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/Sc Purpose/Scope ope 1.1
2 .0
Responsibility 2.1 2.2 2.3 2.4 2.5
2.5
3 .0
It is is the the respo responsi nsibil bility ity of any any empl employe oyeee who receiv receives es a comp complai laint nt from from a custom customer er to inform the Operations manager or Quality Assurance (QA) manager. QA manag manager er and/or and/or Operat Operation ionss mana manager ger shall shall docume document nt all all compla complaint intss rece receive ived d from customers and assign employees to perform investigation. QA depa departm rtment ent mainta maintains ins record recordss of compla complaint intss and and all all assoc associat iated ed docum document entati ation on including the Complaint Log and Corrective Action Reports, if applicable. Employ Employees ees are resp respons onsibl iblee for for perfo performi rming ng inves investig tigati ation on to determ determine ine the cause cause of complaints, when assigned. QA manag manager er and/or and/or Operat Operation ionss mana manager ger are respons responsibl iblee for for determ determini ining ng what what customer satisfaction measures shall be taken to resolve customer complaints, i.e., reprocess the product, issue credit for damage, etc. QA is is resp respons onsibl iblee for for resp respondi onding ng to to custo customer merss conce concerni rning ng comp complai laint nt acti activit vities ies performed.
Reference Do Documents 3.1 3.1 3.2 3.2 3.3 3.3 3.4 3.4 3.5 3.5 3.6 3.6 3.7 3.7
4 .0
The purp purpose ose of this this proced procedure ure is is to provid providee a syste system m and to ass assign ign resp respons onsibi ibilit lities ies for receiving and processing customer complaints.
QOPQOP-42 42-0 -01, 1, curr curren entt Rev Rev.. – Doc Docum umen entt Con Contr trol ol QOPQOP-83 83-0 -01, 1, cur curre rent nt Rev Rev.. – Con Contr trol ol of of Nonco Nonconf nfor ormi ming ng Pro Produ duct ct QOPQOP-85 85-0 -01, 1, cur curre rent nt Rev Rev.. – Conti Continu nual al Imp Impro rove veme ment nt QOPQOP-85 85-0 -02, 2, cur curre rent nt Rev Rev.. – Cor Corre rect ctiv ivee and and Pre Preve vent ntiv ivee Acti Action on QOFQOF-72 72-0 -011-01 01,, curr curren entt Rev. Rev. – Com Compl plai aint nt Rep Repor ortt QOFQOF-72 72-0 -011-02 02,, cur curre rent nt Rev. Rev.-- Com Compl plai aint nt Log Log QOFQOF-85 85-0 -022-01, 01, curr current ent Rev. Rev. – Cor Corre rect ctiv ivee Act Actio ion n Rep Repor ortt
Definitions 4.1
Complaint – Customer statement that our service does not meet requirements and / or expectations
QMS Operational Procedure Revision: C Rev. Date:
Eff. Date:
QOP-72-01 Page 2 of 3
Customer Complaints
5.0
General 5.1 5.1.1
6.0
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
6.2 6.3 6.4
6.5 6.6 6.7 6.8 6.9 6.10
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.
QMS Operational Procedure Revision: C Rev. Date:
Eff. Date:
QOP-72-01 Page 3 of 3
Customer Complaints
7.0
Attachments 7.1
8.0
None
Revision History
Document Change Number Periodic Review Periodic Review Periodic Review Periodic Review 08-005 08-xxx
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
