Purpose
To lay down the procedure for receipt, record,
classification, investigation cause and CAPA, response, closure, trending of
Product Complaint to ensure that all product complaints are handled in
accordance with the regulatory requirements and are appropriately responded to
satisfy customer and avoid repetition.
Procedure
Definition
Any type of "un-satisfaction" received from
consumer against product (it may be deficiency in strength, identity, safety,
purity or the quality of the products.
Classification of Complaint:
Critical: Which directly affects the
quality, safety, purity, identity and strength of product and making the
product unsafe for consumption. Serious complaints pertaining to product
quality non-conformances, confirmed adverse reactions & probability of
spurious drugs, Product Batch mix-up.
Major: Which indirectly affects the quality,
safety, purity, identity and strength of product and may make the product
unsafe for consumption. Complaints pertaining to batch coding, improper spray
pattern, actuator missing etc.
Minor: Complaints which do not have potential to
cause death or permanent physical disability to the consumer and does not fall
in above mentioned two classifications. Complaints pertaining to Shortages,
Empty can or Short fill in can, temper seal damaged etc.
Receipt of Complaint:
Product complaint may be received orally /
telephonically / e-mail from various sources at Head -QA, Depot, Sales &
Marketing, customer or other department/ Location/ agency/ authority (hereafter
called as "Originator"), shall be sent/forwarded/informed to Head
-Quality.
Complaints shall be sent / informed to Head–QA in the
prescribed format “Complaint Form”.
Logging of the Complaint:
On receipt of the complaint the Head-QAD shall
acknowledge the receipt of complaint within two working days.
Head-QAD shall evaluate the genuineness, intensity and
nature of complaint. Any additional
information if required, it shall be forwarded to the complainant / initiator
of complaint.
Head-QAD/Designee or the receiver of complaint shall
insist for complaint sample with original packaging details along with storage
conditions of sample (Wherever possible and applicable).
Head-QAD/Designee shall categories the complaint on
basis of nature of complaint and investigation and keeping in mind impact of
complaint on complainer/customer and user.
Categorization of the complaint can be done by using
relevant tool of Quality Risk Management like Brain storming etc.
The nature of complaint shall be categorized as:
Physical Appearance Related.
Process related.
Analytical Related.
Medical related.
Packaging related.
Storage and Transportation related.
Shortage related.
Others.
Handling, Counterfeit of
Complaint Sample:
Executive/Designee-QAD shall receive the complaint
sample.
Executive/Designee-QAD shall check the complaint sample
for its genuineness and keep the sample under lock and key until closure of
complaint.
When the retained sample is within the specification
but the complaint sample does not match, complaint sample shall be considered
as a counterfeit or tampered product. Further Investigation is not required in
such cases.
The Legal affairs and the competent authorities or
customer must immediately be informed for further action (if required).
Executive/Designee-QAD must also check if the complaint
represents a serious and unexpected adverse experience, which is required to be
reported to the health authorities, according to the specific safety reporting
regulations of the respective countries.
Initial feedback & review
Executive/Designee-QAD shall send the initial feedback
(where investigation requires more time) to the customer within 24 to 48 hours
and it shall include:
Acknowledgment of the complaint.
Additional information/ sample, if required.
Counterfeit/Tamper Suspicion (If Complaint Sample
Available).
Review of Reserve sample and results of its analysis,
if available.
Evaluation of customer’s sample, if evaluation is over,
if applicable.
Executive/Designee-QAD shall communicate the authority,
customer regarding product complaint based on the nature of complaint.
Executive/Designee-QAD shall record the complaint in
the “Complaint Register”
Investigation:
Investigation shall include following steps:
Initiation of Investigation
Collection of Data
Identification of possible factors (Root Cause
Analysis)
Summarization and Completion of Investigation
Initiation of Investigation:
Investigation shall be initiated to identify the
non-compliance or suspect quality issue. It shall be compressive so as to
understand the fundamental or underlying cause of the discrepancies and to find
the solution so that reoccurrence of the problem does not take place. The aim
of the Investigation is to identify the incident, ascertain the probable causes
of incident and to suggest and implement corrective and preventive actions to
eliminate the cause & recurrence.
Collection of Data:
Executive/Designee-QAD shall collect the data/documents
needed to carry out the investigation as per SOP of “Root Cause Analysis”. Data shall be collected
from various sources but not limited to the following:
General sources: Previous Similar
Investigations, APQR data and interview of associated personnel.
Analytical Data: In process, finished
product, Stability and hold time study data.
Process Deviations:
Process/Packaging validations, cleaning validations, batch manufacturing and packing record of
complaint batch.
QMS Review: Deviations, OOS/OOT if
observed during processing of complaint batch.
Equipment/instrument logs: Preventive
Maintenance/Breakdowns.
Raw Material nonconformance: Raw
material receiving test procedures and testing reports.
Environmental Monitoring:
Microbiological trend data, temperature and humidity data.
Data for each question such as what specific
system/process has the problem shall be collected. Data can also be collected
by discussion with personnel from concerned department to carry out the
investigation.
Review of Documents:
Documentation based investigation shall be carried out
by review of documents. It consists of checking if this complaint occurred
previously in the other lot or if any non-conformance was found in the lot
during its manufacturing or packing that could explain the complaint.
The primary documentation to be reviewed consists of
the complaint log and the batch records. Complaint log can be checked that how
many other complaints of the same nature had occurred and how they were
handled.
Batch records shall be verified in order to see if
there was any non-conformance during the production that can explain or confirm
the quality deviation, and how it was investigated and concluded. In-process
checks details during the processing of the batch shall also be checked.
Identification of possible
factors (Root cause Analysis):
Executive/Designee-QAD shall carry out the
investigation by Identifying possible contributing factors (Root Cause
Analysis) as per SOP of “Root Cause Analysis”, and by analyzing the situation
from different perspectives.
The scope shall determine (but not limited to) the area
under investigation, the duration under investigation, the activity under
investigation, the document under investigation, the equipment/instrument under
investigation etc.
A comprehensive root cause analysis shall be performed
for the investigation of discrepancies. Tools can be used on the basis of
identification of assignable cause or root cause.
Appropriate investigation techniques (tool) shall be
used to determine the root cause as per SOP of “Root Cause Analysis”
Based on the nature of the complaint, it shall be
forwarded to:
Quality Control Department
Production Department
FRD Department
Quality Control: Complaints
requiring analysis, including suspected contamination / adulteration or
mislabeling.
Production: For quality and packaging related
complaints.
FRD: For ADR related and technical review.
Head-QAD/Designee shall be responsible for coordination
and completion of the investigation report.
Laboratory Investigation done
by quality control department:
Executive/Designee-QCD shall examine the reserve sample
of the complaint batch and check for physical observations, and also compare
the reserve sample with the complaint sample, if received along with the
complaint.
If the complaint is related to the quality attributes,
quality control analysis records shall be reviewed.
If required, calculations and test records shall be
checked for calculation mistakes, instrumental errors, and deficiency in the
sampling or sampling errors.
If needed the reserve sample and complaint sample (if
received) shall be analyzed, for ensuring the quality of the product.
Comparison of the results of analysis of the reserve
sample and customer’s complaint sample with those obtained at the time of
release of the batch shall be done.
Executive/Designee-QCD shall send the results of
analysis along with the supporting documents to QA for further action, if, the
results are within the specifications and analysis do not reveal any problem
w.r.t. batch.
If results indicate non-conformance to the
specifications further investigations shall be carried out.
Re-Examine/Re-Test preceding and succeeding batches,
Review the stability records if required.
Executive/Designee-QCD shall send the results of
laboratory investigation to QA along with all supporting documents, i.e.
calculations, graphs, chromatograms, spectra etc.
Corrective & Preventive
actions:
In case laboratory investigation reveals that the
original results were not correct,
review the checking mechanism of the results and
re-qualify the analyst.
If the results of laboratory investigation indicate
that the product does not conform to
specifications full failure investigation shall be carried out.
If observed that the problem was on account of the
original sample, review the sampling
procedure or re-train & re-qualify the chemist responsible for sampling.
If the results of laboratory investigation indicate
that the reserve sample conforms to specifications, while the complaint
sample does not conform reasons for the
possible product failure shall be explored with production and FRD.
In case of proven product failure, Head-QAD shall take
up the matter with FRD for further
study and review of the process to address the problem.
Production (Manufacturing /
Packing) Investigation done by Production & QA:
Executive/Officer/Designee Production and QA shall
review the packaging and labeling records.
If the specimen label and overprinting details on the
label are correct and checked by production and verified by QA. If the line
clearance was carried out and signed by both Production and QA.
In case no problem is found, examine the feasibility of
checking the consignment at the customer’s place to ascertain the cause and
take appropriate corrective and preventive action.
Missing batch coding or improper spray pattern is
considered to be a critical mistake as it may tantamount to mislabeling or
misbranding.
Empty can, low fill weight actuator missing or damage
etc.
Damage to the consignment shall be verified.
Shortages related to quantity missing etc.
Factors that can contribute to the shortages shall also
be examined.
Corrective and Preventive
action:
In case the complaint relates to wrong batch coding
mistake product recall shall be immediately initiated.
Labeling and packaging operations & systems shall
be reviewed and more rigid controls
shall be introduced.
Monitoring the activities of personnel at the packaging
belt.
Possibility of pilferage shall be ruled out.
Investigation Period:
In case of critical complaint, investigation shall be
completed within seven working days after receipt of complaint. However,
product recall if required shall be initiated within 48 hours of receipt of
product complaint.
In case of major complaint, investigation shall be
completed within three weeks after receipt of complaint.
In case of minor complaint, investigation shall be
completed within four weeks after receipt of complaint.
Summarization and Completion
of Investigation:
The information from all concerned departments involved
in investigation shall be complied and summarized in the “Investigation of product complaint”.
QA shall make an investigation report based on the
information, highlighting all the findings, risk assessment, proposed
corrective actions, where required, steps taken – where applicable to prevent
the recurrence of the problem.
Closure of complaint:
Head-QAD shall review the investigation report and
outcome of investigation along with CAPA and ensure that there is effective
implementation of CAPA to eliminate reoccurrence of complaint.
Executive/Designee-QAD shall ensure the adequacy and
completeness of the investigation report.
Head QA shall approve the investigation report.
Executive/Designee-QAD shall send the investigation
report to the customer or to the regulatory bodies.
QA shall preserve all the data pertaining to the
investigation as well as final conclusions, corrective and preventive actions
and the complaint shall be treated as “Closed”.
If any complainer wants to reopen the closed report
then it can be reopened within seven days after closing of report, based on
management decision and on the basis of criticality of complaint with
supporting data provided by complainer.
In case complaint is not closed within defined
timeframe justification shall be filled by
Head-QAD/Designee for delay in closure.
Trending of Complaints:
Product Complaints shall be reviewed on quarterly basis
for indication of specific or recurring problem requiring attention and
possible recall of marketed products.
The trend report shall be prepared in order to
take CAPA to avoid recurrence.
A brief summary of Product Complaints received, shall
be addressed in APQR to identify the Corrective and Preventive Actions (CAPA)
and its effective implementation.
Trend of complaints including details of critical
Product complaint shall be discussed in Management Meeting.