Quality Procedures Manual
DOC. NO QSP: [Link] Page1 of 2 ISSUE : 1 REV:0 Dec31,2009
Handling of Complaints
1.0 Objective:
To describes the procedure for handling of Complaints.
2.0 Purpose:
To ensure that all quality related complaints are investigated immediately and effective corrective
and preventive actions taken without delay.
3.0 Scope:
Applicable to complaints / defects observed in the products processed by the company.
4.0 Responsibility:
FIC / Quality Assurance.
5.0 Definition:
Complaint: A Product defect that may render the radiation processed product unsuitable for use.
Complaint can be categorized as follows:
Minor
Major
Critical
Minor complaint: A complaint that may not have an impact upon the identity, quality,
purity, strength, stability, safety and efficacy or physical characteristic of the product.
Major complaint: A complaint that may have an impact upon the identity, quality, purity,
strength, stability, safety and efficacy or physical characteristic of the product.
Critical complaint: A complaint that has a significant impact on quality and / or safety of
the final product.
6.0 Method:
6.1 All product complaints received from all possible sources shall be forwarded to QA through
Facility in charge along with the complaint letters, complaint samples if received.
6.2 The alphanumeric complaint number for the Complaints of the products irradiated at ISOMED
site shall be given by QA person as follow
ISMC:XXX/YY.
Where,
‘ISM’ stands for ISOMED CHEMBUR location code
‘C’ stand for ‘complaint’.
XXX’ stands for the three-digit serial number for the Complaint starting from
001.
‘YY’ stands for year of receipt of the complaint.
Quality Procedures Manual
DOC. NO QSP: [Link] Page 2 of 2 ISSUE : 1 REV:0 Dec31,2009
Handling of Complaints
6.3 A complaint log shall be maintained by QA and the investigation for the complaint shall be
initiated by filling a customer Complaint Form by the QA. He shall also categorize the complaint
as Minor, Major or Critical and then forward the complaint to respective department for
investigation.
6.6 The Dept. head shall the review Customer Complaint and investigate along with QA. On
investigation, he shall identify the root cause of complaint and records the same in the form.
6.7 The investigation shall include review of routine product dosimetry records , reverification of the
product processing records for any deviation or nonconformance.
6.8 The investigation shall extend to other batches those have been found to be processed during
that period, if applicable.
6.9 QA shall review the investigation and if found satisfactory shall propose the CAPA, if required, in
consultation with facility in-charge.
6.10 On basis of investigation, appropriate response shall be given to complainant and CAPA shall be
monitored for completion.
6.11 QA shall keep follow-ups for corrective and Preventive actions if any for completion.
6.12 After completion of the corrective and preventive action by concerned department QA shall review
and close out the market complaint.
6.13 In case of result of an investigation of a complaint of one customer, the root cause shows that the
same is applicable to other customer and action shall be initiated for those customers.
6.14 All critical complaint shall be responded within two working days. Major and minor complaint shall
be responded within 15 working days.
7.0 Evaluation and Trends of the complaints:
7.1 Records of complaints shall be retained in order to evaluate trends and for taking additional, and if
necessary, corrective action and preventive action.
7.2 The complaints shall be reviewed annually and assessment shall be documented.
12.0 Data Analysis
Nil.
13.0 Records:
Individual Complaint file/ Records
14.0 Appendices:
14.1 Customer complaint Form
14.2 Customer complaint Log
Quality Procedures Manual
DOC. NO QSP: [Link] Page1 of 2 ISSUE : 1 REV:0 Dec31,2009
Customer Complain Form No. : _______________
Department : Name of the originator :
1.0 Description of Complaint :
Date of Complaint :
Name of Complaining Person :
Name of the customer :
Location :
Nature of Complaint :
Client Registration No :
Order Registration No :
Number of Cartons :
Product Description :
Invoice No & Date :
Complaint received through :
(Letter ,Phone, E mail etc)
Complaint sample ( If any)
Complaint Received by :
Category of Complaint : Minor/Major/Critical
Forwarded to QA : Yes/ No Date
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
Complaint reviewed by QA
Quality Procedures Manual
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Customer Complain Form No. : _______________
1.1 Investigation of complaints by Individual department (Attach additional sheet
If required)
:__________________________________________________________________
:___________________________________________________________________
:___________________________________________________________________
1.2 Root cause identification :
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
1.3 Comments by QA: Date :
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
1.4Initiation of CAPA ( If any):
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
1.5 Action carried out.
1.6 Close out:
_________________________
Close out date: Sign of QA / Date
Quality Procedures Manual
DOC. NO QSP: [Link] Page1 of 1 ISSUE : 1 REV:0 Dec31,2009
Complaint Log
Complaint Date Description of Investigation Done on Initiation of CAPA Close out Sign/Date
No. complain