SOP for Handling of Customer Complaints

This document details the procedure for handling Customer Complaints. It is the policy of XYZ Limited that a written procedure shall be followed for handling and investigating customer complaints systematically in compliance with regulatory requirements and its use to avoid reoccurrences. This procedure is to be applied at the time of customer complaints of the reports.

RESPONSIBILITY 

Persons along with their responsibilities are given below:

Executive -  Corporate  Quality Assurance:- To prepare and follow the SOP accordingly. Maintain the record as per SOP.

Manager - Quality Assurance:- To ensure implementation of SOP.

VP Technical Analytical Division:- To ensure implementation of SOP.

1.0 Procedure for Handling Customer Complaints

1.0.1 Any complaints received by e-mail, telephonically, or in writing are forwarded to the Manager of Quality Assurance to investigate the root cause of the problem.  The complaint received is recorded and maintained in a file meant for customer complaints. The quality Assurance department shall investigate the root cause of the problem in association with VP-Technical, and Manager-Technical.

1.0.2 Manager Quality Assurance shall identify the type of the problem. The complaints may be because of any of the following or may be due to other reasons.

1.0.3 Due to the typing error.

1.0.4 Due to the calculation.

1.0.5 Due to the transfer of results from the datasheet to the final report.

1.0.6 Due to the analytical mistake.

1.0.7 Due to the change in the sample.

1.0.8 Due to the improper environmental conditions etc.

1.0.9 The Quality Assurance department shall take necessary actions to resolve the problems as per requirement.

1.0.10 If the typing error is observed, the Manager of Quality Assurance shall discuss the matter with VP-technical, and Manager –Technical. A fresh report shall be issued to the customer after retrieval of the previous report. The mistaken report shall be filed and documented as per APL/CQA/SOP- 033/FR-01 Logbook of Customer Complaint. The next report will be issued as amendment -1.

1.0.11 He shall ensure that such mistakes should not be repeated in the future. Necessary corrective actions shall be carried out.

1.0.12 A training shall be imparted to the personnel of the typing Section and records for the same shall be maintained accordingly.

1.0.13 Analysts responsible for signing the report shall also be intimidated to check the report properly before signing it. Similarly, the other probability of the error shall be properly checked to establish the root cause of the problem.

1.0.14 Once the root cause is identified, the Manager of Quality Assurance shall take corrective actions. Record for the corrective actions shall be maintained.

1.0.15 The complaints may be of incidents, suggestions, observations, quality of services, or non-compliance of testing is considered in the same category. All customer complaints, whether written, e-mail, or telephonically received are forwarded to the Manager of Quality Assurance.  The complaints received are reviewed by the Manager Quality Assurance/ VP-Technical /Technical Manager and are assigned to the appropriate personnel for investigation. It shall be ensured that corrective action is taken if any deviation is observed after investigation.

1.0.16 The complaints, which are of human error or services, are discussed with the concerned personnel and resolved by taking necessary corrective measures. Complaints, that require any technical discussions/ clarifications, are discussed with the customers. Complaints regarding non-compliance of test results are either retested / joint analysis is carried out if required. However, if the customer in the form of a complaint brings any variation to the notice and is subsequently confirmed after investigation, the earlier test report is retrieved, canceled, and a revised test report issued. When a customer insists that the verification is to be undertaken jointly with their representative, the following procedure is adopted:

1.0.17 The Analytical Division undertakes the testing jointly with the representative of the customer and only the Senior Analyst shall undertake the joint analysis. Commercial aspects will be followed as per company policy.

1.0.18 Joint analysis will be conducted only on the submitted sample remnants available in the Analytical Division in sufficient quantity on which the testing can be undertaken.

1.0.19 The Analytical Division will be negotiable and answerable only to the company that has submitted the samples for testing and in no way to the supplier, distributor, or manufacturer of the product whoever it may be. In case the test results of the joint analysis match with the test results reported earlier or are within the experimental limits i.e. the sample reported in conformity/ non-conformity with respect to the standards as reported earlier.

1.0.20 If marked deviations are observed from the test results reported earlier, the test report issued is retrieved, and canceled, and a revised test report issued accordingly. However, if any variation is brought to the notice by the customer in the form of a complaint and if subsequently confirmed after investigation, the earlier test report is retrieved, canceled, and a revised test report issued. When a customer insists that the verification is to be undertaken jointly with their representative, the following procedure is adopted:

1.0.21 The Analytical Division undertakes the testing jointly with the representative of the customer and only one undertaking the joint analysis is permitted in the test laboratory for undertaking the testing.

1.0.22 Joint analysis will be conducted only on the submitted sample remnants available in the Analytical Division in sufficient quantity on which the testing can be undertaken.

1.0.23 The Analytical Division will be negotiable and answerable only to the company that has submitted the samples for testing and in no way to the supplier, distributor, or manufacturer of the product whoever it may be. 

1.0.24 Any other sample of the same batch/lot provided by the supplier, distributor, or manufacturer during the joint analysis and to the tested simultaneously for joint analysis will be treated as a separate sample and the testing charges will be levied on an urgent basis i.e. double the amount of the normal testing charges. The representative of the company submitting the testing on an urgent basis will not be permitted in the laboratory during the joint analysis. However the sample will be tested as per the joint analysis, but only a normal test report without any comments/documentation of joint analysis will be issued.

1.0.25 If marked deviations are observed from the test results reported earlier, the test report issued is retrieved and canceled, and a revised test report is issued accordingly. Also, the normal testing charges levied are returned to the customer.

1.0.26 A joint analysis report to the effect of the joint analysis undertaken is duly signed by the customer’s representative and the Laboratory’s Sr. Analyst undertaking the testing, which is authenticated by the Manager (Technical). The same is documented for records.

1.0.27 Customer complaints will be accepted only within one month after the issue of the test report. Complaints will not be accepted and entertained after the expiry of one month in any case.

2.0 CATEGORIZATION OF COMPLAINTS

2.0.1 Any communication in written or by e-mail received directly from any customer, tie-up company, or regulatory authority regarding the reports, purity, efficacy, labeling defects, or any other such complaints shall be considered a Customer Complaint.

2.0.2  All complaints shall be categorized as follows but not limited to the examples:

 Critical:  Wrong reports, Analytical Errors

 Major:  Use of the wrong STP, improper environmental conditions, and Tests that were not match with the tests requested.

 Minor: Typographical errors, Wrong calculations, Transcription errors.

2.0.4 All complaints shall be categorized as mentioned in step 6.0.3 by Manager Quality Assurance.

2.0.5 The Quality Assurance Manager or his designate shall register the complaints on the SOP  Logbook of Customer Complaints.

2.0.6 Send an internal notification of customer complaints to the Analytical Division on the Customer Complaint Report.

2.0.7 Follow-up shall be done for corrective action and preventive action as per SOP CAPA to prevent the reoccurrence of such complaints.

2.0.8  The investigation of Customer complaints shall be done as per SOP Handling of Out of Specification results by Manager-Quality Assurance, Analytical Division.

2.0.8.1 Investigation and resolution of all customer complaints is a priority matter, hence investigation shall be completed in a time-bound period.

2.0.8.2 All critical complaints shall be investigated within a week or earlier depending upon the severity of the complaints.

2.0.8.3 All major complaints shall be investigated within one month or earlier depending upon the severity of the complaints.

2.0.8.4 All minor complaints shall be investigated within two months or earlier depending upon the severity of the complaint.

2.0.9 A joint discussion of the Customer, Quality Assurance Manager, and concerned personnel of related departments shall be organized to find out the probable causes for the complaints.

2.0.10 The VP- Technical, Manager - Technical his designate shall check all records for dispensing, dispatch of reports manufacturing and packaging records, and send a written investigation report to the Quality Assurance Manager.

2.0.11 In case the complaint is related to the product quality, result quality, and efficacy (report defect), the Quality Assurance and Quality Control Manager shall carry out thorough investigations and arrange for the analysis of complaint samples.

2.0.12 The Analytical Division shall also analyze the complaint samples along with retaining samples of the same batch. Consideration shall also be given to checking other reports/samples in order to determine whether they are also affected.

2.0.13 The Analytical Division shall submit the report of test results to Quality Assurance for review.

2.0.14 The Quality Assurance Manager or his designate must ensure that complaint samples shall be kept under defined conditions and retained as long as the associated complaint documentation.  

2.0.15 Quality Assurance Manager, VP- Technical and Manager Technical or their designate shall check the record of the report, the complete Record for any deviations or abnormalities reported or recorded during manufacturing of the said batch.

2.0.16 During investigation special attention shall be given to establishing whether a complaint was caused because of counterfeiting.

2.0.18 On completion of the investigation, the Quality Assurance Manager shall discuss his findings with the VP Technical/Director Executive/Director.

2.0.19 A written reply shall be sent to the customer complainant and tie-up company (if required) under intimation to VP - Technical and to the concerned marketing manager (in case, the complaint has been directly received from marketing).

2.0.20 The Quality Assurance Manager shall notify the regulatory authority(s) (drug office), in case of quality issues, detection of counterfeiting, or any other serious quality problems with a product.

2.0.21 Reply of complaints from the Drug department, Critical complaints of product quality failure, or critical complaints related to system failure shall be sent to tie up a company under intimation to VP Technical.

2.0.22 The Quality Assurance Manager or his designate must ensure that all relevant correspondence along with the investigating report, corrective and preventive action as well as all other associated documentation shall be complied with and maintain the record.

2.0.23 The complied complaint documentation shall be retained as per SOP Good Documentation Practices.

2.0.24 Numbering System for Customer Complaint Report: The first three characters shall be MCR which is followed by ‘/’ and the year is written as (XXXX). The year shall be followed by ‘/’ and a sequential number of the MCR. Example: The number for the first MCR of the year 2009 shall be MCR/2009/001.

2.0.25 A periodical half-yearly review of the complaints on SOP Review of Customer Complaints (Appendix ) shall be done by Quality Assurance and sent to the VP Technical and Director Executive for his comments if any.

ABBREVIATIONS

CQA: Corporate Quality Assurance

SOP: Standard Operating Procedure

VP:  Vice President

FR: Format

MCR: Customer Complaint Report

CCR: Change Control Reference

QA:  Quality Assurance

QC:  Quality Control

No.  :  Number