PRODUCT RETRIEVAL PROCEDURES
X-1 INDEX
PAGE
Overview 3
Analysis of FDA Recall Guidelines 4
A Product Retrieval Blueprint for Action 11
Food & Drug Regulations Title 21, Chapter 1 32 Subchapter A, Parts 7, 7.1 through 7.49
Method for Conducting Retrieval Effectiveness Checks 46 Published by Food and Drug Administration
Example -- Corporate Retrieval Program 56
X-2 FOOD AND DRUG RECALL GUIDELINES
OVERVIEW
The regulations set forth in the Federal Register on June 16, 1978, established the following facts:
1. If an emergency of retrieval arises, it is the responsibility of a manufacturer or distributor to initiate voluntarily and carry out a retrieval of its product that is found to be in violation of the Food and Drug Act.
2. The retrieval must be initiated when the manufacturer discovers or is informed of the infraction.
3. The burden in carrying out a retrieval is totally that of a manufacturer or distributor.
4. Although a retrieval will be conducted by a manufacturer or distributor, it must be carried out to satisfaction of the FDA.
To be able to conduct a product retrieval to the satisfaction of the FDA, the following preparation and conditions are essential:
1. An established contingency plan.
2. Assigned responsibility and authority to specific management personnel to carry out the contingency plan.
3. A thorough understanding of the regulation guidelines on retrieval.
4. Recognition of the urgency that FDA places on effectiveness, promptness and thoroughness.
5. Accurate documentation of ingredient and materials used.
6. Accurate documentation of distribution of products.
7. Accurate coding.
The proof of effectiveness can only be learned through Trial Runs.
X-3
ANALYSIS OF FDA RECALL GUIDELINES
X-4 TABLE OF CONTENTS
PAGE
Legal Status 6
Recalls and Non-Recalls 6
Types of Recalls 7
Recall Conduct 8
FDA-Company Relations 9
X-5 RETRIEVALS AND RECALLS: FDA’s RECALL GUIDELINES
FDA, on June 16, 1978, issued final regulations establishing recall guidelines, setting out current FDA policy on recalls, and the relationship between FDA and industry in conducting recalls. The final regulations, effective July 17, 1978, became 21 C.F.R. §7.3, 7.40-59.
LEGAL STATUS
The regulations are formally called “Guidelines” and, as to food products, are voluntary procedures recommended to industry. Their voluntary nature should not detract from recognizing the FDA power where industry cooperation is not given: FDA retains the court- enforced powers of seizure, injunction and criminal prosecution, and FDA claims that it can get a court to order a recall. While the basis for this claim is open to question, FDA’s unquestioned authority, as well as its control over publicity, as practical matter demand cooperation where FDA requests a recall.
While FDA will not prosecute solely for failure to conduct a recall, such a failure may weigh heavily on the issue of company and individual good faith compliance with the law, and avoidance of product illegality, which are recognized criteria in prosecution decisions.
RECALLS AND NON-RECALLS
Recalls
The guidelines recognize that not all removals of product from the distribution chain are “recalls.” Only where a product (1) has left the physical control of the vendor; (2) is in violation of the Act as adulterated or misbranded; and (3) would be subject to court action by FDA absent a recall, is a product removal a “recall.”
Non-Recalls
Any removal where the product in under the physical control of the manufacturer or distributor named on the label (and a public warehouse does not qualify for “physical control”) is a “stock recovery.” Any removal not involving a violation of the Act, or such a minor violation that FDA would not bring a court action if it knew of it, is a “market withdrawal.”
Neither of these two removals needs to be reported to FDA and, if reported, neither will appear on FDA recall lists or enforcement reports. FDA encourages reporting “market withdrawals” wherever there is any doubt as to the issue of FDA’s enforcement policy absent a recall.
X-6 Warning
Manufacturers should be extremely careful in labeling their action -- for if it is labeled a “recall,” Attorney Eugene I. Lambert, of Covington & Burling, states “FDA or the manufacturer will have determined that there is sufficient evidence for FDA to demonstrate in court that a violation of the Act has taken place.” He further comments: “...if the manufacturer calls the action a ‘recall,’ it amounts to an admission that he has violated the Act with implications in product liability actions.”
As a practical matter, manufacturers may be well advised to adopt a descriptive phrase not included in the FDA Guidelines for all internal corporate communications. For example, “product retrieval,” “product removal,” or a similar designation can be adopted for a firm for all internal use -- leaving the official determination of “recall,” “stock recovery,” or “market recovery” to the corporate lawyers and FDA.
TYPES OF RECALLS
Where a removal qualifies as a “recall,” it is either “Firm-initiated” or “FDA-requested.” An FDA requested recall exists only where a specific request is made by the Commissioner’s office in Washington (not by any field office) after FDA decides that there is a risk of illness, injury or gross deception, that action is needed to protect the public health, and the firm has not already initiated a recall. All other recalls, including those begun by a firm after being notified by FDA that a product is in violation of the Act, are “firm-initiated.”
Recalls are also classified by the degree of hazard involved from the product, using the existing “I,” “II” and “III” designations.
Class I recalls involve a “reasonable probability” of serious injury, illness or death.
Class II recalls involve temporary or reversible adverse health effect, where the risk of serious effects is “remote.”
Class III recalls are those where any adverse health effects are “not likely.”
This classification is made by FDA and included in FDA reports of recalls. The hazard classification no longer automatically determines the depth of the recall; that is a separate issue often determined before any formal FDA type classification takes place. Based on recall classes, it is unlikely FDA would request what would be a Class III recall.
X-7 RECALL CONDUCT
FDA urges all firms to develop contingency plans for conducting a recall. In the absence of such plans, a recalling firm must develop a recall plan on a crash basis for a firm-initiated recall; where FDA requests a recall, it also provides instructions for the conduct of the recall.
Recall planning must take into account (1) the depth of the recall; (2) recall publicity; (3) recall communications; and (4) effectiveness checks.
Depth of Recall
A recall plan may call for a warehouse, retail shelf or consumer return recall. The minimum recall level must take into account the amount of product distributed, its disposal at warehouse, retail and use levels, the nature and “obviousness” of the hazard involved and the difficulty of retrieval. While as a rule of thumb, recall Classes I, II and III generally correlate with consumer, retail and wholesale level recalls, the depth of the recall must be determined and justified in each case.
Recall Publicity
FDA media publicity concerning a specific recall (as opposed to routine listing of all recalls) is reserved for “urgent” cases where other means “for preventing use” appear inadequate; it will ordinarily be undertaken in consultation with the recalling form. As a practical matter, broad media publicity is more likely in an FDA-requested recall than in a firm-initiated recall. FDA also asks that it be given the opportunity to review any company press releases.
Recall Communications
In carrying out a recall, communicating with recipients of the product in a clear and direct fashion is of utmost importance. The recalling firm must:
Identify specific product, down to lot or batch number;
Describe the defect;
Caution against further distribution or use, and;
Instruct how to return the goods.
An important element in these communications is prompt response from the recipient. The availability of a toll free number or the use of preaddressed, prepaid postcards can help both spur up and ensure prompt and full response from consignees about goods on hand and return preparations.
X-8 Where a recall must operate through a number of levels of distribution, only one of which may be known to the manufacturer, it will be necessary to enlist and direct the assistance of subsequent distributors in spreading the recall message and retrieving the goods. Manufacturers must recognize that these services will not be provided gratuitously, and that the communications problems to be overcome will require extra effort. The alternative, however, to inadequate direct communications is media publicity, either by the recalling firm or FDA.
Effectiveness Checks
The guidelines place on the recalling firm the initial decision of the scope effectiveness checks, as well as the job of conducting those checks. A written guide on effectiveness checks is available from FDA.
The vigor of the follow-up to see if direct accounts received and followed the recall message is essentially dictated by the same health considerations as the depth of recall: the greater the risk of serious adverse health consequences, the greater the need to check that the message was received and carried out. A significant risk of serious illness may require 100% follow-up; a labeling violation, 2% or none. FDA will state the level of effectiveness checks as an FDA- requested recall and will comment on the level proposed in a company-initiated action.
FDA-COMPANY RELATIONS
While FDA only “requests” that it be informed of recalls and stock recoveries, the Agency clearly anticipates compliance with this request. Companies have routinely learned that it is virtually impossible to undertake a major product retrieval without FDA learning of it.
A company should plan on forthright communications with FDA, and to avoid any actions that might raise FDA suspicions that the nature of the defect and hazard have been underestimated, or that the company is responding in less than complete commitment and good faith.
The guidelines spell out the information FDA will expect from a company concerning the product, its quantity and destination, the defect and the recall program. The recalling firm will also be expected to report periodically on the progress of the recall.
FDA, in turn, will comment on the recall program (called the “strategy” throughout the guidelines), assign a classification number to the recall, place the recall on the weekly recall list and ultimately notify the company of the termination of the recall. Companies can also expect an FDA inspection of the manufacturing facility as part of the overall review of the recall action.
X-9 Recalls are an important and desirable aspect of food regulation, preferred by FDA and industry to court-enforced seizures and other sanctions. The new guidelines formalize FDA policy while leaving firms free to develop individual recall plans. Voluntary compliance with the guidelines not only serves consumer and industry interests, but also can forestall Congressional or FDA moves to impose mandatory procedures for the conduct of recalls.
X-10
A PRODUCT RETRIEVAL BLUEPRINT FOR ACTION
X-11 FOREWORD
To many manufacturers, a product recall is something that happens to someone else. Most feel that by following normal good manufacturing practices, established over a period of years, along with a reasonable quality control program, a recall will never be necessary.
It may not . . . BUT IT COULD!
This matter was the subject of a industry seminar. Among the topics considered were:
• WHAT CONSTITUTES A RECALL
• WHAT PRODUCTS ARE SUSCEPTIBLE TO A RECALL
• WHY RECALLS OCCUR
• WHAT ARE THE MANUFACTURERS’ RESPONSIBILITIES
• WHO IS RESPONSIBLE - LEGALLY AND FINANCIALLY
• COMMUNICATIONS AND COOPERATION WITH THE BROKER- WHOLESALER
A summary of this discussion follows to help prepare for the recall you, hopefully, will never have.
X-12 TABLE OF CONTENTS
PAGE
Recalls: An Overview 14
A Recall 16
Food and Drug Position 19
Identifying Distribution 22
What the Broker Needs 24
The Wholesaler’s Position 26
Organization - Acceptance of Responsibility 28
In Summary 30
X-13 RECALLS: AN OVERVIEW
Recall, verb, transitive: (1) to remember, (2) to take back.
While years past may be recalled with nostalgia, to recall in the present tense is to retrieve or bring back goods that have gotten out into the marketplace when they should not have.
Almost equally by definition, a recall is not planned; it is a surprise and requires concentrated effort on the part of the shipping manufacturer.
Not all product removals from the market are recalls. Removal of a product that does not meet a manufacturer’s internal quality control standards or removal of a product that has become a sales dud are not recalls. A recall is a retrieval of a product that violates the health and safety standards of the Federal Food, Drug, and Cosmetic Act.
If there is an immediate threat of danger, the product must be recalled even from the hands of the ultimate consumer. If the threat is less severe, it can be removed in an orderly fashion from the retail level of distribution. In either event, a company must act with speed and with organization.
A recall may only be initiated by the company when it finds that a defect exists, or it may be requested by FDA if that agency first learns of the defect. A recall, however, is not a statutory procedure. No law defines when it may be invoked, or specifies the procedure to be used either by FDA or by the manufacturer to achieve a recall.
Recalls exist as a regulatory tool because they operate faster and more accurately than conventional government regulatory action in the form of an injunction or seizure. They can act more thoroughly, because they put the resources of the manufacturer and the sales organization behind the recall. But, recalls can also operate capriciously because there are no statutory standards.
What must be remembered is that goods subject to a recall have been shipped in interstate commerce and have violated the Federal Food, Drug and Cosmetic Act. Thus, the goods and the shipper are both subject to regulatory action: the goods to condemnation and the shipper to criminal penalties. It is the threat of these two legal actions that inevitably hands over the head of a shipper when trying to determine how and to what extent a product should be recalled.
If there is one single message to be conveyed, it be “be prepared.” One cannot create a full- blown recall operation where none previously existed in the midst of a crisis; any such recall is going to be highly unorganized, subject to serious government second-guessing and always subject to the threat of serious adverse publicity. The first rule, then, is to plan for the recall that has not yet happened.
X-14 In the following pages, you will see some of the elements that go into the recall. Within every company, there must be someone to make the decision, and then someone charged with carrying that decision into action. Regardless of vacation schedules, business travel or other contingencies, there must be people having this delegated responsibility available 24 hours a day, 7 days a week, 52 weeks of the year.
However quietly a recall is made, it is always in fact carried out publicly. Wholesale accounts know of it, brokers know of it, salesmen know of it --- and FDA knows of it. It is, thus, also of high priority that the company and FDA know why it’s recalling, how it’s recalling and be able to account for what it has recalled.
How much gets recalled? That depends on how much is subject to the unexpected defect that you suddenly have found. That decision in turn depends upon how finely coded your production and distribution are. The more you can afford to throw away and have destroyed, the less precise needs to be your coding system. The more important it is to destroy only what is in fact unfit for use, the finer will be your coding system and the ability of the company to trace codes through various levels of distribution.
Finally, recalls are expensive. There is the cost of communicating the recall decision to the trade and possibly even to consumers. There is the cost of hiring a force to go out and find the goods. There is the cost of storing those goods preparatory to destroying them. There is the cost of paying people for goods that are being recalled. There is the cost finally of destruction itself. These are measurable out-of-pocket costs. There are also the intangible, but often much more important costs: the cost in lost goodwill, in lost consumer confidence, in lost sales while all efforts are being placed on the recall, in the administrative time and overheading dealing with the recall and its aftermath. And finally, there is the cost of finding out what went wrong and assuring that it does not happen again.
Read and ponder the following pages. Recall them well, so that they will be the only recall you will face.
X-15 A RECALL
Setting the state for discussion of the specifics, a hypothetical situation was presented. It postulated a product manufactured with a raw material determined to have had a pesticide residue in excess of allowed levels.
THE PROBLEM One morning, the telephone rings. It’s your egg supplier and he says that representatives of Food and Drug are in his office reporting that the samples they picked up last month were contaminated with excessive levels of the pesticide dieldrin. The eggs were shipped to you on February 1st, and you probably received them that afternoon or the next morning. Food and Drug wants the supplier to locate the eggs.
About that time, there is a call on another line, and it is Food and Drug informing you that on February 1st you received eggs from XYZ Egg Company. Those eggs have been tested and found to contain six parts per million of dieldrin. You decide you are going to have to get back the products in which those eggs were used. What happened to the eggs?
IDENTIFYING PRODUCT FOR RETRIEVAL You call your Quality Control man. He reports that they were used about the 2nd, 3rd, 4th and 5th of February to make mayonnaise and salad dressing. Eggs from two or three other sources were also used, so it wouldn’t be all the eggs from XYZ Egg Company. Where do you go from here?
First, you get a laboratory lined up. You run dieldrin tests on some of your mayonnaise; and to your surprise, you learn that all of it has just a little bit of dieldrin in it. You go out and buy Kraft, Hellmans -- samples of everybody’s mayonnaise -- and you find they all contain just a little bit.
Now, you have to go to Food and Drug and explain your problem. They tell you they don’t know the problem level any more than you do. So, you must establish a background level.
All this time, you are testing your mayonnaise and salad dressing that were manufactured during the time period in question, you find that all of it contains a bit of dieldrin -- let’s say a tenth of a part per million. All of a sudden, you find a batch with four parts per million. Was it made during that period? Yes, it was! What day, what hour of the day was it made? Now, you start looking at your hourly code.
X-16 When you start looking for a retrieval in the absence of a good coding system within your plant, the only thing Food and Drug can do is condemn everything that was produced during the period in question. If you could only determine that the product was produced on February 3rd, everything for that date would be recalled. If, however, you can find the approximate hour the product was made, you are in a better position.
THE IMPORTANCE OF CODING Through your coding, you determine this particular sample was made between 10:00 and 11:00 on February 3rd. You check samples for every hour of that day; and you find that for three or four hours -- say from 11:00 until 3:00 -- all materials produced, according to the samples, shows levels of dieldrin higher than the background levels.
When the call came initially, you called your shipping department to locate destinations of productions for the 2nd, 3rd, 4th and 5th of February. Your shipping department supplied you with a list as long as your arm and, at this point, you are convinced everyone in the world is trying to buy your mayonnaise (you had earlier thought sales were way off).
RETRIEVING THE PRODUCT But, now you have identified the problem product as having been produced within a four-hour span on February 3rd, and you are ready to retrieve it. Everybody in your office and plant able to communicate intelligently is put on the phones. You must get the word out to the warehouses informing them of the problem, finding out where products went if any were sold, telling them to hold the product and asking for a count of the cases they have. It is now about 1:00 and you need all of this information for a meeting with Food and Drug by 3:00 that same afternoon.
(At this point, you can see how important it is to have a definite policy in regard to organization of a recall. A definite chain of command should be set up and everyone informed of their exact responsibilities.)
Back to our case. Your people are on the phone telling customers to hold anything that has the suspect codes. You want them to hold -- not ship back -- and not to let any of it get out. One warehouseman says he received some, but has already sold it to the stores. This is when the situation can get very serious.
X-17 DECIDING ON RECALL CLASSIFICATION WITH FDA You meet with Food and Drug and work out the depth of recall required, based primarily on FDA’s classification of the recall. If FDA sees little or no hazard, a warehouse level recall (Class III) is sufficient. If, on the other hand, FDA believes there is a possibility of injury to the consumer, then a retail level recall (Class II) will be required.
When this happens, you have to send everybody in your company out to the stores, check the code and pick up the product in question. You CAN’T do it by phone; you CAN’T ask the stores to read your code; you can’t depend on them to do it. You’ve got to get out there yourself and make sure the product is picked up.
IMPORTANCE OF RECORD KEEPING Back to organization. Now, we are concerned with coding and record keeping. No matter how well prepared you are, when a recall comes you never have the records you wish you had, because you cannot prepare for the recall to come for the particular reason it comes. Example: In the hypothetical case, no one tested the eggs for dieldrin when they came in; you just can’t test everything when it comes in.
About the best insurance you can have is a proper receiving report that lists products by lot number from your suppliers and a system that indicates when and where they were used, by batch number of raw material, coded so you can know how it was used and where the end product winds up. You must have shipping records and coded cases so you can readily retrieve designated lots. If you are unable to do this, everything produced during the time in question can be pulled off the market.
X-18 THE FOOD AND DRUG POSITION
A representative of the Food and Drug Administration commented on the hypothetical recall, outlining how they work with the manufacturer -- their willingness to cooperate with a manufacturer who is making a sincere effort to do a thorough recall.
FOOD AND DRUG ADMINISTRATION Corporations need a commander. Food and Drug has the equivalent. They have a Coordinator, and he is an essential cog in their emergency control system. In each FDA district, there is and R. and E. Coordinator. The R stands for RECALL and the E stands for EMERGENCY. Emergencies are related to fires, floods, hurricanes, etc. At one time, all product removal was considered recall. Then, it became apparent that Food and Drug was spending a lot of manpower on recalls that could be better spent elsewhere.
CLASS I RECALL FDA has defined a threat to the consumer as a Class I Recall. A Class I Recall is for botulism. This recall is carried all the way to the consumer and Food and Drug insists on 100% contact. FDA will try to find every package. This type of recall is made public, if indicated, and FDA can issue a public warning, such as a press release or television and radio warnings. The adequacy of the recall will be extensively checked.
CLASS II RECALL A Class II Recall is a potential threat. On a Class II Recall, FDA does the effectiveness check to the dispensing level, not to the consuming level. It will generally be carried to the retail level or the distributing level, but not to the consumer. If indicated, FDA can issue a press release, but this will be determined in each case. Naturally, FDA will make appropriate checks to see how well the manufacturer is doing toward recalling the product.
CLASS III RECALL Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. Generally, this recall just affects customer’s warehouses.
WHAT IS NOT A RECALL When FDA redefined what they mean by recall, they specifically excluded certain product removal. There are three types of product removal which are not considered recalls. They are: (a) when the product has not left the plant or is in the warehouse and has not been distributed to the public; (b) if there has been a change in color or separation; or (c) a minor violation of the FD & C Act which falls within FDA compliance guidelines and would not be sufficient for them to take regulatory action. Needless to say, FDA does not forget these product removals. It investigates every one of them if manpower is available at the time, because it indicates a manufacturer’s quality control may be faulty, or GMPs are not being followed.
ACTION BY
X-19 FDA When FDA is informed of a product removal -- one instituted by a manufacturer or one indicated through sampling procedures -- the product is analyzed and the data is sent to a Coordinator in the Administration, who in turn takes it to the Office of the Commissioner. At the same time that they notify the Administration, they notify the manufacturer of their findings.
In doing so, they are extremely careful that there is no implication on their part that the product should be recalled. FDA goes out of its way to do so because, if they so recommend to the Administration, and it concurs, the Commissioner will call the affected firm and request a cooperative removal of the product. This takes it out of the “voluntary” category. When the Commissioner telephones a firm, that call will be promptly confirmed in writing.
When you are notified Food and Drug has found something wrong with one of your products, they don’t tell you that you should recall it, but they give you all that information that is available. FDA will want to know what you are going to do about it, but you will have to make that decision. Are you going to voluntarily recall it or are you going to wait until the Commissioner calls you and tells you to do it? If you voluntarily do it, it is a voluntary recall. If FDA tells you to do it, it is an FDA initiated recall.
Recalls are violations of the law. What are you doing about it? Your managers are responsible. If you instituted a voluntary recall, FDA will get an inspector there as soon as possible. What will he do? First of all, he will make an inspection. The information he obtains will be reported to the Coordinator.
Here is some information he will develop as furnished by the company:
Determine the product involved Identify the product codes Number of products involved Estimated amount on the market Probable use and degree of risk Name of the manufacturer Who is going to recall Reason for recall, and the depth How the firm learned of the problem
X-20 One of the most important things that the inspector must determine is the distribution -- where did the product go? All of this information is sent to all districts by TWX, so when a regional office sees Class I, it is top priority.
INFORMATION FDA NEEDS What is the distribution? First, the FDA representative will check and see that the particular product was distributed in a particular region, say the southeastern United States. Then, it is broken down by state. FDA gets on the phone and notifies their state counterparts that there is a Class I recall and gives them all the information available.
When there is a voluntary recall, FDA is interested, but the recall is the manufacturer’s problem. What are you going to do about it? How are you going to proceed? FDA will let you tell them what you plan to do about this. And, if you can effectively do the job, FDA will stay in the background. BUT IF YOU DON’T DO THE JOB, THEN FDA WILL STEP IN. And remember -- if you don’t do the job effectively, FDA MAY HAVE TO GO TO THE PRESS TO GET THE JOB DONE.
INCENTIVE FOR ACTION When the recall job is completed, someone is legally responsible for the violation. The FD & C Act has been violated. That in itself should be enough incentive to get the job done effectively. If you don’t have a plan, FDA will tell you exactly what you should do; in writing, if necessary.
If you don’t have a quality control system, I don’t know how the FDA or anyone can help you. FDA can tell you what you can do as far as the recall is concerned; but, if you can’t define the problem for them, then they will start full samples on everything down the line, and it may be a total recall.
If a manufacturer has set up a plan -- and you are doing your best -- then Food and Drug will go right along with you. In my opinion, if anyone has ever experienced a recall, they have found this to be true.
X-21 IDENTIFYING DISTRIBUTION
A manufacturer of dressings outlines the problems of tracing the product to be recalled through channels of distribution.
In a recall situation, everyone wants to protect the consumer. By protecting the consumer, we obviously protect our brand name. This is what enables us to stay in business and maintain our place in the free enterprise system.
WAREHOUSE RECORDS In our firm, we know that after the products are manufactured approximately 50% go into our own warehouse and 50% to public warehouses. After that, approximately 70% find their way to a co-op chain warehouse. Once the product leaves our own factory warehouse and enters another warehouse, it is very difficult to learn more than when the product went into the warehouse. It is difficult to get warehousemen to record the manufacturer’s code with actual batch numbers on their invoices as products go in and out. So, essentially, you have only the date when a product entered the warehouse. Theoretically, the UPC would take care of this. But, I don’t think it will.
THE SCOPE OF DISTRIBUTION One distribution system in a large metropolitan area consists of 11 major warehousing distribution centers, with a total of 518 supermarkets -- each of which usually has over 3,500 or more different items. In addition, this area has 3,000 or more grocery stores of varying size. Warehouses in this area serve 16 to 788 stores, with an average of 250 stores. So, obviously, if we wanted to get our product out of this particular warehousing system, we would have to cover all 11 warehouses, and so on.
If we had a captive sales force, we could have people there within a short period of time. And these people could very adequately cover the major warehousing situation. However, it is difficult to see how they could cover, say, the 518 supermarkets, if that were the situation. It would be even more impossible to cover the 3,000 grocery stores in a short enough time so that the product could be pulled back 100%.
ORGANIZING THE DISTRIBUTION SYSTEM You must organize to take care of the situation. You must build in an organization just like the elementary schools with fire drills. Someone has to be appointed monitor; and someone has to be able to coordinate with the Food and Drug Administration, and the technical arm of the whole operation. And someone has to organize the distribution system.
When you do start to recall, there are two things which you must do. First, make it perfectly obvious to anybody working with this product that it is suspect. Second, put it somewhere where you will eliminate the probability that anybody will pick up and move it out to a supermarket.
X-22
USE OUTSIDE STORAGE There is a shortage of space at the wholesale level. If the wholesaler brings the merchandise back to his warehouse, there is the chance of its getting back into distribution. One recommendation is to use an outside storage point where there will be no product segregation problems.
What will you do with the recalled product? When a recall becomes a reality, you must be able to give the answer and give it quick -- and make it stick.
X-23 WHAT THE BROKER NEEDS
A broker speaks -- identifying the problems he faces in working with the manufacturer on a recall and what he needs to more effectively work with you.
THE FUNCTION OF THE BROKER The food broker acts as a sales agent for many manufacturing firms. The average food broker represents an average of 23 manufacturers. Each covers a certain geographical area as stipulated by a particular manufacturer, and it may differ with each of the manufacturers represented. The broker employs a sales force and, in essence, attempts to cut the manufacturer’s costs, because the broker pools the efforts of his sales force and gives the principal a set sales cost.
The broker actually performs not only a sales function, but also a merchandising and marketing function, because he has two sales forces -- one covering the direct (or wholesale) buying level, and the other covering the retail (or merchandising) buying level.
When any recall problem comes to the sales level, it reaches the broker. The manufacturer CANNOT contact EVERYONE currently handling the product without using sales personnel, whether it be a direct sales force or a food broker force.
QUICK COMMUNICATION The sales agent, then, performs two functions for you. One, and the most important, is communication with the retailer. Food brokers have a responsibility to their customers first and foremost because they sell them a lot of products, and he answers to the consumer.
It is important that the broker get direct communication from you as quickly as possible so they can give their customers some specifics. As soon as any consumer information is given out, the local man is the one who gets the calls and must have some answers.
The broker needs to know:
What the problem is; How you would like it handled; As many details as possible, including code numbers, time limits, description of the difficulty.
Communication is urgent and necessary, including specifics as to how you want to dispose of the product.
X-24 SUPERVISION IS VITAL The next area of responsibility is the supervision of getting the job done. This is probably the most difficult thing because we are dealing with geography and time. More important, there are 25,000 supermarkets in this country. There is no physical way to get into all these stores. Supervision is more important and any keys that you give as to the specific parameters we must operate within to get the job done are going to help. Brokers, as the local marketing arm of your company, can have whatever is necessary done.
COMPENSATION Brokers operate on a percentage of sales, and if they don’t sell anything -- they don’t make any money. We would hope that in a recall situation there would be some form of compensation to us. We realize that you, as a manufacturer, have a lot of costs involved, and you are going to be throwing away a lot of product. That, basically, is a tax write-off for you. We pull our salesmen off the street to do a total recall for you, and we are losing income because our salesmen are not out there selling anything.
We understand, because we are in this thing jointly, but we would hope to have some means of compensation for doing the job quickly and properly, which we are capable of doing.
X-25 THE WHOLESALER’S POSITION
A wholesale cooperative buying chain representative identifies the problems particular to this operation.
As a wholesaler, we probably have less headaches than any of you, because all we will really be doing is handling merchandise back into the warehouse and to your distribution point. This is really what we do every day of the week, so it won’t be anything new.
WE NEED INFORMATION However, we do deal with the retailer; and he gets the customer reaction immediately when it becomes public there is a problem with any item. And, of course, he looks to the wholesaler for information from the manufacturer.
If we are not aware of a recall and if we don’t know what is going on and how it is to be handled, we have to put the retailer off until we can get this information.
We need to make our plans as far as picking up the merchandise from the retailer, if that has to be. How soon do we begin to pick it up? We have to await notification from you as to when you want this merchandise picked up. First, we need to notify our retailers to remove the merchandise from their shelves. To avoid any excess costs, we would like to be able, if possible, to pick up with our regular deliveries to these retailers. We deliver at least once or twice a week. However, if it is serious, we will make a special pickup for this particular merchandise and handle it by itself.
IT TAKES TIME We can get at least 75% of the merchandise back in our warehouse within one week; and in two weeks, we should have another 15%. After that, you will always have 10% stragglers for some reason or other. But, in a matter of three weeks or so, we would probably have 100% of the merchandise picked up from our retailers.
At the same time, we need to know from the manufacturer what the local representative or food broker is doing with regard to contacting retailers, because we would like to have our communications clear to them. We wouldn’t want the broker to be telling customers one thing and the wholesaler telling them another.
X-26 Once the merchandise begins coming back into our warehouse, we have the biggest problem. We need to know what arrangements you have made to have the product returned to the distribution point, or wherever you plan to send it. We have to know when the merchandise is going to be picked up to prevent a space problem. At the same time, we need verification from you as to what merchandise has been picked up (a receipt) and who it is from, if that is necessary.
WHAT THE WHOLESALER NEEDS TO KNOW We also need to know how you want the merchandise billed back to you. As a wholesaler, we should do everything we can to assist you in getting this merchandise out of the retail store, back into the warehouse and back to your distribution point.
If we do this fast enough and prove to the retailer that we know what we are going, it helps create loyalty to your product with that retailer and the consumer. Then, once the problem is corrected, it may be easier to convince the retailer to put this product back on his shelves.
X-27 ORGANIZATION ACCEPTANCE OF RESPONSIBILITY
Another manufacturer speaks . . . the importance of the chain of command and the ultimate responsibility of the supplier.
DON’T “UN-SELL” YOUR BRAND Recalls cost money. They are expensive. They are time-consuming. But, when you have a first-class major recall, the job has to be done. It has to be the number one job of the company to get the product back, even if every salesman has to come off the street and quit selling to round up the merchandise.
There is no way in the world that you can “un-sell” your name or “un-sell” your brand more effectively than through adverse publicity about a recall. So, you have to bear in mind that you are not only trying to protect the consumer, you are trying to save your company.
ORGANIZE! You must organize your own company to handle a recall situation. Organization can be everything. You should have a written company policy so that everyone will know who is in charge. As an example, in my company today, my office (even though I am out of town) is the headquarters for every distributor in the state. We have designated four people who should be contacted if a problem arises. Each has a chain of command for getting out the word within the company. This is spelled out in a written policy program so that my office becomes headquarters. Everyone knows who to contact, what to do and the steps that should be taken.
DEVELOP PROCEDURES In our company, we have what we call a “red alert,” which applies to a recall of a product which could conceivably cause sickness or death. We would never use a “red alert” for anything else. We hope we never have to use it. But, we are organized so that if a “red alert” is sent out within the company, the understanding is that everything else stops. This is done first. If we don’t sell a thing today, tomorrow or the next day, first we clean up the problem. This “red alert” can only go from one place -- from my office -- with the concurrence of the chief executive office of the company.
X-28 WRITE IT DOWN Every organization needs something like that. In a large company, this would need to have a more formal format than in a smaller organization. No organization of any size can be too well organized for a “red alert,” if one occurs. Regardless of the size of your company, you must be organized, it must be written down, there must be a chain of command, someone has to be in charge.
You must be able to determine products that are safe, products which are questionable and products which must be destroyed. This must be done by laboratory analyses. If a product is questionable, you are wasting your time and running a big risk if you try to justify keeping it. The safest and best way is to put questionable products with the tentatively defective product, and let the whole works go.
You cannot be too well organized -- your records cannot be too good -- nothing will be set up as well as you would like because you can’t tell today what the recall tomorrow will be for.
It has been our experience in working with Food and Drug, with regard to a recall, that as long as the company is working hard and trying to do the job and are conscientiously producing results, they will cooperate with you.
SUPPLIER RESPONSIBILITY In the hypothetical case outlined, the supplier of the ingredient caused a violation of the Food and Drug Act -- either the raw material or the resulting food utilizing that material was shipped in interstate commerce. This supplier has a responsibility, and FDA will inform him of that responsibility.
There are also questions of product liability for the supplier. There are insurance ramifications. If the firm was supplying the material under a continuing Food and Drug guarantee, that guarantee is equally valid as a warranty under the Uniform Commercial Code of Quality of that ingredient. There is also a responsibility for the proximate injury -- the cost of goods destroyed, the cost of retrieval, the cost of destroying, the laboratory costs -- all the costs that can be defined and isolated.
The manufacturer of a raw material is hoping to stay in business, and the manner in which he handles this responsibility will, to a large extent, determine whether or not he retains a good customer. A supplier is morally obligated, as well as legally obligated, to cooperate in this effort.
X-29 IN SUMMARY
Within the FDA organization, the decision-maker is the Chief Executive Officer of FDA, the Commissioner. Only the Commissioner’s office can formally request the initiation of a recall. There will be inputs; the field may spot the problem; there will be requests up the line, but there has to be a decision-making function.
Then, there is a coordinating function, regionalized initially to where the primary manufacturer is located, and then branching out to take in where the product has been distributed. There are laboratory functions, and there are those who do the spot checks, working with the local FDA inspectors.
Manufacturers have to have exactly the same kind of concept in their individual companies.
You have to have a DECISION-MAKER . . . somebody with the responsibility (and it cannot be a diffused responsibility) saying, ‘WE ARE GOING TO RECALL”. It is the kind of decision that needs:
- input from laboratory analysis - input from public relations - input from legal and marketing
Somebody has to push the button and say “GO.” This basically must be the CHIEF EXECUTIVE OFFICER.
You then need the COORDINATOR. The man who has been deputized to order people to actually do the job. He needs the back-up of either:
in-house laboratories or contract laboratories to define the problem and set limits on it;
his own sales force or his contract sales force (a brokerage organization or a specialty organization, such as Nielson who can get out and do the leg work);
and he needs communication to perform these functions quickly and properly.
There is no question that preparing for the hopeful uneventuality of a recall takes time and money. There is no question that coding products in finer and finer production gradations costs money. What you are doing is building up insurance so that if the unexpected eventuality takes place, you can then define and limit the problem.
X-30 Anyone in the industry who is willing to throw out everything does not need a code.
Anyone who is working with the profit margins that most industry works with is going to find that it is to his own best interest to code finer and finer gradations. That is from a management standpoint, not just a quality control standpoint.
X-31
FOOD & DRUG REGULATION TITLE 21 CHAPTER 1, SUBCHAPTER A PART 7, 7.1 THROUGH 7.49
X-32 TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 7--ENFORCEMENT POLICY
Subpart A--General Provisions
Sec. 7.1 Scope. 7.3 Definitions. 7.12 Guaranty. 7.13 Suggested forms of guaranty.
Subpart B [Reserved]
Subpart C--Recalls (Including Product Corrections)--Guidelines on Policy, Procedures, and Industry Responsibilities
7.40 Recall policy. 7.41 Health hazard evaluation and recall classification. 7.42 Recall strategy. 7.45 Food and Drug Administration-requested recall. 7.46 Firm-initiated recall. 7.49 Recall communications. 7.50 Public notification of recall. 7.53 Recall status reports. 7.55 Termination of a recall. 7.59 General industry guidance.
Subpart D [Reserved]
Subpart E--Criminal Violations
7.84 Opportunity for presentation of views before report of criminal violation. 7.85 Conduct of a presentation of views before report of criminal violation. 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.
Subpart A--General Provisions
X-33 Sec. 7.1 Scope.
This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) and other laws that it administers. This part also provides guidelines for manufacturers and distributors to follow with respect to their voluntary removal or correction of marketed violative products. This part is promulgated to clarify and explain the regulatory practices and procedures of the Food and Drug Administration, enhance public understanding, improve consumer protection, and assure uniform and consistent application of practices and procedures throughout the agency. [43 FR 26218, June 16, 1978]
Sec. 7.3 Definitions.
(a) Agency means the Food and Drug Administration. (b) Citation or cite means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of the opportunity to present views to the agency regarding an alleged violation. (c) Respondent means a person named in a notice who presents views concerning an alleged violation either in person, by designated representative, or in writing. (d) Responsible individual includes those in positions of power or authority to detect, prevent, or correct violations of the Federal Food, Drug, and Cosmetic Act. (e) [Reserved] (f) Product means an article subject to the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, and any item subject to a quarantine regulation under part 1240 of this chapter. Product does not include an electronic product that emits radiation and is subject to parts 1003 and 1004 of this chapter. (g) Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. (h) Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. (i) Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled. (j) Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. (k) Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. (l) Recall strategy means a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.
X-34 (m) Recall classification means the numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. (2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. (3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. (n) Consignee means anyone who received, purchased, or used the product being recalled. [42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979]
Sec. 7.12 Guaranty.
In case of the giving of a guaranty or undertaking referred to in section 303(c)(2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. Sec. 7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or (2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking. (b) The following are suggested forms of guaranty or undertaking under section 303(c)(2) of the act: (1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty or undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or in the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty of undertaking.) (c) The application of a guaranty or undertaking referred to in section 303(c)(2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes
X-35 adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (d) A guaranty or undertaking referred to in section 303(c)(3) of the act shall state that the shipment or other delivery of the color additive covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States. (e) The following are suggested forms of guaranty or undertaking under section 303(c)(3) of the act: (1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act. (Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act. (Signature and post-office address of manufacturer.) (Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section 303(c)(3) of the act the manufacturer of a shipment or other delivery of a color additive is the person who packaged such color. (g) A guaranty or undertaking, if signed by two or more persons, shall state that such persons severally guarantee the article to which it applies. (h) No representation or suggestion that an article is guaranteed under the act shall be made in labeling.
Subpart B [Reserved] Subpart C--Recalls (Including Product Corrections)--Guidelines on Policy, Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
Sec. 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. This section and Secs. 7.41 through 7.59 recognize the voluntary nature of recall by providing guidelines so that responsible firms may effectively discharge their recall responsibilities. These sections also recognize that recall is an alternative
X-36 to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products by setting forth specific recall procedures for the Food and Drug Administration to monitor recalls and assess the adequacy of a firm's efforts in recall. (b) Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled. (c) Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.
Sec. 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration scientists and will take into account, but need not be limited to, the following factors: (1) Whether any disease or injuries have already occurred from the use of the product. (2) Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination. (3) Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk. (4) Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed. (5) Assessment of the likelihood of occurrence of the hazard. (6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard. (b) On the basis of this determination, the Food and Drug Administration will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.
Sec. 7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the following factors will be developed by the agency for a Food and Drug Administration-requested recall and by the recalling firm for a firm-initiated recall to suit the individual circumstances of the particular recall: (i) Results of health hazard evaluation. (ii) Ease in identifying the product. (iii) Degree to which the product's deficiency is obvious to the consumer or user. (iv) Degree to which the product remains unused in the market place. (v) Continued availability of essential products.
X-37 (2) The Food and Drug Administration will review the adequacy of a proposed recall strategy developed by a recalling firm and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy. (b) Elements of a recall strategy. A recall strategy will address the following elements regarding the conduct of the recall: (1) Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows: (i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or (ii) Retail level, including any intermediate wholesale level; or (iii) Wholesale level. (2) Public warning. The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. The Food and Drug Administration in consultation with the recalling firm will ordinarily issue such publicity. The recalling firm that decides to issue its own public warning is requested to submit its proposed public warning and plan for distribution of the warning for review and comment by the Food and Drug Administration. The recall strategy will specify whether a public warning is needed and whether it will issue as: (i) General public warning through the general news media, either national or local as appropriate, or (ii) Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc. (3) Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. A guide entitled ``Methods for Conducting Recall Effectiveness Checks'' that describes the use of these different methods is available upon request from the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the Food and Drug Administration will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows: (i) Level A--100 percent of the total number of consignees to be contacted; (ii) Level B--Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees; (iii) Level C--10 percent of the total number of consignees to be contacted; (iv) Level D--2 percent of the total number of consignees to be contacted; or (v) Level E--No effectiveness checks. [43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, 1994]
Sec. 7.45 Food and Drug Administration-requested recall.
X-38 (a) The Commissioner of Food and Drugs or his designee under Sec. 5.20 of this chapter may request a firm to initiate a recall when the following determinations have been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect the public health and welfare. (b) The Commissioner or his designee will notify the firm of this determination and of the need to begin immediately a recall of the product. Such notification will be by letter or telegram to a responsible official of the firm, but may be preceded by oral communication or by a visit from an authorized representative of the local Food and Drug Administration district office, with formal, written confirmation from the Commissioner or his designee afterward. The notification will specify the violation, the health hazard classification of the violative product, the recall strategy, and other appropriate instructions for conducting the recall. (c) Upon receipt of a request to recall, the firm may be asked to provide the Food and Drug Administration any or all of the information listed in Sec. 7.46(a). The firm, upon agreeing to the recall request, may also provide other information relevant to the agency's determination of the need for the recall or how the recall should be conducted.
Sec. 7.46 Firm-initiated recall.
(a) A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate Food and Drug Administration district office listed in Sec. 5.115 of this chapter. Such removal or correction will be considered a recall only if the Food and Drug Administration regards the product as involving a violation that is subject to legal action, e.g., seizure. In such cases, the firm will be asked to provide the Food and Drug Administration the following information: (1) Identity of the product involved. (2) Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered. (3) Evaluation of the risk associated with the deficiency or possible deficiency. (4) Total amount of such products produced and/or the timespan of the production. (5) Total amount of such products estimated to be in distribution channels. (6) Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts. (7) A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued. (8) Proposed strategy for conducting the recall. (9) Name and telephone number of the firm official who should be contacted concerning the recall. (b) The Food and Drug Administration will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction. (c) A firm may decide to recall a product when informed by the Food and Drug Administration that the agency has determined that the product in question violates the law, but
X-39 the agency has not specifically requested a recall. The firm's action also is considered a firm- initiated recall and is subject to paragraphs (a) and (b) of this section. (d) A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the appropriate Food and Drug Administration district office when the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the Food and Drug Administration will assist the firm in determining the exact nature of the problem.
Sec. 7.49 Recall communications.
(a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey: (1) That the product in question is subject to a recall. (2) That further distribution or use of any remaining product should cease immediately. (3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall. (4) Instructions regarding what to do with the product. (b) Implementation. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: ``drug [or food, biologic, etc.] recall [or correction]''. The letter and the envelope should be also marked: ``urgent'' for class I and class II recalls and, when appropriate, for class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner. (c) Contents. (1) A recall communication should be written in accordance with the following guidelines: (i) Be brief and to the point; (ii) Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product; (iii) Explain concisely the reason for the recall and the hazard involved, if any; (iv) Provide specific instructions on what should be done with respect to the recalled products; and (v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm. (2) The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication. (d) Responsibility of recipient. Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with paragraphs (b) and (c) of this section.
Sec. 7.50 Public notification of recall.
X-40
The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was Food and Drug Administration-requested or firm-initiated, and the specific action being taken by the recalling firm. The Food and Drug Administration will intentionally delay public notification of recalls of certain drugs and devices where the agency determines that public notification may cause unnecessary and harmful anxiety in patients and that initial consultation between patients and their physicians is essential. The report will not include a firm's product removals or corrections, which the agency determines to be market withdrawals or stock recoveries. The report, which also includes other Food and Drug Administration regulatory actions, e.g., seizures that were effected and injunctions and prosecutions that were filed, is available upon request from the Office of Public Affairs (HFI- 1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Sec. 7.53 Recall status reports.
(a) The recalling firm is requested to submit periodic recall status reports to the appropriate Food and Drug Administration district office so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the Food and Drug Administration in each recall case; generally the reporting interval will be between 2 and 4 weeks. (b) Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information: (1) Number of consignees notified of the recall, and date and method of notification. (2) Number of consignees responding to the recall communication and quantity of products on hand at the time it was received. (3) Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the Food and Drug Administration). (4) Number of products returned or corrected by each consignee contacted and the quantity of products accounted for. (5) Number and results of effectiveness checks that were made. (6) Estimated time frames for completion of the recall. (c) Recall status reports are to be discontinued when the recall is terminated by the Food and Drug Administration.
Sec. 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the appropriate Food and Drug Administration district office to the recalling firm. (b) A recalling firm may request termination of its recall by submitting a written request to the appropriate Food and Drug Administration district office stating that the recall is effective in accordance with the criteria set forth in paragraph (a) of this section, and by accompanying the request with the most current recall status report and a description of the disposition of the recalled product.
Sec. 7.59 General industry guidance.
X-41
A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in advance to minimize this disruptive effect. Notwithstanding similar specific requirements for certain products in other parts of this chapter, the following is provided by the Food and Drug Administration as guidance for a firm's consideration: (a) Prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with Secs. 7.40 through 7.49, 7.53, and 7.55. (b) Use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots. (c) Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.
Subpart D [Reserved]
Subpart E--Criminal Violations
Sec. 7.84 Opportunity for presentation of views before report of criminal violation.
(a) (1) Except as provided in paragraph (a) (2) and (3) of this section, a person against whom criminal prosecution under the Federal Food, Drug, and Cosmetic Act is contemplated by the Commissioner of Food and Drugs shall be given appropriate notice and an opportunity to present information and views to show cause why criminal prosecution should not be recommended to a United States attorney. (2) Notice and opportunity need not be provided if the Commissioner has reason to believe that they may result in the alteration or destruction of evidence or in the prospective defendant's fleeing to avoid prosecution. (3) Notice and opportunity need not be provided if the Commissioner contemplates recommending further investigation by the Department of Justice. (b) If a statute enforced by the Commissioner does not contain a provision for an opportunity to present views, the Commissioner need not, but may in the Commissioner's discretion, provide notice and an opportunity to present views. (c) If an apparent violation of the Federal Food, Drug, and Cosmetic Act also constitutes a violation of any other Federal statute(s), and the Commissioner contemplates recommending prosecution under such other statute(s) as well, the notice of opportunity to present views will include all violations. (d) Notice of an opportunity to present views may be by letter, standard form, or other document(s) identifying the products and/or conduct alleged to violate the law. The notice shall-- (1) Be sent by registered or certified mail, telegram, telex, personal delivery, or any other appropriate mode of written communication; (2) Specify the time and place where those named may present their views; (3) Summarize the violations that constitute the basis of the contemplated prosecution; (4) Describe the purpose and procedure of the presentation; and (5) Furnish a form on which the legal status of any person named in the notice may be designated. (e) If more than one person is named in a notice, a separate opportunity for presentation of views shall be scheduled on request. Otherwise, the time and place specified in
X-42 a notice may be changed only upon a showing of reasonable grounds. A request for any change shall be addressed to the Food and Drug Administration office that issued the notice and shall be received in that office at least 3 working days before the date set in the notice. (f) A person who has received a notice is under no legal obligation to appear or answer in any manner. A person choosing to respond may appear personally, with or without a representative, or may designate a representative to appear for him or her. Alternatively, a person may respond in writing. If a person elects not to respond on or before the time scheduled, the Commissioner will, without further notice, decide whether to recommend criminal prosecution to a United States attorney on the basis of the information available. (g) If a respondent chooses to appear solely by designated representative, that representative shall present a signed statement of authorization. If a representative appears for more than one respondent, the representative shall submit independent documentation of authority to act for each respondent. If a representative appears without written authorization, the opportunity to present views with respect to that respondent may be provided at that time only if the authenticity of the representative's authority is first verified by telephone or other appropriate means. [44 FR 12167, Mar. 6, 1979]
Sec. 7.85 Conduct of a presentation of views before report of criminal violation.
(a) The presentation of views shall be heard by a designated Food and Drug Administration employee. Other Food and Drug Administration employees may be present. (b) A presentation of views shall not be open to the public. The agency employee designated to receive views will permit participation of other persons only if they appear with the respondent or the respondent's designated representative, and at the request of, and on behalf of, the respondent. (c) A respondent may present any information of any kind bearing on the Commissioner's determination to recommend prosecution. Information may include statements of persons appearing on the respondent's behalf, letters, documents, laboratory analyses, if applicable, or other relevant information or arguments. The opportunity to present views shall be informal. The rules of evidence shall not apply. Any information given by a respondent, including statements by the respondent, shall become part of the agency's records concerning the matter and may be used for any official purpose. The Food and Drug Administration is under no obligation to present evidence or witnesses. (d) If the respondent holds a ``guaranty or undertaking'' as described in section 303(c) of the act (21 U.S.C. 333(c)) that is applicable to the notice, that document, or a verified copy of it, may be presented by the respondent. (e) A respondent may have an oral presentation recorded and transcribed at his or her expense, in which case a copy of the transcription shall be furnished to the Food and Drug Administration office from which the notice issued. The employee designated to receive views may order a presentation of views recorded and transcribed at agency expense, in which case a copy of such transcription shall be provided to each respondent. (f) If an oral presentation is not recorded and transcribed, the agency employee designated to receive views shall dictate a written summary of the presentation. A copy of the summary shall be provided to each respondent. (g) A respondent may comment on the summary or may supplement any response by additional written or documentary evidence. Any comment or addition shall be furnished to the Food and Drug Administration office where the respondent's views were presented. If materials are submitted within 10 calendar days after receipt of the copy of the summary or transcription of the presentation, as applicable, they will be considered before a final decision as to whether or not to recommend prosecution. Any materials received after the supplemental
X-43 response period generally will be considered only if the final agency decision has not yet been made. (h) (1) When consideration of a criminal prosecution recommendation involving the same violations is closed by the Commissioner with respect to all persons named in the notice, the Commissioner will so notify each person in writing. (2) When it is determined that a person named in a notice will not be included in the Commissioner's recommendation for criminal prosecution, the Commissioner will so notify that person, if and when the Commissioner concludes that notification will not prejudice the prosecution of any other person. (3) When a United States attorney informs the agency that no persons recommended will be prosecuted, the Commissioner will so notify each person in writing, unless the United States attorney has already done so. (4) When a United States attorney informs the agency of intent to prosecute some, but not all, persons who had been provided an opportunity to present views and were subsequently named in the Commissioner's recommendation for criminal prosecution, the Commissioner, after being advised by the United States attorney that the notification will not prejudice the prosecution of any other person, will so notify those persons eliminated from further consideration, unless the United States attorney has already done so. [44 FR 12168, Mar. 6, 1979]
Sec. 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
(a) Records related to a section 305 opportunity for presentation of views constitute investigatory records for law enforcement purposes and may include inter- and intra-agency memorandums. (1) Notwithstanding the rule established in Sec. 20.21 of this chapter, no record related to a section 305 presentation is available for public disclosure until consideration of criminal prosecution has been closed in accordance with paragraph (b) of this section, except as provided in Sec. 20.82 of this chapter. Only very rarely and only under circumstances that demonstrate a compelling public interest will the Commissioner exercise, in accordance with Sec. 20.82 of this chapter, the authorized discretion to disclose records related to a section 305 presentation before the consideration of criminal prosecution is closed. (2) After consideration of criminal prosecution is closed, the records are available for public disclosure in response to a request under the Freedom of Information Act, except to the extent that the exemptions from disclosure in subpart D of part 20 of this chapter are applicable. No statements obtained through promises of confidentiality shall be available for public disclosure. (b) Consideration of criminal prosecution based on a particular section 305 notice of opportunity for presentation of views shall be deemed to be closed within the meaning of this section and Sec. 7.85 when a final decision has been made not to recommend criminal prosecution to a United States attorney based on charges set forth in the notice and considered at the presentation, or when such a recommendation has been finally refused by the United States attorney, or when criminal prosecution has been instituted and the matter and all related appeals have been concluded, or when the statute of limitations has run. (c) Before disclosure of any record specifically reflecting consideration of a possible recommendation for criminal prosecution of any individual, all names and other information that would identify an individual whose prosecution was considered but not recommended, or who was not prosecuted, shall be deleted, unless the Commissioner concludes that there is a compelling public interest in the disclosure of the names.
X-44 (d) Names and other information that would identify a Food and Drug Administration employee shall be deleted from records related to a section 305 presentation of views before public disclosure only under Sec. 20.32 of this chapter. [44 FR 12168, Mar. 6, 1979]
X-45
METHODS FOR CONDUCTING
RECALL EFFECTIVENESS CHECKS
Prepared by The Food and Drug Administration
X-46 METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS
INTRODUCTION
In the Federal Register of June 16, 1978, (43FR26202), the Food and Drug Administration (FDA) issued a final rule, Recalls (including product corrections) -- guidelines on policy, procedures, and industry responsibilities. Section 7.42(b)(3) of these guidelines states that the recalling firm will ordinarily be responsible for conducting recall effectiveness checks. Such checks are for the purpose of verifying that the recalling firm’s consignees have received notification about the recall and have taken appropriate action.
To assist the recalling firm in carrying-out this responsibility and in accordance with Section 7.42(b)(3) of the FDA recall guidelines, the following may be used as a guide on how to use different methods for conducting recall effectiveness checks. The methods described include mail, telephone calls, personal visits, and combinations of these alternatives. Each of these methods has been tested by FDA and the results have been analyzed in a report available through the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161 (Order #277-174/AS).
METHODS
1. General
All the methods for conducting recall effectiveness checks have several common aspects: a consignee list, a common identifier, a questionnaire, and a procedure for recording responses.
A consignee list is to be prepared when a recall is initiated by a firm. Each of the consignees notified of the recall is, therefore, a candidate for a recall effectiveness check. However, if there is suitable documentation that a consignee has been notified and has either made the proper disposition of the recalled product or has submitted a negative report on having the product, it may not be necessary to perform a recall effectiveness check at this consignee.
In order to minimize problems in correlating responses from consignees to the consignee list, each consignee on the list should be assigned a unique number which will serve as the common identifier. The consignee’s zip code can be used as part of the number.
In conducting a recall effectiveness check, there are certain basic questions that consignees should be asked. The purpose of these questions is to determine whether: the recall notification was received, the product involved was handled as instructed in the recall notification, the product was further distributed by the
X-47 consignee before receipt of the recall notification and, if so, were these additional consignees notified. Other questions may need to be asked depending upon the nature of the recall. Also, the design and format of the questionnaire may vary depending upon which method of contact is to be used.
Pressure sensitive labels should be prepared for each consignee which contain the name, address, and number assigned to that consignee. The number of such labels required for each consignee will vary according to which method is used, i.e., five labels for mail (if two mailings are used), and two for telephone calls and personal visits. For all methods, one of the labels is to be placed on a 3x5 card to be used as a control file. The second label is to be used for the consignee’s questionnaire.
As a questionnaire is returned and/or completed, it is placed with the control file card for that consignee for “logging in” purposes.
2. Mail
There are four elements to the use of mail:
a. a letter to the consignee,
b. an envelope prominently inscribed with “IMPORTANT RECALL INFORMATION INSIDE”,
c. a questionnaire, and
d. a self-addressed stamped envelope for the consignee to return the completed questionnaire.
The letter to the consignee should state exactly the reason for the recall, a complete description of the product being recalled or corrected, instructions as to disposition of the recalled product, and a request for cooperation in completing and returning the questionnaire. Exhibit A provides an example of the type of letter that can be used. An example of the questionnaire to accompany the effectiveness check letter is shown as Exhibit B. It should be noted that the exhibit questionnaires are only examples and that actual circumstances may necessitate changes in the questionnaire wording. Some pretesting of the questionnaire prior to mass mailing is also suggested.
Upon receipt of the completed questionnaires and after “logging in,” a master file should be prepared to identify responding consignees by the unique identification number and to record their answers to the questions.
About 2-3 weeks after the first mailing, a follow-up mailing should be sent to the consignees who did not respond to the first mailing. Upon receipt of the completed questionnaires from the second mailing, the same procedure as used previously should be used to log the questionnaires and to record the answers to the questions asked.
Note: A telephone follow-up to the non-respondents and non-deliverable letters from the first mailing may be made instead of a second mailing. Similarly, the non-respondents from the second mailing and the questionnaires from both mailings which were returned
X-48 as undeliverable, comprise the consignee list for the telephone follow-up if two mailing are used. Further information about the telephone method is given in the next section.
3. Telephone
The consignee list for the telephone method is the same as the mail contact method except when it is used as a follow-up to the mail method.
Interviewers doing the telephone effectiveness checks should be thoroughly knowledgeable about the background and purpose of the recall. Each interviewer should also be given a detailed question-by-question review of the questionnaire. An example of the telephone questionnaire is shown as Exhibit C.
Completed questionnaires are logged as under Section 2, including preparation of a master file on the replies.
4. Personal Visit
This method is much like the telephone method in that you are actively questioning a responsible person. The same type of knowledge about the background and purpose of the recall is required by the interviewer. The questionnaire shown in Exhibit C also can be used for personal visits with some modification; the interviewer should be familiar with the questionnaire.
This method has several advantages over the other methods in that:
(1) a concrete disposition can be made of the status of each consignee, i.e., if the firm has moved, one can probably determine the new address and complete the interview; or establish that the firm is out of business, and
(2) the interviewer can sometimes (depending on the product and type of consignee) look on the shelves and other locations to see if the product has been removed or corrected as a check on the answers.
When the disposition of each firm has been determined and the questionnaires completed, the responses should be logged and compiled as in the other methods.
X-49 5. Assessing Recall Effectiveness
Periodic status reports should be prepared by the recalling firm on the progress of the recall effectiveness checks. These reports are also helpful in determining if there is any problem with the questionnaire or the checks at an early stage.
Any reports of illness or injury should be reported to a responsible firm official immediately upon receipt so that arrangements for immediate follow-up can be made.
When the last of the recall effectiveness checks have been made, a final tabulation of the results of the contacts and questionnaires should be made. Evaluation of this data and the results of the recall should give an estimate of the effectiveness of the recall.
X-50 EXHIBIT A
Consignee Date Name and Address
(Pressure Sensitive Label)
Dear Sir:
On (date), you were notified by letter that John Doe Company, Someplace, Somewhere 12345, is recalling (product name), container size, code number. All products were manufactured by John Doe Company and distributed solely under the manufacturer’s label.
Recall of the product was initiated following a change in their formulation which resulted in products in distribution channels having the same brand name, but different ingredients. The old formulation contained X and there is concern that consumers may receive the old formula. Use of the old formulation by such consumers represents a potential health hazard.
The recall notice from John Doe Company requested consignees (wholesalers and retailers) to hold and discontinue selling their existing stock of the old formulations, and return existing inventories of the recalled formulations to John Doe Company.
In order to advise the Food and Drug Administration about the effectiveness of this John Doe Company recall, you are requested to complete and return the enclosed questionnaire promptly using the prepaid, self-addressed envelope.
If you have any questions or problems with this request, please call (name and telephone number).
Thank you for your cooperation.
Sincerely,
NOTE: If this letter is sent to distributors who may have sold the product to retail outlets, a request should be included in the above letter to have such distributors notify their customers as to the status of the product(s) in question.
X-51 EXHIBIT B
Recall Effectiveness Checks-Mail Method
Consignee Name and Address (Pressure Sensitive Label)
JOHN DOE PRODUCT RECALL
______PLEASE READ EACH QUESTION AND CHECK THE PROPER ANSWER YOU HAVE CHOSEN. PLEASE CHECK WITH ANYONE WHO MAY HAVE RECEIVED THIS NOTIFICATION BEFORE ANSWERING.
DATE ______
1. Did you firm receive notification that the John Doe Company is recalling its (Name) product?
Yes _____ No _____
2. Did your firm receive shipments of the product being recalled? (If no, please sign and return).
Yes _____ No _____
3. Do you now have any of the recalled product on hand? (Please check inventories before answering).
Yes _____ No _____
4. If the answer to question 3 is YES, do you intend to return the product to the John Doe Company as requested?
Yes _____ No _____
5. If the answer to question 4 is NO, please explain your intentions.
______
6. Have you received any reports of illness or injury related to this product?
Yes _____ No _____
If yes, please provide details.
X-52 Name of person completing questionnaire: Title:
______
IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE CONTACT YOUR LOCAL WHOLESALER OR THE JOHN DOE COMPANY, SOMEPLACE, SOMEWHERE 12345.
X-53 EXHIBIT C
Recall Effectiveness Checks-Telephone and Personal Visits
Consignee Name and Address (Pressure Sensitive Label)
JOHN DOE PRODUCT RECALL
After contacting the consignee and locating the person responsible for handling recall notifications and/or the product involved, an opening similar to the following may be used:
This is (Name of Interviewer). I am calling for (recalling firm) to check on the effectiveness of the company recall of (product description, including codes). On (date), (recalling firm) notified (how: letter, telephone, visit, mailgram, etc.), all firms which may have purchased (product) that all stock should be (returned, destroyed, modified, relabeled, etc.). I have the following questions to ask you about this recall:
DATE ______
1. Did your firm receive notification that (product name) products manufactured by John Doe Company are being recalled?
Yes _____ No _____
2. Did your firm receive shipments of the product being recalled? (If no, terminate questioning and go to the closing).
Yes _____ No _____
3. Do you have any of the recalled product on hand? (Please check inventories before answering).
Yes _____ No _____
4. If the answer to question 3 is YES, do you intend to return the product to the John Doe Company as requested?
Yes _____ No _____
5. If the answer to question 4 is NO, please explain your intentions.
______
X-54 6. Have you received any reports of illness or injury related to this product?
Yes _____ No _____
If yes, please provide details.
Thank you for your cooperation.
And your name is ______
And what is your title please ______
Interviewer ______
Date ______
IF RESPONDENT HAS ANY FURTHER QUESTIONS, ASK HIM/HER TO CONTACT THE JOHN DOE COMPANY, SOMEPLACE, SOMEWHERE 12345.
X-55
EXAMPLE
CORPORATE RETRIEVAL PROGRAM
X-56 EXAMPLE - RETRIEVAL COMMITTEE STRUCTURE
Vice President and General Manager Vice President Manufacturing Director of Manufacturing Vice President Sales East Vice President Sales West Manager of Technical Services
It is the responsibility of this committee to review any situation regarding products distributed by the firm that may constitute a health hazard to the consumer, and make specific recommendations to the President of the Corporation as to whether a retrieval, or stop sale should be carried out (in accordance with existing policy).
OPERATIONAL RETRIEVAL COMMITTEE
Director of Manufacturing Manager of Distribution Manager of Technical Services Manager of Administration and Purchasing Manager of Quality Control
* General Plant Manager * Plant Production Manager * Plant Distribution Manager * Plant Quality Control Supervisor
* of the plant or plants involved
It is the responsibility of the committee, under the direction of the Director of Manufacturing, to carry out an efficient retrieval, or stop sale according to an established procedure.
X-57 EXAMPLE - RETRIEVAL PROCEDURE
Method of Tracing (where ingredient/supply item is cause for retrieval).
Step #1
Research Purchase Order to determine if item was purchased.
Step #2
Research Ingredient/Supply Movement tickets to determine:
1. When received 2. If lot number is one in question 3. When it was used
Step #3
Research Item - Products Reference List to determine what products use item in question.
Step #4
Research Daily Production Report and/or Inventory Change Notice to determine which of which products identified in Step #3 were product during period item was used.
Step #5
Identify Finished Goods Movement Tickets of products produced.
Step #6
Research Shipping Orders to determine which customer received products of the identified movement tickets.
Step #7
Contact customers and isolate products.
X-58 EXAMPLE - INFORMATION REQUIRED
Information necessary to trace product.
Purchase Order
(1) Item, (2) Quantity, (3) Date of Order, (4) Order Number, (5) Supplier
Receiving Movement Ticket
1. Purchase Order Number 2. Date of Receipt 3. Supplier 4. Lot Number 5. Quality Control Inspection and Sampling Date 6. Total Quantity 7. Quantity Assigned to RMT 8. Ticket Number 9. Date or Period Used in Production
Item - Product Reference List
1. List of All Product Using Item
Daily Production Record
1. Product and Quantity Produced 2. Date of Production 3. Copies of Finished Goods Move Tickets (attached)
Finished Goods Move Ticket
1. Ticket Number 2. Product 3. Quantity 4. Date
Shipping Order
1. Product Shipped 2. Date Shipped 3. Customer 4. Finished Goods Move Ticket Number(s)
X-59 EXAMPLE - RECORD RESOURCES
1. Records to be considered
2. Ingredient/Supply - Receiving & Movement Ticket
3. Purchase Order
a. Item - Products Reference List b. Daily Production Report
4. Inventory Change Notice
5. Finished Goods Move Ticket
a. Copies in Move Ticket
(1) Production Department (2) Distribution Group (3) 2 Copies not designated
6. Shipping Order
X-60