Presentation on customer focus / customer satisfactioon , customer delight and customer complaints handling. In a sense, customer service attains importance within the context of customer focus. In customer focus, the company puts great emphasis on customer success and customer happiness while customer service is one of the various activities to ensure customer happiness.Make the Effort to Follow-up. Some customer service situations require a follow-up contact. ...
Use Clear Language. It's easy to fall into the trap of using unclear language. ...
Do the Time Zone Math. ...
Anticipate Hidden Needs. ...
Use the Pre-Emptive Acknowledgement. ...
Take the Thank You Letter Challenge. ...
Take Action!
10 Steps to Create a Customer-Focused Culture
Define the culture. If you want to have a customer-centric culture, think about exactly what it should look like. ...
Communicate the culture. ...
Hire the right people. ...
Train your people right. ...
5. Make the training inclusive. ...
Be an example. ...
Empower employees to succeed. ...
Give recognition.
The orientation of an organization toward serving its clients' needs. Having a customer focus is usually a strong contributor to the overall success of a business and involves ensuring that all aspects of the company put its customers' satisfaction first.
1) Recalls and returns are a fundamental element of good manufacturing practices and ensure that defective products are removed from the market.
2) Manufacturers are obligated to initiate a recall if one is necessary to protect public health, and regulatory authorities may order a recall.
3) It is important to monitor a recall closely and maintain thorough records to ensure its effectiveness in removing defective products from distribution and use.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
This document summarizes a seminar on customer focus. It defines internal and external customers and discusses the importance of customer focus for organizations. It also covers key topics like classifying different types of customers, understanding customer perceptions of quality and requirements, satisfying and delighting customers, handling complaints, and factors that influence customer behavior. The overall goal is to emphasize the importance of understanding customers to ensure their needs are met.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
The economy is developing very fast and it is becoming more competitive with each passing day as customers also become more difficult (Weckenmann and Akkasoglu, 2012). The organization has to face more fierce competitions and challenges every day. Many companies provide the same products or services for the same customers (Weckenmann, Akkasoglu and Werner, 2015). To survive on this conjuncture, they must build up their reputation based on great product quality.
Many foundational principles of quality were introduced and developed by Deming in 1986 (Wicks. A and Roethlein. C, 2009). They had quickly become essential factors in many companies’ operation. Consequently, quality management must be given more attention like an important strategy (Khaled Omar and Murgan, 2014). Many authors think that quality of products or services has a close relationship with customer satisfaction. In order to help companies control their product quality more efficiently, the concept of cost of quality (CoQ) was formed and developed continuously.
Quality cost philosophy was first described by Armand V. Feigenbaum (1956) in his book, “Total quality management”. After that, many modified definitions of CoQ had appeared. Chiadamrong (2003) said, “The cost of quality is a comprehensive system, not a piecemeal tool.” According to Chopra and Garg (2012), quality cost is the gap between actual cost and perfect cost of products or service. In general, quality cost is a useful methodology that helps companies to build trust with customers, ensure sustainable development and increase their profit.
Crandall and Julien (2010) said that The American Society of Quality (ASQ) define cost of quality as follows: “Quality costs are the total of the cost incurred by investing in the prevention of nonconformance to requirements, appraising a product or service for conformance to requirements, and failing to meet requirements. The sum of these costs represents the difference between the actual cost of a product or service and what the reduced cost would be if there were no possibility of substandard service, failure of products or defects in their manufacturing.”
This paper will provide general and in-depth information about costs of quality and its development up to the present day with two main parts. The first part will concentrate on concepts, definitions, and models of quality costs as well as how it was formed. The second part will contain real example, discussion and analysis about how CoQ concept is as relevant today as it has ever been.
The document discusses cost of quality and its categories. It explains that cost of quality refers to the costs incurred to prevent non-conformance and the costs associated with poor quality. There are two main categories - costs of achieving good quality like prevention and appraisal costs, and costs of poor quality like internal and external failure costs. Measuring these costs helps identify opportunities to improve quality and reduce costs. It provides an example of measuring quality costs at a motor company over four years which showed prevention costs increasing and overall quality costs decreasing as quality improved.
The document discusses quality audit checklists and their benefits. It explains that checklists help auditors sample key elements of a quality management system in a logical, unbiased way. Checklists also keep the audit focused and reduce workload. The document then provides guidance on creating checklists for adequacy audits to evaluate whether documentation addresses all standard requirements and ensures policy and objective achievement.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Documentation in pharmaceutical industryPRANJAY PATIL
Pranjay Sadashiv Patil, a first year M.Pharm student, presented on documentation in pharmaceutical quality assurance. Documentation defines a system to minimize risks from misinterpretation or errors in oral communication. It includes specifications, test procedures, distribution records, and electronic data handling. Specifications provide parameters and limits for materials, equipment, and products. Test procedures must validate compliance to the end of shelf life. Controlled documents require approval and management of changes, while uncontrolled copies are for reference with a watermark.
This document provides an overview of benchmarking. It defines benchmarking as continuously identifying and adapting best practices from inside and outside an organization to improve performance. The document outlines the objectives of benchmarking as establishing achievable improvement goals and motivating employees. It also discusses the types of benchmarking based on what is compared (e.g. products, processes) and who is compared to (e.g. competitors, best in class). Additionally, the benchmarking process and its advantages in improving competitiveness through learning from others are summarized.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
The document provides an overview of a 2-day technical seminar on vendor validation presented by APPON Quality Circle. It discusses key topics covered in the seminar including why vendor validation is important, areas that require validation, methods of validation, requirements, vendor monitoring, evaluation, and disqualification. Vendor validation helps ensure consistent quality of materials and compliance with regulations to reduce risks and costs. A risk-based approach is recommended to qualify and monitor vendors based on performance metrics and compliance.
Market Complaint Investigation and RecallDhanjay Singh
This document discusses market complaints, product recalls, and complaint handling procedures at Simpex Pharma Pvt. Ltd. It defines complaints and explains the need for an effective complaint handling system. Complaints are classified into types A, B, and C based on severity. The complaint handling process involves receiving, investigating, taking corrective actions, and providing feedback to customers. It also defines and classifies product recalls based on health hazard. The duration and types of recalls - voluntary vs forced - are explained. The document states that the Head QA will decide on recalls in consultation with management and key personnel based on defect category.
This document summarizes a seminar on statistical process control. It discusses key topics like process capability, estimating inherent capability from control charts, and Juran's 10 steps for quality improvement. Process capability refers to a process's ability to achieve results within specifications. It is quantified using indices like Cp and Cpk which measure potential and performance based on process data. Assumptions like statistical control are important for accurately applying these indices. Quality improvement involves building awareness, setting goals, training, implementing projects, and maintaining momentum through regular systems.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
The document discusses product complaints and recalls in the pharmaceutical industry. It defines a complaint as customer dissatisfaction about a product and outlines four types of complaints. It details the four-step process of handling complaints, which includes receiving, investigating, implementing corrective actions, and reporting. The document also defines a recall as removing a product from distribution due to quality, safety or efficacy issues. It describes the reasons and types of recalls, as well as the classification, levels and timelines involved in an effective recall system.
1. The document discusses procedures for handling complaints and product recalls in the pharmaceutical industry. It defines complaints, outlines standard operating procedures for complaint handling, investigation and corrective actions.
2. Recall procedures include classification of recalls based on health hazards, forming a recall team, developing a recall strategy, notifying customers, and terminating a recall once all affected products are removed from the market.
3. Key aspects of complaint handling covered are documentation of complaints, investigating complaints by analyzing customer and retained samples, determining if complaints are confirmed or non-confirmed, and providing feedback to customers.
This document discusses product complaints and recalls. It defines a complaint as any expression of dissatisfaction with a product. Complaints can come internally from production or quality control or externally from customers. Complaints are classified as critical, major, or minor depending on their severity and health risks. The document outlines guidelines for designating a person to handle complaints, investigating complaints, providing corrective actions and feedback, and analyzing complaint trends. It also defines and discusses the types and procedures for product recalls when serious quality issues are found.
The document discusses complaint handling and product recalls in pharmaceutical companies. It defines a complaint as an expression of customer dissatisfaction and explains the need for an effective complaint handling system to improve quality, maintain regulatory compliance and build customer relationships. It outlines the objectives, responsibilities and types of complaints, as well as the steps to handle complaints which include receiving, investigating, implementing corrective actions, providing feedback and reporting. The document also defines and discusses the objectives, classification, strategy and procedures for conducting an effective product recall.
1. The document discusses key aspects of customer satisfaction including defining customers, obtaining customer feedback, using customer complaints to improve, and providing good customer service.
2. It emphasizes that customer needs are constantly changing and businesses must continually solicit feedback to understand how to exceed customer expectations.
3. Effective use of customer feedback drives new product development and allows businesses to identify improvement opportunities from the customer's perspective.
COMPLAINTS
TOPIC COVERED
1.Definition
2.Principle
3.Need for complaint handling system
4.Objectives
5.Responsibility
6.Type of complaints (CRITICAL,MAJOR ,MINOR)
7.Key for handling complaint
8.Content of product complaint data sheet
9.Steps involved in handling of complaint
10.Recordings of complain
A COMPLETE STUDY ON COMPLAINTS, DRUG RECALL, RETURNED PRODUCTS, AND WASTE DIS...Teny Thomas
a detailed study on complaints, drug recall, returned goods and waste disposal is studied here in the presentation for the students of sixthe semester b.pharm following the PCI syllabus.
1. The document outlines the standard operating procedure (SOP) for handling product complaints at a pharmaceutical company. It describes the process for receiving, investigating, taking corrective actions for complaints, and generating monthly reports.
2. Key aspects of the SOP include categorizing complaints, timelines for investigation, using a product complaint data sheet to document details, conducting documentation-based and laboratory investigations, and providing feedback and corrective actions to customers.
3. Monthly reports analyze complaint trends to assess quantities and types of complaints received. This allows the company to improve product quality and maintain good customer relationships.
The document provides information on various methods for measuring customer satisfaction and loyalty. It discusses customer satisfaction surveys, the customer satisfaction score (CSAT), net promoter score (NPS), customer effort score (CES), social media monitoring, and tracking "things gone wrong." The key methods are surveys, CSAT which measures satisfaction levels, NPS which measures likelihood of recommendation, and CES which measures ease of resolving issues. Social media can also provide insights and complaints can be tracked to identify problems.
This document discusses product complaint handling procedures. It defines a complaint and provides reasons for having a complaint handling process. It describes the types of complaints that may occur and the steps involved in handling complaints which include receiving the complaint, investigating it technically and through documentation, determining if it is confirmed or not, taking corrective actions and feedback to customers, and performing monthly reporting and trend analysis. It also discusses regulatory guidelines around complaint handling and provides an example standard operating procedure on complaint handling.
This document outlines the process for handling pharmaceutical product complaints. It defines a complaint and discusses the need for proper complaint handling procedures. It classifies complaints as critical, major, or minor and describes the 4 main steps to handling complaints: receiving complaints, technical investigation, corrective and preventive actions/feedback, and trend analysis/reporting. Key aspects of each step like documentation, sampling, testing, reporting, and record keeping are described. Regulatory guidelines for complaint management are also provided.
CX Service and Quality Mgt. Credits to the rightful owners of the information...GAGAYObera
Here are 3 key ways that businesses can motivate staff to maintain high quality standards:
1. Implement quality circles where staff meet regularly to discuss quality issues and improvement ideas. Seeing their ideas succeed is motivating.
2. Use total quality management (TQM) which trains all employees to achieve the highest standards and continuously improve the product. This gives employees pride and ownership.
3. Offer incentives like bonuses or rewards for meeting quality targets. Publicly recognizing quality work also boosts morale. Motivated staff are more likely to focus on quality.
Quality management in businesses involves using quality resources, quality control, and quality assurance to produce high-quality products. It also requires motivating staff through quality circles and total quality management approaches. This helps ensure customer satisfaction by meeting expectations for reliable products and keeping customers from taking their business elsewhere.
This document outlines a 5-step approach to turning customer complaints into loyalty. The steps are: 1) Review the current complaint situation; 2) Identify areas for improvement; 3) Define actions and procedures; 4) Implement the plan; and 5) Follow up. The goal is to understand customer problems, avoid conflict, and find acceptable solutions in order to create conditions for future sales. Complaints contain valuable feedback and are an opportunity to improve and keep customers satisfied.
Case study of whirlpool quality managementTushar G
Whirlpool is a leading home appliance manufacturer with a vision of pride, passion and performance in every home. It focuses on innovation, operational excellence and customer centricity. For quality management, Whirlpool uses tools like Six Sigma and the Kano model to understand customer needs and improve products and processes. It aims to satisfy customers through attributes like effective products, good service, reasonable prices and a strong reputation. Whirlpool seeks customer feedback to address issues and enhance the customer experience.
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
pharmaceutical shrink packaging (foil, plastic pouches, bottle seals, tape seals, breakable seals, sealed tubes)
pharmacy
technology
packaging
covers
plastics
Shrink packaging
Shrink packaging indicates the process in which sheets of transparent plastic film are wrapped around a product to form a solid, weather-resistant packaging layer.
Shrink packaging customarily refers to plastic films which have been pre-heated, stretched and cooled prior to use. This causes their initially randomly scattered molecules to align themselves in rigid structures, creating flat sheets of plastic film.
Shrink-wrap
When the shrink packaging films are applied to the product and re-heated, the molecules revert to their previous non-aligned state. This causes the plastic film to shrink and wrap itself tightly around the form and shape of the product (therefore the name ‘shrink-wrap’).
Stretch-wrap
When shrink packaging is simply stretched and wrapped around the product without being re-heated, it is known as ‘stretch-wrap’.
Benefits of shrink-packaging
Shrink packaging offers a versatile, cost-effective packaging solution for several reasons.
First, the materials used (plastic derivatives) are strong yet flexible, and provide effective protection, as well as making the product tamper-proof.
Second, shrink packaging is transparent, making it suitable for retail and wholesale display, and ideal for general marketing purposes due to its clear surface.
Third, shrink packaging is a relatively inexpensive option and ideal for low-cost packaging solutions.
This document discusses the qualification of dissolution test apparatus and validation of utility systems. It covers the installation qualification, operational qualification, and performance qualification of dissolution test apparatus. This includes procedures, acceptance criteria, and maintenance schedules for qualifying the apparatus. It also summarizes validation test functions and acceptance criteria for key utility systems like plant steam, pure steam, water for injection, and emergency power generators. The goal is to ensure dissolution testing provides reliable and reproducible results for assessing drug release and bioavailability.
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
The document discusses the Common Technical Document (CTD) format, which is used for new drug applications submitted to regulatory agencies in Europe, Japan, and the United States. The CTD format aims to increase harmonization across regions. It is organized into five modules covering administrative information, summaries, quality information, nonclinical study reports, and clinical study reports. An electronic version of the CTD (eCTD) uses XML formatting to improve the submission and review process. The eCTD allows for increased accuracy, reduced costs and time to market, and easier navigation compared to the paper CTD format.
Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.
Research article discussion and validation of a HPLC method for the simultaneous estimation of amlodipine and telmisartan in pharmaceutical dosage form.
A sensitive and simple reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed and validated for the simultaneous determination of four α-adrenergic receptor blockers: terazosin (TER), alfuzosin (ALF), tamsulosin (TAM) and doxazosin (DOX) using moxifloxacin (MOX) as an internal standard.
Various development trials were performed for the development of a chromatographic system for the estimation of RSV and EZE in their fixed dosage form. On the basis of their structural formula, the reversed-phase liquid chromatography was selected. ... Various columns were available for RP-HPLC method.
Presentatio on IPQC for Capsules by Akshay Trivedi
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1]
This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]:
Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3]
The quality of the outputs is at risk if any of these three aspec
Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7]
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6]
Notable approaches
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1. Customer Focus : Customer Satisfaction And Delight
Handling Customer Complaints
Presented by : Akshay G. Trivedi
Guided by : Dr. Pintu Prajapati
Department of Pharmaceutical Quality Assurance
Enrollment No : 201804103910007
Maliba Pharmacy College
Uka Tarsadia University
2. Customer
What is customer :-
A party that receives or consumes products (goods or services) and has the
ability to choose between different products and suppliers.
Customer is most important person in any business.
3. Customer Satisfaction
Definition :-
Customer satisfaction is a marketing term that measures how product or
services supplied by a company meet or surpass a customer’s expectation.
Customer expectation is the needs, wants and idea of customer about a
product or service.
If customer expectations are met it means that customer is satisfied with
service or product.
4. Following are the reason why customer satisfaction is important :-
Growth of organization depends on customer.
Satisfied customer will help in bringing the new customers by the “mouth
publicity”.
Customer is the boss of the market.
Customer satisfaction leads to customer loyalty towards an organization.
5. A process of customer satisfaction include following steps :-
1. Understanding customer expectations :
To fulfil the customer expectation first the organization needs to understand
what is the expectation of the customer for the particular product or service.
2. Promises to customers :
After identifying the customer expectation or needs assure the customer that
they will be provided with their expectation for the product or service & give
commitment.
6. 3. Execution :
After committing, fulfil the commitment and try to execute the plan for
customer satisfaction, take appropriate steps to fulfill customer needs and
expectation.
4. Customer satisfaction surveys :
After providing appropriate services and product according to the customers
expectation, check that whether customer expectations are met or not,
whether the customer is satisfied with product (service) or not.
8. Following steps are the ways to ensure customer satisfaction :-
Surveys
Customer feedback
Employee feedback
Internet blogs
Toll free numbers (customer call centre)
9. Example of customer satisfaction :-
Suppose, Mr. Shah (customer) is searching for a drug related to “DIABETES”
on the MEDLIFE.COM and he finds a tablet for diabetes if that satisfies his
expectation about that tablet, then he will buy that tablet everytime without
switching to other sites because he is already satisfied with that particular
tablet (or a product).
10. Five great ways to improve your customer satisfaction :-
Treat every customer as a VIP, give every customer the same excellent
treatment as you would like to receive yourself.
Keep measuring customer satisfaction.
Know how you should survey your customers.
Keep an eye on what customers say about you on social media.
Study complaints and compliments.
11. Customer Delight
Definition :-
Customer delight is surprising a customer by exceeding his or her
expectations and thus creating a positive emotional reaction.
If customer get much better than expectation or unexpected service or
product from the supplier then it will become a loyal customer for that
specific supplier or company.
12. From past few years it has been seen that only satisfaction of customer does
not make the customer loyal to the product to make the customer loyal extra
efforts for customer delight is required.
When the perceived service provided is much better than the expected
service the customer will be delighted and become loyal.
When the customer is delighted it will become beneficial for the
organization.
13. Following are the factors that affects customer delight :-
Price
Quality
Service
Brand name
Reputation
Features
14. Customer delight deals with extra features :-
Example : When a customer is searching online for a cough & cold relieving
tablet and he/she found cough & cold relieving tablet with good taste & in
less price (cheaper than other sites) then he/she will be delighted for that
product & become loyal customer to that particular tablet (or product).
15. How to improve customer delight :-
Always try to do better
Deliver more than the customer expectations
Eliminate dis-satisfaction (so you can focus on loyalty)
Know your customers top issues
Help customers to achieve their goals
Listen to your customer
Respond quickly
16. Handling Customer Complaints
Complaint :-
Statement that is something wrong or not good enough, which shows
customer dis-satisfaction about the company and the product.
Example : Complaint about packaging materials, Complaint about the
product and quality.
17. Why Are Complaints A Good Thing ?
Customer complaints are good for business.
Customer complaints may be the most valuable asset for the company.
Company can learn from complaints and use them to improve their business or
appreciate each complaining customer and use the complaint as an opportunity
to improve.
18. Benefits of Effective Complaint Management
It gives the company an opportunity to improve the quality of the product.
It is helpful to maintain cGMP.
It maintains committed relationship between the customer and company.
Identify poor performance in the overall quality system.
Reduce costs and improve production schedules.
Reduce employee confusion.
Improve the safety and performance of devices.
Improve customer relations by reducing the frequency of problems, complaints,
and recalls.
19. Types of Complaints
Quality complaints :- Originate at consumer level and concern with physical,
chemical and biological properties or condition of labelling or packaging of the
product.
Adverse reaction complaints :- Due to allergic reaction and fatal reaction
or near fatal reaction.
Other medically related complaints :- Include complaints such as lack of
efficacy or clinical response.
20. Steps Involved In Handling of Complaints
STEP 1 :- Receiving Complaints
It is important to have open channels with customers in order to receive the
suggestions, doubts and complaints.
Generally, these channels are toll free numbers, e-mails, chat-rooms and P.O.
boxes.
It is necessary to have a person in charge of receiving the complaints and in
putting them into an appropriate investigation from the shall be addressed to
the Quality assurance (QA unit) for investigation.
21. STEP 2 :- Technical Investigation
Upon receipt of the investigation form, the QA unit is able to start the
investigation, which can be divided in two phases :
Documentation based
Laboratory analysis phase
22. Documentation based :-
Checking complaint files looking for the previous complaints of the same
nature and a lot.
If any non-conformance was found in the lot then that can confirms quality
problem in complaint sample or a product.
23. Laboratory analysis phase :-
Requesting QC laboratory to analyse both samples (complaint & retained).
If the customer did not send the complaint sample for analysis, the lab.
Investigation will be carried out only with the retained sample.
24. After receiving the analytical results, there are three possible conclusion, as
follows:
(1) Confirmed complaint :-
When both complaint and retained sample showed out-of-specification
(OOS) results or when only the complaint sample showed OOS results, it is
clearly a single unexplained failing product.
Example : a single unexplained failure may be when one tablet is missing in
the blister strip in the complaint sample, but no deviation was found in the
retained samples or during the in-process controls and final QC analysis
recorded in the batch record.
25. (2) Non-confirmed complaint :-
When both complaint and retained samples showed result in compliance
with specifications or when only the complaint sample showed OOS results
that cannot be considered a single unexplained failing product. OOS results in
complaint sample can be attributed to misuse or mishandling.
Example : Tablets of the complaint sample show a change in their
appearance that is characteristic of light, humidity or high temperature
exposure.
26. (3) Counterfeit / temper suspicion :-
When the retained sample is within the specification but the complaint
sample is clearly OOS with no reason for that,
Ex – packaging material is different from the original.
27. STEP 3 :- Corrective Actions and Feedback to Customers
Corrective actions can range from a simple and quick training to some
employees to a formal corrective action and preventive action (CAPA)
handling.
The criteria for choosing appropriate action depends on the nature of the
complaint.
write a response letter to the customer to describe the investigative
approach taken, and the results found and their effects.
The customer should be sent a free replacement product together with the
response letter, since the customer returned the product (a complaint
sample) to the company for analysis and a quality problem was found.
28. STEP 4 :- Monthly Reports and Trend Analysis
QA complaint office to elaborate monthly reports, amount and nature of the
complaints received and to perform trend analysis of these complaints.
The monthly reports must answer the following questions :
How many complaints did the company receive in the period ?
How many were confirmed ?
How many were non-confirmed or were counterfeit / temper suspicion ?