ROYES INDUSTRIES LIMITED STANDARD OPERATING PROCEDURE

Plot No.127/128, IDA Medchal, R.R Dist-501 401 Department : Quality Assurance
SOP N0: L_PR_QA_030_03032012_RV000
Title Product Recall

REVISION HISTORY

Rev Description of Change Effective Date

000 Initial Release 03/03/2012

1 Purpose
To define the responsibilities of the factory team during a product recall situation is
encountered
2 Scope
The procedure is applicable to Hyderabad region Contract manufacturing operations factory.
3 Responsibility
Role Responsibility

QA Manager Lead the Recall facilitation team in the factory

Conduct the Root cause analysis

Evaluate the findings and conclude the Class of Recall

Compile the report and keep the Recall committee updated

QA Executive First cut traceability of the Batch

Collect the analytical details of Finished product

Collect the analytical results of involved EM / PM / Utilities

Collect the change management details during this period

Manufacturing Collect all Process log sheets of involved batch

Manager
Collect all Breakdown details of involved batch

Provide all mass balance and Yield details of the batch

Stores In charge Provide the dispatch details of the batches to various depots

Provide the details of EM/PM issues for this batch

Inform to CIL representative to BLOCK the available stock in SAP and

inform Depots.

CIL representative Compile all the data with detailed action plans and escalate to CMO
operations Head

Plant manager Co-ordinate with factory team and CIL representative to overcome
the issues.

Contract Analyze the issue with detailed discussion with factory team and
manufacturing Regional QFS Manager (RQFSM) and escalate to AVP operations South
operations Head region for further action.

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ROYES INDUSTRIES LIMITED STANDARD OPERATING PROCEDURE
Plot No.127/128, IDA Medchal, R.R Dist-501 401 Department : Quality Assurance
SOP N0: L_PR_QA_030_03032012_RV000
Title Product Recall

4 Definition and acronyms

Risk rating for Deviations
Deviation Risk Degree of Severity

 Pathogen contamination Food Safety  High (Big Population)

 Foreign matter Food Safety  High (Contained)

contamination

 Net weight Deviation Regulatory (SWAM Rules)  High (risk of loss of license)

 Regulatory parameters Regulatory (FSSA)  Medium (High Penalties)

deviation (Moisture, Ash)

 Sensory deviations Quality  Medium (Complaints)

 Batch code deviations Regulatory (SWAM /  Medium (High Penalties)

FSSA)

Recall types and their relevance to Hyderabad CMO factory products

Class Definition Category for Royes

I Likely to be extremely expensive. Particularly  Pathogen contamination in the

in the case of consumer products. It would be product
essential in all urgent cases and probably in
most serious cases. It entails recall from users,  Foreign matter contamination in
retail outlets and warehouses. Subsequently it the product
would be necessary to reimburse the owners
for losses sustained as a result of the
withdrawal. The order for such a recall would
always be made at Board level

II Less serious cases to do with probable law  Net weight deviation

breaking, particularly in cases where an
existing product has been in widespread use  Regulatory parameter
for some considerable time, and now deviations (Moisture, Fat etc)
information has revealed a minor hazard

III Will entail product recovery from the first stage  Sensory Deviation
in the distribution chain and may be applied in
the case of non-safety critical situations  Regulatory parameter
deviations (Ash etc)

Withdrawa Will mean the recall of individual batches and  Secondary packing deviations
l consignments and will probably occur most
often when manufacturing faults have been  Batch code deviations
discovered or suspected in an established
product

Page 2 of 4
ROYES INDUSTRIES LIMITED STANDARD OPERATING PROCEDURE
Plot No.127/128, IDA Medchal, R.R Dist-501 401 Department : Quality Assurance
SOP N0: L_PR_QA_030_03032012_RV000
Title Product Recall

5 Procedure
Trig
ger

Consumer Independent Internal Test Government Internal Audit

Complaints Test reports Reports Sources Reports

Recall Team:
Factory Manager
QA Manager
Reac
First

tion

MFG Manager
Emergency meeting QA In charge
CIL representative
of Recall Team
Stores In charge/Logistics
(QAM) CMO Head
iscussion
AVP operation South
with factory
team and
Regional
ectio
Data
Coll

QFS
n

First cut EM / PM Manufacturingmangaer

/ EM/PM/FG QA log
traceability from consumption BD Log sheets sheets, Change
SAP (QAI) records (Stores) (Mfg Exec) mgmt (QA Exec)
Data
Anal

RCA Tools:
ysis

1. Counter sample analysis Deviation reports

2. Data analysis for root cause QEN
3. Substantiate data Change management
E mail communication
Interpretations with facts
Shift communication records
(QAM) and submit the report to Audit reports
south Region QFS manager
miss
Rep

Sub

ion
ort

Recall Report: Details of

Cause
Submit the report to Recall Available analytical reports
Implicated Batches
Committee through AVP South Despatch details
at HO (RQFSM) Stock status at depots
ectiv
Corr

Acti
ons
e

Develop RCA and CAPA for

the above cause and
implement the actions
(QAM)

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ROYES INDUSTRIES LIMITED STANDARD OPERATING PROCEDURE
Plot No.127/128, IDA Medchal, R.R Dist-501 401 Department : Quality Assurance
SOP N0: L_PR_QA_030_03032012_RV000
Title Product Recall

6 Associated record
Traceability record:
Recall record :

7 EHS requirements
NA
8 Cross reference
EMRQ
9 Approval

CH.K.Gangadhar Sr.Microbiologist

Name Designation Signature Date

Prepared By

Satya Kumar QA -In charge

Name Designation Signature Date

Reviewed and Checked By

George Kurian Director (Operations)

Name Designation Signature Date

Approved By

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