Handling of complaint.pptx

Presented by:
Jagruti Kachchhi
M. Pharm, Semester – 1
Department of Pharmaceutical Quality
Assurance
Topic: Complaints – evaluation & handling,
Investigation and determination of root cause
Guided By:
Dr. Dulendra P. Damahe
M. Pharm, PhD
Associate Professor
Department of Pharmaceutical Chemistry

• Introduction
• Types of complaints
• Key points for handling of complaints
• Content of a product complaint data sheet
• Steps involved in handling of complaints
• Recording of complaints
• Root cause analysis
• Determination of root cause
• Questions
• References
29/11/2021 2
Jagruti Kachchhi, Smt. BNB SPC, Salvav-Vapi

 Definition: A complaint simply designates that something is
wrong or not good enough. Generally in the pharmaceutical
industry, complaints are regarding the quality of drug
product. A complaint shows customer dissatisfaction about a
product and consequently, about a company.
 Principle:
 All complaints and other information concerning potentially
defective products should be carefully reviewed according to
written procedures and the corrective action should be taken.
29/11/2021 3

 It gives the company an opportunity to improve the quality of a
product.
 It is helpful to maintain cGMP.
 It maintains committed relationship between the customer and
company.
 It is the regulatory obligation.
• Objective: To immediately recall, investigate or to take remedial
measures against the defective product.
• Responsibility: The quality assurance manager along with
manager of complaint related department.
29/11/2021 4

 Basically it is of 3 types:
1) Quality Complaints: Originate at customer level and concern
with physical, chemical and biological properties or conditions of
labeling and packaging of product.
• Investigation time period: Within 10 days (after receipt of
complaints)
2) Adverse reaction Complaints: Due to allergic reactions of any
other untoward reaction or fatal reaction.
complaints)
3) Other medically related complaints: Include complaint such as
lack of efficacy or clinical response.
complaints)
29/11/2021 Jagruti Kachchhi, Smt. BNB SPC, Salvav-Vapi 5

 Complaint record shall be maintained at least one year after
expiration date of medicines. Complaint record shall be reviewed
and a monthly summary shall be prepared for the management.
 Also the complaints are categorized as following:
1) Critical defects
2) Major defects
3) Other defects

 Don’t take it personally.
 Never act on a complaint without hearing(at least) two sides
to the story.
 Say what you will do and do what you say: set the time
frame.
 Keep notes.

 Serial number assigned to the complaints
 Exact nature of the complaints
 Name of the complainants
 Address of the complainants
 Date of complaint received
 Name of the product, strength & batch number of the product
 Quantity involved in the complaint
 Size of the sample obtained from complainant
 Evaluation of complaint by QC department
 Name and signature of the investigator and date
 Action taken by the company
 Copy of reply sent to complaint

Step 1: Receiving complaints
 It is important to have open channels with customers
in order to receive their suggestions, doubts and
complaints.
 Generally, these channels are toll-free numbers, e-
mails, chat rooms.
 Whatever the channel, it is necessary to have a person
in charge of receiving the complaints and inputting
them into an appropriate investigation form that shall
be addressed to the quality assurance unit for
investigation.

Step 2: Technical Investigation
 Upon receipt of the investigation form, the QA unit is able to start
the investigation, which can be divided into two phases:
1) Documentation – based: Consist of checking if this complaint
occurred previously in the same lot or if any nonconformance
was found in the lot during its production that could explain the
complaint.
2) Laboratory analysis: Consist of requesting the quality control
laboratory to analyze both complaint samples and retained
samples- the reserve samples representative of the lot
manufactured.

 After receiving the analytical results, there are 3 possible conclusions
which are as follows:
1) Confirmed complaint: When both complaint and retained samples
showed out-of-specification (OOS) results or when only the complaint
sample showed OOS results.
2) Non-confirmed complaint: When both complaint and retained
samples showed results in compliance with specifications or when only
the complaint sample showed OOS results that can’t be considered a
single unexplained failing product.
3) Counterfeit/ tamper suspicion: When the retained sample is within
the specification but the complaint sample is clearly OOS with no
reason for that, such as a counterfeit or tampered drug product.

Step 3: Corrective action and preventive action
Corrective action: Eliminate detected non-conformity.
 It aims to correct an existing non-conformity and to avoid
reoccurrence of the same non-conformity.
 Examples: Arises from manufacturing deviations, OOS
investigation, Complaints, audit findings and recall.
Preventive action: Prevent non-conformity occurrence.
 It aims to avoid the initial occurrence of a non-conformity by
proactively implementing improvements.
 Examples: Results from trending of in process data, analytical
data, audit findings, trending of root cause for non-conformities or
complaints, annual product review, quality risk analysis.

Step 4: Feedback to customers
 As feedback to the customer, the company must write a
response letter to the complainant to explain the
investigation approach taken, the results obtained and
implications, in case the quality problem was confirmed.
 The company should be sent a free replacement product
together with the response letter, since the customer
returned the product (Complaint sample) to the company for
analysis and a quality problem was found.

Step 5: Monthly Reports and trend analysis
 Monthly reports should be elaborated in order to evaluate the
amount and the nature of the complaints received and to
perform a trend analysis of these complaints.

 It is the responsibility of the in-charge, Quality Control to see
that each complaint is recorded, evaluated and reported to the
management. Records of the complaint should include the
following information:
1) Content of complaints
• Name, dosage form package form, batch no.
• Date and the place of occurrence of complaint
• Cause of complaint
• Name and address of complainant in detail

2) Results of investigation
• Regarding market place, circulation condition and condition
in which the defect was observed
• Result of investigation of analysis and testing records,
production and storage records
3) Evaluation
4) Follow up measures
• Reply to the complaint
• Remedial action so that complaint of this type should not
reoccur.

ROOT CAUSE ANALYSIS

 Root cause analysis is the method that is used to address a
problem or non-conformance, in order to get the root cause
of the problem.
 It is used so we can correct or eliminate that cause, and
prevent the problem from recurring.
 Traditional application of root cause analysis:
• Resolution of a customer complaints and returns.
• Disposition of non-conforming material (Scrap and repair)
via the material review process.
• Corrective action plans resulting from internal and customer
audit.

1) 5 Why analysis
2) Fishbone or Ishikawa diagram (Cause and effect analysis)
3) Pareto analysis
4) Brainstroming

The steps of determining cause and effect on a fishbone diagram
are:
 Define your problem
 Brainstrom with the team on possible causes for the problem
 Use the 6Ms while doing so (Man, Machine, Method,
Material, Measurement, Mother nature)
 Categorize all the cause as per 6Ms
 Prioritize basic data and team view. In the diagram
highlighted causes are the major contributory factors.
 Brainstrom solutions for the prioritized causes and
implement

Steps to conduct Pareto analysis are:
 Classification for the causes
 Collect data from historical sources
 Assign a time period for which the data collected
 Calculate the no. of occurrence for each categories
 Convert the no. into percentage of total
 Sort the data by no., largest to smallest
 Compute cumulative percentages
 Draw a graph using Minitab or Microsoft Excel

The process steps are:
 Organized by champion, attended by process owner, project team,
SMEs and six sigma team
 Review the problem defined
 Find all possible causes to the problem- hand post- its to attendees
and request individual views (No discussion)
 Use 6M to stimulate possible causes
 Categories the cause using affinity diagram
 Prioritize the causes, discuss and shortlist possible solutions
 Review of shortlisted solutions by champion for buy- in followed
by next step to subsequent research

1) Write a note on handling of customer complaints.

1) Gavande Sonali Shashikant, Chhabra Gurmeet, Gujaranthi
Nayan, “Handling of market complaints and recalls, review
of FDA-483 form.” Asian Journal of Pharmaceutical
Research and development. 2018, 55-59.
2) Glaucia Karime Braga, “ Complaint handling in
Pharmaceutical companies.” Published in Wiley Inter
Science, 2007, 16-21.

3) Mohammad Javad Ershadi, Roozbeh Aiasi and Shirin
Kazemi, “Root cause analysis in quality problem solving of
research information systems: A case study.” International
Journal of Productivity and Quality management. 2018,
24(2), 284-299.

THANK YOU

Handling of complaint.pptx

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