Standard Operating Procedure- SOP

Name of institution

Customer Complaint ID Code:

Ap 18

Topic & Purpose: Review Period:

Explains how to collect customers complaints 1 year

Location: Distribution:

Version number: Annex:

V 1.0 None

Written by:

Name(s), Date(s) and Signature(s) of the Author(s)

Reviewed by:

Name(s), Date(s) and Signature(s)

Authorized by:

Name, Date and Signature

Replaces the version:
Not applicable (1st version)

Changes to the last authorized version:

Not applicable (1st version)
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap18
3 procedure:
Customer QM chapter: 10
Complaint
Procedure

Customer Complaint Procedure

Application...............................................................................................................2
Objective.................................................................................................................2
Definitions...............................................................................................................2
References..............................................................................................................2
Responsibilities.......................................................................................................2
Operating mode......................................................................................................3
Related documents.................................................................................................3

Application
This procedure ensures proper collection and investigation of customer
complaints, and design of corrective plans where needed.

Objective
The procedure establishes the process to track and investigate potential non-
satisfaction of customers.

Definitions
Correction: Action to eliminate a detected nonconformity.

Customer: Organization or person that receives a product or service from a

supplier organization.

Customer satisfaction: Customer's perception of the degree to which the

customer's requirements have been fulfilled.

References
To be filled in if necessary

Responsibilities
The Laboratory Director:
develops and oversees the customer complaint procedure.

The Quality Committee:

2
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap18
3 procedure:
Customer QM chapter: 10
Complaint
Procedure

coordinates with the Laboratory Director in overseeing the customer

complaint procedure;
coordinates with the Quality Manager in validating customer complaints
where needed;
designs corrective action plans.

The Quality Manager:

ensures the customer complaint procedure is implemented and monitored;
collects the complaint registration forms;
validates customer complaints by, e.g., reviewing the complaint,
interviewing laboratory staff referenced by the complaint;
maintains documentation of the complaint procedure.

Staff:
direct unsatisfied customers to fill in complaint registration forms.

Operating mode
Errors that escape detection by the laboratory may be detected or suspected by
the customers. Although this particular type of quality control may not be popular,
it should in no case be ignored and can be useful. For dealing with complaints, a
protocol must be developed and followed, with an accompanying Complaint
Registration Form.

1. Design a customer complaint registration form with at least the following items:
customers name;
date the complaint was received;
description of complaint;
name of person who received the complaint (usually the head of
laboratory);
person charged with investigation;
result of investigation (evaluation and possible action);
name of person(s) who dealt with the complaint;
date when report was sent to customer.

2. The complaints will be submitted to the Quality Committee for analysis and all
negative points will be traced and eventual corrections will be designed to correct
these points as indicated in SOP Corrective Actions.

3. A record of complaints should be kept.

3
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap18
3 procedure:
Customer QM chapter: 10
Complaint
Procedure

Related documents
Filled in complaint registration forms will be filed with records Ref XXX
SOP Corrective Actions Ref XXX
Customer complaint logbook Ref XXX