Developing A Recall Plan For Acidified
Foods
J.E.
Rushing
This material is intended to be a guide to the major points which should
be covered in a recall plan. It is the responsibility of the manufacturer
to construct the appendices to this outline to produce an adequate recall
plan.
A commercial processor engaged in the processing of acidified foods
is required by 21CFR108.25 to prepare and maintain a written recall plan.
Guidelines for product recalls are contained in 21CFR7. This plan will
provide a current procedure for implementation, including:
-
notifying FDA of any recalls
-
a procedure for distributors to follow to recall products which may be
injurious to health
-
a procedure for identifying, collecting, warehousing and controlling products
and a method for determining the effectiveness of any recalls.
Recall is a voluntary action taken by manufacturers and distributors to
remove food which is in violation of laws administrered by the FDA. FDA
may request a recall, but cannot order one without a court order. Product
recovery is only classified as a recall when the product is violative.
Product Identification
Each batch or production lot of the product will be properly coded as described
in Appendix A. This code will allow the product lot to be identified as
to date, batch product personnel production records, and ingredient records.
Records
Records are key to the recall plan and must be maintained for three years.
They include:
Records of examination of raw materials, packaging materials, and finished
product along with any supplier guarantees or certifications (Appendix
B).
Processing and production records showing adherence to scheduled processes,
including records of pH measurement and other critical factors (Appendix
C).
A log of all departures from scheduled processes, actions taken to
rectify them, and disposition records of the portion of product involved
(Appendix D).
Records of initial distribution of the finished product adequate to
facilitate separation of food lots which may have become contaminated or
otherwise unfit for use (Appendix E).
Notification
Persons to be notified in the event of a recall include FDA, key company
personnel, and distributors. Prepare a list of names and phone numbers
(Appendix F).
In the event of a recall, the media may also need to be notified. Only
one employee should be assigned the duty of spokesperson. Others should
refer questions to him.
The notification shall include the product, container size, and code
of affected lots. The extent of the hazard and the level of the recall
will be as determined by FDA. On the basis of this determination, FDA will
approve the recall strategy. The notification will include instructions
for consumers and distributors for product recovery and information feedback
(Appendix G). The contact person should be listed on the notification form.
Product Recovery
Plans for recovery include procedures for segregation of affected lots,
storage, warehousing, and control. Procedures in place shall allow determination
of the effectiveness of the recall (Appendix H).
The recall is concluded when FDA determines that recovery is adequate
and there is no longer any threat to the public.
Some Thoughts
Recall is time consuming and costly. It may and often has, destroyed a
company's reputation. Careful control over production and processing is
an absolute necessity to prevent the need for a recall.
In the event a recall is necessary, use the plan, paying close attention
to the notification step, the use of designated spokespersons, and good
communications to all involved. Careful planning will allow the processor
to implement the recall in a timely, organized fashion with a minimum of
confusion. This will help to minimize the public health consequences and
losses to the company.
Appendices
A. Product coding
B. Raw materials records
C. Processing & production records
D. Departures from scheduled processes
E. Records of initial distribution
F. Key contacts and phone numbers
G. Sample notification form
H. Plans for recovery of recalled product and evaluation of effectiveness
Distributed in furtherance of the Acts of Congress of
May 8 and June 30, 1914. Employment and program opportunities are offered
to all people regardless of race, color, national origin, sex, age or disability.
North Carolina State University, North Carolina A & T State University,
U.S. Department of Agriculture, and local governments cooperating.
ACIDIFIED FOODS FSE 95-2(08-95)
Send comments to foodsafety@ncsu.edu
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