SOP for Product Recall

1. OBJECTIVE:

To evolve suitable procedure and their implementation to recall finished products in case of any
Product safety related issues that may be of major types like physical, chemical or microbiological
contamination or any epidemic outbreak, customer complaint or to meet regulatory requirements.

2. SCOPE:

This covers recall of finished products from the market.

3. RESPONSIBILITY:

Department / Designation Responsibility

Site Head/Top Management/Designee To approve Product Recall
Quality Head/Designee To Investigate and Recommend for Product Recall
Production Head/ Designee To investigate the reasons jointly with Quality Head/
Designee
Head – Sales & Marketing/ Designee To monitor and follow up the Product Recalls

4. PROCEDURE:

4.1. Key Definitions:

4.1.1. Product recall is a process taken by the Responsible person who places the product
on the market, to remove or withdraw a particular packaging product from all links of
distribution.
4.1.2. The removal or withdrawal may be due to critical quality defects discovered or serious
reactions reported which might cause health risks to users during and after
distribution of the product.
4.1.3. Recall for Product Correction: the removal of product for rework Corrective action may
take place at the user’s or the manufacturer’s premises or at any other agreed
location. All corrective actions should be reported to the person responsible who
place the product on the market.
4.1.4. Safety Alert: Advice regarding a specific situation of a product, which is not
conforming to the safety specification. When there is a risk of significant hazard to
consumers of a product which has been distributed on the market, the manufacturer
should disseminate the safety alert through mass communication media available
including newspaper, radio and television.
4.1.5. Product Notification: the issue of precautionary information about a product, in a
situation that is unlikely to involve significant adverse health consequences.
4.1.6. Withdrawal: Removal of product from sale or use for reasons not connected with
quality and safety such as change of packaging etc. as a marketing strategy.

4.2. Classification of Recall:

SOP for Product Recall

4.2.1. The class of recall is classified according to the seriousness of quality defects and
adverse events of the products.
– Class I: Products with major health risks that might be present.
– Class II: Products with minor/ unlikely health risks or substandard.

4.3. Level of Recall:

4.3.1. The level of the recall depends on the nature of the problem, the extent of the
product's distribution and the degree of hazard involved.
– LEVEL A: To all consumers (end users)
– LEVEL B: To all points of sales (e.g. retail shop, own outlet, distributors).
– LEVEL C:To all sub distributors (wholesalers)
– LEVEL D: From the particular institute. (Hotel, Salon, etc)

4.4. Product Recall Requirements:

4.4.1. Responsible person should be independent from seller or marketing

4.4.2. Must have an effective recall in place, must be tested.
4.4.3. Must notify all distributors and retail shops to which product may have been
distributed.
4.4.4. Distribution records should be readily available to responsible person.
4.4.5. Secure storage of goods awaiting disposition.
4.4.6. Progress recorded, and final report issued
4.4.7. Reconciliation between delivered and recovered quantities.

4.5. Notification of Recall:

4.5.1. A sample of the recall notice must exist. Recall notices (As per Annexure I) must be
physically mailed in envelopes or emailed or communicated through appropriate
social media channels, which can be clearly recognized as such. The notification of
recall should include:
– The name of the product, and pack size
– The product batch number
– The nature of the defect
– The action to be taken
– The urgency of the action (with reasons, indication of health risk, as
appropriate)

4.6. Process for Recall:

4.6.1. To address unexpected outbreak of Product borne diseases, due to microbial and
chemical residue contamination and also contamination with pathogenic toxin, a
product recall procedure is developed and being followed.
4.6.2. Immediately when an outbreak is noticed or potential for major Product safety issue
arises, the entire quantity of finished product whose integrity is under doubt shall be
taken back. Site Head/Designee and Quality Head/Designee are authorized to recall
the product.
SOP for Product Recall

4.6.3. The recalled finished product as well as any portion if inventory lying in the finished
product store or in transit of the same session are identified and recalled. These
sessions are kept separately, rejected after thorough investigation by Quality
Head/Designee. All such actions shall be authorized by Quality Head/Designee and
recorded in product recall record.
4.6.4. Wherever applicable depending on the seriousness of the Product safety issue, the
statutory authorities and customers shall be informed by the top management through
appropriate channels.
4.6.5. All stocks of recalled products are either destroyed or reprocessed based on the
investigation by quality department and nature of the problem. The identity of entire
reprocessed product is being maintained for traceability purpose. Production
Head/Designee along with Quality Head/Designee is authorized to destroy or
reprocess the product.
4.6.6. The effectiveness of product recall is periodically tested for its effectiveness by mock
drills and all actions are recorded.

4.7. Organization of Product Recall:

4.7.1. Once a decision is made, the responsible persons appointed are to initiate and
undertake the product recall as well as to follow-up on any matters arising from such
a recall. The primary distribution records should be maintained and made readily
available to the persons responsible for recalls. They should also contain sufficient
information of distributors.
4.7.2. Product Recall Team Members:

Sr. No. Designation Roles and Responsibility

Site Head/ Designee Held responsible person for deciding all the
1
decision relating to product recall
Quality Head/Designee Ensure the problem and its severity level to
2 recall. Coordinating with the entire team to
ensure its complete recall activities.
Responsible person to arrange the method of
Commercial & Logistics
3 logistics requirements as well as transport
Executive/Officer
arrangements
Ensure the quantity of concerned batch no.
Ware house Head/ And its distribution
4
Designee Responsible to communicate all the relevant
department and authorities.
Responsible to communicate with customer
about the proceedings of product recall
Head – Sales &
5
Marketing/ Designee
Authoritative and Responsible to comply the
legal and statutory regulatory requirements
Responsible person to guide and educate the
6 Legal advisor protocol of product recalls. depends upon the
concerned country requirements.

4.7.3. List of mandatory authorities to communicate the recall activities:

Sr. Contact person and

Authorities
No. communication details
Concerned Top management of
1
relevant customer / Distributors
2 Certification body (service partner)
SOP for Product Recall

4.7.4. A centre, which collects and stores all returned stocks of the recalled product need to
be named. This centre shall note details such as date returned, name and address of
customer, batch number, expiry date, quantity and nature of product down.
4.7.5. Depending on the class of product recall, the most effective and appropriate mode of
transportation of such recalled product will be decided and agreed upon by the
manufacturer/importer.
4.7.6. All affected stocks of the recalled products will be stored separately and sealed
appropriately in a different section of the warehouse to prevent any mix-up.
4.7.7. The manufacturer has to prepare a report regarding the progress of the recall
including the reconciliation between the delivered and recovered quantities

4.8. Fate Of The Recalled Product

4.8.1. All available records and information on the returned stocks will be collected for
evaluation of the recall situation.
4.8.2. A report of the affected stocks will be presented to the product recall committee and
the fate of the product shall be made.
4.8.3. The recalled product shall be destroyed if the conditions under which the packaging
product, its container, carton or labelling as a result of storage or transportation, casts
doubt on its safety, identity and quality.
4.8.4. Upon approval from the relevant authorities, proper destruction with appropriate
precautionary measures will be taken to ensure total elimination of affected stock. The
destruction should be carried out and witnessed by authorised personnel.
4.8.5. A packaging product may be reworked provided the recalled product meets
appropriate standards, specifications, and characteristics e.g. Mislabelling ...
4.8.6. The effectiveness of the recall the manufacturer has to evaluate the effectiveness of
the recall from time to time.
4.8.7. Product Recall Record shall be maintained as per Annexure II “Product Recall
Record”

4.9. Mock Recall

4.9.1. Mock Recall is an exercise carried out to check the preparedness and effectiveness
for an actual product recall.
4.9.2. Mock recall shall be carried out at least for one product, dispatched for sale where
maximum distributors are involved and details shall be recorded in Annexure III “Mock
Recall”.
4.9.3. Mock recall shall be aimed at the following objective:
– Alert recall team
– Performing the reconciliation to test product traceability.
– Test the responsiveness and knowledge of the team operating the recall
system
– To implement any corrective action to improve the recall system.
Mock Recall process shall be completed within 30 working days from the date of
initiation.
4.9.4. During mock recall, perform the traceability for at least, one of the raw materials used
in the batches identified for mock recall.
SOP for Product Recall

4.9.5. The mock recall file should include the name, address and telephone number of
clients for the lot tested, production records, the inventory, and distribution of each lot
distributed.
4.9.6. A mock recall will identify potential problems and allow personnel to become familiar
with recall procedures. If problems are identified in the recall procedures, they should
be corrected. All corrective actions and deficiencies shall be documented in the
Annexure III “Mock Recall”

5. DISTRIBUTION:

5.1. This SOP (Controlled Copy) shall be distributed to following Department of the
Plant.

5.1.1. Quality.
5.1.2. Warehouse.
5.1.3. Production
5.1.4. Marketing

5.2. Master Copy remains with Quality Department.

6. ANNEXURES:

Annexure – I Product Recall Circular

Annexure – II Product Recall Record.
Annexure – III Mock Recall

7. FORMATS:

Sr. No. Document No. Title

1.

8. REFERENCE DOCUMENTS:

Sr. No Reference Detail

1. Drugs and Cosmetics Act/Rules

9. REVISION HISTORY:

Revision No. Effective Date Details of changes

00 01/11/2020 New SOP