CUSTOMER FOCUS, FEEDBACK and COMPLAINTS
1. Purpose
This document provides the process for the practices that must be followed for handling, reporting and recording customer complaints, achieving customer feedback and focusing on customer aspects in compliance of ISO13485 & GWP in regards to medical devices and medicines
2. Approval
(Version at end of page)
Signed V17 SCR AA 15.03.2022
3. Scope
The process covers all documents and process and products as defined in the SOP
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis, SCR RP
Changes: Author of the document, Alexi Arhondonis
5. Definitions
Customer Complaint - A consumer complaint is "an expression of dissatisfaction on a consumer's behalf to a responsible party" (Landon, 1980). It can also be described in a positive sense as a report from a consumer providing documentation about a problem with a product or service
6. Abbreviations
CA - Corrective Action
NCCA – Non Conformance Corrective Action
SOP – Standard Operating Procedure
7. References
ISO13485 Clause 7.2, 8.1, 8.2.2, 8.3, 8.5.2, 8.5.3
SOP Non Conformance Corrective Action
8. Procedure
This procedure provides the process for managing Customer, feedback and customer complaints.
8.1 Essential Principles
The company establishes the customer requirements related to product refer SALES.
8.2 Customer Focus (5.2)
Top management ensure that customer requirements and applicable regulatory requirements are determined and met refer Quality Manual
8.3 Customer Feedback (8.2.1)
As one of the measurements of the effectiveness of the quality management system, the organization needs to gather and monitor information relating to whether the organization has met customer requirements.
A customer SURVEY Form can be sent to significant CUSTOMERS i.e. those that have a major impact on the business; as selected by Management. A record is located in a REGISTER
Should a customer not have a google email then a email can be sent to the customer and the Finance manager manually completes a FORM to enable the Data analysis collection
Records are filed in - Customer Feedback Survey Folder in the Google Drive
Survey to cover a sample of customers bi-annually and the Feedback Survey to be completed either through the FORM or the REGISTER
This feedback process includes provisions to gather data from production as well as post-production activities. The information gathered in the feedback process serves as potential input into risk management for monitoring and maintaining the product requirements as well as the product realization or improvement processes.
Reports from Sales at management meetings provides feedback on the activities performed by the representative, including customer feedback.
If applicable regulatory requirements require the organization to gain specific experience from post production activities, the review of this experience forms part of the feedback process.
Feedback is therefore reviewed by management as input in the management review and as a guide the following data maybe analyzed:
a) Customer Complaint / Non Conformances (non conforming Product)
b) Credit Note / Returns; if any are processed - data can be collated from Granite warehousing management system
c) Exhibition / Seminars; if attended, and
d) Information from Suppliers / Principles
8.4 Customer Complaints (8.2.2)
Complaints can be logged on a COMPLINT FORM where the requirement for a INCIDENT FORM is decided and the SOP Non conformance corrective action is followed to have timely complaint handling and in accordance with applicable regulatory requirements. RECORDS are located in the REGISTER
NOTE: that not all complaints result in NON CONFORMING Product or CORRECTIVE ACTION
These procedures include responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions.
If any complaint is not investigated, justification is to be documented.
Any correction or corrective action resulting from the complaint handling process is documented through SOP Non conformance corrective action
If an investigation determines activities outside the organization contributed to the complaint, relevant information is to be exchanged between the organization and the external party involved.
8.5 New Products
In the event of a new product then a Motivation is completed by the sales representative.
In the event of non-conformances then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
9.1 Trend Analysis and Continual Improvement
An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review
The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
10. Revision History
Revision 17, 15.03.2022 - AA, SCR- Inclusion of Medicines / Pharmacy
Revision 16, 30.12.2021 - AA- Inclusion of 8.3 SURVEY email for manual FORM input
Revision 15, 15.12.2021 - AA - Inclusion of SURVEY point 8.3 and a COMPLAINTS 8.4 forms and registers
Revision 14, 21.09.2021 - AA - Review and corrections to point 8.3 Customer Feedback
Revision 13, 13.05.2021 - AA - addition of Customer Survey Folder link and updating Responsibilities
Revision 12, 03.05.2021 - AA Approved
Revision 11, 28.04.2021 - TNA - Updating the SOP to the new format. Approval / Scope / Responsibilities / Risk Based Approach / Records and Revision History. Amending links
Revision 10, Digitally signed on 24.06.2020 by AA
Revision 1-9, unknown due to googlesite change to new googlesite
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Complaints refer NCCA SOP
Customer Feedback input to management review
Customer Survey REGISTER