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QMS Operational Procedure Revision: C Rev.

Date: Approved By / Date ________________/_________

QOP-72-01 Eff. Date: Page 1 of 3 Approved By / Date ________________/_________

Customer Complaints 1.0 Purpose/Scope 1.1 2.0 The purpose of this procedure is to provide a system and to assign responsibilities for receiving and processing customer complaints.

Responsibility 2.1 2.2 2.3 2.4 2.5 2.5 It is the responsibility of any employee who receives a complaint from a customer to inform the Operations manager or Quality Assurance (QA) manager. QA manager and/or Operations manager shall document all complaints received from customers and assign employees to perform investigation. QA department maintains records of complaints and all associated documentation including the Complaint Log and Corrective Action Reports, if applicable. Employees are responsible for performing investigation to determine the cause of complaints, when assigned. QA manager and/or Operations manager are responsible for determining what customer satisfaction measures shall be taken to resolve customer complaints, i.e., reprocess the product, issue credit for damage, etc. QA is responsible for responding to customers concerning complaint activities performed.


Reference Documents 3.1 3.2 3.3 3.4 3.5 3.6 3.7 QOP-42-01, current Rev. Document Control QOP-83-01, current Rev. Control of Nonconforming Product QOP-85-01, current Rev. Continual Improvement QOP-85-02, current Rev. Corrective and Preventive Action QOF-72-01-01, current Rev. Complaint Report QOF-72-01-02, current Rev.- Complaint Log QOF-85-02-01, current Rev. Corrective Action Report


Definitions 4.1 Complaint Customer statement that our service does not meet requirements and / or expectations

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Customer Complaints 5.0 General 5.1 5.1.1 Complaints are classified into categories to for trending as a tool for continual improvement. The following categories are used for classifying complaints: A Nonconforming or otherwise unsatisfactory product shipped B Product labeling problem C Product damaged in delivery D Insufficient or inadequate quality records E Wrong product or quantity shipped F Problems with communication and responsiveness H Incorrect invoicing I Other


Procedure 6.1 Any employee who receives customer complaint information, whether written or verbal shall report the complaint to the QA manager or Operations manager. 6.1.1 A written report shall be prepared, if necessary, to document complaint information for verbal complaints. The complaint is recorded in the Complaint Log, a complaint # is assigned and the complaint classification is determined by Quality Assurance. A Complaint Report is generated to document all available complaint information, and investigation activity. A determination is made whether or not Corrective Action is required. If Yes, the CAR # shall be referenced on the report and corrective action shall be performed in accordance with standard procedures. If No, justification for not implementing corrective action shall be documented and approved by General Manager. Complaint investigation and corrective action, if required, are performed by assigned employees. Results of investigation activities are documented on the Complaint Report. Customer satisfaction measures to be taken are determined and documented on the Complaint Report. A response to the customer complaint is made by QA to summarize all actions taken to resolve the complaint. The complaint is considered closed at the time the response is issued to the customer. The Complaint Report, Complaint Log and all associated complaint documentation is maintained by QA.

6.2 6.3 6.4

6.5 6.6 6.7 6.8 6.9 6.10

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Customer Complaints 7.0 Attachments 7.1 8.0 None

Revision History Approval Date 10/12/04 10/06/05 10/25/06 11/19/07 04/16/08 Proposed Revision NA NA NA NA A B

Document Change Number Periodic Review Periodic Review Periodic Review Periodic Review 08-005 08-xxx