Handling of complaint.pptx

Complaints - evaluation & handling, Investigation and determination of root cause

1. QUALITY MANAGEMENT SYSTEM (MQA102T) 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

2. CONTENT 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

3. INTRODUCTION 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 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi

4. NEED FOR COMPLAINT HANDLING SYSTEM 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 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi

5. TYPES OF COMPLAINTS 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. Investigation time period: Within 5 days (after receipt of complaints) 3) Other medically related complaints: Include complaint such as lack of efficacy or clinical response. Investigation time period: Within 3 days (after receipt of complaints) 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 5

6. 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: Critical defects Major defects Other defects 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 6

7. KEY POINTS FOR HANDLING OF COMPLAINTS: 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 7

8. CONTENT OF PRODUCT COMPLAINT DATA SHEET 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 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 8

9. STEPS INVOLVED IN HANDLING OF COMPLAINT 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 9

10. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 10 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.

11. 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: 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. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 11

12. After receiving the analytical results, there are 3 possible conclusions which are as follows: Confirmed complaint: When both complaint and retained samples showed out-of-specification (OOS) results or when only the complaint sample showed OOS results. 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. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 12

13. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 13

14. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 14

15. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 15

16. RECORDING OF 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 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 16

17. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 17

18. ROOT CAUSE ANALYSIS 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 18

19. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 19

20. HOW TO CONDUCT ROOT CAUSE ANALYSIS 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 20

21. ROOT CAUSE ANALYSIS METHODS 5 Why analysis Fishbone or I shikawa diagram (Cause and effect analysis) Pareto analysis Brainstroming 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 21

22. 1) 5 WHY ANALYSIS 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 22

23. 2) FISHBONE OR ISHIKAWA DIAGRAM 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 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 23

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25. 3) PARETO ANALYSIS 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 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 25

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27. 4) BRAINSTROMING 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 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 27

28. QUESTION 1) Write a note on handling of customer complaints. 29/11/2021 Jagruti Kachchhi, Smt. BNB SPC, Salvav-Vapi 28

29. REFERENCES 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 29

30. 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. 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 30

31. THANK YOU 29/11/2021 Jagruti Kachchhi , Smt. BNB SPC, Salvav -Vapi 31