Customer Complaint Process at any
Pharmaceuticals SOP
1.0
PURPOSE:
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1.1. To ensure timely resolution of product & packaging
related complaints received from the market.
2.0 SCOPE:
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2.1. This procedure is applicable for product & packaging
related complaints received by
Quality Assurance
Department at _________________ Pharmaceuticals.
3.0 RESPONSIBILITY:
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3. Responsibilities:
3.1. Q.A.
Manager / Incharge is responsible to investigate all complaints, maintain a
record & liaison with Marketing.
3.2. Manager
Plant & Production & Manager Q.C. are responsible to assist Q.A.
Manager
in investigation of root cause of
non-conformance & implementing corrective action.
3.3. Q.A.
Officer is responsible to maintain complaint log, complaint related non-
conformance report & forward copies
of NCR to Marketing.
3.4. Q.A.
Manager is responsible to ensure resolving complaints within time limits
specified in this procedure.
3.5.
Marketing Manager & Manager International Marketing are responsible to
forward
product complaints in writing along with
sample of the product.
4.0 PROCEDURE:
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4.1.
All customer complaints related to the
4.1.1. Product Quality (Appearance,
Potency) and
4.1.2 Product Packing (Primary &
Secondary Packing)
are recorded by Marketing Department in Head Office & Marketing
Manager then forwards complaints along
with Product Sample in question to Q.A.
Manager at Plant..
4.2.
Q.A. Manager records the complaint on Non conformance form NCR (F-07-009) to
initiate investigation and corrective
action.
4.3.
Q.A. Manager arranges a meeting with Plant & Production Manager and Q.C.
Manager for investigating the root cause
of the non-conformance described in
customer complaint.
4.4.
If required the product is evaluated for appearance & potency against
retained
product sample of the same batch &
screen product batch record.
4.5.
Packaging related complaints are evaluated by
4.5.1. Observing & recording physical
condition of sample received & compares it
with products packing
specification.
4.5.2.
Screen batch record to evaluate potential causes of nonconformance
during
packing operation.
4.5.3
Review material release report from Quality Control.
4.6. Q.A. Manager after investigation records the
root cause & corrective action taken on
NCR & forward copies of NCRs to
Marketing.
4.7. Q.A. Department ensures to provide
preliminary report to Marketing within 15 days
of receiving the complaint.
4.8. If nature of complaint requires product
recall Q.A. Manager recommend Recall
to Marketing as per SOP-07-013 (Product
Recall).
4.9.
Q.A. Manager maintains all complaints record for 2 years from date of complaint
received
5.0
REVIEW FREQUENCY:
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SOP
will be reviewed at least annually.
EVIDENCES
OF RECORDS & REFERENCES
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Master File of customer complaint Process
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FORMAL
KPIs
(Key Performance Indicators)
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Access and retrieval time NMT 5Mints.
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GENERAL
RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Complaint not processed
on time.
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Reputation
in market falls.
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Customer
complaint should be processed on time.
Inform
all department heads and precautionary and control measures should be taken
accordingly.
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QA
Officer/QA Manager
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