using the product. If the chance is low, a recall may not be necessary. That is why performing a comprehensive health hazard risk assessment is a critical step in determining a course of action. Often companies use product, process, and regulatory experts such as ABC to consult or help perform the assessment in order to lessen in-house bias or to help possibly lessen regulatory authority (e.g. FDA, State Department of Health, etc.) scrutiny.

After the health hazard risk assessment has been initiated, information needs to be gathered in preparation for an eventual consultation with the Food and Drug Administration (FDA) regional office and other regulatory agencies. For example, the following information needs to be obtained promptly:

* Number of Units Produced

* Number of Units Remaining In-House

* Number of Units Distributed and To Whom

* Could Other Lots or Products Be Affected

This information together with the health hazard assessment is used to determine whether or not the company (not the regulatory agencies) believes a recall is necessary. Once the company has gathered all the necessary information and made its conclusions as to whether or not if feels feel a recall is necessary, the FDA and other regulatory agency regional offices are consulted to discuss the situation and discuss the company's proposed course of action. Again, many companies employ expert services from a firm like Advanced Biomedical Consulting when meeting and discussing options with the regulatory bodies.

Oh No, It Is A Recall

So, a recall has been deemed necessary. After the initial shock of dealing with the regulatory agencies, filing mountains of paperwork, and losing a chunk of sales due to competitor scare tactics sets in, a documented recall strategy.

The recall strategy includes a communication plan which is the means by which the details of the recall and the instructions to the recipients are relayed. The depth of the recall determines the level to which this communication is disseminated to customers. For example, does the company have to contact its distributors only or all the way through to the consumer?

The recall strategy should also include systems to address each area that will be affected by the recall (e.g. Receiving, Accounting, Customer service, etc). Proper planning at this stage will avoid chaos later down the road when telephone calls and recalled product start pouring in.

Keep An Eye On the Ball



Often companies have to dedicate a full-time resource or consulting organization to effectively manage the recall effort and keeps tasks on track. This is critical for the following three main reasons:

1. Safety (i.e. Getting Product Off the Market)

2. Regulatory Compliance

3. Financial Impacts (e.g. Customer Perception of the Company)

Two ways that help the recalling company stay focused are effectiveness checks and status reports. Most times, depending on the type and depth of the recall, FDA will require that effectiveness checks be performed as part of the recall strategy. Effectiveness checks are additional verifications that each of the consignees has received the recall communication and is taking the appropriate action as directed by the recalling company.

As part of the recall strategy status reports to FDA are required at intervals agreed upon by the company and FDA. Status reports summarize the current state of the recall (e.g. how many consignees have responded, how much product has been accounted for, how much has not been accounted for, etc.). This information is not only required by FDA but is a great way to keep upper management informed and to ensure that the recall process does not get stalled.

Are We Done Yet?

OK. The recalling company has sent communications out, consignees have responded, product has been returned, status reports have been submitted, and effectiveness checks have been completed. The recall is now over, right? Wrong! Actually a company cannot decide that a recall is over. The official recall termination notice must come from FDA. A company can request that the recall be terminated by submitting a recall summary report stating that all efforts have been exhausted for the product retrieval and justifying that the recall strategy has been successfully and completely implemented. Only if FDA agrees, will FDA send the recall termination letter to the recalling company.

Summary

Product recalls are very time consuming, requiring cooperation, organization and level-headedness for a company to survive relatively unscathed. Resources are often stretched to accommodate the increased requirements and the company usually becomes under increased scrutiny by FDA and other regulatory agencies especially if the recall if mismanaged. Even massive recalls such as the recent situation with Wright County Egg can be managed successfully allowing the company to bounce back.

Advanced Biomedical Consulting has been involved in hundreds of successful recalls for food, pharmaceutical, medical device, cosmetic, and dietary supplement manufacturers and distributors from a pure consultative perspective all the way to full outsourced management of a recall. If your organization has a potential recall, wants to be prepared for a recall, or is already involved in a recall, call us directly at the toll free number below or contact us on the web here, and we can generate a quick and easy quote for your specific needs and get the job done quickly and right the first time. Ask us to quote on a project before Septemember 30th, and receive a 10% discount off of our current consulting rates.

Thank you for reading this edition of Cost Effective Quality!