SOP - Product Recall

Doc. No.
KBE/FSQMS/R-001
Kay Bee Exports Issue No. & Date: 01/ 01 05 2019
Title: SOP – Product Recall/ Version/ Last Revision Date: 02/ 01 04 2020
Next Revision Date: 01 04 2021
Withdrawn
Amendments to last version: Number of Pages: 1 / 7
TITLE: PRODUCT RECALL
1. Introduction:
Food on sale for human consumption must be wholesome, unadulterated, uncontaminated,

properly labelled and fit for human consumption. Violation of the provisions in these regards
may lead to regulatory action against the concerned FBO under the Act, or rules and
regulations made thereunder.
2. Definition of Product Recall:
Food recalls are an appropriate method for removing or correcting marketed food products
and their labelling that violate the laws administered by the regulatory authority. Recall can
be defined as an action to remove food products from market at any stage of the food chain,
including that possessed by consumer, which may pose a threat to the public health or food
that violate the Act, or the rules or regulations made thereunder. Recall of food product is in
the common interest of the industry, the government and in particular the consumer.
Recalls afford equal consumer protection but generally are more efficient and timelier than
formal administrative or civil actions, especially when the product has been widely
distributed.
Manufacturers and/or distributors should initiate a recall at any time to fulfil their
responsibility to protect the public health from products that present a risk of injury or gross
deception, or are otherwise defective. Firms may also initiate a recall following notification
of a problem by Food Authority or a state agency, in response to a formal request by
authority, or as ordered by Authority.
3. Purpose:
• To have a procedure for effective recall of product under deviation or not

meeting the customers/ regulatory requirements/ Country legislation, where the
product is sold.
• To describe the factors to be considered in making a decision to recall.
• To state the responsibilities and actions to be taken to manage a recall.
• To describe the co-coordinating groups involved in a product recall, and their
roles.
• Inform the competent authorities in no time.
Doc. No. KBE/FSQMS/R-001
Withdrawn
• To define the responsibilities for investigating, documenting and reporting the

causes of a recall.
4. Justification:
• Effective product recall management is essential to minimize risks on the

consumers and any adverse effect on the company.
• To have a physical control of non-compliant product so as to address the
customer’s/regulatory concerns and ensure corrective actions for future.
• It will assist in identifying products which are unsafe that violate the Act, or the rules or
regulations made thereunder and enable recall of the product(s) from the market place.
5. Scope:
This procedure is applicable to all Kay Bee Exports products.
6. Role of the Food Authority:
The Food Authority’s main role in a recall is to monitor the progress of the recall and assess the adequacy of
the action taken by the FBO in this regard. After a recall is completed, the Food Authority will make sure that
the product is destroyed or suitably improved. Where the recall is related to serious defects in the
manufacturing process, the concerned authority may review the license of the FBO concerned.
The Food Authority will publicise the recall when it is of the opinion that the public need to be alerted about
a health hazard or that clarification of the situation needs to be made to allay public worries.
In cases of public health emergencies, the Food Authority may, depending on the available evidence, alert
the public before a decision on recall has been reached.
6. Responsibility:
C.E.O., Director, Operation Manager and Manager – Quality Assurance
➢ C.E.O:
C.E.O. is responsible for analyzing the severity of the situation and to inform the same to
Director – Operation Manger – through Manager – Quality Assurance for recalling the
product. C.E.O / Director/ Manager – Quality Assurance to co-ordinate with Recall
Management Team at HO till the completion of the activity of product recall.
Operation Manager is responsible for ensuring that the product identified for recall is
Withdrawn
completely pulled out from the affected markets and also to co-ordinate with Recall
Management Team till the completion of the activity of product recall.
7. Food Recall Plan:
At the time of recall being carried out, detailed recall plan shall be submitted to the CEO, FSSAI,
Director of APEDA and the Auditor of Certification Body as as prescribed in the regulation 7 of
Food Safety and standards (Food Recall Procedure) regulations, 2017 brief step by step
procedure and its description are as below:
Withdrawn
8. Recall Management Team (RMT):

- Recall Management team comprises of the following members:
Sr. Name of the Person Designation Contact details Email

No.
Withdrawn
1 Mr. Kaushal Khakhar CEO 9870405667 kaushal@kaybeeexports.com

2 Mr. Sachin B. Yadav Director 9673003060 Sachin@kaybeeexports.com
3 Mr. Nanda Kisore Biswas LA and 9662150406 nandakisore@kaybeeexports.
FSMTL Com
4 Mr. Sameer Khilare Manager - 9833672898 Sameer@kaybeeexports.com
Operation
4 Mrs. Vrunda Quality 7066036616 vrunda@kaybeeexports.com
Rudrabhate Officer
5 Mr. Ganesh Nikam Asst. 8788465873 Ganesh@kaybeeexports.c
Manager - om
Production
6 Regulatory FDA office 02162233243 Satara.fda-mah@nic.in
authority Satara
7 Kay Bee Veg Ltd (UK) Customer 447983216600 rajan@kaybeeve.co.uk
8 Astron Packaging Ltd Supplier 9909963329 Tushar_nimavat@astronpack.
Com
9 Mr. Neeraj Puri Lead Auditor 9815020999 neeraj.puri@dnvgl.com
(Food
Certification
Body)
10 Mr. Robert Hooper Lead +44(0)7711559 Robert.hooper@uk.tesco.co m
Technical 490
Manager
Code: KBE/ FSM/ R-001
Kay Bee Exports Issue Date: 01 01 2019
SOP – Product Recall Version: 02
Revision Date: 20 02 2010
- Recall Management Team is responsible to communicate with media, government,

certification Body or any consumer agencies as per the situation.
9. Inform the Authority:
Inform the concerned regulatory authority (Director of FSSAI and Director of APEDA) at the earliest
opportunity (With in 48 Hrs), after an incident is identified that may lead to a recall and should be updated
throughout the process. The information should include the following:
• A detailed description of the nature of the problem
• The name, brand, size, lot code(s) affected
• Details of complaints received and any reported illnesses
• The distribution of the product
• When was the product distributed (specific dates)
• Label(s) of the product(s) which may be recalled
• The total quantity of product manufactured and distributed
• The name of our firm’s contact with the authority
• The name and telephone number(s) for our firm’s after-hours contact
10. Consumer Response Coordinator (CRC):
CRC is based at Kay bee exports who inform Quality officer about any product related
complaints.
1. PROCEDURE
- Product Recall is warranted based on the following situations:
• Reference Sample Analysis

• Customer Feedback/ Complaint
• Change in regulation
• Positive pathogen result
- If the product has been identified as non-conforming and possess a threat to the health of
the consumers and thus image of the company, the Director shall call for a RMT meeting.
RMT will assess & evaluate the severity & associated implications of the deviation/ problem
and decide on product recall.
- As soon as the recall is approved, same will be sent to C.E.O. for authorization. Accordingly,
recall notification will be issued to all concerned.
- Recall notification include the complete details of the product (quantity, batch number
etc.) to be recalled.
Nanda Kisore Biswas Sachin B. Yadav Kaushal Khakhar

Prepared by Verified by Approved by
(LA & Team Leader - Food Safety Management Director C.E.O
System)
Code: KBE/ FSM/ R-001
Kay Bee Exports Issue Date: 01 01 2019
SOP – Product Recall Version: 02
Revision Date: 20 02 2010
- If there is any regulatory requirement to notify the concerned agency/ country authorities
before initiating the recall, same will be ensured by local managers/ marketing.
- RMT shall manage the recall, from the investigation of the root causes (duly supported by
analysis report) and to arrange re-supply of product to the affected market/ locations.
- Returned product must be held in a secure place to avoid mix-up with other products,
identified as “rejected” and disposed in a safe and secure manner as soon as the
investigation of the recall is complete. In case, re-work is required, same will be ensured in a
segregated premise as per the re-work protocol and quality assurance procedure.
- All discussions and decisions relating to product recall must be documented along with
receipt, origin, and quantity of the returned products. Thereafter reconciliation of the stocks
shall be carried out. Any deviation during reconciliation shall be documented properly.
- If the RMT considers that all recoverable product has actually been returned (after
confirmation with Marketing/ sales dept.) they shall write a closure report summarizing
batches involved, quantities sold, quantities returned and corrective action recommended.
- If the positive pathogen result is found either on product or product’s contact surface. In
no time when the sample for testing was taken, the date is got found.
- Production team and the dispatch team both are informed to collect the data from the day
sample for testing taken to till how much quantity produced and dispatched.
- For the shelf life study the samples are kept for 21 days, the sample which one was kept 21
days ago, 7 days ago and 15 days are sent to NABL accredited lab for testing.
- If the result will come negative, then sample of 3rd day ago from the day sample taken is
sent to external lab for testing.
- Meanwhile, from the day of sample taken to till, the total production (FG) is recalled by the
RMT.
- And the external lab is called in no time to take the sample again for testing.
- Until the negative result is confirmed, product is kept paused.
- The product recall procedure itself must be reviewed at least once a year to ensure its
effectiveness and familiarity to all key personnel.
Nanda Kisore Biswas Sachin B. Yadav Kaushal Khakhar

Prepared by Verified by Approved by
(LA & Team Leader - Food Safety Management Director C.E.O
System)

SOP - Product Recall

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Doc. No.

TITLE: PRODUCT RECALL

Food on sale for human consumption must be wholesome, unadulterated, uncontaminated,

2. Definition of Product Recall:

• To have a procedure for effective recall of product under deviation or not

• To define the responsibilities for investigating, documenting and reporting the

• Effective product recall management is essential to minimize risks on the

This procedure is applicable to all Kay Bee Exports products.

6. Role of the Food Authority:

C.E.O., Director, Operation Manager and Manager – Quality Assurance

7. Food Recall Plan:

8. Recall Management Team (RMT):

Sr. Name of the Person Designation Contact details Email

1 Mr. Kaushal Khakhar CEO 9870405667 kaushal@kaybeeexports.com

- Recall Management Team is responsible to communicate with media, government,

10. Consumer Response Coordinator (CRC):

- Product Recall is warranted based on the following situations:

• Reference Sample Analysis

Nanda Kisore Biswas Sachin B. Yadav Kaushal Khakhar

- Until the negative result is confirmed, product is kept paused.

Nanda Kisore Biswas Sachin B. Yadav Kaushal Khakhar

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